Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
Conditions: SARS-CoV-2, COVID-19 Vaccines
Sponsor: Pfizer

 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1  of 4 6  
N O N -I N T E R V E N TI O N A L ( NI) S T U D Y P R O T O C O L 
St u d y i nf or m ati o n  
Title  
Effecti ve n ess of B N T 1 6 2 b 2 f or m ulati o ns usi n g state vacci n e re gistr y 
a n d i ns ura nce clai ms dat a  
Pr ot oc ol n u m ber  
C 4 5 9 1 0 6 5  
Pr ot oc ol ve rsi o n 
i de ntifier 
1. 0  
D ate  
1 5  N o ve m ber  2 0 2 3  
Me dici n al pr o d uct  
Pfizer B N T 1 6 2 b 2  f or m ul ati o ns 
Rese arc h q uesti o n 
a n d o bjecti ves  
W h at is t he re al -w orl d effecti ve ness of B N T 1 6 2 b 2 f or m ul ati o ns ?  
Pri mar y o bjecti ve:  
1.  T o e val uate v acci n e effecti ve ness ( V E) of B N T 1 6 2 b 2 
f or m ulati o ns i n n o n-pre g na nt, n o n -i m m u n oc o m pr o mise d 
a d ults (a ge 1 8 +) a gai nst me dicall y atte n de d C O VI D -1 9 , 
m ortalit y , a n d healt hcare res o urce utilizati o n b y a g e a n d 
a da pte d vacci n e f or m ulati o n.  
Sec o n dar y o bjecti ves  
2.  T o assess V E  of B N T 1 6 2 b 2 f or m ulati o ns i n pe diatrics (a ge < 
1 8) a gai nst me dicall y att e n de d C O VI D -1 9,  n o n -C O VI D -1 9  
res pirat or y i nfecti o ns, m ortalit y , a n d healt hcare res o urce 
utilizati o n b y a ge a n d a d a pte d vacci ne f or m ulati o n .  
3.  T o esti mate s h ort -ter m ( 3 A) a n d l o n g -ter m ( 3 B) healt hcare 
res o urce utilizati o n a n d c osts ass ociate d wit h C O VI D -1 9  b y 
vacci nati o n stat us , a g e, a n d site of care.  
E x pl orat or y o bjecti ves  
4.  T o meas ure V E  of B N T 1 6 2 b 2 f or m ulati o ns i n n o n -pre g na nt 
i m m u n oc o m pr o mise d a d ults (a ge 1 8 +) a gai nst me dicall y 
atte n de d C O VI D -1 9 , m ortalit y a n d healt hcare res o urce 
utilizati o n b y a ge a n d a d a pte d vacci ne f or m ulati o n .  
5.  T o q ua ntif y differe nces i n V E  of B N T 1 6 2 b 2 f or m ulati o ns i n 
n o n -pre g na nt, n o n -i m m u n oc o m pr o mise d a d ults (a ge 1 8 +) 
w he n c o-a d mi nistere d wit h seas o nal i nfl ue nza vacci nes 
vers us w he n eac h v acci n e is gi ve n se paratel y, b y a ge gr o u ps .  
A ut h or  
, P h D, M Sc 
 
Pfizer I nc.  
E vi de nce G e nerati o n Platf or m  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)
P P D
P P D

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2  of 4 6  
 
 
T his d oc u me nt c o ntai ns c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer.  E xce pt as ot her wise 
a gree d t o i n writi n g, b y acce pti n g or re vie wi n g t his d oc u me nt, y o u a gree t o h ol d t his 
i nf or mati o n i n c o nfi de nce a n d n ot c o p y or discl os e it t o ot hers (e xce pt w here re q uir e d b y 
a p plica ble la w) or use it f or u na ut h orize d p ur p oses.  I n t he e ve nt of a n y act ual or s us pecte d 
breac h of t his o bli gati o n, Pfizer m ust be pr o m ptl y n otifie d.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)
P P D

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3  of 4 6  
1.  T A B L E O F C O N T E N T S  
1. T A B L E O F C O N T E N T S  .......................................................................................................3  
2.  LI S T O F A B B R E VI A TI O N S  ................................................................................................5  
3. R E S P O N SI B L E P A R TI E S  ....................................................................................................6  
4. A M E N D M E N T S A N D U P D A T E S  .......................................................................................8  
5. MI L E S T O N E S  .......................................................................................................................9  
6. R A TI O N A L E A N D B A C K G R O U N D  ..................................................................................9  
7. R E S E A R C H Q U E S TI O N A N D O BJ E C TI V E S  .................................................................1 1  
8. R E S E A R C H M E T H O D S  ....................................................................................................1 2  
8. 1. St u d y Desi g n  ...........................................................................................................1 2  
8. 2. Setti n g  ......................................................................................................................1 7  
8. 2. 1. I n cl usi o n Criteria  ........................................................................................1 8  
8. 2. 1. 1. Ai m 1 I n cl usi o n Criteria  ............................................................1 8  
8. 2. 1. 2. Ai m 2 I n cl usi o n Criteria  ............................................................1 8  
8. 2. 1. 3. Ai m 3 A I n cl usi o n Criteria  .........................................................1 8  
8. 2. 1. 4. Ai m 3 B I ncl usi o n Criteria  .........................................................1 9  
8. 2. 1. 5. Ai m 4 I n cl usi o n Criteria  ............................................................1 9  
8. 2. 1. 6. Ai m 5 I n cl usi o n Criteria  ............................................................2 0  
8. 2. 2. E xcl usi o n Criteria  .......................................................................................2 0  
8. 2. 2. 1. Ai m 1 E xcl usi o n Criteria  ...........................................................2 0  
8. 2. 2. 2. Ai m 2 E xcl usi o n C riteria ...........................................................2 0  
8. 2. 2. 3. Ai m 3 A E xcl usi o n Criteria  ........................................................2 0  
8. 2. 2. 4. Ai m 3 B E xcl usi o n Criteria  ........................................................2 1  
8. 2. 2. 5.  Ai m 4 E xcl usi o n Criteria  ...........................................................2 1  
8. 2. 2. 6. Ai m 5 E xcl usi o n Criteria  ...........................................................2 1  
8. 3. Varia bles  ..................................................................................................................2 2  
8. 4. Data S o urces  ............................................................................................................2 7  
8. 4. 1. Calif or nia a n d L o uisia na I m m u nizati o n Re gistr y  .......................................2 8  
8. 4. 2. Healt h Verit y’s A d mi nistrati ve Clai ms Data  ...............................................2 8  
8. 4. 3. C o m paris o n t o Ot her Real -W orl d Dat a S o urces  ........................................2 9  
8. 5. St u d y Size  ................................................................................................................3 0  
8. 6. Data Ma n a ge me nt  ...................................................................................................3 1  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4  of 4 6  
8. 7.  Data A nal ysis  ..........................................................................................................3 1  
8. 7. 1. Ai m 1  ..........................................................................................................3 1  
8. 7. 2. Ai m 2  ..........................................................................................................3 4  
8. 7. 3. Ai m 3 A  .......................................................................................................3 6  
8. 7. 4. Ai m 3 B ........................................................................................................3 6  
8. 7. 5. Ai m 4  ..........................................................................................................3 7  
8. 7. 6. Ai m 5  ..........................................................................................................4 0  
8. 8. Q ualit y C o ntr ol  ........................................................................................................4 2  
8. 9. Li mitati o ns of t he Researc h Met h o ds  ......................................................................4 2  
8. 1 0. Ot her As pects  ........................................................................................................4 3  
9. P R O T E C TI O N O F H U M A N P A R TI CI P A N T S  .................................................................4 3  
9. 1. Patie nt I nf or mati o n  ..................................................................................................4 3  
9. 2. Patie nt C o nse nt  ........................................................................................................4 3  
9. 3. I nstit uti o nal Re vie w B oar d (I R B)/ Et hics C o m mittee ( E C)  ....................................4 3  
9. 4. Et hical C o n d uct of t he St u d y  ..................................................................................4 3  
1 0. M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E 
R E A C TI O N S  ......................................................................................................................4 3  
1 1. P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S ........4 3  
1 2. R E F E R E N C E S  ..................................................................................................................4 4  
1 3. LI S T O F T A B L E S  .............................................................................................................4 6  
1 4. LI S T O F FI G U R E S  ...........................................................................................................4 6  
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  ..........................................................4 6  
A N N E X 2. E N C E P P C H E C K LI S T F O R S T U D Y P R O T O C O L S  .........................................4 6  
A N N E X 3. A D DI TI O N A L I N F O R M A TI O N  .........................................................................4 6  
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 5  of 4 6  
2.  LI S T O F A B B R E VI A TI O N S  
A b bre vi ati o n  
Defi niti o n  
a H R 
A dj uste d hazar d rati o  
a R R  
A dj uste d ris k rati o  
C D C  
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n  
CI  
C o nfi de nce i nter val  
C V X  
Cli nical V acci nes A d mi nistere d c o de  
E H R  
Electr o nic healt h rec or ds  
E U A  
E mer ge nc y u s e aut h orizati o n  
F D A  
U S F o o d a n d Dr u g A d mi nistrati o n  
I C D-1 0 -C M  
I nter nati o nal Classificati o n of Diseases, T e nt h Re visi o n, Cli nical 
M o dificati o n  
I C U 
I nte nsi v e care u nit 
I P T W 
I n v erse pr o ba bilit y of treat me nt wei g hti n g 
K P S C  
Kaiser Per ma ne nte of S o ut her n Calif or nia  
O R  
O d ds rati o  
R D  
Ris k differe nces  
R S V  
Res pirat or y s y nc yt ial vir us 
S M D  
Sta n dar dize d me a n differe nces  
T N D  
Test ne gati ve desi g n  
N PI  
Nati o nal pr o vi der i de ntifi er  
V E  
Vacci n e effecti ve n ess  
U S  
U nite d States  
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
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3.  R E S P O N SI B L E P A R TI E S  
N a me, De gree(s)  
J o b Title  
Affili ati o n  
A d dress  
T his pr ot oc ol will be le d b y t he E vi de nce Ge nerati o n Platf or m . 
 
P h D, M Sc  
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
 
M B A M S  
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
 
, P h D  
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, 
M P H  
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
 
, P h D 
 
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
C o -I n v esti gat ors 
, 
P h D  
Pfizer I nc.  
Researc h & 
De vel o p me nt  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, M P H 
Pfizer I nc.  
Vacci n es Scie ntific 
Affairs  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, M P H 
Pfizer I nc.  
Vacci n es Scie ntific 
Affairs  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, 
M D  
Pfizer I nc.  
Gl o bal Me dical 
Affairs  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 7  of 4 6  
, M S  
Pfizer I nc.  
Gl o bal Val ue & 
E vi de nce  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, 
P h D  
Pfizer I nc.  
Vacci n es Scie ntific 
Affairs  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, 
P h D, M P H  
Pf izer I nc. 
Vacci n es Scie ntific 
Affairs  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, 
P har m D, M S  
Pfizer I nc.  
Gl o bal Val ue & 
E vi de nce  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
, P h D 
Vacci n es Me dical 
& Scie ntific Affairs  
6 6 H u ds o n Bl v d. East, N Y, 
N Y 1 0 0 0 1  
 
Pri nci p al I n vesti g at or (s) of t he Pr ot oc ol  
N a me, D e gree(s)  
J o b Title  
Affili ati o n  
A d dress  
Ka yte A n derse n, 
P h D, M S c 
Direct or, R W E 
Scie ntist, m R N A 
Vacci n es  
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
 
Lea h Mc Grat h, P h D  
 
 
Se ni or Direct or, 
R W E Scie ntist, 
Vacci n es  
 
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
T h o mas P orter, 
M P H  
Se ni or Ma na ger, 
Cli nical Scie ntist, 
m R N A Vacci n es & 
A nti virals  
Pfizer I nc.  
E vi de nce 
Ge nerati o n Platf or m  
6 6 H u ds o n Bl v d. East  
Ne w Y or k, N Y 1 0 0 0 1  
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)
P P D
P P D
P P D
P P D
P P D
P P D

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 8  of 4 6  
4.  A M E N D M E N T S A N D U P D A T E S  
N o ne.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 9  of 4 6  
5.  MI L E S T O N E S  
 
Milest o ne  
Pl a n ne d D ate  
Start of data c ollecti o n  
0 1 Ja n uar y  2 0 2 4  
E n d of data c ollecti o n   
3 1  Marc h  2 0 2 4  
Fi nal st u d y re p or t 
3 1  Ma y  2 0 2 4  
 
6.  R A TI O N A L E A N D B A C K G R O U N D  
A d mi nistrati ve clai ms data ha ve tra diti o nall y ha d li mite d ca pa bilities f or st u d yi n g vacci nate d 
p o p ulati o ns. T his li mitati o n is a f u ncti o n of t he varie d setti n gs  i n w hic h vacci nes ma y be 
a d mi nistere d t o a patie nt a n d w het her a n i n di vi d ual tra nsacti o n is ge nerate d. N o n -me dical setti n gs 
(e.g ., w or k pla ce, s c h o ols, p ublic ve n ues, etc.) a n d mass e ve nts (e .g ., v acci n ati o n cli nics, Fe deral 
E mer ge nc y M a na ge m e nt A ge nc y , et c.) t y picall y o nl y re q uire r oster billi n g f or rei m b urse m e nt. A 
r oster clai m f or m o nl y rec or ds t he date of vacci ne a d mi nistrati o n; pr o vi der’s na me a n d nati o nal 
pr o vi der i de ntifier  ( N PI); a n d patie nt’s I D (e.g ., M e dicare I D, dri v er’s lice nse, etc.), d ate of birt h, 
na me, ge n der, a n d a d dress. 1 I m p orta ntl y, t he r oster is s u b mitte d wit h a m o difie d C M S-1 5 0 0 “c o ver” 
clai m t o ca pt ure t he v acci ne i nf or mati o n, h o we ver, i n di vi d ual C M S -1 5 0 0 clai ms t hat li n k t he patie nt 
i nf or mati o n t o t he c o ver clai m are n e ver ge nerate d. Si nce tra ditio nal clai ms data bases ca pt ure a n d 
re p ort t he i n di vi d ual C M S-1 5 0 0 clai m f or m, vacci nati o ns c o n d ucte d via r oster billi n g were l ost. 
H o we ver, alt h o u g h r oster billi n g d oes n ot ge nerate i n di vi d ual C M S -1 5 0 0 clai ms, t he li n ka ge 
bet wee n t he r oster a n d v acci ne i nf o r m ati o n are rec o ncile d b y vari o us state e ntities t o p o p ulate 
vacci ne re gistries.  
U ntil rece ntl y, vacci ne re gistries were n ot a vaila bl e f or de -i de ntificati o n a n d li n ka ge t o sec o n dar y 
clai ms -base d dat a bases. H o we ver, t hr o u g h a c olla b orati o n wit h Healt h Verit y , a lea di n g s u p plier of 
sec o n dar y healt h data, t h e State of Calif or nia a n d t he State of L o uisia na ha ve  ma de t heir v acci n e 
re gistries a vaila bl e f or li n ka ge f or researc h p ur p oses. Calif or nia a n d L o uisia na dei de ntif y  t he 
re gistries, usi n g Healt h V erit y’s s oft ware t o c o n vert eac h p atie nt’s pr otect e d healt h i nf or mati o n t o a 
u ni q ue Healt h Verit y I D w hic h ca n t he n be li n ke d t o t he f ull Healt h Verit y data base t o gat h er cli nical 
hist or y a n d o utc o mes. T his pr ot oc ol defi nes t he utilizati o n of Healt h Verit y data, li n ke d t o  t he State 
of Calif or nia / L o uisia na’s vacci ne re gistr y, f or st u dies of V E a n d u pta ke f or p o p ulati o ns of i nterest.  
T he a bilit y t o li n k t he State of Calif or nia / L o uisia n a’s vacci ne re gistr y t o a s ec o n dar y clai ms-bas e d 
data base pr o vi des a u ni q ue o p p ort u nit y t o ma xi mize t he ca pa bilities of real -w orl d data a n d 
efficie ntl y c o n d u ct V E st u dies o n a variet y of t ar gete d p o p ulati o ns a n d e n d p oi nts, i ncl u di n g t he 
u p date d m o n o vale nt X B B. 1. 5 C O VI D -1 9 vacci ne f or m ulati o n.  
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 0  of 4 6  
T A B L E 1. TI M E LI N E  O F K E Y B N T 1 6 2 B 2 R E G U L A T O R Y MI L E S T O N E S  
V acci ne 
f or m ul ati o n 
A ge gr o u p  
E ve nt  
B N T 1 6 2 b 2 
m o n o vale nt 
X B B. 1. 5 C O VI D -
1 9 vacci ne  
A ge 1 2 a n d ol der  
1 1 Se pte m ber 2 0 2 3 : U. S. F o o d a n d Dr u g 
A d mi nistrati o n ( F D A) a p pr o val 2 
 
A ge 6 m o nt hs t o 1 1 years  
1 1 Se pte m ber 2 0 2 3: F D A e mer ge n c y use 
a ut h orizati o n ( E U A) 2 
 
N/ A  
1 5 J u ne 2 0 2 3: ( F D A)’s V acci nes a n d 
Relate d Bi ol o gical Pr o d ucts A d vis or y 
C o m mittee rec o m me n de d t hat C O VI D -1 9 
vacci nes f or 2 0 2 3 -2 0 2 4 b e u p date d t o a 
m o n o vale nt X B B. 1. 5 vacci ne. 3 
B N T 1 6 2 b 2 bi vale nt 
B A. 4/ 5 C O VI D -1 9 
vacci ne  
A ge 1 2 a n d ol der  
3 1 A u g ust 2 0 2 2: F D A E U A 4 
 
A ge 5 t o 1 1  
1 2 Oct o ber 2 0 2 2: F D A E U A 5 
 
A ge 6 m o nt hs t o 4 years  
0 8 Dece m b er  2 0 2 2 : F D A E U A6 
B N T 1 6 2 b 2 wil d -
t y pe b o oster 
d ose(s) C O VI D -1 9 
vacci ne  
A ge 5 t o 1 1  
1 7 Ma y 2 0 2 2: F D A a ut h orize d first 
b o oster d ose  
 
A ge 5 0 a n d ol der, a n d 
i m m u n oc o m pr o mise d 
i n di vi d uals 
2 9 Marc h 2 0 2 2: F D A a ut h orize d sec o n d 
b o oster d ose  
 
A ge 6 5 a n d ol der, a n d 
i n di vi d uals wit h p ote ntiall y 
hi g h ris k t hat were a g e 1 8 -6 4  
2 2 Se pte m ber 2 0 2 1: F D A a ut h orize d 
si n gle b o oster d ose 
B N T 1 6 2 b 2 wil d -
t y pe pri mar y seri es 
C O VI D -1 9 vacci ne  
A ge 6 m o nt hs t o 4 years  
1 7 J u ne 2 0 2 2: F D A E U A  
 
A ge 5 t o 1 1  
2 9 Oct o ber 2 0 2 1: F D A E U A  
 
A ge 1 6 a n d ol der  
2 3 A u g ust 2 0 2 1: F D A a p pr o val  
 
A ge 1 2 t o 1 5  
1 0 Ma y 2 0 2 1: F D A E U A  
 
A ge 1 6 a n d ol der  
1 1 Dece m b er  2 0 2 0: F D A E U A  
 
T his pr ot oc ol is n ot desi g nate d as a p ost -a p pr o val safet y st u d y ( P A S S ) a n d is n ot a c o m mit me nt t o 
a n y re g ulat or y b o di es.  
 
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 1  of 4 6  
7.  R E S E A R C H Q U E S TI O N A N D O B J E C TI V E S  
W h at is t he re al -w orl d effecti ve ness of B N T 1 6 2 b 2 f or m ul ati o ns ?  
T his st u d y is descri pti ve i n nat ure a n d as s u c h  d oes n ot i ncl u de a n y pre -s p ecifie d h y p ot heses.  
Pri mar y o bj ecti ve:  
1.  T o e val uate t he V E  of B N T 1 6 2 b 2 f or m ulati o ns i n n o n -pre g na nt, n o n -i m m u n oc o m pr o mise d 
a d ults a gai nst me dicall y atte n de d C O VI D -1 9 , m ortalit y a n d healt hcare res o urce utilizati o n b y 
a ge a n d a da pte d v acci ne f or m ulati o n .  
Mai n s u m mar y meas ure: V E  = ( 1 –  a dj uste d h azar d rati o  [a H R]) * 1 0 0 , c o m pari n g 
vacci nat e d t o u n vacci n ate d pers o ns  
Sec o n dar y o bje cti ves  
2.  T o assess V E  of B N T 1 6 2 b 2 f or m ulati o ns i n pe diatrics a gai nst me dicall y att e n de d C O VI D -
1 9,  n o n -C O VI D -1 9  res pirat or y i nfecti o ns, m ortalit y a n d healt h care res o urce utilizati o n b y 
a ge a n d a da pte d v acci ne f or m ulati o n .  
Mai n s u m mar y meas ure: V E = ( 1 – a H R) * 1 0 0 , c o m pari n g vacci n ate d t o 
u n vacci nat e d pers o ns   
3.  T o esti mate s h ort-ter m ( 3 A) a n d l o n g -ter m ( 3 B) healt hcare res o urce utilizati o n  a n d c osts 
ass ociate d wit h C O VI D -1 9  b y vacci nati o n stat us , a ge, a n d site of care. 
Mai n s u m mar y meas ure: I n p atie nt healt hcare e x pe n dit ure c o m pari n g vacci n ate d t o 
u n vacci nat e d pers o n s ( 3 A); a n d t otal healt hcare e x pe n dit ure c o m pari n g C O VI D -1 9  t o 
n o n -C O VI D -1 9  p atie nts  ( 3 B). 
E x pl orat or y o bjecti ves  
4.  T o meas ure V E  of B N T 1 6 2 b 2 f or m ulati o ns i n n o n -pre g na nt i m m u n oc o m pr o mise d a d ults 
a gai nst me dicall y atte n de d C O VI D -1 9 , m ortalit y a n d healt hcare res o urce utilizati o n b y a ge 
a n d a da pte d v acci ne f or m ulati o n .  
Mai n s u m mar y meas ure: V E = ( 1 – a H R) * 1 0 0 , c o m pari n g vacci n ate d t o 
u n vacci nat e d pers o ns  
5.  T o q ua ntif y differe nces i n V E  of B N T 1 6 2 b 2 f or m ulati o ns i n n o n -pre g na nt, n o n -
i m m u n oc o m pr o mise d a d ults w he n c o-a d mi nistere d wit h seas o nal i nfl ue nza vacci nes v ers us 
w he n e ac h vacci ne is gi v e n se paratel y, b y a g e gr o u ps .  
Mai n s u m mar y meas ure: a R R  t o e val uate n o n-i nf eri orit y, c o m pari n g pe o ple wit h c o-
a d mi nistere d vacci nes t o B N T 1 6 2 b 2 vacci ne al o ne  f or C O VI D-1 9 -relate d o utc o mes 
Mai n s u m mar y meas ure: a R R  t o e val uate n o n-i nf eri orit y, c o m pari n g pe o ple wit h c o-
a d mi nistere d vacci nes t o seas o nal i nfl ue nza vacci n e al o ne  f or i nfl ue nza-relate d 
o utc o mes  
  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 2  of 4 6  
8.  R E S E A R C H M E T H O D S  
We will utilize a tar g et trial e m ulati o n desi g n i n or der t o i de ntif y patie nts f or f oll o w -u p base d o n 
q ualif yi n g e ve nts .7 T he tar get trial e m ulati o n desi g n is a pra g matic fra me w or k t hat reflects real-life 
cli nical be ha vi ors of n o n -ra n d o mize d e x p os ures a n d s u bse que nt o utc o mes  (see Ta bl e 1 ). 
A t est-ne gati ve d esi g n  ( T N D), w hic h is a m o difie d f or m of a case-c o ntr ol st u d y , is c o m m o nl y use d 
i n V E st u dies. I n t he T N D, cases a n d c o ntr ols are i de ntifie d fr o m pers o ns w h o s o u g ht testi n g f or a 
pat h o ge n, w hic h ma y i ncrease c o m para bilit y bet wee n gr o u ps as t h ere is a n ass ociati o n wit h 
vacci nati o n a n d h ealt hcare see ki n g be h a vi or. H o we ver , f or t his st u d y a retr os pecti ve c o h ort d esi g n  
was c h ose n o v er t he T N D  f or t he foll o wi n g reas o ns : 
1.  A d mi nistrati ve clai ms data d o n ot c o ntai n test res ults , w hic h w o ul d be a necessar y d ata 
ele me nt f or c o n d ucti n g a T N D st u d y . W hile Healt h Verit y offers t he o pti o n t o p ote ntial l y a d d 
E H R data, a n d se p arat el y t o ke nizati o n t o la b orat or y res ults t hr o u g h La b C or p or Q uest, t his is 
n ot part of t he c urre nt s uite of p urc h ase d data.  
2.  Gi ve n t he e n d of t he C O VI D -1 9  P u blic Healt h E mer ge nc y i n Ma y 2 0 2 3, C O VI D -1 9  tests are 
n o l o n ger re q uir e d t o be c o vere d b y pri vate or p u blic i ns urers u nless or dere d b y a 
p h ysicia n. 8, 9 T his ma y  create selecti o n b ias, i n t hat pers o ns pa yi n g o ut of p oc ket t o access 
testi n g li kel y differ fr o m t h ose w h o are n ot testi n g.1 0 A T N D of  t h ose w h o ha ve s o u g ht 
testi n g f or C O VI D -1 9  h as t he p ote ntial f or esti mates t hat are differe nt fr o m t he ge neral 
p o p ulati o n , 1 1 o wi n g t o dist orte d ass ociati o ns bet wee n fact ors relate d t o h ealt hcare  see ki n g i n 
t he a nal ysis p o p ulati o n c o m pare d wit h t he ge n eral p o p ulati o n.1 2 
a. If t h ose testi n g at t heir o w n e x pe nse are m ore li kel y t o bec o me dia g n ose d wit h 
C O VI D -1 9,  s uc h as t h ose at hi g her ris k of s e vere disease, t he n V E esti mates w o ul d 
be bi ase d t o war ds t he n ull.  
b.  C o n versel y, if t here was a healt h y -user effect or i ncreas e d u pta ke a m o n g hi g her 
s oci oec o n o mic p ositi o n gr o u ps, V E esti mates w o ul d be biase d a wa y fr o m t he n ull.  
3.  A ke y ass u m pti o n of t he T N D is t hat e x p os ure ( here, C O VI D -1 9  vacci nati o n ) d oes n ot  
i m pact t he pr o ba bilit y of selecti o n i n t he cas e (a p ositi ve test res ult o n a C O VI D -1 9  test) or 
c o ntr ol p o p ulati o n ( a ne g ati ve test res ult o n a C O VI D -1 9  test). It is p ossi ble  that vacci nate d 
pers o ns ma y be less li kel y t o be see k testin g i n or der t o bec o me a case t ha n  u n vacci nat e d 
pers o ns . T his, if prese nt, w o ul d creat e c olli der str atificati o n bias  via t he re q uire me nt f or 
testi ng  i n a T N D, w hic h biases esti mates a wa y fr o m t he n ull a n d ma y lea d t o o veresti mati o ns 
of V E .1 2 -1 4  
4.  O wi n g t o t he case -c o ntr ol nat ure of t he d esi g n, T N D all o ws f or esti mati o n of o d ds rati os 
( O R) b ut n ot hazar d or ris k rati os. O R are n ot directl y i nter preta ble as perce nta ge re d ucti o n 
i n ris k, w hic h is a n  easil y i nter preta ble s u m mar y meas ure of V E . O R  wit h a pr otecti ve 
directi o n of effect (rati o < 1) will u n deresti mate  ris k, lea di n g t o u n deresti mati o ns of V E.1 5 A 
c o h ort desi g n all o ws f or a bs ol ute esti mates of ris k s uc h as ris k differe n ces.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 3  of 4 6  
T he use of a retr os p ecti v e c o h ort st u d y all o ws f or t he a d o pti o n of desi g n pri nci ples of ra n d o mize d 
c o ntr ol trials t o hel p miti gate s o me of t hese bi ases.7 
C o h ort  i de ntificati o n will be gi n fr o m  t he date of E U A or F D A a p pr o val f or t he B N T 1 6 2 b 2 
f or m ulati o n. St u d y f oll o w -u p will occ ur fr o m F D A E U A  or a p pr o val dat e u ntil  C O VI D -1 9  di a g n osis 
or ot her o utc o me of i nterest ( h os pitalizati o n, e mer ge nc y de p art me nt visit, o ut patie nt e nc o u nter, e n d 
of me dical a n d/ or p h ar m ac y e nr oll me nt, or d eat h [acc or di n g t o t he m ortalit y data base]).  
I n ai ms 1, 2 a n d 4, vacci nati o n stat us will be meas ure d as a ti me -v ar y in g e x p os ure. I n ai ms 3 a n d 5, 
vacci nati o n stat us will be meas ure d as a ti me -fi xe d e x p os ure. E x p ose d p ers o n -ti me be gi ns 1 4  da ys 
after recei pt of a B N T 1 6 2 b 2 f or m ulati o n . U ne x p ose d pers o n -ti me is u n vacci nate d pers o n-ti me, as 
well as 0 -1 3 da ys after vacci nati o n . T he u n e x p ose d gr o u p will be f urt her stratifie d b y pre vi o us 
vacci nati o n stat us f or rel ati ve V E : X B B. 1. 5 u n vacci nate d a n d B A. 4/ 5 vacci nate d; X B B. 1. 5 a n d 
B A. 4/ 5 u n vacci nate d  a n d at least 2 d oses of m R N A vacci n e  (re gar dless of f or m ulati o n); ne ver 
C O VI D -1 9  vacci nat e d.  
T he f ull data a v aila ble, fr o m 0 1 Dece m ber 2 0 1 8, will be use d as t he l o o k -bac k peri o d t o defi ne 
patie nt’s c haracteristics, cli nical hist or y, ris k fact ors, a n d healt hcare utilizati o n.  
T A B L E 2 . T A R G E T T RI A L A N D T A R G E T T RI A L E M U L A TI O N 
T ar get Tri al S pecific ati o n 1 6, 1 7 
T ar get Tri al E m ul ati o n  
Eli gi bilit y criteri a  
I ncl usi o n criteri a i n tri als ge ner all y reflecte d 
a ge -rel ate d eli gi bilit y f or v acci n ati o n .   
F or bre vit y, we will n ot disc uss eac h of t h e 5 
ai m’s differe nt i ncl usi o n criteria h ere. 
T hr o u g h o ut, we use d a ge at ti me vacci ne was 
a ut h orize d or a p pr o ve d b y F D A f or ti me -
var yi n g e x p os ures, a ge at vacci nati o n f or ti me-
fi xe d e x p os ures t o reflect a ge-relate d 
eli gi bilit y.  
 
We re q uire  c o nti n u o us p har mac y a n d me dical 
e nr oll me nt i n Healt h Verit y pri or t o i n de x date 
( F D A E U A date per vacci ne) f or f oll o w-u p . 
T his is i n or der t o  esta blis h pre-e xisti n g healt h 
stat us, w hic h w o ul d ha ve bee n q ueri e d at st u d y 
e ntr y i n t he cli nical trials.  
 
We re q uire c o nti n u o us C alif or nia / L o uisia na 
resi de nc y t o ma xi mize pre -i n de x ca pt ure of 
vacci nes, as pe o ple li vi n g o utsi de of Calif or nia 
/ L o uisia na w o ul d n ot ha ve pri or vacci nes well 
ca pt ure d i n t he re gistr y.  
 
 
T hr o u g h o ut, we will e xcl u de pe o ple w h o are 
curre ntl y pre g na nt , usi n g a vali date d 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 4  of 4 6  
 
•  E xcl usi o n criteria  
o  Pre g na nt  
o  Treat me nt wit h i m m u n os u p pressi ve 
t hera p y or dia g n osis wit h a n 
i m m u n oc o m pr o misi n g c o n diti o n 
o  Hist or y of C O VI D -1 9  
gestati o nal a ge al g orit h m wit h u p t o 9 m o nt hs 
l o o k bac k.1 8  
 
E xce pt i n ai m 4, w here t he a nal yses are s p ecifi c 
t o i m m u n oc o m pr o mise d pers o ns, we will 
e xcl u de i m m u n oc o m pr o mise d pe o ple 
c o nsi deri n g clai ms f or m e dicati o ns dis pe nse d 
as well as a n d dia g n osis c o des.  
 
We will e xcl u de pers o ns wit h a dia g n osis of 
C O VI D -1 9  i n a n y setti n g ≤ 9 0 da ys pri or t o 
i n de x. We are li miti n g t o 9 0 da ys as 
rei nfecti o ns ha ve bec o me m ore c o m m o n o ver 
t he pa n de mic a n d  were rare d uri n g t he Fall 
2 0 2 0 cli nical trial peri o d. We belie v e 9 0 da ys 
re pres e nts a reas o na ble peri o d i n w hic h pers o ns 
t he n ca n be c o nsi dere d t o be at ris k f or 
rei nfecti o n, a nd als o are eli gi ble f or 
vacci nati o n. 1 9  
 
We will e xcl u de i n di vi d u als wit h discre pa nci es 
i n se x a n d/ or year of birt h bet wee n 
Healt h Verit y cl ai ms a n d Calif or nia / L o uisia na 
i m m u nizati o n re gistr y datasets, as t hese are ke y 
c o nf o u n ders i n all a nal ys es. Sec o n dar y 
dei de ntifie d data ma k es it i m p ossi ble t o 
rec o ncile differe nces, w hic h w o ul d be e x pecte d 
t o be res ol ve d wit h pri mar y data c ollecti o n.  
 
Tre at me nt str ate gies  
Recei ve 1 d ose of a B N T 1 6 2 b 2 a da pte d 
f or m ulati o n vs. n o B N T 1 6 2 b 2 f or m ulati o n or 
ot her C O VI D -1 9  v acci ne (X B B. 1. 5 or B A. 4/ 5 
de pe n di n g o n ti mi n g)  
All pers o ns will be c o nsi dere d u n vacci nat e d 
fr o m date of U S F o o d a n d Dr u g A d mi nistrati o n 
( F D A) date of vacci ne a ut h orizati o n/a p pr o val 
u ntil, w here a p plica bl e, 1 3  da ys after recei pt of 
vacci ne. I n or der t o all o w f or ti me after d ose 
f or mea ni n gf ul i m m u n ol o gic pr otecti o n t o 
accr ue, pers o ns will be c o nsi dere d vacci nate d 
1 4  da ys after vacci nati o n. 2 0, 2 1 
•  F or B A. 4/ 5 vacci ne  i n a d ults: F D A 
e mer ge n c y use a ut h ori zati o n date 3 1 
A u g ust  2 0 2 2 4 
•  F or X B B. 1. 5 vacci ne: F D A a p pr o val date 
1 1 Se pte m ber 2 0 2 3 2 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 5  of 4 6  
Assi g n me nt pr oce d ures  
Ra n d o mizati o n:  Eli gi ble partici pa nts ra n d o ml y 
assi g ne d t o recei ve d ose of B N T 1 6 2 b 2 
X B B. 1. 5 vs. n o B N T 1 6 2 b 2 X B B. 1. 5  
A dj ust me nt f or c o nf o u n di n g fact ors w hic h 
mi g ht i nfl ue nce a pers o n’s pr o ba bilit y of 
e x p os ure, usi n g direct a dj ust me nt i n ti me-
var yi n g e x p os ure m o dels a n d i n verse 
pr o ba bilit y of treat me nt wei g hti n g ( wit h d o u bl y 
r o b ust a dj ust me nt, if necessar y) i n ti me-fi x e d 
e x p os ure m o dels.  
O utc o me(s)  
C o nfir me d C O VI D -1 9  
Me dicall y atte n de d C O VI D -1 9 , as  
1.  A C O VI D -1 9 -relat e d e nc o u nter, re g ar dless 
of setti n g ( pri mar y o utc o me)  
2.  A n o ut patie nt e nc o u nter wit h I C D -1 0 -C M 
U 0 7. 1 “ C O VI D -1 9” c o d e  
3.  A n i n patie nt e nc o u nter wit h I C D -1 0 -C M 
U 0 7. 1 “ C O VI D -1 9” liste d i n a n y dia g n osis  
p ositi o n . As a se nsiti vit y a nal ysis, we will 
restrict t o U 0 7. 1 i n pri mar y dia g n osis fiel d.  
4.  A n e mer ge n c y de p art me nt e nc o u nter wit h 
I C D-1 0 -C M U 0 7. 1 “ C O VI D -1 9” c o de  
5.  Critical ill ness , defi ne d as i nte nsi ve care 
u nit [I C U] a d missi o n, mec ha nical 
ve ntilati o n, or i n patie nt deat h . If sa m ple 
size all o ws, we will e v al uate V E a g ai nst 
eac h c o m p o ne nt se paratel y i n or der t o 
s u p p ort V & E m o dels, i ncl u di n g w here 
p ossi ble I C U wit h a n d  wit h o ut mec ha nical 
ve ntilati o n .  
6.  A n ur ge nt care visit wit h I C D -1 0 -C M 
U 0 7. 1 “ C O VI D -1 9” c o d e  
A n d  se paratel y, n ot necessaril y d ue t o C O VI D -
1 9 : 
7.  All -ca use m ortalit y  wit hi n  3 -m o nt hs  of 
C O VI D -1 9  e n c o u nter, re gar dless of setti n g  
8.  All -ca use m ortalit y wit hi n 3 -m o nt hs of 
C O VI D -1 9  o ut patie nt e n c o u nter  
9.  All -ca use m ortalit y wit hi n 3 -m o nt hs of 
C O VI D -1 9  i n patie nt e n c o u nter 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 6  of 4 6  
1 0.  All -ca use m ortalit y  wit hi n 3 -m o nt hs of 
C O VI D -1 9  e m er ge n c y d e part me nt 
e nc o u nter  
1 1.  All -ca use m ortalit y wit hi n 3 -m o nt hs of 
C O VI D -1 9  critical ill ness  
1 2.  All -ca use m ortalit y wit hi n 3 -m o nt hs of 
ur ge nt care e n c o u nter f or C O VI D -1 9  
 
N ote: ai m 2 h as a d diti o n al n o n -C O VI D -1 9  
res pir at ory ill ness o utc o mes a n d ai m 5 h as 
i nfl ue nz a o utc o mes. T hey are n ot re prese nte d 
here as t he p ur p ose of t his c h art is t o 
de m o nstr ate t he t ar get tri al fr a me w ork, a n d 
t hese o utc o mes wer e n ot assesse d i n cli nic al 
tri als f or lice ns ure.  
F oll o w -u p  
A nal ysis is li mite d t o i n di vi d uals still at ris k o n 
da y 1 4  after vacci nati o n/ra n d o mizati o n  
U n vacci n ate d f oll o w -u p ti me will occ ur f r o m 
t he date of F D A a ut h orizati o n/a p pr o val u ntil 1 3 
da ys after t h e recei pt of vacci nati o n, t he 
o utc o me of i nterest, or are ce ns ore d at t he first 
of t he f oll o wi n g: 6 m o nt hs of f oll o w -u p , e n d of 
me dical a n d/ or p har mac y e nr oll me nt, recei pt of 
a n o n-Pfizer Bi o N T ec h v acci ne or recei pt of a 
sec o n d B N T 1 6 2 b 2 C O VI D -1 9  vacci ne d ose.  
 
Vacci n ate d f oll o w -u p ti me will occ ur fr o m 1 4 
da ys after  t h e recei pt of vacci nati o n u ntil t he 
o utc o me of i nterest  or are ce ns ore d at t he first 
of t he f oll o wi n g: 6 m o nt hs of f oll o w -u p, e n d of 
me dical a n d/ or p har mac y e nr oll me nt, recei pt of 
a n o n-Pfizer Bi o N T ec h v acci ne or recei pt of a 
sec o n d B N T 1 6 2 b 2 C O VI D -1 9  vacci ne d ose.  
C a us al c o ntr asts of i nterest  
Per -pr ot oc ol effect  
O bser vati o nal a nal o g of t he per -pr ot oc ol effect , 
usi n g se nsiti vit y a nal yses a n d ne gati ve c o ntr ol 
o utc o mes t o e xa mi ne t he q ua ntitati ve i m pact of 
desi g n a n d a nal ytic ass u m pti o ns.  
St at istic al a n al ysis 
I n B N T 1 6 2 b 2 Fall 2 0 2 0 cli nical trial, V E 
esti mate d as ( 1 -I R R)* 1 0 0, c o m pari n g 
vacci nat e d wit h u n vacci nate d pers o ns , w here 
I R R is t he i nci de nce rat e rati o per 1 0 0 0 pers o n-
years .  
V E  esti mate d as ( 1 -a H R) f or ai ms 1, 2 a n d 4 
(ti me-var yi n g e x p os ures ), a n d ( 1-a R R) f or ai m 
5 ( ti me-fi xe d e x p os ure).  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 7  of 4 6  
 
I n m R N A-1 2 7 3  Fall 2 0 2 0 cli nical trial, ( 1-
a H R) * 1 0 0.  
 
8. 2.  Setti n g  
Patie nts w h o were Calif or nia or L o uisia na resi de nts i n t he Healt h Verit y clai ms data base will be 
defi ne d usi n g t he f oll o wi n g hierarc hical defi niti o n:  
1.  Pers o ns w h o ha ve t heir e nr oll me nt file rec or d i n dicati n g a patie nt l ocati o n of Calif or nia  or 
L o uisia na  i n Healt h Verit y clai ms e nr oll me nt file.  
2.  Pers o ns w h o ha ve a patie nt state l ocati o n ot her t ha n Calif or nia  or L o uisia na  i n Healt h Verit y 
clai ms e nr oll me nt b ut ha ve o ne or m ore rec or ds i n t he Calif or nia or L o uisi a na I m m u nizati o n 
Re gistr y. Ex a m ples i ncl u de pe o ple w h o previ o usly live d i n Tex as b ut m ove d t o C alif or ni a 
a n d receiv e d a v ac ci ne, or pers o ns w h o cr osse d st ate li nes f or a v acci ne a n d re m ai n i n t heir 
n o n -C alif or ni a st ate i n cl ai ms d at a.  
 X B B v acci nati o ns will be e n u merate d usi n g t he f oll o wi n g hierarc hical defi niti o n:  
1.  A n y pers o n i n Healt h Verit y clai ms data w h o has a rec or d i n t h e Calif or nia / L o uisia na 
I m m u nizati o n Re gistr y wit h a C V X c o de i n dicati n g ha vi n g recei ve d t he B N T 1 6 2 b 2 X B B. 1. 5 
m o n o vale nt  m R N A vacci ne will be c o nsi dere d vacci nate d 1 4 da ys after re gistr y e ve nt date.  
2.  A n y pers o n i n Healt h Verit y clai ms data w h o d oes n ot ha ve a rec or d i n t he 
Calif or nia / L o uisia na I m m u nizati o n Re gistr y b ut has a p har m ac y cl ai m wit h a n N D C c o de 
i n dicati n g a B N T 1 6 2 b 2 X B B. 1. 5 m o n o vale nt m R N A vacci ne d ose  will be c o nsi dere d 
vacci nat e d 1 4 da ys after clai m date.  
3.  A n y pers o n i n Healt h Verit y clai ms data w h o d oes n ot ha ve a rec or d i n t he 
Calif or nia / L o uisia na I m m u nizati o n Re gistr y a n d d oes n ot ha ve a p h ar mac y clai m wit h a n 
N D C c o de i n dicati n g a B N T 1 6 2 b 2 X B B. 1. 5 m o n o vale nt m R N A vacci n e d ose b ut has a 
me dical clai m wit h a C P T c o de i n dicati n g a B N T 1 6 2 b 2 X B B. 1. 5 m o n o vale nt m R N A vacci ne 
d ose will be c o nsi dere d v acci nat e d 1 4 da ys after cl ai m date.  
4.  A n y pers o n i n Healt h Verit y clai ms data w h o d oes n ot ha ve a rec or d i n t he 
Calif or nia / L o uisia na I m m u nizati o n Re gistr y, d oes n ot ha ve a p har mac y clai m wit h a n N D C 
c o de i n d icati n g a B N T 1 6 2 b 2 X B B. 1. 5 m o n o vale nt m R N A vacci ne d ose a n d d oes n ot ha ve a 
me dical clai m wit h a C P T c o de i n dicati n g a B N T 1 6 2 b 2 X B B. 1. 5 m o n o vale nt m R N A vacci ne 
d ose will be c o nsi dere d B N T 1 6 2 b 2 X B B. 1. 5 u n vacci nat e d.  
B A. 4/ 5 vacci nati o ns will be e n u merate d i n t he sa m e ma n ner as X B B. 1. 5. F or i nfl ue nza , h er pes 
z oster a n d p n e u m oc occal  vacci nati o ns, Pfizer has n ot yet lice nse d t hese s pecific 
Calif or nia / L o uisia na state re gistries; i nstea d, we will rel y w h oll y o n N D C a n d C P T c o des i n 
a d mi nistrati ve clai ms.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 8  of 4 6  
E n d p oi n ts, patie nt c haracteristics, cli nical c haracteristics, healt hcare utilizati o n, a n d a n y varia bl es f or 
t he a nal ysis will be deri v e d fr o m t he H ealt h Verit y clai ms data base restricte d t o t he state of 
Calif or nia / L o uisia na. M e dical setti n gs of o ut patie nt, a m b ulat or y, p har mac y, e mer ge n c y de part me nt, 
a n d h os pital will be i ncl u de d i n t he a nal ysis f or all varia bles.  Ur ge nt care visits will be c o nsi dere d  
se parat el y fr o m e mer ge n c y de part me nt visits, as differe n ces i n t he p o p ulati o ns ass ociate d wit h 
ur ge nt care as c o m pare d t o e mer ge nc y d e part me nt e nc o u nters  are e x pect e d .  
8. 2. 1.  I ncl usi o n C riteri a 
I n cl usi o n criteria are s p ecifie d b y eac h st u d y ai m. Wit hi n eac h ai m, patie nts m ust meet all of t he 
f oll o wi n g criteria t o be eli gi ble f or i ncl usi o n i n t he st u d y: 
8. 2. 1. 1.  Ai m 1 I ncl usi o n Criteri a  
1)  B or n i n 2 0 0 5 or earlier  (as a ge 1 8 or ol der  i n 2 0 2 3, o wi n g t o t he data pr o vi di n g year b ut n ot 
m o nt h or da y of birt h).  
2)  At least o ne year of p har mac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o i n de x date  
(F D A E U A date p er  v acci ne ). A ga p of u p t o 3 0 d a ys will be all o we d.  
3)  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least o ne y ear pri or t o i n de x date  
(F D A E U A date p er vacci ne ) 
8. 2. 1. 2.  Ai m 2 I ncl usi o n Criteri a  
1)  B or n i n 2 0 0 6 or later (as a ge 0-1 7 years  i n 2 0 2 3, o wi n g t o t he data pr o vi di n g year b ut n ot 
m o nt h or da y of birt h)  
2)  At least si x m o nt hs of p har m ac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o i n de x date  
(F D A E U A date p er a ge gr o u p vacci n e ). Si x m o nt hs was selecte d t o all o w f or a nal ysis t o 
i ncl u de c hil dre n a g e < 1  y ear. A ga p of u p t o 3 0 da ys will be all o we d.  
3)  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least si x m o nt hs pri or t o i n de x date  
(F D A E U A date p er a ge gr o u p a n d vacci ne ) 
8. 2. 1. 3.  Ai m 3 A  I ncl usi o n Criteri a 
Ai m 3 A  criteria are differe nt base d o n t he pe diatric a n d a d ult p o p ulati o n a nal yses as f oll o ws:  
8. 2. 1. 3. 1.  Ai m 3 A A d ult I ncl usi o n Criteri a  
1.  B or n i n 2 0 0 5 or earlier (as a ge 1 8 or ol der i n 2 0 2 3, o wi n g t o t he data pr o vi di n g year b ut n ot 
m o nt h or da y of birt h).  
2.  H os pitalize d f or C O VI D -1 9  (a n i n patie nt e nc o u nt er wit h I C D-1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” i n 
t he pri nci pal dia g n osis p ositi o n)  
3.  At least o ne year of c o nti n u o us p har mac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o 
i n de x date (i.e. h os pitalizati o n date). A ga p of u p t o 3 0 da ys will be all o we d.  
4.  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least o ne y ear pri or t o i n de x date 
(i.e. h os pitalizati o n date)  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 9  of 4 6  
8. 2. 1. 3. 2.  Ai m 3 A Pe di atric  I ncl usi o n Criteri a  
1.  B or n i n 2 0 0 6 or later (as a ge 0 -1 7 years i n 2 0 2 3, o wi n g t o t he data pr o vi di n g year b ut n ot 
m o nt h or da y of birt h)  
2.  H os pital ize d f or C O VI D -1 9  (a n i n patie nt e nc o u nt er wit h I C D-1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” i n 
t he pri nci pal dia g n osis p ositi o n)  
3.  At least si x m o nt hs of c o nti n u o us p har mac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o 
i n de x date. Si x m o nt hs was selecte d t o all o w f or a nalysis t o i ncl u de c hil dre n < 1 yr d ue t o 
patie nt pri vac y me as ures i n Healt h Verit y data . A ga p of u p t o 3 0 da ys will be all o we d.  
4.  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least si x m o nt hs pri or t o i n de x date 
 
8. 2. 1. 4.  Ai m 3 B  I ncl usi o n Criteri a 
Ai m 3 B criteria are differe nt base d o n t he pe di atric a n d a d ult p o p ulati o n a nal yses as f oll o ws:  
8. 2. 1. 4. 1.  Ai m 3 B A d ult I ncl usi o n Criteri a  
1.  B or n i n 2 0 0 5 or earlier (as a ge 1 8 or ol der i n 2 0 2 3, o wi n g t o t he data pr o vi di n g year b ut n ot 
m o nt h or da y of birt h).  
2.  At least o ne year of c o nti n u o us p har mac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o 
i n de x date (i.e. C O VI D -1 9  dia g n osis) . A ga p of up t o 3 0 da ys will be all o we d.    
3.  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least o ne y ear pri or t o i n de x date 
(i.e. C O VI D -1 9  di a g n osis)  
8. 2. 1. 4. 2.  Ai m 3 B Pe di atric I ncl usi o n Criteri a  
1.  B or n i n 2 0 0 6 or later (as a ge 0 -1 7 years i n 2 0 2 3, o wi n g t o t he dat a pr o vi di n g year b ut n ot 
m o nt h or da y of birt h)  
2.  At least si x m o nt hs of p har mac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o i n de x date. 
Si x m o nt hs was selecte d t o all o w f or a nal ysis t o i ncl u de c hil dre n < 1  y ea r d ue t o patie nt 
pri vac y meas ures i n Healt h Verit y data . A ga p of u p t o 3 0 da ys will be all o we d  
3.  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least si x m o nt hs pri or t o i n de x date 
 
8. 2. 1. 5.  Ai m 4 I ncl usi o n Criteri a  
1)  B or n i n 2 0 0 5 or earlier (as a ge 1 8 or ol der i n 2 0 2 3, o wi n g t o t he data pr o vi di n g year b ut n ot 
m o nt h or da y of birt h).  
2)  At least o ne year of p har mac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o i n de x date . A 
ga p of u p t o 3 0 da ys will be all o we d.   
3)  I m m u n oc o m pr o mise d at t he ti me of st u d y i n de x, usi n g all-a vaila ble l o o k bac k data  
(i m m u n oco m pr o mise d defi niti o n as per I nfecti o us Disease S ociet y of A m erica Cli nical 
Practice G ui deli ne f or V acci nati o n of t he I m m u n oc o m pr o mise d H ost )2 2, 2 3 
4)  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least o ne y ear pri or t o i n de x date  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 0  of 4 6  
8. 2. 1. 6.  Ai m 5 I ncl usi o n Criteri a  
1)  B or n i n 2 0 0 5 or earlier (as a ge 1 8 or ol der i n 2 0 2 3, o wi n g t o t he data pr o vi di n g year b ut n ot 
m o nt h or da y of birt h) . 
2)  Recei ve d a B N T 1 6 2 b 2 v acci ne a n d/ or seas o nal i nfl ue nza v acci n e  bet we e n 1 1 Se pte m ber  
2 0 2 3 a n d e n d of d ata.  
3)  At least o ne year of p har mac y a n d me dical e nr oll me nt i n Healt h Verit y pri or t o i n de x date 
(earliest va cci nati o n dat e is i n de x date). A ga p of u p t o 3 0 da ys will be all o we d.   
4)  Ha ve bee n a State of C alif or nia / L o uisia na resi de nt f or at least o ne y ear pri or t o i n de x date  
8. 2. 2.  E xcl usi o n C riteri a 
E xcl usi o n criteria are s p ecifie d b y eac h st u d y ai m. Wit hi n eac h ai m, patie nts  meeti n g  a n y of t he 
f oll o wi n g criteria will n ot be i ncl u de d i n t he st u d y:   
8. 2. 2. 1.  Ai m 1 E xcl usi o n Criteri a  
1)  C urre ntl y p re g na nt ( usi n g a vali date d gestati o nal a ge al g orit h m wit h u p t o 9 m o nt hs  
l o o k bac k) or i m m u n oc o m pr o mise d ( usi n g all-a vaila ble l o o k bac k) at t he ti me of st u d y i n de x1 8 
(c o de list t o be liste d i n t he a p pe n di x) 
2)  I n di vi d uals wit h discre pa ncies i n se x a n d/ or year of birt h bet wee n Healt h Verit y clai ms a n d 
Calif or nia / L o uisia na i m m u nizati o n re gistr y datas ets. 
3)  Pers o ns wit h a dia g n osis of C O VI D -1 9  i n a n y s etti n g ≤ 9 0 da ys pri or t o i n de x ( F D A E U A 
date per vacci n e)    
4)  Recei pt C O VI D -1 9  v acci ne ≤ 9 0 da ys pri or t o i n d e x ( F D A E U A date per vacci ne)   
8. 2. 2. 2.  Ai m 2 E xcl usi o n Criteri a  
1)  C urre ntl y p re g na nt ( usi n g a vali date d gestati o nal a ge al g orit h m wit h u p t o 9 m o nt hs 
l o o k bac k) or i m m u n oc o m pr o mise d ( usi n g all-a vaila ble l o o k bac k) at t he ti me of st u d y i n d e x 
(c o de list t o be liste d i n t he a p pe n di x) 
2)  I n di vi d uals wit h discre pa ncies i n se x a n d/ or year of birt h bet wee n Healt h Verit y clai ms a n d 
Calif or nia / L o uisia na i m m u nizati o n re gistr y datas ets. 
3)  Pers o ns wit h a dia g n osis of C O VI D -1 9  i n a n y s etti n g ≤ 9 0 da ys pri or t o i n de x ( F D A E U A 
date per vacci n e a n d a g e gr o u p)    
4)  Recei pt C O VI D -1 9  v acci ne ≤ 9 0 da ys pri or t o i n d e x ( F D A E U A date per vacci ne)   
8. 2. 2. 3.  Ai m 3 A  E xcl usi o n Criteri a  
F or eac h of a d ult a n d pe diatric:  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 1  of 4 6  
1.  C urre ntl y pre g na nt  ( usi n g a vali date d gestati o nal a ge al g orit h m wit h u p t o 9 m o nt hs 
l o o k bac k) or i m m u n oc o m pr o mise d ( usi n g all-a vaila ble l o o k bac k) at t he ti me of st u d y i n de x 
(c o de list t o be liste d i n t he a p pe n di x) 
2.  I n di vi d uals wit h discre pa ncies i n se x a n d/ or year of birt h bet wee n Healt h Verit y clai ms a n d 
Calif or nia / L o uisia na i m m u nizati o n re gistr y datas ets.   
3.  I n di vi d uals w h o w ere vacci nate d wit hi n 1 3 da y of i n de x.  
4.  I n di vi d uals w h o h a d a c h a n ge i n vacci nati o n stat us c ha n ge d d uri n g f oll o w-u p (i.e. patie nts 
w h o recei ve d a v acci n ati o n d ur i n g h os pitalizati o n).  
8. 2. 2. 4.  Ai m 3 B E xcl usi o n Criteri a  
F or eac h of a d ult a n d pe diatric:  
•  C urre ntl y pre g na nt ( usi n g a vali date d gestati o nal a ge al g orit h m wit h u p t o 9 m o nt hs 
l o o k bac k) or i m m u n oc o m pr o mise d ( usi n g all-a vaila ble l o o k bac k) at t he ti me of st u d y i n de x 
(c o de list t o be liste d i n t he a p pe n di x) 
•  I n di vi d uals wit h discre pa ncies i n se x a n d/ or year of birt h bet wee n Healt h Verit y clai ms a n d 
Calif or nia / L o uisia na i m m u nizati o n re gistr y datas ets.   
•  I n di vi d uals wit h a dia g n osis of C O VI D -1 9  i n a n y setti n g ≤ 9 0 da ys pri or t o i n de x. 
•  I n di vi d uals w h o w ere vacci nate d wit hi n 1 3 da y of i n de x.  
•  I n di vi d uals w h o h a d a c h a n ge i n vacci nati o n stat us c ha n ge d d uri n g f oll o w-u p.   
 
8. 2. 2. 5.  Ai m 4 E xcl usi o n Criteri a  
1)  C urre ntl y p re g na nt ( usi n g a vali date d gestati o nal a g e al g orit h m wit h u p t o 9 m o nt hs 
l o o k bac k) at t he ti me of st u d y i n de x (c o de list t o be liste d i n t he a p pe n di x)  
2)  I n di vi d uals wit h discre pa ncies i n se x a n d/ or year of birt h bet wee n Healt h Verit y clai ms a n d 
Calif or nia / L o uisia na i m m u nizati o n re gistr y datas ets.   
3)  Pers o ns wit h a dia g n osis of C O VI D -1 9  i n a n y s etti n g ≤9 0 da ys pri or t o i n de x ( F D A E U A 
date per vacci n e)  
4)  Recei pt C O VI D -1 9  v acci ne ≤ 9 0 da ys pri or t o i n d e x ( F D A E U A date per vacci ne)   
8. 2. 2. 6.  Ai m 5 E xcl usi o n Criteri a  
1)  C urre ntl y p re g na nt ( usi n g a vali date d gestati o nal a ge al g orit h m wit h u p t o 9 m o nt hs 
l o o k bac k) or i m m u n oc o m pr o mise d ( usi n g all-a vaila ble l o o k bac k) at t he ti me of st u d y i n de x 
(c o de list t o be liste d i n t he a p pe n di x) 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 2  of 4 6  
2)  I n di vi d uals wit h discre pa ncies i n se x a n d/ or year of birt h bet wee n Healt h Verit y clai ms a n d 
Calif or nia / L o uisia na i m m u nizati o n re gistr y datas ets.   
3)  D ie d, dise nr olle d, ha d a C O VI D -1 9  or i nfl u e nza dia g n osis, or recei ve d a s ec o n d d ose of 
eit her vacci ne ≤1 4 da ys after t heir first d ose  
4)  Pers o ns wit h a dia g n osis of C O VI D -1 9  i n a n y s etti n g  ≤9 0 da ys pri or t o i n de x  ( vacci n ati o n 
date)  
5)  R ecei ve d i nfl ue n za vacci ne bet wee n A u g ust 1 -Se pte m ber  1 0 , 2 02 3 , as t hes e pers o ns are n ot 
at ris k of c oa d mi nistrati o n wit h a n X B B. 1. 5 m o n o vale nt vacci ne gi ve n t his peri o d pre d ates 
its a vaila bilit y. 
6)  R ecei ve d a n y t y p e of C O VI D -1 9  vacci ne ot h er t ha n B N T 1 6 2 b 2  X B B. 1. 5  o n t he i n de x date  
7)  F or patie nts > = 6 5, ha d a sta n dar d d ose i nfl ue n za v acci ne or u n k n o w n t y pe i nfl ue nza v acci n e.  
8. 3.  V ari a bles  
T A B L E 3 . E X P O S U R E V A RI A B L E S  
V ari a ble  
D at a s o urce(s)  
O per ati o n al defi niti o n  
B N T 1 6 2 b 2 X B B. 1. 5  
m R N A vacci ne after F D A 
a ut h orizati o n date a n d 1 4 
or m ore da ys  
Calif or nia / L o uisia na 
I m m u nizati o n Re gistr y as 
well as H V Clai ms  
Vacci n es will be e n u merate d as per 
secti o n 8. 2. Date of v acci nati o n will 
be use d t o assess ti me -base d 
i ncl usi o n/e xcl usi o n criteria. 
B N T 1 6 2 b 2 B A. 4/ 5 
m R N A vacci ne after F D A 
a ut h orizati o n date a n d 1 4 
or m ore da ys  
Calif or nia / L o uisia na 
I m m u nizati o n Re gistr y as 
well as H V Clai ms  
Vacci n es will be e n u merate d as per 
secti o n 8. 2. Date of v acci nati o n will 
be use d t o assess ti me-base d 
i ncl usi o n/e xcl usi o n criteria. 
I nfl ue nza vacci ne 
H V Clai ms  
I d e ntifie d usi n g N D C or C P T c o de 
 
T A B L E 4 . O U T C O M E V A RI A B L E S  
V ari a ble  
D at a 
s o urce(s) 
O per ati o n al defi niti o n  
C O VI D -1 9  dia g n osis  
H V Clai ms  
A n y e nc o u nter re g ar dless of dia g n osis p ositi o n or 
setti n g wit h I C D-1 0 -C M c o de: U 0 7. 1  
C O VI D -1 9  h os pitalizati o n  
H V Clai ms  
I n p atie nt e nc o u nter at a n ac ute care facilit y wit h 
I C D-1 0 -C M c o de: U 0 7. 1  “ C O VI D -1 9 ” liste d i n 
a n y dia g n osis p ositi o n  
C O VI D -1 9  e m er ge n c y 
de part me nt visit  
H V Clai ms  
E mer ge nc y d e part me nt visit wit h I C D -1 0 -C M 
c o de: U 0 7. 1  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 3  of 4 6  
V ari a ble  
D at a 
s o urce(s) 
O per ati o n al defi niti o n  
C O VI D -1 9  o ut patie nt 
e nc o u nter  
H V Clai ms  
O ut patie nt e nc o u nter wit h I C D -1 0 -C M c o de: 
U 0 7. 1  
C O VI D -1 9  critical ill ness  
H V Clai ms  
I nte nsi v e care u nit [I C U] a d missi o n, mec ha nical 
ve ntilati o n, or i n patie nt deat h  
All -ca use m ortalit y  
H V 
M ortalit y 
Data base  
Healt h Verit y I D i n M ortalit y Data base  
N o n -C O VI D -1 9  res pir at or y 
i nfecti o ns ( p ne u m o nia, R S V, 
r hi n o vir us, a nti bi otic 
prescri pti o ns)  
H V Clai ms  
A n y e nc o u nter re g ar dless of setti n g wit h I C D -1 0 -
C M c o de f or dia g n osis or N D C c o des f or 
a nti bi otics ( C o des i n A n ne x)  
H os pitalizati o n le n gt h of sta y 
( da ys) 
H V Clai ms  
Da te of ser vice e n d –  dat e of ser vice  
I C U a d missi o n 
H V Clai ms  
As per Healt h Verit y’s s u g gesti o n, I C U relate d 
ser vices/i n patie nt sta ys will be f o u n d o n 
I nstit uti o nal clai ms, a n d ca n be i de ntifie d usi n g 
re ve n ue c o des (c o des i n A n ne x). 
I n v asi ve ve ntilati o n 
H V Clai ms  
C P T, H C P C S a n d I C D -1 0 (c o des i n A n ne x)  
C ost of h os pitalizati o n  
H V Clai ms  
Usi n g Healt h Verit y’s  
“ Pr o x y Fi na ncial Al g orit h m”, base d o n C M S 
Me dicare pr os pecti ve pa y me nt s yste m fee 
sc he d ules 
I nfl ue nza dia g n osis 
H V Clai ms  
A n y e nc o u nter re g ar dless of setti n g wit h I C D -1 0 -
C M c o de: J 0 9 -J 1 1 
I nfl ue nza h os pitalizati o n 
H V Clai ms  
I n p atie nt e nc o u nter wit h I C D-1 0 -C M c o de: J 0 9 -
J 1 1 liste d as i n a n y dia g n osis p ositio n  
I nfl ue nza e mer g e nc y 
de part me nt  visit  
H V Clai ms  
E mer ge nc y d e part me nt visit wit h I C D -1 0 -C M 
c o de: J 0 9 -J 1 1 
I nfl ue nza o ut patie nt e nc o u nter 
H V Clai ms  
O ut patie nt e nc o u nter wit h I C D -1 0 -C M c o de: 
J 0 9-J 1 1 
Ne gati ve c o ntr ol o utc o m e, s uc h 
as acci d e ntal i nj ur y, i n gr o w n 
t oe nail or at o pic der matitis 
H V Clai ms  
A n y  e nc o u nter re g ar dless of setti n g, wit h I C D -
1 0 -C M c o de f or  n e gati ve c o ntr ol o utc o mes  
(c o des i n a n n e x) 
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 4  of 4 6  
T A B L E 5 . C O V A RI A T E S  
V ari a ble  
D at a s o urce(s)  
O per at i o n al defi niti o n 
A ge  
H V 
Clai ms/ C A R  
A ge assesse d at i n de x dat e. W here n ot stratifie d, 
a ge will be a dj uste d as:  
 
F or ai ms 1  a n d 4, a ge will be directl y a dj uste d 
usi n g  i n dicat or varia bles f or 1 8 -4 9, 5 0 -6 4 a n d 6 5 + .  
 
F or ai m 2, a g e will be dir ectl y a dj uste d usi n g 
i n dicat or varia bles f or < 5 years, 5-1 1  a n d 1 2-1 7 
years.  
 
F or ai m 5, a g e will be i ncl u de d i n t he pr o pe nsit y 
sc ore as a c o nti n u o us varia ble.   
Se x  
H V 
Clai ms/ C A R  
Se x assesse d at i n de x date as male, fe male or 
u n k n o w n. M o dels will be a dj uste d f or se x w he n n ot 
stratifie d b y se x.  
State of resi de nce  
H V Clai ms  
M o dels will be a dj uste d f or state ( Calif or nia or 
L o uisia na) , e xce pt t h ose w hic h are str atifie d b y 
state.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 5  of 4 6  
C D C -defi ne d hi g h ris k f or 
se vere C O VI D -1 9 2 4 
H V Clai ms  
Assesse d usi n g all a vaila ble l o o k bac k data , wit h 
hi g h ris k defi ne d as at least o ne of t he f oll o wi n g : 
•  A ge ≥ 5 0 years  
•  Ast h ma  
•  Ca ncer , as h e mat ol o gic mali g na ncies  
•  Cere br o vas c ular dise ase  
•  C hr o nic ki d ne y disease : p e o ple recei vi n g 
dial ysis  
•  C hr o nic l u n g diseases: br o nc hiectasis, C O P D, 
i nterstitial l u n g disease, p ul m o nar y e m b olis m, 
p ul m o nar y h y perte nsi o n  
•  C hr o nic li ver diseases: cirr h osis, n o n -alc o h olic 
fatt y li ver disease, alc o h olic li ver disease, 
a ut oi m m u ne he patitis  
•  C ystic fi br osis  
•  Dia betes mellit us, t y pe 1  
•  Dia betes mellit us, t y pe 2  
•  Disa bilities, i ncl u di n g D o w n s y n dr o me  
•  Heart c o n diti o ns : heart fail ure, c or o nar y art er y 
disease, or car di o m y o pat hies  
•  HI V  
•  Me ntal healt h c o n diti o ns: m o o d dis or ders 
i ncl u di n g de pressi o n; Sc hiz o p hre nia s pectr u m 
dis or ders  
•  Ne ur ol o gic c o n diti o ns li mite d t o de me ntia  
•  O besit y ( B MI ≥3 0 k g/ m 2 or ≥9 5 t h perce ntile i n 
c hil dre n)  
•  P h ysical i nacti vit y  
•  Pri mar y i m m u n o deficie ncies  
•  S m o ki n g, c urre n t a n d f or mer 
•  S oli d or ga n or bl o o d ste m tra ns pla ntati o n  
•  T u berc ul osis  
•  Use of c ortic oster oi ds or ot her 
i m m u n os u p pressi ve me dicati o ns 
 
N ote: r aci al/et h nic mi n ority st at us is i ncl u de d i n 
t he hi g h risk defi niti o n, b ut n ot i ncl u de d i n 
He alt h Verity d at a a n d t heref ore u n a ble t o be 
assesse d. Pre g n a ncy is i ncl u de d i n t he hi g h risk 
defi niti o n, b ut is a n excl usi o n criteri a f or e ac h ai m 
i n t his pr ot oc ol a n d t heref ore is n ot liste d here. 
Give n t he n at ure of a d mi nistr ative cl ai ms d at a, 
o besity, p hysic al i n activity, a n d s m o ki n g are likel y 
t o be u n derc a pt ure d.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 6  of 4 6  
V ari a ble  
D at a s o urce(s)  
O per at i o n al defi niti o n 
C harls o n -De y o  
C o m or bi dit y In de x ,2 5 
o perati o nalize d as sc ores 
of 0, 1 or 2 usi n g  
H V Clai ms  
Assesse d usi n g all -a vaila ble l o o k bac k data . C o des 
are i n a n ne x, a n d c o n diti o ns are sc ore d as:  
 
1 p oi nt f or eac h of:  
•  M y ocar dial i nfarcti o n  
•  C H F  
•  Peri p heral vas c ular dise ase  
•  Cere br o vas c ular dise ase  
•  De me ntia  
•  C hr o nic p ul m o nar y disease  
•  C o n necti ve tiss ue disease  
•  Pe ptic ulcer diseas e  
•  Mil d l i ver disease 
•  Dia betes mellit us  wit h o ut c hr o nic 
c o m plicati o ns  
 
2 p oi nts f or eac h of:  
•  He mi ple gia  
•  M o derate t o se v ere re nal disease 
•  Dia betes wit h c hr o ni c c o m plicati o ns  
•  Ca ncer, i ncl u di n g le u k e mia a n d l y m p h o ma  
 
3 p oi nts f or m o derate or se vere li ver disease  
 
6 p oi nts f or eac h of:  
•  Metastatic carci n o ma  
•  HI V/ AI D S  
 
Recei pt of s kille d n ursi n g 
care a n d/ or l o n g -ter m care 
facilit y sta y i n year pri or 
t o i n de x 
H V Clai ms  
C o des i n A n ne x  
Well ness visit  
H V Clai ms  
C o des i n A n ne x  
Decrease d f u ncti o nal 
stat us 
H V Clai ms  
C o des i n A n ne x  
Infl ue nza vacci nati o n  i n 
year pri or t o i n de x  
H V Clai ms  
Vacci n es will be e n u merate d as per secti o n 8. 2.  
I nfl ue nza vacci nes are rec o m me n de d a n n u all y, a n d 
t heref ore we will meas ure i nfl ue nza v acci nati o n i n 
pri or year.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 7  of 4 6  
V ari a ble  
D at a s o urce(s)  
O per at i o n al defi niti o n 
P ne u m oc occal v acci nati o n  
usi n g all -a vaila ble ti me 
pri or t o i n de x  
H V Clai ms  
Vacci n es will be e n u merate d as per secti o n 8. 2. 
P ne u m oc occal v acci nati o ns are ge n erall y n ot 
re peat e d e ve nts, a n d t heref ore we will use all-
a vaila ble l o o k bac k data t o assess recei pt.  
H er pes z oster vacci nati o n  
usi n g all -a vaila ble ti me 
pri or t o i n de x  
H V Clai ms  
Vacci n es will be e n u merate d as per secti o n 8 . 2. 
Her pes z oster vacci nati o ns are ge n erall y n ot 
re peat e d aft er pri mar y series, a n d t heref ore we will 
use all -a vaila ble l o o k b ac k data t o assess recei pt.  
O ut patie nt visits pri or t o 
i n de x  
H V Clai ms  
N u m ber of  o ut patie nt visit (s) i n 1 8 0 da ys pri or t o 
i n de x 
In p atie nt a d missi o n (s) 
pri or t o i n de x  
H V Clai ms  
N u m ber of  i n patie nt a d missi o n(s) i n 1 8 0 da ys pri or 
t o i n de x 
T ele healt h visits pri or t o 
i n de x 
H V Clai ms  
N u m ber of t ele healt h e n c o u nter s (C P T: 9 9 2 0 1 -
9 9 2 1 5 ) i n 1 8 0 da ys pri or t o i n de x 
N u m ber of d oc u m e nte d 
S A R S -C o V -2 tests i n t he 
1 8 0 da ys pri or t o i n de x  
H V Clai ms  
N u m ber of visits i n a n y setti n g wit h C P T: 8 6 4 0 8, 
8 6 4 0 9, 0 2 2 5 U, 0 2 2 6 U  
Pri or p ost -C O VI D -1 9  
c o n diti o ns  
H V Clai ms  
Usi n g all -a vaila ble l o o k b ac k data, a n y e n c o u nter 
re gar dl ess of setti n g wit h I C D-1 0 -C M U 0 9. 9  “ P ost -
C O VI D -1 9 c o n diti o n”  
F or ai m 5 o nl y 
(c oa d mi nistrati o n): 
N u m ber of d oc u m e nte d 
i nfl ue nza tests i n t he 1 8 0 
da ys pri or t o i n de x  
H V Clai ms  
N u m ber of visits i n a n y setti n g wit h C P T: 8 7 4 0 0  
F or ai m 5 o nl y 
(c oa d mi nistrati o n): Li pi d 
a n d/ or H b A 1 C la bs i n t he 
1 8 0 da ys pri or t o i n de x  
H V Clai ms  
E nc o u nter wit h C P T: A 5 6 6 8 6 . T hese la bs were 
selecte d as p ot e ntial meas ures of healt h s yste m 
usa ge , as pe o pl e w h o m o nit or t heir li pi ds or bl o o d 
g l uc ose ma y s hare s o me be ha vi ors as v acci nati o ns. 
We are a ble t o i nc or p orat e  t his i n pr o pe nsit y sc ore 
a dj uste d a nal yses (ai m 5) b ut n ot a nal yses wit h 
direct a dj ust me nt (ai m 1, 2 a n d 4), gi ve n t he nee d 
f or s maller sets of c o vari ates. 
F or ai m 5 o nl y 
(c oa d mi nistrati o n): 
vacci ne a d mi nistrati o n 
setti n g 
Calif or nia 
/ L o uisia na 
Vacci n e 
Re gistr y  
As p har mac y, d o ct or’s office, or ot her.  
 
8. 4.  D at a S o urces   
T his st u d y will use vacci nati o n data fr o m t he Calif or nia / L o uisia na I m m u ni zati o n Re gistr y li n ke d t o 
cl ose d clai ms f or p atie nts i n Calif or nia s o urce d fr o m Healt h Verit y.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 8  of 4 6  
8. 4. 1.  C alif or ni a  a n d L o uisi a n a  I m m u niz ati o n Re gistr y 
T he Calif or nia I m m u nizati o n Re gistr y is r u n b y t he Calif or nia De p art me nt of P u blic Healt h a n d 
c ollects nearl y all rec or ds of C O VI D -1 9  v acci n ati o ns a d mi nistere d i n t he state of Calif or nia. Sites 
e xe m pte d fr o m r e p orti n g are t he De part me nt of Defe nse, Vetera ns Affairs a n d I n dia n Healt h 
Ser vices ; t hese sites are n ot i ncl u de d i n t he re gistr y  a n d will n ot c o ntri b ute t o a n y o bjecti ve herei n . 
I n t he J ul y 2 0 2 3 d eli ver y of t hese data, t h ere were 8 8 milli o n C O VI D -1 9  v acci nati o ns r ec or de d f or 
3 2 milli o n u ni q ue i n di vi d uals. I n t his deli ver y, we i de ntifie d 7 2. 2 % of pers o ns ha d recei ve d at least 
t w o wil d t y pe vacci ne d oses ( n ote: f or n o n-i m m u n oc o m pr o mise d pers o ns o ver a ge 5 t his re pres e nts 
t he c o m pleti o n of pri mar y vacci nati o n series), wit h Calif or nia’s state das h b oar d2 6 re p orte d 7 2. 9 %. 
Si milarl y, we i de ntifie d 2 0. 9 % of pers o ns  i n t he re gistr y ha vi n g recei v e d at least o ne bi vale nt 
vacci ne d os e, as c o m p are d t o Calif or nia state’s esti mate of 2 1. 2 %.  
Data i ncl u de a u ni q ue Healt h Verit y pers o n i de ntifi cati o n c o de, v acci nati o n e ve nt date a n d Cli nical 
V acci n es A d mi nistere d ( C V X) c o de . C V X c o des are u ni q ue t o bra n d a n d f or m ulati o n  of vacci n e.  
Data is li n ke d usi n g Healt h Verit y’s t o ke nizati o n s oft ware, w here b y s pecific patie nt i de ntifiers are 
passe d t hr o u g h t he s oft w are a n d a de -i de ntifie d patie nt I D is assi g ne d. T h e sa me t o ke nizati o n 
pr ocess is a p plie d t o cl os e d clai ms s o urce d b y H ealt h Verit y, a n d patie nts c a n t h us be li n ke d acr oss 
data s o urces. T he t o ke nizati o n pr ocess occ urs o utsi de of Pfizer, n o p ers o nal i de ntif yi n g i nf or mati o n 
will be tra nsferre d, a n d Pfizer will o nl y ha ve access t o de -i de ntifie d data. T he data c o m pl y wit h 
Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y A ct ( HI P A A) re g ulati o ns.  
T he L o uisia na Vacci ne R e gistr y is str uct ure d a n d accesse d i n t he sa me wa y as Calif or nia.  
8. 4. 2.  He alt h Verit y’s A d mi nistr ati ve Cl ai ms D at a  
Healt h Verit y  cl os e d clai ms will be li mite d t o a p pr o xi matel y 1 9 milli o n patie nts resi di n g i n 
Calif or nia  a n d a p pr o xi matel y 3 . 8 milli o n i n L o uisia na . Patie nts w h o were Calif or nia /L o uisia na  
resi de nts i n t he Healt h V erit y clai ms data base will be defi ne d usi n g t he f oll o wi n g hierarc hical 
defi niti o n:  
1.  Pers o ns w h o ha ve t heir m ost rece nt e nr oll me nt file rec or d i n dicati n g a pati e nt l ocati o n of 
Calif or nia  or L o uisia na  i n Healt h Verit y cl ai ms e nr oll me nt file.  
2.  Pers o ns w h o ha ve a pat ie nt state l ocati o n ot her t ha n Calif or nia/ L o uisia na  i n Healt h Verit y 
clai ms e nr oll me nt b ut ha ve o ne or m ore rec or ds i n t he Calif or nia / L o uisia na  I m m u nizati o n 
Re gistr y. Ex a m ples i ncl u de pe o ple w h o previ o usly live d i n Tex as b ut m ove d t o C alif or ni a 
a n d receiv e d a v acci ne, or pers o ns w h o cr osse d st ate li nes f or a v acci ne a n d re m ai n i n t heir 
n o n -C alif or ni a st ate i n cl ai ms d at a.  
Healt h Verit y’s d escri pti o n of t heir data is t hat t he y are ge n erall y re prese ntati ve of t he a ge a n d se x 
distri b uti o n of t he p o p ulati o n . F or o ur s pecific res earc h c o nte xt, sa m ples cr eate d fr o m Healt h Verit y 
clai ms als o ge nerall y f oll o w Calif or nia’s de m o gr a p hic patter ns wit h res p ect t o a ge & se x. H o we v er, 
t here are se v eral ca veats t o n ote. O ur clai ms p o p ulati o n is sli g htl y m ore fe male a n d y o u n g pe o ple 
( partic ularl y a ge 5-1 7) are o verre pres e nte d i n o ur clai ms relati ve t o ot her gr o u ps.  C hil dre n u n der 5, 
a n d a d ults 6 5 +, are sli g htl y u n derre prese nte d.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2 9  of 4 6  
T he  Calif or nia s u bset of Healt h Verit y d oes n ot i n cl u de patie nts i n t he Kais er Per ma ne nte net w or k.  
I ns urers c o ntri b uti n g t o cl ose d clai ms i n b ot h states i ncl u de a mi x of c o m m ercial pa y ers, Me di care 
A d va nta ge/ Part C pai ns, a n d Me dicai d Ma n a ge d Care pla ns . Data ele me nts i ncl u de patie nt 
de m o gra p hic i nf or m ati o n, i n patie nt/ o ut patie nt visit -le vel i nf or mati o n s uc h as dia g n oses, pr oce d ures, 
a n d le n gt h of sta y, h os pital c haracteristics, a n d me dicati o n i nf or mati o n. O wi n g t o t he nat ure of 
clai ms, t he data re pres e nt  t he fi nal set of dia g n oses o ver t he c o urse of t he h os pitalizati o n se nt t o t he 
patie nt’s i ns urer f or rei m b urse me nt, wit h dia g n osis pri oritizati o n assi g ne d b y cli nicia ns  or h os pital 
staff. F or i n patie nt e nc o u nters, t he data will be ass u me d  t o re pres e nt t he o v erarc hi n g e ve nts d uri n g 
h os pitalizati o n a n d  ma y be less s u bject t o r ule o ut dia g n os is c o des t ha n electr o nic healt h rec or d  d ata .   
Deat h i nf or mati o n is a vaila ble a n d is s o urce d fr o m o ver 4 0, 0 0 0 p u blic a n d pri vate s o urces 
nati o nall y. T he c o vera ge rate, esti mate d at o v er 9 0 % of C D C re p orte d d eat hs t hr o u g h prese nt da y, is 
base d o n t he n u m ber of deat hs i n t he Fact of Deat h M ortalit y I n de x c o m pare d t o t he n u m ber of 
deat hs re p ort e d b y t he C D C. D ue t o HI P A A pri vac y restricti o ns, date of deat h is re p orte d  as m o nt h 
a n d year. C a use of deat h is n ot a vaila ble.  
8. 4. 3.  C o m p aris o n t o Ot her Re al -W orl d D at a S o urces  
T he res ults of t his st u d y ma y differ fr o m t h ose pr o d uce d i n ot her real -w orl d datasets , f or reas o ns 
i ncl u di n g b ut n ot li mite d t o: 
•  Healt h Verit y is a n a d mi nistra ti ve clai ms data s o urce.  
o  Clai ms data c o ntai n rec or ds of all me dical e n c o u nters t hat were bille d t o t he i ns urer. 
Gi ve n t he o ut -of -p o c ket  c ost t hat w o ul d be i nc urre d if e nc o u nters were n ot bille d t o 
t he i ns urer, it is reas o n a ble t o ass u me t hat a d mi nistrati v e clai ms s h o ul d ca pt ure  
nearl y all e n c o u nters w h ereas a l ocal E H R w o ul d ha ve c o v era g e of e n c o u nters  i n 
t heir h os pital net w or k b ut n ot o utsi de.  
o  Clai ms data c o ntai n e nr oll me nt rec or ds, w hic h are use d t o i m ple me nt c o nti n u o us 
e nr oll me nt re q uire m e nts i n or der t o ascertai n pr e vi o us me dical hist or y m ore f ull y. 
Gi ve n c o m or bi d c o n diti o ns are i m p orta nt ris k f act ors f or se v ere C O VI D -1 9 2 4, 
ma xi mal ca pt ure is cr uci al t o be gi n t o a d dress p ot e ntial c o nf o u n di n g i n o bser vati o nal 
researc h. 
o  I n ma n y E H R data bas es, t here is n o wa y t o e ns ure a n i n di vi d ual is ca pt ure d i n t he 
data l o n git u di nall y, e xce pt t hr o u g h healt hcare e n c o u nters.  
•  T he use of a retr os p ecti v e c o h ort rat her t ha n T N D all o ws f or esti mati o n of ris k rat her t ha n 
o d ds.  
•  T he p o p ulati o n  i n t he li n ke d state vacci ne re gistr y wit h i ns ura nce cl ai ms data is f o ur ti mes 
t he size of t he K aiser Per ma ne nte S o ut her n Calif or nia ( K P S C) p o p ulati o n ( 1 8. 4 milli o n 
vers us 4. 8  milli o n) . Ha vi n g m ore pe o ple i n t he dat aset mea ns t here are li kel y t o be m ore 
e vents, w hic h is partic ularl y i m p orta nt gi ve n t he ra pi d res p o nse nat ur e of t h e X B B. 1. 5 
vacci ne e val uati o ns pla n ne d.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 0  of 4 6  
Of n ote, fi n di n gs are e x p ecte d t o be c o m ple me ntar y (all s h o wi n g pr otecti v e effect of v acci n ati o n, b ut 
per ha ps of v ar yi n g ma g nit u des a n d statis tical precisi o n). Si milar p o p ulati o ns  wit h a mi x of 
c o m mercial, Me di care A d va nta ge a n d M e dicai d Ma na ge d Care s o urces are e x pecte d i n b ot h K P S C 
a n d t he c o m bi ne d set of Calif or nia vacci ne re gistr y a n d i ns ura nce clai ms.  
T h us, t here is utilit y i n p ote ntial differe n ces bet wee n t his data s o urce a n d ot hers. T he p ote ntial t o use 
clai ms data f or V E st u dies will pr o vi de s u p p ort f or f ut ure e n d ea v ors , ma y res ult i n c ost sa vi n gs of 
milli o ns of d ollars o ver ti me,  a n d pr o m otes Pfizer’s c o m mit me nt t o i n n o vati o n.  
8. 5.  St u d y S ize 
Si nce t he c urre nt st u d y utilizes retr os pecti ve dei de ntifie d data wit h o ut a bilit y t o recr uit t o a tar g et, 
sa m ple size calc ulati o ns are n ot a p plic a ble. F urt her, t his is a descri pti ve st u d y wit h o ut a pri ori  
s pecifie d h y p ot heses.  
I nitial data feasi bilit y w or k has re v eale d a p pr o xi m atel y 1 9 milli o n pers o ns i n t he state of Calif or nia 
wit h clai ms a vaila ble i n Healt h Verit y , a m o n g w hi c h a p pr o xi matel y 2 5 % are pe diatric  a n d 7 5 % 
a d ult . A m o n g t hese, a p pr o xi matel y 1 2 milli o n ha ve at least o ne y ear of c o nti n u o us me dic al a n d 
p har mac y e nr oll me nt. B y e n d of 2 0 2 3, we e x pect t o ha ve fi nis he d c o ntr acti n g t o a d d a p pr o xi matel y 
5 6 5, 0 0 0 a d diti o nal pers o ns. T he pr o p orti o n of t hese a d diti o nal pers o ns w h o will ha ve 1 -year 
c o nti n u o us e nr oll me nt, a n d t heref ore t he sa m ple size esti mates bel o w h a ve ta ke n t he c o nser vati ve 
a p pr oac h t o n ot yet i ncl u de t hese pe o ple.  
We ha v e i de ntifie d 6 3 % of pers o ns i n t he clai ms data ha ve at least o ne C O VI D -1 9  vacci ne, a n d 1 6 % 
recei v e d at least o ne bi v ale nt d ose. T he clai ms p o p ulati o n we ha ve is n ot a ra n d o m sa m ple of 
Calif or nia ns a n d ma y differ fr o m t he state’s p o p ul ati o n i n s yste matic wa ys (e. g. t he a g e distri b uti o n). 
W hile differe nces ma y e xist, we ha ve hi g h c o nfi d e nce i n o ur a bilit y t o re prese nt vacci nati o n stat us 
f or t he i n di vi d uals i n o ur clai ms p o p ulati o n.  
We e x p ect t o be gi n t o see X B B d oses i n data deli vere d i n N o ve m b er 2 0 2 3. Ass u mi n g  u pta ke si milar 
t o t hat see n wit h t he B A. 4/ 5 vacci ne, a n d n o n-differe ntial u pta ke b y a ge gr o u ps, we c o ul d a ntici pate  
i n Calif or nia: 
( 2 5 % of 12  milli o n are p e diatric) *( 1 6 % u pta ke) *( 6 0 % of d oses were Pfizer -Bi o N Tec h)   
~ 2 8 8 , 0 0 0 pe diatric X B B d oses  i n Calif or nia 
( 7 5 % of 12  milli o n are a d ult) *( 1 6 % u pta ke) *( 6 0 % of d oses were Pfizer -Bi o N Tec h)  
 ~ 8 6 4 , 0 0 0 a d ult X B B d oses i n Calif or nia 
A d diti o nal d oses will be o bser ve d i n L o uisia na. I n or der t o mai ntai n patie nt de-i de ntificati o n, 
o utc o mes, c o vari ates a n d s u b gr o u ps will ha ve at least 1 0 pe o ple i n eac h cate g or y f or i ncl usi o n i n 
o ut p uts. T hr o u g h o ut t he pr ot oc ol, t his is referre d t o as “ If sa m ple size all o ws”.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 1  of 4 6  
8. 6.  D at a M a n a ge me nt  
Clai ms a n d vacci ne re gistr y d ata refres h es are deli vere d b y Healt h Verit y m o nt hl y, a n d m ortalit y data 
a n n uall y.  
All Healt h Verit y  str uct ur e d data des cri be d a b o ve are st ore d wit hi n Pfizer’s data i nfrastr u ct ure. Data 
are q uerie d a n d a nal yz e d usi n g S A S.  T he Healt h Verit y clai ms, m ortalit y , a n d dei de ntifie d State of 
Calif or nia  a n d L o uisia na  vacci ne re gistr ies are st or e d as se parate data bas es.  T he data are o nl y 
accessi ble t o Pfizer c ollea g ues w h o ha v e bee n trai ne d a n d a p pr o ve d t o access Pfizer’s data 
ware h o us e.  
I n brief, all pers o ns li vi n g i n t he state of Calif or ni a  or L o uisia na  will be e xtracte d fr o m t he nati o nal 
data deli ver y, a n d , w here a p plica ble,  c orres p o n di n g rec or ds i n t he Calif or nia /L o uisia na  
I m m u nizati o n Re gistr y f or t h ose Healt h Verit y pers o n i de ntificati o n n u m bers will be e xtract e d.  
 
8. 7.  D at a A n al ysis  
Detaile d met h o d ol o g y f or s u m mar y a n d statistical a nal yses of d ata c ollect e d i n t his st u d y will be 
d oc u me nte d i n a statistical anal ysis p la n ( S A P), w hic h will be date d, file d, a n d mai ntai ne d b y t he 
s p o ns or.  T he S A P ma y m o dif y t he pla ns o utli ne d i n t he pr ot oc ol; a n y maj or m o dificati o ns of 
pri mar y e n d p oi nt defi niti o ns or t heir a nal yses w o ul d be reflecte d i n a pr ot o c ol a me n d me nt . 
T hr o u g h o ut, we will use missi n g data i n dicat or varia bles f or a bse nce of val ues i n cate g ori cal 
varia bles (s u c h as i ns ura nce pa y or) a n d e xcl u de pers o ns wit h missi n g data i n c o nti n u o us varia bles 
(a ge). Usi n g i n dicat or varia bles rat her t ha n i m p utati o n all o ws f or t he missi n g data patter ns t o be 
mat he maticall y i nf or mati ve. Varia bl es wit h data d eli vere d of stri n gs as ‘ Missi n g’ or ‘ U n k n o w n’ 
va l ues will be re p ort e d a n d a nal yze d as se parate cate g ories a n d i n cl u de d i n t he t otals. 
All ste ps will be c o m plete d usi n g S A S versi o n 9. 4 a n d/ or R.  
 
8. 7. 1.  Ai m 1  
T o e v al u ate t he V E  of B N T 1 6 2 b 2 f or m ul ati o ns i n n o n -pre g n a nt, n o n -i m m u n oc o m pr o mise d 
a d ults a g ai nst me d ic all y atte n de d C O VI D -1 9 , m ort alit y a n d he alt hc are res o urce utiliz ati o n b y 
a ge a n d a d a pte d v acci ne f or m ul ati o n .  
 
 
 
 
 
 
 
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 2  of 4 6  
Fi g ure 1. Ai m 1 st u d y desi g n  
 
 
E x p os ure:  ti me-var yi n g e x p os ure . All pers o ns will be c o nsi dere d u n vacci nate d fr o m F D A  date of 
vacci ne a ut h orizati o n/a p pr o val  u ntil , w here a p plica ble, 1 3  da ys after recei pt of vacci ne. I n or der t o 
all o w f or ti me after d ose  f or mea ni n gf ul i m m u n ol o gic pr otecti o n t o accr ue, pers o ns will be 
c o nsi dere d v acci n ate d 1 4  da ys after vacci nati o n  (i. e. patie nts will be ce ns ore d fr o m t he u n vacci nat e d 
gr o u p) .2 0, 2 1 
F or X B B. 1. 5 vacci ne: F D A a p pr o val date 1 1 Se pte m ber  2 0 2 3 2 
I n t he e ve nt t hat X B B u pta ke is l o w, we will i nstea d e xa mi ne B A. 4/ 5 V E . F or B A. 4/ 5 vacci ne: F D A 
e mer ge n c y use a ut h ori zati o n  date 3 1 A u g ust 2 0 2 2 4 
 
N ote: t his ai m pert ai ns t o a d ults o nly, a n d t heref ore d oes n ot re q uire a ge-s p ecific E U A d ates.  
F oll o w -u p ti me:  Fr o m date of F D A a ut h orizati o n/a p pr o val u ntil t he o utc o me of i nterest , or are 
ce ns ore d at t he first of t h e f oll o wi n g: 6 m o nt hs of f oll o w -u p , e n d of me dical a n d/ or p har mac y  
e nr oll me nt , recei pt of a n o n-Pfizer  Bi o N Tec h vacci ne  or recei pt of a s ec o n d B N T 1 6 2 b 2 C O VI D -1 9  
vacci ne d os e . 
Pri mar y o utc o me:  
1.  A C O VI D -1 9 -relat e d e nc o u nter, re g ar dless of s etti n g 
Sec o n dar y o utc o mes:   
1.  A n o ut patie nt e nc o u nter  wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9 ”  c o d e  
2.  A n i n patie nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9”  liste d i n a n y dia g n osis  
p ositi o n . As a se nsiti vit y a nal ysis, we will restrict t o U 0 7. 1 i n pri mar y dia g n osis fiel d.  
3.  A n e mer ge n c y de p art me nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1  “ C O VI D -1 9”  c o de  
4.  C O VI D -1 9  critical ill ness , defi ne d as i nte nsi ve care u nit [I C U] a d missi o n, mec ha nical 
ve ntilati o n, or i n patie nt deat h . If sa m ple si ze all o ws, we will e val uate V E a g ai nst eac h 
c o m p o ne nt se paratel y i n or der t o s u p p ort V & E m o dels.  
P e o pl e will b e c o n si d er e d v a c ci n at e d 1 4 
d a y s aft er B N T 1 6 2 b 2 v a c ci n ati o n.
All p er s o n s will b e 
c o n si d er e d 
u n v a c ci n at e d u ntil, 
w h er e a p pli c a bl e, 1 3 
d a y s aft er v a c ci n ati o n. 
B a s eli n e p eri o d: 
3 6 5 d c o nti n u o u s e nr oll m e nt a n d 
C alif or ni a r e si d e n c y
S e pt e m b er 1 1, 
2 0 2 3 f or X B B. 1. 5
A u g u st 3 1, 2 0 2 2 f or 
B A. 4/ 5
St art of H e alt h V erit y
d at a
D e c e m b er 1, 2 0 1 8
F oll o w e d u ntil t h e o ut c o m e 
of i nt er e st, or ar e c e n s or e d 
at t h e fir st of t h e f oll o wi n g: 
6 m o nt h s of f oll o w- u p, e n d 
of m e di c al a n d/ or 
p h ar m a c y e nr oll m e nt, 
r e c ei pt of a n o n- Pfi z er 
Bi o N T e c h v a c ci n e or 
r e c ei pt of a s e c o n d 
B N T 1 6 2 b 2 C O VI D v a c ci n e 
d o s e.
I n d e x d at e: 
F D A E U A d at e
F or c o v ari at e
a s c ert ai n m e nt, all-
a v ail a bl e i nf or m ati o n 
pri or t o i n d e x will b e 
u s e d, b ut n ot r e q uir e d
Ti m e- v ar yi n g e x p o s ur e
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 3  of 4 6  
5.  Ne gati ve c o ntr ol o utc o m es s u c h as acci de ntal i nj ur y, i n gr o w n t oe nail or at o pic der matitis  
E x pl orat or y o utc o mes:  
1.  A n ur ge nt care e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” c o d e  
2.  All -ca use m ortalit y  wit hi n 3 -m o nt hs of C O VI D -1 9  e nc o u nter, re gar dless of setti n g  
3.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  o ut patie nt e nc o u nter  
4.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  i n patie nt e nc o u nter 
5.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  e mer ge n c y de part me nt e nc o u nter  
6.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  critical ill ness  
7.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9 ur ge nt care e n c o u nter  
Meas ures of a bs ol ute a n d relati ve V E : F or eac h o utc o me a b o ve, res ults will be calc ul ate d as:  
1.  A bs ol ute V E  c o m pari n g vacci nat e d t o u n vacci n ate d pers o ns , re gar dl ess of pri or vacci nati o n 
2.  Relati ve V E will be calc ulate d f or eac h of t h e f oll o wi n g m ut uall y e xcl usi ve s u b gr o u ps.  
a. X B B. 1. 5 vacci nate d vs X B B. 1. 5 u n vacci nate d pers o ns w h o recei ve d B A. 4/ 5 bi vale nt 
vacci ne.  
b.  X B B. 1. 5 vacci nate d vs X B B. 1. 5 u n vacci nate d pers o ns w h o di d n ot recei ve B A. 4/ 5 
bi vale nt vacci ne b ut di d recei ve at least 2 d oses of m R N A vacci ne  (re g ar dless of 
f or m ulati o n).  
c. X B B. 1. 5 vacci nate d vs n e ver C O VI D -1 9  vacci nat e d.  
Stratificati o ns: Res ults will be stratifie d b y a ge gr o u p ( o verall, a g e 1 8-4 9, 5 0 -6 4, 6 5 +) as well as b y 
cale n dar ti me ( B A. 4/ 5 vers us X B B. 1. 5 vacci ne a v aila ble eras).  
Statistical m et h o ds:   All a nal yses will be p o ole d acr oss Calif or nia a n d L o uisia na . T o c o nsi der t h e 
p ote ntial f or effect meas ure m o dificati o n, we will a d diti o nall y  stratify  b y state , rat her t ha n a dj ust, f or 
t he pri mar y e n d p oi nt. Descri pti ve statistics will be use d t o s u m marize patie nt c haracteristics, wit h 
mea n (sta n dar d de viati o n) or me dia n ( 2 5 t h perce ntile –  7 5 t h pe rce ntile) f or c o nti n u o us varia bles a n d 
c o u nts ( perce nta ges) f or cate g oric al varia bl es. Ti me -de pe n d e nt C o x pr o p orti o nal hazar ds m o dels 
will be use d t o esti mate t he ris k of eac h o utc o me of i nterest wit h ti me -var yi n g e x p os ure a n d ti me -
fi xe d c o variates, res ulti n g i n a H R a n d 9 5 % c o nfi de nce i nter vals ( 9 5 % CI) . V E will be defi ne d as ( 1 
–  a H R) * 1 0 0. We will f urt her use i nci de n ce of t he C O VI D -1 9 e n d p oi nt i n u n vacci nat e d pers o ns a n d 
a p pl y V E esti mates t o esti mate t he n u m ber of cases a verte d.  
M o dels will be a dj uste d f o r c o vari ates liste d i n “ T a ble 5: C o variates” . Ne g ati ve c o ntr ol o utc o mes 
will be use d t o q ua ntif y resi d ual a n d u n meas ure d c o nf o u n di n g . I n t he e v e nt a H R f or ne g ati ve c o ntr ol 
o utc o mes ha ve a si g nifica nt effect ( 9 5 % CI d o n ot i ncl u de n ull val ue of 1), t he n t he  set of 
c o nf o u n ders will be a dj uste d t o all o w f or cali brati o n. Se nsiti vit y a nal yses will c o nsi der t he i m pact of 
st u d y desi g n a n d a nal ytic ass u m pti o ns, s uc h as var yi n g t he e x p os ure defi niti o n t o 7 da ys p ost 
vacci nati o n r at her t ha n 1 4 da ys.   
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 4  of 4 6  
8. 7. 2.  Ai m 2  
T o assess V E  of B N T 1 6 2 b 2 f or m ul ati o ns i n pe di atrics a g ai nst me dic all y atte n de d C O VI D -1 9,  
n o n -C O VI D -1 9  res pir at or y i nfecti o ns, m ort alit y a n d he alt hc are res o urce utiliz ati o n b y  a ge 
a n d a d a pte d v acci ne f or m ul ati o n .  
 
Fi g ure 2. Ai m 2 st u d y desi g n  
 
 
E x p os ure:  ti me-var yi n g e x p os ure. All pers o ns will be c o nsi dere d u n vacci nate d F D A  d ate of v acci ne 
a ut h orizati o n/a p pr o v al u ntil, w here a p plica bl e, 1 3  da ys after recei pt of vacci ne. I n or der t o  all o w f or 
ti me after d ose f or mea ni n gf ul i m m u n ol o gic pr otecti o n t o accr ue, pers o ns will be c o nsi dere d 
vacci nat e d 1 4  da ys after vacci nati o n.  
F or B A. 4/ 5 vacci ne: F D A e mer ge n c y use a ut h orizati o n date 3 1 A u g ust  2 0 2 2 4 f or a ge 1 2-1 7, 
1 2 Oct o ber 2 0 2 2 f or a g es 5 -1 1, 5 a n d 0 8 Dece m b er  2 0 2 2 f or a ges 6 m o nt hs t o 4 years 6 
 
F or X B B. 1. 5 vacci ne: F D A a p pr o val date 1 1 Se pte m ber  2 0 2 3  re g ar dless of a ge3 
F oll o w -u p ti me:  Fr o m date of F D A a ut h orizati o n/a p pr o val u ntil t he o utc o me of i nterest, or are 
ce ns ore d at t he first of t h e f oll o wi n g: 6 m o nt hs of f oll o w -u p , e n d of me dical a n d/ or p har mac y 
e nr oll me nt, recei pt of a n o n -Pfizer Bi o N Tec h vacci ne or recei pt of a s ec o n d B N T 1 6 2 b 2 C O VI D -1 9  
vacci ne d os e.  
Pri mar y o utc o me:  
1.  A C O VI D -1 9 -relat e d e nc o u nter, re g ar dless of s etti n g ( pri mar y o utc o me)  
Sec o n dar y o utc o mes:  
1.  A n o ut patie nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” c o d e  
2.  A n i n patie nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9” liste d i n a n y dia g n osis  
p ositi o n . As a se nsiti vit y a nal ysis, we will restrict t o U 0 7. 1 i n pri mar y dia g n osis fiel d.  
P e o pl e will b e c o n si d er e d v a c ci n at e d 1 4 
d a y s aft er B N T 1 6 2 b 2 v a c ci n ati o n.
All p er s o n s will b e 
c o n si d er e d 
u n v a c ci n at e d u ntil, 
w h er e a p pli c a bl e, 1 3 
d a y s aft er v a c ci n ati o n. 
B a s eli n e p eri o d: 
1 8 3 d c o nti n u o u s e nr oll m e nt a n d 
C alif or ni a r e si d e n c y
S e pt e m b er 1 1, 
2 0 2 3 f or X B B. 1. 5
A u g u st 3 1, 2 0 2 2 f or 
B A. 4/ 5 a g e 1 2- 1 7
O ct o b er 1 2, 2 0 2 2
f or B A. 4/ 5 a g e 5- 1 1
D e c e m b er 8, 2 0 2 2
f or B A. 4/ 5 a g e < 5
St art of H e alt h V erit y
d at a
D e c e m b er 1, 2 0 1 8
F oll o w e d u ntil t h e o ut c o m e 
of i nt er e st, or ar e c e n s or e d 
at t h e fir st of t h e f oll o wi n g: 
6 m o nt h s of f oll o w- u p, e n d 
of m e di c al a n d/ or 
p h ar m a c y e nr oll m e nt, 
r e c ei pt of a n o n- Pfi z er 
Bi o N T e c h v a c ci n e or 
r e c ei pt of a s e c o n d 
B N T 1 6 2 b 2 C O VI D v a c ci n e 
d o s e.
I n d e x d at e: 
F D A E U A d at e
F or c o v ari at e
a s c ert ai n m e nt, all-
a v ail a bl e i nf or m ati o n 
pri or t o i n d e x will b e 
u s e d, b ut n ot r e q uir e d
Ti m e- v ar yi n g e x p o s ur e
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 5  of 4 6  
3.  A n e mer ge n c y de p art me nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9” c o de  
4.  C O VI D -1 9  critical ill ness , defi ne d as i nte nsi ve care u nit [I C U] a d missi o n, mec ha nical 
ve ntilati o n, or i n patie nt deat h . If sa m ple si ze all o ws, we will e val uate V E a g ai nst eac h 
c o m p o ne nt se paratel y i n or der t o s u p p ort V & E m o dels.  
5.  N o n -C O VI D -1 9 res pir at or y i nfecti o n: dia g n osis of a n y of p ne u m o nia, res pirat or y s y nc ytial 
vir us ( R S V), r hi n o vir u s a n d/ or recei pt of a nti bi otic prescri pti o n. If sa m ple size all o ws, we 
will e val uate V E a g ai nst eac h c o m p o ne nt se paratel y i n or der t o s u p p ort V & E m o dels.  
6.  Ne gati ve c o ntr ol o utc o m es s uc h as acci de ntal i nj ur y, i n gr o w n t oe nail or at o pic der matitis  
E x pl orat or y  o utc o mes:  
1.  A n ur ge nt care e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” c o d e  
2.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  e nc o u nter, re gar dless of setti n g  
3.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  o ut patie nt e nc o u nter  
4.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  i n patie nt e nc o u nter 
5.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  e mer ge n c y de part me nt e nc o u nter  
6.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  critical ill ness  
7.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9 ur ge nt care e n c o u nter  
 
Meas ures of a bs ol ute a n d relati ve V E:  F or eac h o utc o me a b o ve, res ults will be calc ul ate d as:  
1.  A bs ol ute V E c o m pari n g vacci nat e d t o u n vacci n ate d pers o ns, re gar dl ess of pri or vacci nati o n  
2.  Relati ve V E will be calc ulate d f or eac h of t h e f oll o wi n g m ut ua ll y e xcl usi ve s u b gr o u ps.  
a. X B B. 1. 5 vacci nate d vs X B B. 1. 5 u n vacci nate d pers o ns w h o recei ve d B A. 4/ 5 bi vale nt 
vacci ne.  
b.  X B B. 1. 5 vacci nate d vs X B B. 1. 5 u n vacci nate d pers o ns w h o di d n ot recei ve B A. 4/ 5 
bi vale nt vacci ne b ut di d recei ve at least 2 d oses of m R N A vacci ne  (re g ar dless of 
f or m ulati o n).  
c. X B B. 1. 5 vacci nate d vs n e ver C O VI D -1 9  vacci nat e d.  
Stratificati o ns: Res ults will be stratifie d b y a ge gr o u p ( o verall, a g e 6 m o nt hs –  4 years , 5-1 1 , 1 2 -1 7 ) 
as well as b y cale n dar ti me ( B A. 4/ 5 vers us X B B. 1. 5 vacci ne a vaila ble eras).  
Statistical Met h o ds:   All a nal yses will be p o ole d acr oss Calif or nia a n d L o uisia na . T o c o nsi der t h e 
p ote ntial f or effect meas ure m o dificati o n, we will a d diti o nall y  stratify  b y state,  rat her t ha n a dj ust, f or 
t he pri mar y e n d p oi nt. Descri pti ve stat istics will be use d t o s u m marize patie nt c haracteristics, wit h 
mea n (sta n dar d de viati o n) or me dia n ( 2 5 t h perce ntile –  7 5 t h perce ntile) f or c o nti n u o us varia bles a n d 
c o u nts ( perce nta ges) f or cate g oric al varia bl es. Ti me -de pe n d e nt C o x pr o p orti o nal hazar ds m o dels 
will be use d t o esti mate t he ris k of eac h o utc o me of i nterest wit h ti me -var yi n g e x p os ure a n d ti me -
fi xe d c o variates, resulti n g i n a H R a n d 9 5 % c o nfi de nce i nter vals ( 9 5 % CI). V E will be defi ne d as ( 1 
–  a H R) * 1 0 0. We will f urt her use i nci de n ce of t he C O VI D -1 9 e n d p oi nt i n u n vacci nat e d pers o ns a n d 
a p pl y V E esti mates t o esti mate t he n u m ber of cases a verte d.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 6  of 4 6  
M o dels will be a dj uste d  f or c o vari ates liste d i n “ T a ble 5: C o variates” . Ne g ati ve c o ntr ol o utc o mes 
will be use d t o q ua ntif y resi d ual a n d u n meas ure d c o nf o u n di n g. I n t he e v e nt a H R f or ne g ati ve c o ntr ol 
o utc o mes ha ve a si g nifica nt effect ( 9 5 % CI d o n ot i ncl u de n ull val ue of 1), t he n t he set of 
c o nf o u n ders will be a dj uste d t o all o w f or cali brati o n. Se nsiti vit y a nal yses will c o nsi der t he i m pact of 
st u d y desi g n a n d a nal ytic ass u m pti o ns, s uc h as var yi n g t he e x p os ure defi niti o n t o 7 da ys p ost 
vacci nati o n r at her t ha n 1 4 da ys.   
8. 7. 3.  Ai m 3 A  
T o es ti m ate s h ort-ter m he alt hc are res o urce utiliz ati o n  a n d c osts ass oci ate d wit h C O VI D -1 9 b y 
v acci n ati o n st at us, a ge, a n d site of c are.  
E x p os ure: Pers o ns will be c o nsi dere d vacci nate d if t he y recei ve d t he X B B. 1. 5 d ose 1 4 or m ore d a ys 
pri or t o a d missi o n. Pers o n s will be c o nsi dere d u n v acci nat e d if t he y ha d n ot recei v e d a d ose. 
St u d y Peri o d: Se pte m ber 2 0 2 3 –  Ja n uar y 2 0 24  
F oll o w -u p ti me: Fr o m a d missi o n (i n de x date) t o disc har ge.  
O utc o mes of i nterest : Si milar t o t h ose i n S o ma ni, Firest o ne, D o n n elle y et al ( 2 0 2 3)2 2 
1.  C ost of h os pitalizati o n  
2.  A vera g e le n gt h of sta y, i n da ys  
3.  I C U a d missi o n 
4.  Recei pt of hi g h -fl o w o x y ge n or mec h a nical ve ntil ati o n 
5.  I n p atie nt M ortalit y 
6.  Use of a nti viral treat me nt  
Statistical Met h o ds:  All a nal yses will be p o ole d acr oss Calif or nia a n d L o uisia na, a n d  stratifie d b y 
state. Descri pti ve statistics will be use d t o s u m marize patie nt c haracteristics, wit h mea n (sta n dar d 
de viati o n) or me dia n ( 2 5 t h perce ntile –  7 5 t h perce ntile) f or c o nti n u o us varia bles a n d c o u nts 
( perce nta ges) f or cate g orical varia bles. L o gistic re gressi o n will be use d t o esti mate o d ds rati os ( O R, 
wit h 9 5 % CI) of I C U a d missi o n c o m pari n g vacci nate d pers o ns t o u n vacci nate d pers o ns. Li near 
re gressi o n wit h a n al ysis of c o vari a nce ( A N C O V A) will be use d t o c o m pare c osts of h os pitalizati o n 
f or vacci nate d a n d u n vacci nate d pers o ns, a n d will be a dj uste d f or a ge, a n d baseli ne c haracteristics . 
Res ults will be stratifie d b y a ge gr o u ps.  
 
8. 7. 4.  Ai m 3 B  
T o esti m ate l o n g -ter m he alt hc are res o urce utiliz ati o n a n d c osts ass oci ate d wit h C O VI D-1 9 b y 
v acci n ati o n st at us, a ge, a n d site of c are.  
E x p os ure: Pers o ns will be c o nsi dere d a C O VI D -1 9  patie nt if t he y e x perie n ce d a C O VI D -1 9 -relat e d 
e nc o u nter, re gar dless of s etti n g (cases). C O VI D -1 9  patie nts (cases) will be matc he d t o 4 patie nts 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 7  of 4 6  
wit h o ut a C O VI D -1 9  dia g n osis (c o ntr ols) usi n g t he matc he d i n de x date. C o ntr ols ma y or ma y n ot 
ha ve ha d h ealt h care e n c o u nters d uri n g t he st u d y peri o d . Cases a n d c o ntr ols will be matc he d base d 
o n a ge, se x, i ns ura nce t y pe, pre vi o us C harls o n C o m or bi dit y I n de x ( C CI), n u m ber of pre vi o us 
h os pitalizati o ns , a n d f oll o w-u p ti me . T he C CI a n d n u m ber of h os pitalizati o ns were calc ulat e d b y 
usi n g dia g n oses d uri n g pre -i n de x. F or stratificati o n/s u b gr o u p a nal yses, a d ult pers o ns will be 
c o nsi dere d v acci n ate d if t he y recei ve d t he B A. 4. 5 d ose 1 4 or m ore d a ys pri or t o i n de x, pers o ns will 
be c o nsi dere d u n vacci nat e d if t he y ha d n ot r ecei v e d a n y C O VI D -1 9  v acci nati o n d oses. C hil dre n will 
be c o nsi dere d vacci nate d if t he y recei ve d t he a n y C O VI D -1 9  vacci nati o n d ose 1 4 or m ore d a ys pri or 
t o i n de x a n d will be c o nsi dere d u n vacci nate d if t h e y ha d n ot recei ve d a n y C O VI D -1 9  vacci nati o n 
d oses . 
St u d y Peri o d ( data i ncl u di n g pre -i n de x a n d f oll o w-u p): 0 1 J u ne 2 0 2 1 –  3 1 A u g ust 2 0 2 3  
Patie nt i de ntificati o n (i n de x) wi n d o w: J u ne 2 0 2 2 –  N o ve m ber 2 0 2 2  
F oll o w -u p ti me: starti n g 3 0 da ys after first C O VI D -1 9  dia g n osis (i n de x date) wit h f oll o w -u ps of 1 
m o nt h, 3 m o nt hs, 6 m o nt h, a n d 9 m o nt hs.  
O utc o mes of i n terest: Si milar t o t h ose i n Pi ke et al, 2 0 2 3 
1.  All -ca use dir ect he alt hcare c osts ( me dical a n d p har mac y)  
2.  All -ca use H ealt hcare res o urce utilizati o n  
3.  C O VI D -1 9 -relate d h os pitalizati o n (f or cases o nl y) 
 
Statistical Met h o ds : All a nal yses will be p o ole d acr oss Cali f or nia a n d L o uisia na, a n d stratifie d b y 
state. Descri pti ve statistics will be use d t o s u m marize patie nt c haracteristics, wit h mea n (sta n dar d 
de viati o n) or me dia n ( 2 5 t h perce ntile –  7 5 t h perce ntile) f or c o nti n u o us varia bles a n d c o u nts 
( perce nta ges) f or categ orical varia bles. A re gressi o n m o del will be de vel o p e d t hat a dj usts f or a g e, 
se x, a n d baseli ne c o m or bi dities. We will stratif y o utc o mes b y vacci n ati o n stat us, healt hcare c ost 
( me dical a n d p h ar mac y), a n d sites of care (i n patie nt, o ut patie nt, etc.). 
 
8. 7. 5.  Ai m 4  
T o me as ure V E  of B N T 1 6 2 b 2 f or m ul ati o ns i n n o n -pre g n a nt i m m u n oc o m pr o mise d a d ults 
a g ai nst me dic all y atte n de d C O VI D -1 9 , m ort alit y a n d he alt hc are res o u rce utiliz ati o n b y a ge 
a n d a d a pte d v acci ne f or m ul ati o n .  
 
 
 
 
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 8  of 4 6  
Fi g ure 3. Ai m 4 st u d y desi g n  
 
 
N ote: f or t his  ai m, t he i ncl usi o n criteria will a d diti o nall y restrict t he p o p ulati o n t o 
i m m u n oc o m pr o mise d a d ults.  
E x p os ure:  ti me-var yi n g e x p os ure. All pers o ns will be c o nsi dere d u n vacci nate d fr o m F D A date of 
vacci ne a ut h orizati o n/a p pr o val u ntil, w here a p plica ble, 1 3  da ys after recei pt of vacci ne. I n or der t o 
all o w f or ti me after d ose f or mea ni n gf ul i m m u n ol o gic pr otecti o n t o ac cr ue, pers o ns will be 
c o nsi dere d v acci n ate d 1 4  da ys after vacci nati o n.  
 
F or B A. 4/ 5 vacci ne: F D A e mer ge n c y use a ut h orizati o n date 3 1 A u g ust 2 0 2 2  
 
F or X B B. 1. 5 vacci ne: F D A a p pr o val date 1 1 Se pte m ber  2 0 2 3  
 
N ote: t his ai m pert ai ns t o a d ults o nly, a n d t heref ore d oes n ot re q uire a ge -s p ecific E U A d ates.  
F oll o w -u p ti me:  Fr o m date of F D A a ut h orizati o n/a p pr o val u ntil t he o utc o me of i nterest, or are 
ce ns ore d at t he first of t h e f oll o wi n g: 6 m o nt hs of f oll o w -u p , e n d of me dical a n d/ or p har mac y 
e nr oll me nt, recei pt of a n o n -Pfizer Bi o N Tec h vacci ne or recei pt of a s ec o n d B N T 1 6 2 b 2 C O VI D -1 9  
vacci ne d os e.  
Pri mar y o utc o me:  
1.  A C O VI D -1 9 -relat e d e nc o u nter, re g ar dless of s etti n g ( pri mar y o utc o me)  
Sec o n dar y o utc o mes:  
1.  A n o ut patie n t e nc o u nter wit h I C D-1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” c o d e  
2.  A n i n patie nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9” liste d i n a n y dia g n osis  
p ositi o n . As a se nsiti vit y a nal ysis, we will restrict t o U 0 7. 1 i n pri mar y dia g n osis fiel d.  
3.  A n e mer ge n c y de p art me nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9” c o de  
P e o pl e will b e c o n si d er e d v a c ci n at e d 1 4 
d a y s aft er B N T 1 6 2 b 2 v a c ci n ati o n.
All p er s o n s will b e 
c o n si d er e d 
u n v a c ci n at e d u ntil, 
w h er e a p pli c a bl e, 1 3 
d a y s aft er v a c ci n ati o n. 
B a s eli n e p eri o d: 
3 6 5 d c o nti n u o u s e nr oll m e nt a n d 
C alif or ni a r e si d e n c y
S e pt e m b er 1 1, 
2 0 2 3 f or X B B. 1. 5
A u g u st 3 1, 2 0 2 2 f or 
B A. 4/ 5
St art of H e alt h V erit y
d at a
D e c e m b er 1, 2 0 1 8
F oll o w e d u ntil t h e o ut c o m e 
of i nt er e st, or ar e c e n s or e d 
at t h e fir st of t h e f oll o wi n g: 
6 m o nt h s of f oll o w- u p, e n d 
of m e di c al a n d/ or 
p h ar m a c y e nr oll m e nt, 
r e c ei pt of a n o n- Pfi z er 
Bi o N T e c h v a c ci n e or 
r e c ei pt of a s e c o n d 
B N T 1 6 2 b 2 C O VI D v a c ci n e 
d o s e.
I n d e x d at e: 
F D A E U A d at e
F or c o v ari at e 
a s c ert ai n m e nt, all-
a v ail a bl e i nf or m ati o n 
pri or t o i n d e x will b e 
u s e d, b ut n ot r e q uir e d
Ti m e- v ar yi n g e x p o s ur e
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3 9  of 4 6  
4.  C O VI D -1 9  critical ill ness , defi ne d as i nte nsi ve care u nit [I C U] a d missi o n, mec ha nical 
ve ntilati o n, or i n patie nt deat h . If sa m ple si ze all o ws, we will e val uate V E a g ai nst eac h 
c o m p o ne nt se paratel y i n or der t o s u p p ort V & E m o dels.  
5.  Ne gati ve c o ntr ol o utc o m es s uc h as acci de ntal i nj ur y, i n gr o w n t oe nail or at o pic der matitis  
E x pl orat or y o utc o mes:  
1.  A n ur ge nt care e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” c o d e  
2.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  e nc o u nter, re gar dless of setti n g  
3.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  o ut patie nt e nc o u nter  
4.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  i n patie nt e nc o u nter 
5.  All -ca use m ortalit y wit hi n 3 -m o nt hs of  C O VI D -1 9  e mer ge n c y de part me nt e nc o u nter  
6.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9  critical ill ness  
7.  All -ca use m ortalit y wit hi n 3 -m o nt hs of C O VI D -1 9 ur ge nt care e n c o u nter  
Meas ures of a bs ol ute a n d relati ve V E:  F or eac h o utc o me a b o ve, res ults will be ca lc ul ate d as: 
1.  A bs ol ute V E c o m pari n g vacci nat e d t o u n vacci n ate d pers o ns, re gar dl ess of pri or vacci nati o n  
2.  Relati ve V E will be calc ulate d f or eac h of t h e f oll o wi n g m ut uall y e xcl usi ve s u b gr o u ps.  
a. X B B. 1. 5 vacci nate d vs X B B. 1. 5  u n vacci nate d pers o ns w h o recei ve d B A. 4/ 5 bi vale nt 
vacci ne.  
b.  X B B. 1. 5 vacci nate d vs X B B. 1. 5 u n vacci nate d pers o ns w h o di d n ot recei ve B A. 4/ 5 
bi vale nt vacci ne b ut di d recei ve at least 2 d oses of m R N A vacci ne  (re g ar dless of 
f or m ulati o n).  
c. X B B. 1. 5 vacci nate d vs n e ver C O VI D -1 9  vacci nat e d.  
Stratificati o ns: Res ults will be stratifie d b y a ge gr o u p ( o verall, a g e 1 8 -4 9, 5 0 -6 4, 6 5 +) as well as b y 
cale n dar ti me ( B A. 4/ 5 vers us X B B. 1. 5 vacci ne a v aila ble eras)  a n d le vel of i m m u n os u p pressi o n .  
Statistical Met h o ds:  All a nal yses will be p o ole d acr oss Calif or nia a n d L o uisia na . T o c o nsi der t h e 
p ote ntial f or effect meas ure m o dificati o n, we will a d diti o nall y  stratify  b y state, rat her t ha n a dj ust, f or 
t he pri mar y e n d p oi nt. Descri pti ve statistics will be use d t o s u m marize patie nt c haracteristics, wit h 
mea n (sta n dar d de viati o n) or me dia n ( 2 5 t h perce ntile –  7 5 t h perce ntile) f or c o nti n u o us varia bles a n d 
c o u nts ( perce nta ges) f or cate g oric al varia bl es. Ti me -de pe n d e nt C o x pr o p orti o nal hazar ds m o dels 
will be use d t o esti mate t he ris k o f eac h o utc o me of i nterest wit h ti me-var yi n g e x p os ure a n d ti me -
fi xe d c o variates, res ulti n g i n a H R a n d 9 5 % c o nfi de nce i nter vals ( 9 5 % CI). A bs ol ute V E will be 
defi ne d as ( 1 –  a H R) * 1 0 0, c o m pari n g vacci nate d t o u n vacci nate d p ers o ns  re gar dless of pri or 
vacci nat i o ns. We will f urt her use  i nci de n ce of t he C O VI D-1 9 e n d p oi nt i n u n vacci nat e d pers o ns a n d 
a p pl y V E esti mates  t o esti mate t he n u m ber of cases a verte d.  
M o dels will be a dj uste d f or  c o vari ates liste d i n “ T a ble 5: C o variates” . Ne g ati ve c o ntr ol o utc o mes 
will be use d t o q ua ntif y resi d ual a n d u n meas ure d c o nf o u n di n g. I n t he e v e nt a H R f or ne g ati ve c o ntr ol 
o utc o mes ha ve a si g nifica nt effect ( 9 5 % CI d o n ot i ncl u de n ull val ue of 1), t he n t he set of 
c o nf o u n ders will be a dj uste d t o all o w f or cali brati o n. Se nsiti vit y a nal y ses will c o nsi der t he i m pact of 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4 0  of 4 6  
st u d y desi g n a n d a nal ytic ass u m pti o ns, s uc h as var yi n g t he e x p os ure defi niti o n t o 7 da ys p ost 
vacci nati o n r at her t ha n 1 4 da ys.   
8. 7. 6.  Ai m 5  
T o q u a ntif y differe nces i n V E  of B N T 1 6 2 b 2 f or m ul ati o ns i n n o n -pre g n a nt, n o n -
i m m u n oc o m pr o mise d a d ults w he n c o-a d mi nistere d wit h se as o n al i nfl ue nz a v acci nes vers us 
w he n e ac h v acci ne is gi ve n se p ar atel y, b y a ge g r o u ps . 
Mai n s u m mar y meas ure: a R R  t o e val uate n o n-i nf eri orit y, c o m pari n g pe o ple wit h c o-
a d mi nistere d vacci nes t o B N T 1 6 2 b 2 vacci ne al o ne  f or C O VI D-1 9 -relate d o utc o mes 
Mai n s u m mar y meas ure: a R R t o e val uate n o n -i nf eri orit y, c o m pari n g pe o ple wit h c o-
a d mi nistere d vacci nes t o seas o nal i nfl ue nza  vacci n e al o ne  f or i nfl ue nza-relate d 
o utc o mes  
 
Fi g ure 4. Ai m 5 st u d y desi g n  
 
 
E x p os ure:  C o -a d mi nistrati o n will be defi ne d as sa me -da y recei pt of B N T 1 6 2 b 2 vacci ne a n d a n y 
f or m ulati o n of seas o nal i nfl ue nza v acci n e (f or i n di vi d uals 6 5 +, o nl y e n ha n ce d i nfl ue nza vacci nes) .  
F oll o w -u p ti me:  Fr o m 1 4  da ys after  v acci nati o n  (i n de x date). u ntil t he o utc o me of i nterest, or are 
ce ns ore d at t he first of t h e f oll o wi n g: 6 m o nt hs of f oll o w -u p , e n d of me dical a n d/ or p har mac y 
e nr oll me nt, recei pt of a n y  p ost -i n de x C O VI D -1 9  or i nfl ue nza d ate vacci ne . 
O utc o mes of i nterest , f or c o-a d mi nistere d v acci n es vers us B N T 1 6 2 1 b 2 X B B. 1. 5 m o n o vale nt al o ne : 
Pri m ary o utc o me:  
1.  A C O VI D -1 9 -relat e d e nc o u nter, re g ar dless of s etti n g ( pri mar y o utc o me)  
Sec o n d ary o utc o mes:  
1.  A n o ut patie nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” c o d e  
P e o pl e will b e c o n si d er e d v a c ci n at e d 1 4 
d a y s aft er B N T 1 6 2 b 2 v a c ci n ati o n.
All p er s o n s will b e 
c o n si d er e d 
u n v a c ci n at e d u ntil, 
w h er e a p pli c a bl e, 1 3 
d a y s aft er v a c ci n ati o n. 
B a s eli n e p eri o d: 
3 6 5 d c o nti n u o u s e nr oll m e nt a n d 
C alif or ni a r e si d e n c y
S e pt e m b er 1 1, 
2 0 2 3 f or X B B. 1. 5
N ot e: t hi s w or k h a s 
alr e a d y b e e n 
c o m pl et e d f or 
B A. 4/ 5 a n d will n ot 
b e p ur s u e d i n t hi s 
pr ot o c ol
St art of H e alt h V erit y
d at a
D e c e m b er 1, 2 0 1 8
F oll o w e d u ntil t h e o ut c o m e 
of i nt er e st, or ar e c e n s or e d 
at t h e fir st of t h e f oll o wi n g: 
6 m o nt h s of f oll o w- u p, e n d 
of m e di c al a n d/ or 
p h ar m a c y e nr oll m e nt, 
r e c ei pt of a n y C O VI D or fl u 
v a c ci n e
I n d e x d at e: 
V a c ci n ati o n d at e 
( C O VI D v a c ci n e al o n e, fl u v a c ci n e 
al o n e, or C O VI D +fl u
c o a d mi ni st er d)
F or c o v ari at e
a s c ert ai n m e nt, all-
a v ail a bl e i nf or m ati o n 
pri or t o i n d e x will b e 
u s e d, b ut n ot r e q uir e d
Ti m e fi x e d e x p o s ur e
St art of f oll o w- u p: 
1 4 d a y s aft er 
v a c ci n ati o n d at e
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4 1  of 4 6  
2.  A n i n patie nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9” liste d i n a n y dia g n osis  
p ositi o n . As a se nsiti vit y a nal ysis, we will restrict t o U 0 7. 1 i n pri mar y dia g n osis fiel d.  
3.  A n e mer ge n c y de p art me nt e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9” c o de  
4.  All -ca use m ortalit y  
5.  Ne gati ve c o ntr ol o utc o m es s uc h as acci de ntal i nj ur y, i n gr o w n t oe nail or at o pic der matitis.  
Ex pl or at ory o utc o me:  
1.  A n ur ge nt care e nc o u nter wit h I C D -1 0 -C M U 0 7. 1 “ C O VI D -1 9 ” c o d e  
O utc o mes of i nterest e d, f or c o -a d mi nistere d vacci nes vers us seas o nal i nfl u e nza v acci n e al o ne:  
Pri m ary o utc o me:  
1.  A fl u -relat e d e nc o u nt er, re gar dless of s etti n g ( pri mar y o utc o me)  
Sec o n d ary o utc o me s: 
1.  A n o ut patie nt e nc o u nter wit h I C D -1 0 -C M c o de  i n dicati n g i nfl ue nza 
2.  A n i n patie nt e nc o u nter wit h i nfl ue nza. N ote, i nfl u e nza will n ot be re q uire d t o be t he pri nci pal 
dia g n osis as  t here is less c o ncer n a b o ut i nci de ntal fi n di n gs a n d pre vi o us e x perie nce fr o m t h e 
fl u tea m s u g gests pri mar y dia g n osis c o di n g i n i nfl ue nza h os pitalizati o ns mi g ht pri oritize 
c o m plicati o ns rat her t ha n t he i nfecti o n.  
3.  A n e mer ge n c y de p art me nt e nc o u nter wit h I C D -1 0 -C M  c o de i n dicati n g i nfl ue nza 
4.  All -ca use m ortalit y  
5.  Ne gati ve c o ntr ol o utc o m es s uc h as acci de ntal i nj ur y, i n gr o w n t oe nail or at o pic der matitis.  
Ex pl or at ory o utc o me:  
1.  A n ur ge nt care e nc o u nter wit h I C D -1 0 -C M c o de i n dicati n g i nfl ue nza  
Meas ures of a bs ol ute a n d relati ve V E:  F or eac h o utc o me a b o ve, res ults will be calc ul ate d as:  
1.  A bs ol ute V E c o m pari n g vacci nat e d t o u n vacci n ate d pers o ns, re gar dl ess of pri or vacci nati o n  
2.  Relati ve V E  will be calc ulate d f or eac h of t h e f oll o wi n g m ut uall y e xcl usi ve s u b gr o u ps.  
a. X B B. 1. 5 vacci nate d vs X B B. 1. 5 u n vacci nate d pers o ns w h o recei ve d B A. 4/ 5 bi vale nt 
vacci ne.  
b.  X B B. 1. 5 vacci nate d vs X B B. 1. 5 u n vacci nate d pers o ns w h o di d n ot recei ve B A. 4/ 5 
bi vale nt vac ci ne b ut di d recei ve at least 2 d oses of m R N A vacci ne  (re g ar dless of 
f or m ulati o n).  
c. X B B. 1. 5 vacci nate d vs n e ver C O VI D -1 9  vacci nat e d.  
Stratificati o ns: Res ults will be stratifie d b y a ge gr o u p ( o verall, a g e 1 8 -4 9, 5 0 -6 4, 6 5 +) as well as b y 
cale n dar ti me ( B A. 4 / 5 vers us X B B. 1. 5 vacci ne a v aila ble eras).  
Statistical Met h o ds:   All a nal yses will be p o ole d acr oss Calif or nia a n d L o uisia na . T o c o nsi der t h e 
p ote ntial f or effect meas ure m o dificati o n, we will a d diti o nall y  stratify  b y state, rat her t ha n a dj ust, f or 
t he pri mar y e n d p oi nt. Descri pti ve statistics will be use d t o s u m marize patie nt c haracteristics, wit h 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4 2  of 4 6  
mea n (sta n dar d de viati o n) or me dia n ( 2 5 t h perce ntile –  7 5 t h perce ntile) f or c o nti n u o us varia bles a n d 
c o u nts ( perce nta ges) f or cate g oric al varia bl es. Sta n dar dize d  mea n differe n ces ( S M D) will be use d t o 
c o m pare c o vari ate bala n ce i n c o h orts bef ore a n d after i n verse pr o ba bilit y of treat me nt wei g hti n g 
(I P T W).2 7, 2 8 Varia bles wit h S M D > 0. 1 0 after wei g hti n g will be i ncl u de d i n m o dels f or d o u bl y 
r o b ust a dj ust me nt.2 9 
Sta bilize d I P T W, tri m me d a t t he 1st a n d 9 9 t h perce ntile if necessar y after e x a mi ni n g t he distri b uti o n 
of wei g hts  t o a v oi d e xerti o n of o utliers,3 0 will be calc ulate d as t he pr o ba bilit y of c oa d mi nistere d 
vacci n es gi ve n t h e c o vari ates o utli ne d i n Mc Gr at h, M al h otr a, Miles et al ( 2 0 2 3, J A M A Net w ork 
O pe n ) w hic h are liste d i n “ Ta ble 5: C o variat es” . S e ns iti vit y a nal yses will c o nsi der t he i m pact of 
st u d y desi g n a n d a nal ytic ass u m pti o ns, s uc h as var yi n g t he e x p os ure defi niti o n t o 7 da ys p ost 
vacci nati o n r at her t ha n 1 4 da ys.   
Wei g hte d s ur vi val f u ncti o ns will be use d t o esti mate a R R wit h 9 5 % CI  a n d ris k differe n ces ( R D) , 
se parat el y f or c o a d mi nistrati o n as c o m pare d t o C O VI D -1 9  v acci n e al o ne a n d f or c o a d mi nistrati o n as 
c o m pare d t o fl u v acci n e al o ne . Gi ve n t he ti me fi x e d e x p os ure d efi niti o n, R R a n d R D will  be use d f or 
t his ai m rat her t ha n H R, as t he pr o p orti o nal hazar ds ass u m pti o n re q uire d t o fit a H R ma y be vi olate d .  
 
8. 8.  Q u alit y C o ntr ol  
Data i n Healt h Verit y’s d ata base are pr o vi de d m o nt hl y  i n a n electr o nic f or mat. Healt h Verit y e m pl o ys 
its f o u n dati o nal pr o d uct t o matc h patie nts bet wee n differe nt d ata s ources wit h hi g h acc urac y. All 
a nal yses will be perf or m e d i nter nall y a n d acc or di n g t o Pfizer a nal ytic sta n dar ds, i ncl u di n g d o u ble 
pr o gra m mi n g t o e ns ure q ualit y c o ntr ol.   
 
8. 9.  Li mit ati o ns  of t he R ese arc h M et h o ds  
•  T his a nal ysis is fr o m  t w o states a n d t h us ma y n ot ge neralize t o ot her areas of t he c o u ntr y.  
Calif or nia is t he lar gest a n d m ost p o p ul o us state i n t he U S  (a p pr o xi matel y t he size of 
Ca na da), w hi c h aff or d u ni q ue o p p ort u nities wit h st u d y p o p ulati o n size. L o uisia na re prese nts 
a differe nt ge o gr a p hical r e gi o n of t he c o u ntr y, w h ere t here ma y be var yi n g patter ns of 
i n di vi d ual healt h c haract eristics a n d healt h see ki n g be ha vi ors.  
•  We d o n ot ha ve l a b orat or y c o nfir mati o n of t he C O VI D -1 9  dia g n osis, t heref ore it is p ossi ble 
t hat s o me patie nts are b ei n g dia g n ose d wit h s y m pt o ms al o ne or t hat we are missi n g p ositi ve 
cases d ue t o at -h o me testi n g.  
•  T he res ults fr o m t his st u d y ma y differ fr o m t h ose of V E  st u dies usi n g ot her data s o urces, 
s uc h as Kaiser Per ma n e nte of S o ut her n Calif or nia . 
•  E x p ose d patie nts ma y ha ve  var yi n g ti mes si nce vacci nati o n, a n d V E  ma y wa ne o ver t h e 6 
m o nt hs of f oll o w-u p , w hic h c o ul d bias t he res ults t o war ds t he n ull .  
•  Atte m pts t o a d dress c o nf o u n di n g ma y n ot be a ble t o f ull y acc o u nt f or c o nf o u n ders.  
 
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4 3  of 4 6  
8. 1 0.  Ot her A s pects 
N ot a p plica ble.  
 
9.  P R O T E C TI O N O F H U M A N P A R TI CI P A N T S  
9. 1.  P atie nt Inf or m ati o n  
T his st u d y i n v ol ves data t hat e xist i n dei de ntifie d/ a n o n y mize d str uct ur e d f or mat  a n d c o ntai n n o 
patie nt pers o nal i nf or m ati o n .   
 
9. 2.  P atie nt C o nse nt  
As t his st u d y i n v ol ves dei de ntifie d /a n o n y mize d  str uct ure d d ata, w hic h acc or di n g t o a p plica ble le gal 
re q uire me nts d o n ot c o nt ai n data s u bject t o pri vac y la ws, o btai ni n g i nf or me d c o nse nt fr o m p atie nts 
b y Pfizer is n ot re q uire d.  
 
9. 3.  I nstit uti o n al R e vie w B o ar d (I R B)/ E t hics C o m mittee ( E C)  
T his  st u d y uses de-i de ntifie d data. As s u c h t his st u d y will be s u b mitte d t o a n I R B f or e x e m pti o n 
u n der cat e g or y 4, p urs u a nt t o t he ter ms of t he U S De part me nt of Healt h a n d H u ma n Ser vice’s P olic y 
f or Pr otecti o n of h u ma n S u bjects at 4 5 C. F. R 4 6. 1 0 4( d).  
 
9. 4.  Et hic al C o n d uct of t he S t u d y 
T he st u d y will be c o n d ucte d i n acc or da nce wit h le gal a n d re g ulat or y re q uir e me nts, as well as wit h 
scie ntific p ur p ose, v al ue a n d ri g or a n d f oll o w ge n erall y acce pte d researc h practices d escri b e d i n 
C T 2 4 -WI -G L 0 2 -R F 0 4 i n cl u di n g G ui deli nes f or G o o d P har mac oe pi d e mi ol o gic Practices ( G P P) a n d 
t he E ur o pea n M e dici nes A ge nc y ( E M A) E ur o p ea n Net w or k of Ce ntr es f or P har mac oe pi de mi ol o g y 
a n d P har mac o vi gila nce ( E N Ce P P) G ui de o n Met h o d ol o gical Sta n dar ds i n P har mac oe pi de mi ol o g y.   
 
1 0.  M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E R E A C TI O N S  
T his st u d y i n v ol ves t he use of data b ases w hic h c o nsist of data t hat e xiste d as str uct ure d d ata at t he 
ti me t hat t he st u d y starte d. I n t his data, i n di vi d ual patie nt data are n ot retri e ve d or vali dat e d, a n d it is 
n ot p ossi ble t o li n k (ie, i de ntif y a p ote ntial ass ociati o n bet wee n) a partic ul ar pr o d uct a n d me dical 
e ve nt f or a n y i n di vi d ual. T h us, t he mi ni m u m criteria f or re p orti n g a n a d v erse e ve nt ( A E) 
(ie, i de ntifia ble patie nt, i de ntifia ble re p orter, a s us pect pr o d uct, a n d e ve nt) ca n n ot be met.  
1 1.  P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S  
F or all p u blicati o ns rel ati n g t o t he st u d y, Pfizer will c o m pl y wit h rec o g nize d et hical sta n dar ds 
c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g Secti o n II - “ Et hical C o nsi derati o ns i n t he 
C o n d uc t a n d Re p orti n g of Researc h” of t h e U nif or m Re q uire me nts f or Ma n uscri pts S u b mitte d t o 
Bi o me dical J o ur nals, htt p:// w w w.ic mje. or g/i n de x. ht ml #a ut h ors hi p, esta blis he d b y t he I nter n ati o nal 
C o m mittee of Me dical J o ur nal E dit ors.   
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4 4  of 4 6  
 
I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (e g, cli nical h ol d) b y a n a p plica ble c o m pete nt 
a ut h orit y i n a n y area of t he w orl d, or if t he p art y res p o nsi ble f or c ollecti n g data fr o m t he partici pa nt 
is a ware of a n y ne w i nf or mati o n w hic h mi g ht i nfl ue nce t he e val uati o n of t h e be nefits a n d ris ks of a 
Pfizer pr o d uct, Pfizer s h o ul d be i nf or me d i m me diatel y.    
 
1 2.  R E F E R E N C E S  
1.  
Pr o vi der s pecialt y: C O VI D -1 9 vacci ne, m o n ocl o n al a nti b o dies, a n d treat me nts. N o vitas 
S ol uti o ns. 0 8/ 1 7/ 2 0 2 2 3 ( htt ps:// w w w. n o vitas -
s ol uti o ns.c o m/ we bce nter/ p ortal/ Me dicareJ L/ p a ge b yi d?c o nte ntI d = 0 0 2 4 3 9 0 4 ). 
2.  
F D A T a kes Acti o n o n U p d ate d m R N A C O VI D -1 9 Vacci n es t o Better Pr otect A gai nst 
C urre ntl y Circ ulati n g Varia nts. U. S. F o o d & Dr u g A d mi nistrati o n. 2 0 2 3 0 9 1 1 
(htt ps:// w w w.f da. g o v/ ne ws -e ve nts/ press -a n n o u nce me nts/f da -ta kes-acti o n -u p date d -mr na -
c o vi d-1 9 -vacci nes -b etter -pr otect -a gai nst -c urre ntl y -circ ulati n g ). 
3.  
U p date d C O VI D -1 9 Vacci nes f or Us e i n t he U nite d States Be gi n ni n g i n Fall 2 0 2 3. U. S. F o o d 
& Dr u g A d mi nistrati o n. 0 6/ 1 6/ 2 0 2 3 ( htt ps:// w w w.f da. g o v/ vacci nes -bl o o d -bi ol o gics/ u p date d -
c o vi d-1 9 -vacci nes -us e -u nite d -states-be gi n ni n g -fall-2 0 2 3 ). 
4.  
C or o na vir us ( C O VI D -1 9) U p date: F D A A ut h orizes M o der na, Pfizer -Bi o N Tec h Bi vale nt 
C O VI D -1 9 V acci n es f or Use as a B o oster D ose. U. S. F o o d & Dr u g A d mi nistrat i o n. 2 0 2 2 0 8 
3 1 ( htt ps:// w w w.f da. g o v/ ne ws -e v e nts/ press -a n n o u nce me nts/c or o na vir us -c o vi d-1 9 -u p date -
f da-a ut h ori zes -m o der na -pfizer -bi o ntec h -bi vale nt -c o vi d-1 9 -vacci nes -us e ). 
5.  
C or o na vir us ( C O VI D -1 9) U p date: F D A A ut h orizes M o der na a n d Pfizer -Bi o N Tec h Bi vale nt 
C O VI D -1 9 V acci n es f or Use as a B o oster D ose i n Y o u n ger A g e  Gr o u ps. U. S. F o o d & Dr u g 
A d mi nistrati o n. 2 0 2 2 1 0 1 2 ( htt ps:// w w w.f da. g o v/ ne ws -e v e nts/ press -
a n n o u nce me nts/c or o na vir us -c o vi d-1 9 -u p d ate -f da-a ut h orizes -m o der na -a n d-pfizer -bi o ntec h -
bi vale nt -c o vi d-1 9 -v acci n es ). 
6.  
C or o na vir us ( C O VI D -1 9) U p date: F D A A ut h orizes U p date d ( Bi vale nt) C O VI D -1 9 Vacci nes 
f or C hil dre n D o w n t o 6 M o nt hs of A ge. U. S. F o o d & Dr u g A d mi nistrati o n. 2 0 2 2 1 2 0 8 
(htt ps:// w w w.f da. g o v/ ne ws -eve nts/ press -a n n o u nce me nts/c or o na vir us -c o vi d -1 9 -u p date -f da-
a ut h orizes -u p d ate d -bi val e nt -c o vi d-1 9 -v acci n es -c hil dre n -d o w n -6 -m o nt hs ). 
7.  
Her na n M A, R o bi ns J M. Usi n g Bi g Data t o E m ulate a Tar get Trial W he n a Ra n d o mize d 
Trial Is  N ot A vaila ble. A m J E pi de mi ol 2 0 1 6; 1 8 3( 8): 7 5 8 -6 4. D OI: 1 0. 1 0 9 3/aje/ k w v 2 5 4.  
8.  
Fact S heet: E n d of t he C O VI D -1 9 P u blic Healt h E mer ge nc y. U. S. De part me nt of Healt h a n d 
H u ma n Ser vices. 0 9 M A Y 2 0 2 3 ( htt ps:// w w w. h hs. g o v/a b o ut/ ne ws/ 2 0 2 3/ 0 5/ 0 9/fact -s heet-
e n d-of -t he-c o vi d-1 9 -p u blic -healt h -e mer ge n c y. ht ml ). 
9.  
E n d of P u blic Healt h E mer ge nc y. C e nters f or Dise ase C o ntr ol  a n d Pre ve nti o n. 1 2 S E P 2 0 2 3 
(htt ps:// w w w.c dc. g o v/c or o na vir us/ 2 0 1 9 -nc o v/ y o ur -healt h/e n d -of -p he. ht ml ). 
1 0.  
Ai nslie K E C, Ha ber M, Ore nstei n W A. Bias of i nfl ue nza v acci n e effecti ve ness esti mates 
fr o m test-ne gati ve st u dies c o n d ucte d d uri n g a n i nfl ue nza pa n d e mic. Vacci n e 
2 0 1 9; 3 7( 1 4): 1 9 8 7 -1 9 9 3. D OI: 1 0. 1 0 1 6/j. vacci ne. 2 0 1 9. 0 2. 0 3 6.  
1 1.  
Ozasa K, F u k us hi ma W. C o m me ntar y: Test -Ne gati ve Desi g n Re d uces  C o nf o u n di n g b y 
Healt hcare -See ki n g Attit u de i n Case -C o ntr ol St u dies. J E pi de mi ol 2 0 1 9; 2 9( 8): 2 7 9 -2 8 1. D OI: 
1 0. 2 1 8 8/jea.J E 2 0 1 8 0 1 7 7.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4 5  of 4 6  
1 2.  
Griffit h GJ, M orris T T, T u d ball MJ, et al. C olli der bias u n der mi nes o ur u n dersta n di n g of 
C O VI D -1 9 diseas e ris k a n d se verit y. Nat C o m m u n 2 0 2 0; 1 1( 1): 5 7 4 9. D OI: 1 0. 1 0 3 8/s 4 1 4 6 7 -
0 2 0 -1 9 4 7 8 -2.  
1 3.  
Nsa nzi ma na S, G u pta A, U wizi hi we J P, et al. T he Nee d f or a Practical A p pr oac h t o E val u ate 
t he Effecti ve ness of C O VI D-1 9 Vacci n es f or L o w - a n d Mi d dle-I n c o me C o u ntries. A m J 
Tr o p Me d H y g 2 0 2 1; 1 0 5( 3): 5 6 1 -5 6 3. D OI: 1 0. 4 2 6 9/ajt m h. 2 1 -0 4 8 2.  
1 4.  
Le w nar d J A, Patel M M, Je well N P, et al. T he oretical Fra me w or k f or Retr os pecti ve St u dies 
of t he Effecti ve ness of S A R S -C o V -2 Vacci n es. E pi de mi ol o g y 2 0 2 1; 3 2( 4): 5 0 8 -5 1 7. D OI: 
1 0. 1 0 9 7/ E D E. 0 0 0 0 0 0 0 0 0 0 0 0 1 3 6 6.  
1 5.  
M a ntel N, Hae nszel W. Statistical as pects of t he a nal ysis of data fr o m retr os pecti ve st u dies of 
disease. J Natl Ca ncer I nst 1 9 5 9; 2 2( 4): 7 1 9 -4 8. 
(htt ps:// w w w. nc bi. nl m. ni h. g o v/ p u b me d/ 1 3 6 5 5 0 6 0 ). 
1 6.  
Ba de n L R, El Sa hl y H M, Essi n k B, et al. Efficac y a n d Safet y of t he m R N A -1 2 7 3 S A R S -
C o V -2 Vacci ne. N E n gl J Me d 2 0 2 1; 3 8 4( 5): 4 0 3 -4 1 6. D OI: 1 0. 1 0 5 6/ N EJ M oa 2 0 3 5 3 8 9.  
1 7.  
P olac k F P, T h o mas SJ, Kitc hi n N, et al. Safet y a n d Efficac y of t he B N T 1 6 2 b 2 m R N A 
C o vi d -1 9 Vacci ne. N E n gl J Me d 2 0 2 0; 3 8 3( 2 7): 2 6 0 3 -2 6 1 5. D OI: 1 0. 1 0 5 6/ N EJ M oa 2 0 3 4 5 7 7.  
1 8.  
M oll K, W o n g H L, Fi n gar K, et al. Vali dati n g Clai ms -Base d Al g orit h ms Deter mi ni n g 
Pre g na nc y O ut c o mes a n d Gestati o nal A ge Usi n g a Li n ke d Clai ms -Electr o nic Me dical 
Rec or d Dat a base. Dr u g Saf 2 0 2 1; 4 4( 1 1): 1 1 5 1 -1 1 6 4. D OI: 1 0. 1 0 0 7/s 4 0 2 6 4 -0 2 1 -0 1 1 1 3 -8.  
1 9.  
W hat is C O VI D -1 9 Rei nfecti o n. Ce nters f or Dise ase C o ntr ol a n d Pre ve nti o n. 2 0 2 3 1 5 M A R 
(htt ps:// w w w.c dc. g o v/c or o na vir us/ 2 0 1 9 -nc o v/ y o ur -healt h/rei nf ecti o n. ht ml ). 
2 0.  
D u n kle L M, Izi ks o n R, Patriarca P, et al. Effi cac y of Rec o m bi na nt I nfl ue n za Vacci ne i n 
A d ults 5 0 Years of A g e or Ol der. N E n gl J Me d 2 0 1 7; 3 7 6( 2 5): 2 4 2 7 -2 4 3 6. D OI: 
1 0. 1 0 5 6/ N EJ M oa 1 6 0 8 8 6 2.  
2 1.  
U preti S, Sa ma nt M. A Re vie w o n I m m u n ol o gical Res p o nses t o S A R S -C o V -2 a n d Vari o us 
C O VI D -1 9 V acci n e Re gi me ns. P har m Res 2 0 2 2; 3 9( 9): 2 1 1 9 -2 1 3 4. (I n e n g). D OI: 
1 0. 1 0 0 7/s 1 1 0 9 5 -0 2 2 -0 3 3 2 3 -w.  
2 2.  
R u bi n L G et al ( Cli n I nfect Dis 2 0 1 4; 5 8:e 4 4 – 1 0 0). Cli nical I nfecti o us Diseases 
2 0 1 4; 5 9( 1): 1 4 4. ( htt ps:// d oi. or g/ 1 0. 1 0 9 3/ci d/ci u 2 5 7 ). 
2 3.  
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vacci nati o n of t he i m m u n oc o m pr o mise d h ost. Cli n I nfect Dis 2 0 1 4; 5 8( 3):e 4 4 -1 0 0. D OI: 
1 0. 1 0 9 3/ci d/cit 6 8 4.  
2 4.  
Pe o ple wit h Certai n Me dical C o n diti o ns. Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. 1 1 
M A Y 2 0 2 3 ( htt ps:// w w w.c dc. g o v/c or o n a vir us/ 2 0 1 9 -nc o v/ nee d -e xtra -preca uti o ns/ pe o ple -
wit h -me dical -c o n diti o ns. ht ml ). 
2 5.  
Q ua n H, S u n dararaja n V, Half o n P, et al. C o di n g al g orit h ms f or defi ni n g c o m or bi dities i n 
I C D-9 -C M a n d I C D -1 0 a d mi nistrati ve data. Me d Care 2 0 0 5; 4 3( 1 1): 1 1 3 0 -9. D OI: 
1 0. 1 0 9 7/ 0 1. mlr. 0 0 0 0 1 8 2 5 3 4. 1 9 8 3 2. 8 3.  
2 6.  
Vacci n ati o n data. Calif or nia De part me nt of P u blic He alt h. 2 0 2 3 0 9 2 2 
(htt ps://c o vi d 1 9.ca. g o v/ vacci nati o n -pr o gress -d ata/ ). 
2 7.  
Desai RJ, Fra n kli n J M. Alter nati ve a p pr oac hes f or c o nf o u n di n g a dj ust me nt i n o bser vati o nal 
st u dies usi n g wei g hti n g base d o n t he pr o p e nsit y sc ore: a pri mer f or practiti o ners. B MJ 
2 0 1 9; 3 6 7:l 5 6 5 7. D OI: 1 0. 1 1 3 6/ b mj.l 5 6 5 7.  
2 8.  
F u n k MJ, Westr eic h D, Wiese n C, St ur mer T, Br o o k hart M A, Da vi dia n M. D o u bl y r o b ust 
esti mati o n of ca usal effects . A m J E pi de mi ol 2 0 1 1; 1 7 3( 7): 7 6 1-7. D OI: 1 0. 1 0 9 3/aje/ k w q 4 3 9.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

B N T 1 6 2 b 2  (C O VI D -1 9 vacci ne f or m ulati o ns )  
C 4 5 9 1 0 6 5 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1. 0, 1 5  N o ve m ber  2 0 2 3  
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4 6  of 4 6  
2 9.  
Ne u ma n n A, Billi o n net C. C o variate a dj ust me nt of c u m ulati ve i nci de nce f u ncti o ns f or 
c o m peti n g ris ks data usi n g i n verse pr o ba bilit y of treat me nt wei g hti n g. C o m p ut Met h o ds 
Pr o gra ms Bi o me d 2 0 1 6; 1 2 9: 6 3 -7 0. D OI: 1 0. 1 0 1 6/j.c m p b. 2 0 1 6. 0 3. 0 0 8.  
3 0.  
Lee B K, Lessler J, St uart E A. Wei g ht tri m mi n g a n d pr o pe nsit y sc ore wei g hti n g. P L o S O ne 
2 0 1 1; 6( 3):e 1 8 1 7 4. D OI: 1 0. 1 3 7 1/j o ur nal. p o ne. 0 0 1 8 1 7 4.  
 
1 3.  LI S T O F T A B L E S  
T A B L E 1. TI M E LI N E O F K E Y B N T 1 6 2 B 2 R E G U L A T O R Y MI L E S T O N E S  ....................1 0  
T A B L E 2. T A R G E T T RI A L A N D T A R G E T T RI A L E M U L A TI O N  ...................................1 3  
T A B L E 3. E X P O S U R E V A RI A B L E S ....................................................................................2 2  
T A B L E 4. O U T C O M E V A RI A B L E S  ....................................................................................2 2  
T A B L E 5. C O V A RI A T E S  ......................................................................................................2 4  
 
1 4.  LI S T O F FI G U R E S  
Fi g ure 1. Ai m 1 st u d y desi g n  ...................................................................................................3 2  
Fi g ure 2. Ai m 2 st u d y desi g n  ...................................................................................................3 4  
Fi g ure 3. Ai m 4 st u d y desi g n  ...................................................................................................3 8  
Fi g ure 4. Ai m 5 st u d y desi g n  ...................................................................................................4 0  
 
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  
N o ne . 
A N N E X 2. E N C E P P C H E C K LI S T F O R S T U D Y P R O T O C O L S  
T his st u d y is n ot a  P A S S pr ot oc ol s u b mitte d i n t he E U/ E E A or U K , a n d t h us t his a n ne x is n ot 
re q uire d. 
A N N E X 3. A D DI TI O N A L I N F O R M A TI O N  
N ot a p plica ble.  
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)

D o c u m e nt A p pr o v al R e c or d
D o c u m e nt N a m e:
D o c u m e nt Titl e:
Si g n e d B y:
D at e( G M T)
Si g ni n g C a p a cit y
0 9 0 1 7 7 e 1 9f 3 2f 1 7f\ A p pr o v e d\ A p pr o v e d O n: 1 7- N o v- 2 0 2 3 1 8: 2 0 ( G M T)
P P D