HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
COMIRNATY safely and effectively. See full prescribing information for
COMIRNATY.

------------------------------ CONTRAINDICATIONS -----------------------------Known history of a severe allergic reaction (e.g., anaphylaxis) to any
component of COMIRNATY. (4)COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection,for intramuscular use
2024-2025 Formula
Initial U.S. Approval: 2021----------------------- WARNINGS AND PRECAUTIONS ----------------------
Postmarketing data with authorized or approved mRNA COVID-19
vaccines demonstrate increased risks of myocarditis and pericarditis,
particularly within the first week following vaccination. For
COMIRNATY, the observed risk is highest in males 12 through 17
years of age. (5.2)

Syncope (fainting) may occur in association with administration of
injectable vaccines, including COMIRNATY. Procedures should be inplace to avoid injury from fainting. (5.3)---------------------------RECENT MAJOR CHANGES --------------------------Dosage and Administration, Preparation for Administration: Plastic prefilled
syringe is no longer available. (2.1)
8/2024
Dosage and Administration, Administration Information (2.2)
9/2023
Dosage and Administration, Vaccination Schedule (2.3)
9/2023Warnings and Precautions, Myocarditis and Pericarditis (5.2)
9/2023--------------------------- INDICATIONS AND USAGE---------------------------COMIRNATY is a vaccine indicated for active immunization to prevent
coronavirus disease 2019 (COVID-19) caused by severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age andolder. (1)------------------------------ ADVERSE REACTIONS -----------------------------
The most commonly reported adverse reactions (≥10%) after a dose of
COMIRNATY were pain at the injection site (up to 90.5%), fatigue (upto 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain
(up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection
site swelling (up to 11.8%), and injection site redness (up to 10.4%).
(6.1)-----------------------DOSAGE AND ADMINISTRATION ----------------------For intramuscular injection only. (2)To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at
1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.



See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved patient labeling.

COMIRNATY is administered as a single 0.3 mL dose. (2.2)
For individuals previously vaccinated with any COVID-19 vaccine,
administer the dose of COMIRNATY at least 2 months after the lastdose of COVID-19 vaccine. (2.3)

Revised: 8/2024--------------------- DOSAGE FORMS AND STRENGTHS---------------------Suspension for injection. A single dose is 0.3 mL. (3)FULL PRESCRIBING INFORMATION: CONTENTS*
1
2

3
4
5

6
8

INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
2.1
Preparation for Administration
2.2
Administration Information
2.3
Vaccination Schedule
DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONSWARNINGS AND PRECAUTIONS
5.1
Management of Acute Allergic Reactions
5.2
Myocarditis and Pericarditis
5.3
Syncope
5.4
Altered Immunocompetence
5.5
Limitation of Effectiveness
ADVERSE REACTIONS
6.1
Clinical Trials Experience
6.2
Postmarketing Experience
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
8.2
Lactation
8.4
Pediatric Use
8.5
Geriatric Use
8.6
Immunocompromised Individuals

11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Immunogenicity Data Supporting the Use of a Single Dose of
COMIRNATY in Seropositive, Vaccine-Naïve Individuals
14.2 Primary Series With COMIRNATY – Efficacy in Participants
16 Years of Age and Older
14.3 Primary Series With COMIRNATY – Efficacy and
Immunogenicity in Adolescents 12 Through 15 Years of Age
14.4 Booster Dose With COMIRNATY – Immunogenicity of a First
Booster Dose in Individuals 18 Through 55 Years of Age
14.5 Booster Dose With Pfizer-BioNTech COVID-19 Vaccine, Bivalent– Immunogenicity of a Second Booster Dose in Individuals
12 Years of Age and Older
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing information are notlisted.

1

FULL PRESCRIBING INFORMATION
1

INDICATIONS AND USAGECOMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19)
caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age andolder.
2

DOSAGE AND ADMINISTRATION

For intramuscular injection only.
2.1

Preparation for Administration

COMIRNATY Single Dose Glass Prefilled SyringesVerify that the glass prefilled syringe states 2024-2025 Formula.
If glass prefilled syringe has been frozen, discard.
Do not shake.
Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile
needle. Use immediately. If COMIRNATY cannot be used immediately, it must be used within 4 hours.

COMIRNATY Single Dose Vials





2.2

Verify that the vial states 2024-2025 Formula.
If vial is frozen, thaw vial in the refrigerator [2ºC to 8ºC (35ºF to 46ºF) for up to 2 hours] or at room
temperature [up to 25ºC (77ºF) for 30 minutes] [see How Supplied/Storage and Handling (16)].
Prior to use, mix by inverting vial gently 10 times. Do not shake.
Withdraw a single 0.3 mL dose using a sterile needle and syringe.
Discard vial and any excess volume.
Administration Information

Parenteral drug products should be inspected visually for particulate matter and discoloration prior toadministration, whenever solution and container permit. The vaccine will be a white to off-white suspension.
Do not administer if vaccine is discolored or contains particulate matter.
Administer the 0.3 mL dose intramuscularly immediately after preparation. For the prefilled syringe, administer
the entire volume to deliver a single 0.3 mL dose.
2.3

Vaccination Schedule

COMIRNATY is administered as a single dose for individuals 12 years of age and older.
For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of COMIRNATY at least
2 months after the last dose of COVID-19 vaccine.

2

3

DOSAGE FORMS AND STRENGTHSCOMIRNATY is a suspension for injection. A single dose is 0.3 mL.
4

CONTRAINDICATIONS

Do not administer COMIRNATY to individuals with known history of a severe allergic reaction (e.g.,
anaphylaxis) to any component of COMIRNATY [see Description (11)] or to individuals who had a severe
allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.
5
5.1

WARNINGS AND PRECAUTIONSManagement of Acute Allergic Reactions

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions
following administration of COMIRNATY.
5.2

Myocarditis and Pericarditis

Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks ofmyocarditis and pericarditis, particularly within the first week following vaccination. For COMIRNATY, theobserved risk is highest in males 12 through 17 years of age. Although some cases required intensive care
support, available data from short-term follow-up suggest that most individuals have had resolution ofsymptoms with conservative management. Information is not yet available about potential long-term sequelae.
The Centers for Disease Control and Prevention (CDC) has published considerations related to myocarditis andpericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or
pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
5.3

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, including
COMIRNATY. Procedures should be in place to avoid injury from fainting.
5.4

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have adiminished immune response to COMIRNATY [see Use in Specific Populations (8.6)].
5.5

Limitation of Effectiveness

COMIRNATY may not protect all vaccine recipients.
6

ADVERSE REACTIONS

An overview of clinical studies contributing to the safety assessment of COMIRNATY is provided in Table 1.
Participants in these clinical studies received a 2-dose series, 3 weeks apart (referred to as a primary series) andsubsequent doses referred to as booster doses.

3

Table 1: Clinical Studies
Study
Primary Series
Study 1
(NCT04380701)
Study 2
(NCT04368728)
Booster DoseStudy 2
(NCT04368728)
Study 4
(NCT04955626)
Study 5
(NCT05472038)

Age Group

Vaccine Strain
Composition

DosingNumber ofParticipants

18 through 55 years
12 through 15 years of age≥16 years of age

Originala
Originala
OriginalaPrimary series
Primary series
Primary series

60
1131b
22026b12 through 15 years of age
18 through 55 years of age
12 through 17 years of age≥16 years of age

Originala
Originala
Originala
Originala
Original and Omicron
BA.4/BA.5c

1st booster
1st booster
1st booster
1st booster

825
306
65
5081b

2nd booster726≥12 years of age

Abbreviation: SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
a. COMIRNATY encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
b. Received COMIRNATY during placebo-control period.
c. Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages
BA.4 and BA.5 (Omicron BA.4/BA.5), authorized as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Primary Series with COMIRNATY
Participants 12 through 15 years of age in Study 2: the most commonly reported adverse reactions (≥8%)
following any dose were pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%),
muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), and injection site
redness (8.6%).
Participants 16 through 55 years of age in Study 2: the most commonly reported adverse reactions (≥10%)
following any dose were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain
(45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).
Participants 56 years of age and older in Study 2: the most commonly reported adverse reactions (≥10%)
following any dose were pain at the injection site (78.2%), fatigue (56.9%), headache, (45.9%), muscle pain
(32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site
redness (10.4%).
Booster Dose with COMIRNATY
Participants 12 years of age and older in Studies 2 and 4: the most commonly reported adverse reactions (≥5%)
following administration of a first booster dose with COMIRNATY were similar to those reported byparticipants who received COMIRNATY in the primary series.
Booster Dose With Pfizer-BioNTech COVID-19 Vaccine, BivalentParticipants 12 years of age and older in Study 5: the most commonly reported adverse reactions (≥5%)
following administration of a second booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent were
pain at the injection site (67.3%), fatigue (52.6%), headache (40.5%), muscle pain (24.6%), chills (18.0%), joint
pain (13.3%), fever (5.3%), injection site swelling (5.3%), and injection site redness (5.3%).

4

6.1

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may
not reflect the rates observed in practice.
Primary Series With COMIRNATY
The safety of a 2-dose primary series of COMIRNATY was evaluated in participants 12 years of age and older
in 2 clinical studies conducted in Germany (Study 1), United States, Argentina, Brazil, Turkey, South Africa,and Germany (Study 2). Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled
60 participants, 18 through 55 years of age and 36 participants, 56 through 85 years of age. Study 2 was a Phase
1/2/3 multicenter, randomized, saline placebo-controlled, double-blinded (Phase 2/3), dose finding-, vaccine
candidate-selection and efficacy study that enrolled approximately 46,000 participants 12 years of age or older.
Of these, approximately 2,260 participants were 12 through 15 years of age (1,131 COMIRNATY; 1,129
placebo) and 754 were 16 through 17 years of age (378 COMIRNATY; 376 placebo). In all, 44,047 participantsin Phase 2/3 were 16 years of age or older (22,026 COMIRNATY; 22,021 placebo).
Study 2 included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection.
Confirmed stable HIV infection was defined as documented viral load <50 copies/mL and CD4 count>200 cells/mm3 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months.
HIV-positive participants are included in the safety population but are summarized separately in the safety
analyses.
In Study 2, participants 12 years and older in the reactogenicity subset were monitored using an electronic diaryfor solicited local and systemic reactions and use of antipyretic medication after each vaccination. Participants
were also monitored for unsolicited adverse events throughout the study (from Dose 1 through 1 month [allunsolicited adverse events] or through 6 months [serious adverse events] after the last vaccination). Tables 2
and 3 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days
following any dose of COMIRNATY.
Adolescents 12 Through 15 Years of Age
In Study 2, 2,260 adolescents (1,131 COMIRNATY; 1,129 placebo) were 12 through 15 years of age. At thetime of the analysis of the ongoing Study 2 with a data cutoff of September 2, 2021, there were 1,559 (69.0%)
adolescents (786 COMIRNATY and 773 placebo) 12 through 15 years of age followed for ≥4 months after thesecond dose.
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity
among adolescents who received COMIRNATY and those who received placebo. Overall, among theadolescents who received COMIRNATY, 50.1% were male and 49.9% were female, 85.8% were White, 4.6%
were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American
Indian/Alaska Native.
Local and Systemic Adverse Reactions Solicited in Study 2
In adolescents 12 through 15 years of age after receiving Dose 2, the mean duration of pain at the injection sitewas 2.5 days (range 1 to 11 days), for redness 1.8 days (range 1 to 5 days), and for swelling 1.6 days (range 1 to
5 days) in the COMIRNATY group.

5

Table 2: Study 2 – Frequency and Percentages of Adolescents With Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of
Age – Safety Population*
COMIRNATY†
Placebo
COMIRNATY†
Placebo
Dose 1
Dose 1
Dose 2
Dose 2aaa
N =1127
N =1127
N =1097
Na=1078
b
b
b
n (%)
n (%)
n (%)
nb (%)
Rednessc
Any (>2 cm)
65 (5.8)
12 (1.1)
55 (5.0)
10 (0.9)
Mild
44 (3.9)
11 (1.0)29 (2.6)
8 (0.7)
Moderate
20 (1.8)
1 (0.1)26 (2.4)
2 (0.2)
Severe1 (0.1)0 (0.0)0 (0.0)0 (0.0)c
Swelling
Any (>2 cm)
78 (6.9)
11 (1.0)
54 (4.9)
6 (0.6)
Mild
55 (4.9)9 (0.8)36 (3.3)
4 (0.4)Moderate
23 (2.0)
2 (0.2)18 (1.6)
2 (0.2)
Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)Pain at the injection sitedAny
971 (86.2)
263 (23.3)
866 (78.9)
193 (17.9)
Mild
467 (41.4)
227 (20.1)
466 (42.5)
164 (15.2)
Moderate
493 (43.7)
36 (3.2)
393 (35.8)
29 (2.7)
Severe11 (1.0)0 (0.0)7 (0.6)0 (0.0)Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
b. n = Number of participants with the specified reaction.
c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

Table 3: Study 2 – Frequency and Percentages of Adolescents With Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of
Age – Safety Population*
COMIRNATY†
Placebo
COMIRNATY†
Placebo
Dose 1
Dose 1
Dose 2
Dose 2
Na=1127
Na=1127
Na=1097
Na=1078nb (%)
nb (%)
nb (%)
nb (%)
Fever≥38.0℃
114 (10.1)
12 (1.1)
215 (19.6)
7 (0.6)≥38.0℃ to 38.4℃
74 (6.6)
8 (0.7)107 (9.8)
5 (0.5)>38.4℃ to 38.9℃
29 (2.6)
2 (0.2)83 (7.6)
1 (0.1)>38.9℃ to 40.0℃
10 (0.9)
2 (0.2)25 (2.3)
1 (0.1)>40.0℃
1 (0.1)0 (0.0)0 (0.0)0 (0.0)c
FatigueAny677 (60.1)
457 (40.6)
726 (66.2)
264 (24.5)
Mild
278 (24.7)
250 (22.2)
232 (21.1)
133 (12.3)
Moderate
384 (34.1)
199 (17.7)
468 (42.7)
127 (11.8)
Severe15 (1.3)
8 (0.7)26 (2.4)
4 (0.4)

6

COMIRNATY†
Dose 1
Na=1127nb (%)HeadachecAny
623 (55.3)
Mild
361 (32.0)
Moderate
251 (22.3)
Severe11 (1.0)
ChillscAny
311 (27.6)
Mild
195 (17.3)
Moderate
111 (9.8)
Severe5 (0.4)
Vomitingd
Any
31 (2.8)
Mild
30 (2.7)
Moderate
0 (0.0)
Severe1 (0.1)e
DiarrheaAny
90 (8.0)
Mild
77 (6.8)
Moderate
13 (1.2)
Severe0 (0.0)c
New or worsened muscle painAny
272 (24.1)
Mild
125 (11.1)
Moderate
145 (12.9)
Severe2 (0.2)c
New or worsened joint painAny
109 (9.7)
Mild
66 (5.9)
Moderate
42 (3.7)
Severe1 (0.1)
Use of antipyretic or
pain medicationf
413 (36.6)

Placebo
Dose 1
Na=1127nb (%)COMIRNATY†
Dose 2
Na=1097
nb (%)

Placebo
Dose 2
Na=1078nb (%)

396 (35.1)
256 (22.7)
131 (11.6)
9 (0.8)708 (64.5)
302 (27.5)
384 (35.0)
22 (2.0)264 (24.5)
170 (15.8)
93 (8.6)
1 (0.1)109 (9.7)
82 (7.3)
25 (2.2)
2 (0.2)455 (41.5)
221 (20.1)
214 (19.5)
20 (1.8)

74 (6.9)53 (4.9)21 (1.9)
0 (0.0)10 (0.9)
8 (0.7)2 (0.2)0 (0.0)29 (2.6)
25 (2.3)
4 (0.4)0 (0.0)12 (1.1)
11 (1.0)
1 (0.1)0 (0.0)82 (7.3)
72 (6.4)
10 (0.9)
0 (0.0)65 (5.9)59 (5.4)
6 (0.5)0 (0.0)44 (4.1)
39 (3.6)
5 (0.5)0 (0.0)148 (13.1)
88 (7.8)
60 (5.3)
0 (0.0)355 (32.4)
152 (13.9)
197 (18.0)
6 (0.5)90 (8.3)
51 (4.7)
37 (3.4)
2 (0.2)77 (6.8)
50 (4.4)
27 (2.4)
0 (0.0)173 (15.8)
91 (8.3)
78 (7.1)
4 (0.4)51 (4.7)
30 (2.8)
21 (1.9)
0 (0.0)111 (9.8)557 (50.8)

95 (8.8)

Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after eachdose.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
b. n = Number of participants with the specified reaction.
c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
f. Severity was not collected for use of antipyretic or pain medication.

7

Unsolicited Adverse Events in Study 2
In Study 2, 2,260 adolescents (1,131 COMIRNATY; 1,129 placebo) were 12 through 15 years of age. Of these,
634 (56.1%) participants in the COMIRNATY group and 629 (55.7%) participants in the placebo group had
follow-up time between ≥4 months to <6 months after Dose 2 in the blinded placebo-controlled follow-up
period with an additional 152 (13.4%) and 144 (12.8%) with ≥6 months of blinded follow-up time in the
COMIRNATY and placebo groups, respectively.
A total of 1,113 (98.4%) participants 12 through 15 years of age originally randomized to COMIRNATY had≥6 months total (blinded and unblinded) follow-up after Dose 2. An analysis of all unsolicited adverse events inStudy 2 from Dose 1 up to the participant unblinding date was conducted. Among participants 12 through15 years of age who received at least 1 dose of study vaccine, unsolicited adverse events were reported by
95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group.
In an analysis of all unsolicited adverse events reported during blinded follow-up from Dose 1 through 1 monthafter Dose 2, in adolescents 12 to 15 years of age, those assessed as adverse reactions not already captured bysolicited local and systemic reactions were lymphadenopathy (9 vs. 2), and nausea (5 vs. 2).
In the analysis of blinded, placebo-controlled follow-up, there were no other notable patterns or numericalimbalances between treatment groups for specific categories of unsolicited adverse events (including otherneurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to
COMIRNATY. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of
non-serious adverse events that would suggest a causal relationship to COMIRNATY.
Serious Adverse Events
In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine orplacebo (COMIRNATY = 1,131; placebo = 1,129), serious adverse events from Dose 1 up to the participant
unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%)
placebo recipients. In these analyses, 69.0% of study participants had at least 4 months of follow-up after
Dose 2. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between
treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory,
and thrombotic events) that would suggest a causal relationship to COMIRNATY. In the analysis of unblindedfollow-up, there were no notable patterns of specific categories of serious adverse events that would suggest acausal relationship to COMIRNATY.
Participants 16 Years of Age and Older
At the time of the analysis of Study 2 with a data cutoff of March 13, 2021, there were 25,651 (58.2%)
participants (13,031 COMIRNATY; 12,620 placebo) 16 years of age and older followed for ≥4 months after thesecond dose.
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity
among participants who received COMIRNATY and those who received placebo. Overall, among the total
participants who received either COMIRNATY or placebo, 50.9% were male, 49.1% were female, 79.3% were
16 through 64 years of age, 20.7% were 65 years of age and older, 82.0% were White, 9.6% were Black or
African American, 25.9% were Hispanic/Latino, 4.3% were Asian, and 1.0% were American Indian or Alaska
Native.

8Local and Systemic Adverse Reactions Solicited in the Study 2
In participants 16 through 55 years of age after receiving Dose 2, the mean duration of pain at the injection sitewas 2.5 days (range 1 to 70 days), for redness 2.2 days (range 1 to 9 days), and for swelling 2.1 days (range 1 to
8 days) for participants in the COMIRNATY group.
In participants 56 years of age and older after receiving Dose 2, the mean duration of pain at the injection sitewas 2.4 days (range 1 to 36 days), for redness 3.0 days (range 1 to 34 days), and for swelling 2.6 days (range 1
to 34 days) for participants in the COMIRNATY group.
Table 4: Study 2 – Frequency and Percentages of Participants With Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 16 Through 55 Years of
Age – Reactogenicity Subset of the Safety Population*
COMIRNATY†
Placebo
COMIRNATY†
Placebo
Dose 1
Dose 1
Dose 2
Dose 2aaaN =2899
N =2908
N =2682
Na=2684
b
b
b
n (%)
n (%)
n (%)
nb (%)
Rednessc
Any (>2.0 cm)
156 (5.4)
28 (1.0)151 (5.6)
18 (0.7)
Mild
113 (3.9)
19 (0.7)
90 (3.4)
12 (0.4)
Moderate
36 (1.2)
6 (0.2)50 (1.9)
6 (0.2)
Severe7 (0.2)3 (0.1)
11 (0.4)0cSwelling
Any (>2.0 cm)
184 (6.3)
16 (0.6)
183 (6.8)
5 (0.2)
Mild
124 (4.3)
6 (0.2)110 (4.1)
3 (0.1)Moderate
54 (1.9)
8 (0.3)66 (2.5)
2 (0.1)
Severe6 (0.2)2 (0.1)7 (0.3)0
Pain at the injection sitedAny2426 (83.7)
414 (14.2)
2101 (78.3)
312 (11.6)
Mild1464 (50.5)
391 (13.4)
1274 (47.5)
284 (10.6)
Moderate
923 (31.8)
20 (0.7)
788 (29.4)
28 (1.0)
Severe39 (1.3)
3 (0.1)39 (1.5)0Notes: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
No Grade 4 solicited local reactions were reported in participants 16 through 55 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. Participants withchronic, stable HIV infection were excluded.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. The N for eachreaction was the same, therefore, this information was included in the column header.
b. n = Number of participants with the specified reaction.
c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

9

Table 5: Study 2 – Frequency and Percentages of Participants With Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 16 Through 55 Years of
Age – Reactogenicity Subset of the Safety Population*
COMIRNATY†
Placebo
COMIRNATY†
Placebo
Dose 1
Dose 1
Dose 2
Dose 2aaaN =2899
N =2908
N =2682
Na=2684
b
b
b
n (%)
n (%)
n (%)
nb (%)
Fever≥38.0℃
119 (4.1)
25 (0.9)440 (16.4)
11 (0.4)≥38.0℃ to 38.4℃
86 (3.0)
16 (0.6)
254 (9.5)
5 (0.2)>38.4℃ to 38.9℃
25 (0.9)
5 (0.2)146 (5.4)
4 (0.1)>38.9℃ to 40.0℃
8 (0.3)4 (0.1)39 (1.5)
2 (0.1)>40.0℃00
1 (0.0)0
FatiguecAny1431 (49.4)
960 (33.0)
1649 (61.5)
614 (22.9)
Mild
760 (26.2)
570 (19.6)
558 (20.8)
317 (11.8)
Moderate
630 (21.7)
372 (12.8)
949 (35.4)
283 (10.5)
Severe41 (1.4)
18 (0.6)
142 (5.3)
14 (0.5)cHeadacheAny1262 (43.5)
975 (33.5)
1448 (54.0)
652 (24.3)
Mild
785 (27.1)
633 (21.8)
699 (26.1)
404 (15.1)
Moderate
444 (15.3)
318 (10.9)658 (24.5)
230 (8.6)
Severe33 (1.1)
24 (0.8)
91 (3.4)
18 (0.7)cChillsAny
479 (16.5)
199 (6.8)1015 (37.8)
114 (4.2)
Mild
338 (11.7)
148 (5.1)
477 (17.8)
89 (3.3)
Moderate
126 (4.3)
49 (1.7)
469 (17.5)
23 (0.9)
Severe15 (0.5)
2 (0.1)69 (2.6)
2 (0.1)d
VomitingAny
34 (1.2)
36 (1.2)
58 (2.2)
30 (1.1)
Mild
29 (1.0)30 (1.0)42 (1.6)
20 (0.7)
Moderate
5 (0.2)5 (0.2)12 (0.4)
10 (0.4)
Severe01 (0.0)4 (0.1)0eDiarrheaAny
309 (10.7)
323 (11.1)
269 (10.0)
205 (7.6)
Mild
251 (8.7)
264 (9.1)
219 (8.2)
169 (6.3)
Moderate55 (1.9)58 (2.0)44 (1.6)35 (1.3)
Severe3 (0.1)1 (0.0)6 (0.2)1 (0.0)c
New or worsened muscle painAny
664 (22.9)
329 (11.3)
1055 (39.3)
237 (8.8)
Mild
353 (12.2)
231 (7.9)
441 (16.4)
150 (5.6)
Moderate
296 (10.2)
96 (3.3)552 (20.6)
84 (3.1)
Severe15 (0.5)
2 (0.1)62 (2.3)
3 (0.1)
New or worsened joint painc
Any
342 (11.8)
168 (5.8)
638 (23.8)
147 (5.5)
Mild
200 (6.9)
112 (3.9)291 (10.9)
82 (3.1)
Moderate
137 (4.7)
55 (1.9)320 (11.9)
61 (2.3)
Severe5 (0.2)1 (0.0)27 (1.0)
4 (0.1)10

Use of antipyretic or
pain medicationf

COMIRNATY†
Dose 1
Na=2899nb (%)

Placebo
Dose 1
Na=2908nb (%)COMIRNATY†
Dose 2
Na=2682
nb (%)

Placebo
Dose 2
Na=2684
nb (%)

805 (27.8)

398 (13.7)

1213 (45.2)

320 (11.9)

Notes: Reactions and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after
each dose.
No Grade 4 solicited systemic reactions were reported in participants 16 through 55 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. Participants withchronic, stable HIV infection were excluded.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. The N for eachreaction or use of antipyretic or pain medication was the same, therefore, this information was included in the column header.
b. n = Number of participants with the specified reaction.
c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
f. Severity was not collected for use of antipyretic or pain medication.

Table 6: Study 2 – Frequency and Percentages of Participants With Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age andOlder – Reactogenicity Subset of the Safety Population*
COMIRNATY†
Placebo
COMIRNATY†
Placebo
Dose 1
Dose 1
Dose 2
Dose 2aaa
N =2008
N =1989
N =1860
Na=1833
b
b
b
n (%)
n (%)
n (%)
nb (%)c
RednessAny (>2.0 cm)
106 (5.3)
20 (1.0)133 (7.2)
14 (0.8)
Mild
71 (3.5)
13 (0.7)
65 (3.5)
10 (0.5)
Moderate
30 (1.5)5 (0.3)58 (3.1)
3 (0.2)
Severe5 (0.2)2 (0.1)10 (0.5)
1 (0.1)
Swellingc
Any (>2.0 cm)
141 (7.0)
23 (1.2)
145 (7.8)
13 (0.7)
Mild
87 (4.3)
11 (0.6)
80 (4.3)
5 (0.3)Moderate
52 (2.6)
12 (0.6)
61 (3.3)
7 (0.4)
Severe2 (0.1)0
4 (0.2)1 (0.1)Pain at the injection sitedAny (>2.0 cm)
1408 (70.1)
185 (9.3)
1230 (66.1)
143 (7.8)
Mild1108 (55.2)
177 (8.9)873 (46.9)
138 (7.5)
Moderate
296 (14.7)
8 (0.4)347 (18.7)
5 (0.3)Severe4 (0.2)0
10 (0.5)0Notes: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
No Grade 4 solicited local reactions were reported in participants 56 years of age and older.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. Participants withchronic, stable HIV infection were excluded.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. The N for eachreaction was the same, therefore, the information was included in the column header.
b. n = Number of participants with the specified reaction.
c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

11

Table 7: Study 2 – Frequency and Percentages of Participants With Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age andOlder – Reactogenicity Subset of the Safety Population*
COMIRNATY†
Placebo
COMIRNATY†
Placebo
Dose 1
Dose 1
Dose 2
Dose 2aaa
N =2008
N =1989
N =1860
Na=1833
b
b
b
n (%)
n (%)
n (%)
nb (%)
Fever≥38.0℃
26 (1.3)
8 (0.4)219 (11.8)
4 (0.2)≥38.0℃ to 38.4℃
23 (1.1)
3 (0.2)158 (8.5)
2 (0.1)>38.4℃ to 38.9℃
2 (0.1)3 (0.2)54 (2.9)
1 (0.1)>38.9℃ to 40.0℃
1 (0.0)2 (0.1)7 (0.4)1 (0.1)>40.0℃
0000
FatiguecAny
677 (33.7)
447 (22.5)
949 (51.0)306 (16.7)
Mild
415 (20.7)
281 (14.1)
391 (21.0)
183 (10.0)
Moderate
259 (12.9)
163 (8.2)
497 (26.7)
121 (6.6)
Severe3 (0.1)3 (0.2)60 (3.2)
2 (0.1)
Grade 400
1 (0.1)0c
HeadacheAny
503 (25.0)
363 (18.3)
733 (39.4)
259 (14.1)
Mild
381 (19.0)
267 (13.4)
464 (24.9)
189 (10.3)
Moderate
120 (6.0)
93 (4.7)
256 (13.8)
65 (3.5)
Severe2 (0.1)3 (0.2)13 (0.7)
5 (0.3)ChillscAny
130 (6.5)
69 (3.5)435 (23.4)
57 (3.1)
Mild
102 (5.1)
49 (2.5)229 (12.3)
45 (2.5)
Moderate
28 (1.4)
19 (1.0)185 (9.9)
12 (0.7)
Severe01 (0.1)21 (1.1)
0Vomitingd
Any
10 (0.5)
9 (0.5)13 (0.7)
5 (0.3)Mild
9 (0.4)9 (0.5)10 (0.5)5 (0.3)Moderate
1 (0.0)01 (0.1)0
Severe002 (0.1)0
Diarrheae
Any
168 (8.4)
130 (6.5)
152 (8.2)
102 (5.6)
Mild
137 (6.8)
109 (5.5)
125 (6.7)
76 (4.1)
Moderate
27 (1.3)
20 (1.0)25 (1.3)
22 (1.2)
Severe4 (0.2)1 (0.1)2 (0.1)4 (0.2)
New or worsened muscle painc
Any
274 (13.6)
165 (8.3)
537 (28.9)
99 (5.4)
Mild
183 (9.1)
111 (5.6)
229 (12.3)
65 (3.5)
Moderate
90 (4.5)
51 (2.6)
288 (15.5)
33 (1.8)
Severe1 (0.0)3 (0.2)20 (1.1)
1 (0.1)

12

New or worsened joint painc
Any
Mild
Moderate
SevereUse of antipyretic or
pain medicationf

COMIRNATY†
Dose 1
Na=2008nb (%)

Placebo
Dose 1
Na=1989nb (%)COMIRNATY†
Dose 2
Na=1860
nb (%)

Placebo
Dose 2
Na=1833
nb (%)

175 (8.7)
119 (5.9)
53 (2.6)
3 (0.1)124 (6.2)
78 (3.9)45 (2.3)
1 (0.1)353 (19.0)
183 (9.8)
161 (8.7)
9 (0.5)72 (3.9)44 (2.4)
27 (1.5)
1 (0.1)382 (19.0)

224 (11.3)

688 (37.0)

170 (9.3)

Notes: Reactions and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after
each dose.
The only Grade 4 solicited systemic reaction reported in participants 56 years of age and older was fatigue.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. Participants withchronic, stable HIV infection were excluded.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. N for eachreaction or use of antipyretic or pain medication was the same, therefore was included in the column header.
b. n = Number of participants with the specified reaction.
c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity; Grade 4 reactions
were defined in the clinical study protocol as emergency room visit or hospitalization for severe fatigue, severe headache, severe
chills, severe muscle pain, or severe joint pain.
d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration; Grade 4 emergency visit or
hospitalization for severe vomiting.
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours; Grade 4:
emergency room or hospitalization for severe diarrhea.
f. Severity was not collected for use of antipyretic or pain medication.

In participants with chronic, stable HIV infection the frequencies of solicited local and systemic adverse
reactions were similar to or lower than those observed for all participants 16 years of age and older.
Unsolicited Adverse Events
Overall, 11,253 (51.1%) participants 16 years of age and older in the COMIRNATY group and 11,316 (51.4%)
participants in the placebo group had follow-up time between ≥4 months to <6 months after Dose 2 in theblinded placebo-controlled follow-up period with an additional 1,778 (8.1%) and 1,304 (5.9%) with ≥6 monthsof blinded follow-up time in the COMIRNATY and placebo groups, respectively.
A total of 12,006 (54.5%) participants originally randomized to COMIRNATY had ≥6 months total (blinded
and unblinded) follow-up after Dose 2.
In an analysis of all unsolicited adverse events reported following any dose, through 1 month after Dose 2, inparticipants 16 years of age and older (N=43,847; 21,926 COMIRNATY group vs. 21,921 placebo group),
those assessed as adverse reactions not already captured by solicited local and systemic reactions were nausea(274 vs. 87), malaise (130 vs. 22), lymphadenopathy (83 vs. 7), asthenia (76 vs. 25), decreased appetite(39 vs. 9), hyperhidrosis (31 vs. 9), lethargy (25 vs. 6), and night sweats (17 vs. 3).
In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date,
58.2% of study participants had at least 4 months of follow-up after Dose 2. Among participants 16 through55 years of age who received at least 1 dose of study vaccine, 12,995 of whom received COMIRNATY and
13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in
the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. In a similar analysis in13participants 56 years of age and older that included 8,931 COMIRNATY recipients and 8,895 placebo
recipients, unsolicited adverse events were reported by 2,551 (28.6%) participants in the COMIRNATY groupand 1,432 (16.1%) participants in the placebo group. Among participants with confirmed stable HIV infectionthat included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events werereported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group.
The higher frequency of reported unsolicited adverse events among COMIRNATY recipients compared toplacebo recipients was primarily attributed to events that are consistent with adverse reactions solicited among
participants in the reactogenicity subset (Table 6 and Table 7).
Throughout the placebo-controlled safety follow-up period, Bell’s palsy (facial paralysis) was reported by
4 participants in the COMIRNATY group and 2 participants in the placebo group. Onset of facial paralysis was
Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. In the placebogroup the onset of facial paralysis was Day 32 and Day 102. Currently available information is insufficient todetermine a causal relationship with the vaccine. In the analysis of blinded, placebo-controlled follow-up, there
were no other notable patterns or numerical imbalances between treatment groups for specific categories of
non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) thatwould suggest a causal relationship to COMIRNATY. In the analysis of unblinded follow-up, there were no
notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to
COMIRNATY.
Serious Adverse Events
Participants 16 through 55 years of age in Study 2 who had received at least 1 dose of vaccine or placebo(COMIRNATY = 12,995; placebo = 13,026), reported serious adverse events from Dose 1 up to the participant
unblinding date in ongoing follow-up as follows: 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo
recipients. In a similar analysis, in participants 56 years of age and older (8,931 COMIRNATY group and 8,895
placebo group), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%)
placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. In these analyses,
58.2% of study participants had at least 4 months of follow-up after Dose 2. Among participants with confirmed
stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing
follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients.
In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatmentgroups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, andthrombotic events) that would suggest a causal relationship to COMIRNATY. In the analysis of unblindedfollow-up, there were no notable patterns of specific categories of serious adverse events that would suggest acausal relationship to COMIRNATY.
First Booster Dose With COMIRNATY Following the Primary Series
12 Through 15 Years of Age
A subset of 825 Study 2 Phase 2/3 participants 12 through 15 years of age received a booster dose of
COMIRNATY 11.2 months (median time, range 6.3 to 20.1 months) after completing the primary series andhad a median follow-up time of 9.5 months up to a data cutoff date of November 3, 2022. The median age ofparticipants was 14.0 years (range 13 through 15 years of age), 49.3% were male and 50.7% were female,
83.5% were White, 10.8% were Hispanic/Latino, 4.6% were Black or African American, 7.5% were Asian, and
0.4% were American Indian/Alaska Native.

14

Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to thosepreviously observed in participants receiving COMIRNATY as part of the primary series. Lymphadenopathy
occurred in 8 (1.0%) participants who received a booster dose of COMIRNATY and in 9 (0.8%) participants
who received COMIRNATY as a primary series.
12 Through 17 Years of Age
A subset of 65 Study 4 participants 12 through 17 years of age received a booster dose of COMIRNATY
13.3 months (median time, range 6.5 to 16.9 months) after completing the primary series and had a medianfollow-up time of 5.6 months up to a data cutoff date of July 14, 2022. The median age of participants was
14 years (range 12 through 17 years of age), 49.2% were male and 50.8% were female, 76.9% were White,
16.9% were Hispanic/Latino, 13.8% were Black or African American, 7.7% were Asian, and 1.5% were
American Indian/Alaska Native.
Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to thosepreviously observed in participants receiving COMIRNATY as part of the primary series. There were no casesof lymphadenopathy reported in participants who received a booster dose of COMIRNATY.
16 Years of Age and Older
In Study 4, a double-blind placebo-controlled booster study, 5,081 participants 16 years of age and older
recruited from Study 2 received a booster dose of COMIRNATY 10.8 months (median time, range of 5.0 to
12.6 months) after completing the primary series of COMIRNATY series and had a median follow-up time of
2.9 months based on data up to the cutoff date of February 8, 2022. The median age of participants who
received COMIRNATY or placebo was 53.0 years (range 16 through 87 years of age), 49.1% were male and50.9% were female, 79.0% were White, 14.9% were Hispanic/Latino, 9.2% were Black or African American,
5.5% were Asian, and 1.7% were American Indian/Alaska Native.
Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to thosepreviously observed in participants receiving COMIRNATY as part of the primary series. Lymphadenopathy
occurred in 141 (2.8%) participants who received a booster dose of COMIRNATY and in 83 (0.4%)
participants who received COMIRNATY as a primary series.
18 Through 55 Years of Age
A subset of 306 Study 2 Phase 2/3 participants 18 through 55 years of age received a booster dose of
COMIRNATY 6.8 months (median time, range 4.8 to 8.0 months) after completing the primary series. These
participants had a median follow-up time of 8.3 months up to a data cutoff date of November 22, 2021. Amongthe 306 participants, the median age was 42 years (range 19 through 55 years of age), 45.8% were male and54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American,
5.2% were Asian, and 0.7% were American Indian/Alaska Native.
Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to thosepreviously observed in participants receiving COMIRNATY as part of the primary series. Lymphadenopathy
occurred in 16 (5.2%) of participants who received a booster dose of COMIRNATY and 83 (0.4%) in
participants who received COMIRNATY as a primary series.

15

Second Booster With Pfizer-BioNTech COVID-19 Vaccine, Bivalent
12 Years of Age and Older
A subset of 107 Study 5 Phase 2/3 participants 12 through 17 years of age, 313 participants 18 through 55 yearsof age and 306 participants 56 years of age and older previously vaccinated with a 2-dose primary series and1 booster dose of COMIRNATY, went on to receive a second booster dose with Pfizer-BioNTech COVID-19
Vaccine, Bivalent.
Participants received a second booster dose 11.1 months (median time; range 5.4 to 16.9 months) after receiving
the first booster dose and had a median follow-up time of 1.5 months up to a data cutoff date ofOctober 31, 2022. The median age was 48.0 years, 42.7% were male, 57.3% were female, 80.6% were White,
11.4% were Hispanic/Latino, 5.9% were Asian, and 11.4% were Black or African American.
Local and Systemic Adverse Reactions Solicited in Study 5
Table 8 and Table 9 present the frequency and severity of reported solicited local reactions and systemic
reactions, respectively, within 7 days of a second booster dose of Pfizer-BioNTech COVID-19 Vaccine,
Bivalent.
In participants 12 years of age and older who received a second booster dose, the mean duration of injection site
pain was 2.1 to 2.4 days (range 1 to 11 days), injection site redness was 1.5 to 2.5 days (range 1 to 4 days), andinjection site swelling was 1.3 to 1.9 days (range 1 to 4 days), respectively.
Table 8: Study 5 – Frequency and Percentages of Participants With Solicited Local Reactions, by
Maximum Severity, Within 7 Days After a Second Booster Dose – Participants 12 Years of Ageand Older – Safety Population
Pfizer-BioNTech COVID-19 Vaccine, Bivalent*
12 Through 17 Years of
18 Through 55 Years ofAge
Age
56 Years of Age and Older
Na=107
Na=309†
Na=300†
b
b
n (%)
n (%)
nb (%)
Rednessc
Any (>2 cm)
6 (5.6)21 (6.8%)
11 (3.7%)
Mild
4 (3.7)16 (5.2%)
7 (2.3)Moderate
2 (1.9)5 (1.6)4 (1.3%)Severe000cSwelling
Any (>2 cm)
8 (7.5)23 (7.4%)
8 (2.7)Mild
6 (5.6)19 (6.1%)
5 (1.7)
Moderate
2 (1.9)4 (1.3)3 (1.0)
Severe000Pain at the
injection sitedAny
75 (70.1)
236 (76.1)
172 (57.1)
Mild
45 (42.1)
178 (57.4)
147 (48.8)
Moderate
29 (27.1)
58 (18.7)
24 (8.0)
Severe1 (0.9)01 (0.3)
Note: Adverse Reactions were collected in the electronic diary (e-diary) from day of vaccination (Day 1) through Day 7 after the study
vaccination.
16

* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages
BA.4 and BA.5 (Omicron BA.4/BA.5).
† N = 310 for redness and pain at injection site in participants 18 through 55 years of age; N=301 for pain at injection site inparticipants 56 years of age and older.
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the study vaccination.
b. n = Number of participants with the specified adverse reaction.
c. Mild: >2.0 to 5.0 cm; Moderate: >5.0 to 10.0 cm; Severe: >10.0 cm.
d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

Table 9: Study 5 – Frequency and Percentages of Participants With Solicited Systemic Adverse
Reactions, by Maximum Severity, Within 7 Days After a Second Booster Dose – Participants
12 Years of Age and Older – Safety Population
Pfizer-BioNTech
COVID-19 Vaccine,
Bivalent*
12 Through 17 Years 18 Through 55 Years
56 Years of Age andof Ageof AgeOlderaa
N =107
N =309
Na=300†
b
b
n (%)
n (%)
nb (%)
Fever≥38.0℃
10 (9.3)
15 (4.9)
14 (4.7)≥38.0℃ to 38.4℃
7 (6.5)9 (2.9)10 (3.3)>38.4℃ to 38.9℃
2 (1.9)6 (1.9)3 (1.0)>38.9℃ to 40.0℃
1 (0.9)00>40.0℃
000c
FatigueAny
72 (67.3)
189 (61.2)
116 (38.5)
Mild
27 (25.2)
83 (26.9)
56 (18.6)
Moderate
45 (42.1)
100 (32.4)
56 (18.6)
Severe06 (1.9)4 (1.3)cHeadacheAny
54 (50.5)144 (46.6)
92 (30.7)
Mild
28 (26.2)
87 (28.2)
62 (20.7)
Moderate
26 (24.3)
55 (17.8)30 (10.0)
Severe02 (0.6)0cChillsAny
25 (23.4)
68 (22.0)
36 (12.0)
Mild
19 (17.8)
38 (12.3)
21 (7.0)
Moderate
6 (5.6)28 (9.1)
14 (4.7)
Severe02 (0.6)
1 (0.3)d
VomitingAny
3 (2.8)6 (1.9)2 (0.7)Mild
3 (2.8)5 (1.6)2 (0.7)
Moderate01 (0.3)0
Severe000
eDiarrheaAny
7 (6.5)33 (10.7)
29 (9.6)Mild
7 (6.5)27 (8.7)
23 (7.6)
Moderate
05 (1.6)6 (2.0)
Severe01 (0.3)0
17

New or worsened muscle painc
Any
Mild
Moderate
SevereNew or worsened joint painc
Any
Mild
Moderate
SevereUse of antipyretic or pain
medicationf

12 Through 17 Yearsof AgeNa=107nb (%)

Pfizer-BioNTech
COVID-19 Vaccine,
Bivalent*
18 Through 55 Yearsof AgeNa=309nb (%)

56 Years of Age andOlder
Na=300†nb (%)

28 (26.2)
12 (11.2)
16 (15.0)0

94 (30.4)
47 (15.2)
47 (15.2)
054 (18.0)30 (10.0)
24 (8.0)013 (12.1)
9 (8.4)4 (3.7)0

46 (14.9)
21 (6.8)
25 (8.1)
036 (12.0)
20 (6.7)
16 (5.3)
036 (33.6)

105 (34.0)

74 (24.7)

Note: Adverse reactions and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from day of
vaccination (Day 1) through Day 7 after the study vaccination.
* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages
BA.4 and BA.5 (Omicron BA.4/BA.5).
† N=301 for fever, fatigue and diarrhea in participants 56 years of age and older.
a. N = Number of participants reporting at least 1 yes or no response for the specified adverse reaction after the study vaccination.
b. n = Number of participants with the specified adverse reaction.
c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
f. Severity was not collected for use of antipyretic or pain medication.

Unsolicited Adverse Events
Among participants 12 years of age and older, unsolicited adverse events were reported by 48 (6.6%)
participants who received a second booster dose through 1 month after the booster dose. Lymphadenopathy
occurred in 7 (1.0%) participants.
6.2

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of COMIRNATY,
Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Because thesereactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to vaccine exposure.
Cardiac Disorders: myocarditis, pericarditis
Gastrointestinal Disorders: diarrhea, vomiting
Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions(e.g., rash, pruritus, urticaria, angioedema)
Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)Nervous System Disorders: syncope, dizziness18

8

USE IN SPECIFIC POPULATIONS

8.1

Pregnancy

Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, theestimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to
4% and 15% to 20%, respectively. Available data on COMIRNATY administered to pregnant women are
insufficient to inform vaccine-associated risks in pregnancy.
A developmental toxicity study has been performed in female rats administered the equivalent of a single
human dose of COMIRNATY [encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu 1 strain(Original)] on 4 occasions, twice prior to mating and twice during gestation. These studies revealed no evidenceof harm to the fetus due to the vaccine (see Animal Data).
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with
non-pregnant individuals.
Data
Animal Data
In a developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of
nucleoside-modified messenger ribonucleic acid (mRNA) (30 mcg) and other ingredients included in a single
human dose of COMIRNATY [encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu 1 strain(Original)] was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior tomating, and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal
development, or postnatal development were reported in the study.
8.2

Lactation

Risk Summary
It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of
COMIRNATY on the breastfed infant or on milk production/excretion. The developmental and health benefitsof breastfeeding should be considered along with the mother’s clinical need for COMIRNATY and any
potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition.
For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
8.4

Pediatric Use

Safety and effectiveness of COMIRNATY in individuals 12 through 17 years of age is based on safety andeffectiveness data in this age group and in adults [see Adverse Reactions (6) and Clinical Studies (14.1)].

19

The safety and effectiveness of COMIRNATY in individuals younger than 12 years of age have not been
established. Evidence from clinical studies in individuals 6 months through 4 years of age strongly suggests thata single dose of COMIRNATY would be ineffective in individuals younger than 6 months of age.
8.5

Geriatric Use

Of the total number of COMIRNATY recipients in Study 2 as of March 13, 2021 (N = 22,026),
20.7% (n = 4,552) were 65 years of age and older and 4.2% (n = 925) were 75 years of age and older [seeClinical Studies (14.1)]. In Study 4, of 5081 recipients who received COMIRNATY as the first booster dose,
23.1% (n = 1175) were 65 years of age and older and 5.2% (n = 265) were 75 years of age and older. In Study5, of 726 recipients who received Pfizer-BioNTech COVID-19 Vaccine, Bivalent as the second booster dose,
21.9% (n = 159) were 65 years of age and older and 4.8% (n = 35) were 75 years of age and older. No overall
differences in safety or effectiveness were observed between these recipients and younger recipients.
8.6

Immunocompromised Individuals

The Centers for Disease Control and Prevention has published considerations related to COVID-19 vaccination
for individuals who are moderately to severely immunocompromised (https://www.cdc.gov/vaccines/covid19/clinical-considerations/covid-19-vaccines-us.html).
11 DESCRIPTIONCOMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use.
Each 0.3 mL dose of COMIRNATY (2024-2025 Formula) is formulated to contain 30 mcg of a
nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2
Omicron variant lineage KP.2.
Each 0.3 mL dose of COMIRNATY also includes the following ingredients:
lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate),
0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide,
0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine,
0.4 mg tromethamine hydrochloride, and 31 mg sucrose.
COMIRNATY does not contain preservatives.
The vial stoppers are not made with natural rubber latex.
The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The nucleoside-modified mRNA in COMIRNATY is formulated in lipid particles, which enable delivery of themRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune
response to the S antigen, which protects against COVID-19.

20

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment ofmale fertility. In a developmental toxicity study in rats with COMIRNATY [encoding the viral spike (S)glycoprotein of SARS-CoV-2 Wuhan-Hu 1 strain (Original)] there were no vaccine-related effects on female
fertility [see Use in Specific Populations (8.1)].
14 CLINICAL STUDIES
14.1 Immunogenicity Data Supporting the Use of a Single Dose of COMIRNATY in Seropositive,
Vaccine-Naïve Individuals
In a post-hoc analysis in a subset of participants 18 through 85 years of age enrolled in Study 7(NCT05004181), immunogenicity of a single 30 mcg dose of a Pfizer-BioNTech bivalent COVID-19 vaccine
containing equal quantities of modRNA encoding the viral spike (S) glycoprotein for the Alpha and Delta
SARS-CoV-2 variants [not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Alphaand Delta)] was assessed in COVID-19 vaccine-naïve participants with evidence of prior SARS-CoV-2
infection (n = 262) compared to participants without prior SARS-CoV-2 infection who received 2 doses of
COMIRNATY in Study 2 (n = 275). Among Study 7 participants, 253 were from study sites in South Africa
and 9 were from study sites in the U.S. The immunogenicity of the bivalent Alpha and Delta vaccine is relevant
to COMIRNATY because these vaccines are manufactured using the same process with differences only in theencoded spike proteins.
Table 10 presents demographic characteristics for participants in the immunogenicity analysis set.
Table 10: Demographic Characteristics – Subset of Participants from Study 7 and Study 2 – Reference
Strain Neutralization – Immunogenicity Analysis Set
Study 2
Study 7
Two Doses ofSingle Dose of Bivalent Vaccine
COMIRNATY*(Alpha and Delta)
Without Evidence ofWith Evidence of Prior Infection
Infectiona(N =262)(Na=275)bN (%)
Nb (%)
SexMale
109 (41.6)
113 (41.1)
Female153 (58.4)
162 (58.9)
Age at Vaccination (Years)
Mean (SD)42.9 (16.21)
42.7 (16.08)
Median41.0
40.0Min, max(18,84)(18, 84)
RaceWhite
4 (1.5)230 (83.6)
Black or African American
169 (64.5)
25 (9.1)
American Indian or Alaska Native0
2 (0.7)Asian0
7 (2.5)cOther
89 (34.0)
11 (4.0)
21

Ethnicity
Hispanic or Latino
Not Hispanic or Latino
Not reported

Study 7Single Dose of Bivalent Vaccine(Alpha and Delta)
With Evidence of Prior Infection(Na=262)
Nb (%)

Study 2
Two Doses of
COMIRNATY*
Without Evidence ofInfection(Na=275)
Nb (%)

5 (1.9)255 (97.3)
2 (0.8)83 (30.2)
192 (69.8)
0* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = number of participants in the specified group. This value is the denominator for the percentage calculations.
b. n = Number of participants with the specified characteristic.
c. Includes multiracial and not reported.

The objective of this analysis was to assess noninferiority with respect to level of 50% neutralizing titer (NT50)
and to the seroresponse rate to the reference strain induced by a single dose of the bivalent Alpha and Delta
vaccine in COVID-19 vaccine-naïve participants with evidence of prior infection relative to participants without
evidence of SARS-CoV-2 infection who received 2 doses of COMIRNATY.
Noninferiority of the reference strain immune response with respect to level of NT50 was met, as the lower
bound of the 2-sided 95% CI for the geometric mean ratio (GMR) was >0.67 (Table 11). Noninferiority of theseroresponse rate to the reference strain was not met, as the lower bound of the 2-sided 95% CIs for thedifference in seroresponse rate of reference strain was -10.04%, below the noninferiority margin of -10%
(Table 12).
Table 11: Geometric Mean Ratios – Single Dose of Bivalent Vaccine (Alpha and Delta) in Vaccine-Naïve
Participants from Study 7 With Evidence of Prior SARS-CoV-2 Infection Compared to
2 Doses of COMIRNATY in a Subset of Participants from Study 2 Without Evidence of
SARS-CoV-2 Infection – Reference Strain Neutralization – Immunogenicity Analysis Set
Study 7
Study 2
Bivalent Vaccine (Alpha
Single Dose of Bivalent
Two Doses ofand Delta) With Evidence
Vaccine (Alpha and Delta)
COMIRNATY*
of Prior Infectionb /With Evidence of Prior
Without Evidence of
COMIRNATYac
Infection
Infection
Without Evidence of3 Weeks After Dose 1b
1 Month After Dose 2b
Infectionc
SARS-CoV-2
Neutralization
GMTe
GMTe
GMRf
Assay
nd
(95% CIe)nd(95% CIe)(95% CIf)
Referencestrain - NT50
17404.2
1328.1
13.12(titer)g
262(15485.1, 19561.1)
275(1183.1, 1491.0)(11.14, 15.45)hAbbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit ofquantitation; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing
titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. Participants with positive N-binding antibody result at baseline, positive NAAT result prior to vaccination, or medical history or
adverse event of COVID-19 prior to vaccination.
b. Protocol-specified timing for blood sample collection.
c. Participants who had no serological or virological evidence (up to the 1-month post–Dose 2 blood sample collection) of past
SARS-CoV-2 infection (i.e., negative N-binding antibody [serum] result at the Dose 1 and 1-month post–Dose 2 visits, negative
22

d.
e.
f.
g.
h.

NAAT [nasal swab] at the Dose 1 and Dose 2 visits, and any unscheduled visit [up to the 1-month post–Dose 2 blood sample
collection]) and had no medical history of COVID-19 were included in the analysis.
n = Number of participants with valid and determinate assay results for the specified assay at the given sampling time point.
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (basedon the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
GMRs and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on theanalysis of logarithmically transformed neutralizing titers using a linear regression model with terms of age, sex, and group. Assay
results below the LLOQ were set to 0.5 × LLOQ.
SARS-CoV-2 NT50 were determined using a validated 384-well assay platform (original strain [USA-WA1/2020, isolated in
January 2020]).
Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.

Table 12: Difference in Percentages of Participants With Seroresponse – Bivalent Vaccine (Alpha andDelta) in Vaccine-Naïve Participants from Study 7 With Evidence of Prior SARS-CoV-2
Infection Compared to 2 Doses of COMIRNATY in a Subset of Participants from Study 2
Without Evidence of Prior SARS-CoV-2 Infection– Reference Strain Neutralization –Immunogenicity Analysis Set
Bivalent Vaccine (Alpha andStudy 7
Delta)
Bivalent Vaccine
Study 2
With Evidence of Prior Infectiona(Alpha and Delta) With
COMIRNATY*
Minus
Evidence of Prior
Without Evidence of
COMIRNATY
Infectiona
Prior Infectionc
Without Evidence of Prior
3 Weeks After Dose 1b
1 Month After Dose 2b
Infectionc
SARS-CoV-2
Neutralizationne (%)ne (%)
Assay
Nd(95% CIf)
Nd(95% CIf)
Difference %g
95% CIh
Referencestrain – NT50
223 (85.8)
249 (90.5)(titer)i
260(80.9, 89.8)
275(86.5, 93.7)-4.55(-10.04, 0.83)jAbbreviations: CI = confidence interval; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test;
NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. Participants with positive N-binding antibody result at baseline, positive NAAT result prior to vaccination, or medical history or
adverse event of COVID-19 prior to vaccination.
b. Protocol-specified timing for blood sample collection.
c. Participants who had no serological or virological evidence (up to the 1-month post–Dose 2 blood sample collection) of past
SARS-CoV-2 infection (i.e., negative N-binding antibody [serum] result at the Dose 1 and 1-month post–Dose 2 visits, negative
NAAT [nasal swab] at the Dose 1 and Dose 2 visits, and any unscheduled visit [up to the 1-month post–Dose 2 blood sample
collection]) and had no medical history of COVID-19 were included in the analysis.
d. N = number of participants with valid and determinate assay results for the specified assay at both the pre-vaccination time point
and the given sampling time point. This value is the denominator for the percentage calculation.
e. n = Number of participants with seroresponse for the given assay at the given sampling time point.
f. Exact 2-sided CI, based on the Clopper and Pearson method.
g. Adjusted difference in proportions estimated using minimum risk weights and stratified by sex and age group (18 to 55 years, 56
to 85 years), expressed as a percentage.
h. 2-Sided CI based on the Newcombe method stratified by sex and age group (18 to 55 years, 56 to 85 years) with minimum risk
weights for the difference in proportions.
i. SARS-CoV-2 NT50 were determined using a validated 384-well assay platform (original strain [USA-WA1/2020, isolated in
January 2020]).
j. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the difference in percentages of participants withseroresponse is >-10%.

23

14.2 Primary Series With COMIRNATY – Efficacy in Participants 16 Years of Age and Older
Study 2 is an ongoing, multicenter, multinational, randomized, placebo-controlled, observer-blind, dose-finding,
vaccine candidate–selection, and efficacy study in participants 12 years of age and older. Randomization was
stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with aminimum of 40% of participants in the ≥56-year stratum. The study excluded participants who were
immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19.
Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or
hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants
with known stable infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
In Study 2, based on data accrued through March 13, 2021, approximately 44,000 participants 12 years of age
and older were randomized equally and received 2 doses of COMIRNATY or placebo. Participants are planned
to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.
Overall, among the total participants who received COMIRNATY or placebo, 51.4% or 50.3% were male and48.6% or 49.7% were female, 79.1% or 79.2% were 16 through 64 years of age, 20.9% or 20.8% were 65 yearsof age and older, 81.9% or 82.1% were White, 9.5% or 9.6% were Black or African American, 1.0% or 0.9%
were American Indian or Alaska Native, 4.4% or 4.3% were Asian, 0.3% or 0.2% Native Hawaiian or other
Pacific Islander, 25.6% or 25.4% were Hispanic/Latino, 73.9% or 74.1% were non-Hispanic/Latino, 0.5% or
0.5% did not report ethnicity, 46.0% or 45.7% had comorbidities [participants who have 1 or morecomorbidities that increase the risk of severe COVID-19 disease: defined as subjects who had at least 1 of theCharlson comorbidity index category or body mass index (BMI) ≥30 kg/m2], respectively. The mean age at
vaccination was 49.8 or 49.7 years and median age was 51.0 or 51.0 in participants who received
COMIRNATY or placebo, respectively.
Efficacy Against COVID-19
The population for the analysis of the protocol pre-specified primary efficacy endpoint included
36,621 participants 12 years of age and older (18,242 in the COMIRNATY group and 18,379 in the placebogroup) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose.
The population in the protocol pre-specified primary efficacy analysis included all participants 12 years of age
and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 throughNovember 14, 2020. Participants 18 through 55 years of age and 56 years of age and older began enrollment
from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through15 years of age began enrollment from October 15, 2020.
For participants without evidence of SARS-CoV-2 infection prior to 7 days after Dose 2, vaccine efficacy
against confirmed COVID-19 occurring at least 7 days after Dose 2 was 95.0% (95% credible interval: 90.3,
97.6), which met the pre-specified success criterion. The case split was 8 COVID-19 cases in the
COMIRNATY group compared to 162 COVID-19 cases in the placebo group.
The population for the updated vaccine efficacy analysis included participants 16 years of age and older who
had been enrolled from July 27, 2020, and followed for the development of COVID-19 during blinded
placebo-controlled follow-up through March 13, 2021, representing up to 6 months of follow-up after Dose 2.
There were 12,796 (60.8%) participants in the COMIRNATY group and 12,449 (58.7%) in the placebo group
followed for ≥4 months after Dose 2 in the blinded placebo-controlled follow-up period.

24

SARS-CoV-2 variants of concern identified from COVID-19 cases for this age group from this data cutoff
include B.1.1.7 (Alpha) and B.1.351 (Beta). Representation of identified variants among cases in vaccine versus
placebo recipients did not suggest decreased vaccine effectiveness against these variants.
The updated vaccine efficacy information is presented in Table 13.
Table 13: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Age
Subgroup – Participants 16 Years of Age and Older Without Evidence of Infection andParticipants With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable
Efficacy (7 Days) Population During the Placebo-Controlled Follow-up Period
First COVID-19 occurrence from 7 days after Dose 2 in participants Without evidence of prior
SARS-CoV-2 infection*
COMIRNATY†
Placebo
Na=19,993
Na=20,118
Cases
Cases
n1b
n1b
Vaccine Efficacy %cdcdSubgroup
Surveillance Time (n2 )Surveillance Time (n2 )(95% CIe)
77
833
91.1
All participants
6.092 (19,711)
5.857 (19,741)(88.8, 93.1)
70
709
90.5
16 through 64 years
4.859 (15,519)
4.654 (15,515)(87.9, 92.7)
7
124
94.5
65 years and older
1.233 (4192)
1.202 (4226)(88.3, 97.8)
First COVID-19 occurrence from 7 days after Dose 2 in participants With or without* evidence of prior
SARS-CoV-2 infection
COMIRNATY†
Placeboa
N =21,047
Na=21,210
Cases
Cases
b
n1
n1b
Vaccine Efficacy %cdSubgroup
Surveillance Time (n2 )Surveillance Timec (n2d)(95% CIe)
81
854
90.9
All participants
6.340 (20,533)
6.110 (20,595)(88.5, 92.8)
74
726
90.2
16 through 64 years
5.073 (16,218)
4.879 (16,269)(87.5, 92.4)
7
128
94.7
65 years and older
1.267 (4315)
1.232 (4326)(88.7, 97.9)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new orincreased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2) and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint.
Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to thesurveillance time.

25

Subgroup analyses of vaccine efficacy (although limited by small numbers of cases in some subgroups) did notsuggest meaningful differences in efficacy across genders, ethnic groups, geographies, or for participants withobesity or medical comorbidities associated with high risk of severe COVID-19.
Efficacy Against Severe COVID-19
Efficacy analyses of secondary efficacy endpoints supported the benefit of COMIRNATY in preventing severe
COVID-19. Vaccine efficacy against severe COVID-19 is presented only for participants with or without prior
SARS-CoV-2 infection (Table 14) as the COVID-19 case counts in participants without prior SARS-CoV-2
infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the
COMIRNATY and placebo groups.
Table 14: Vaccine Efficacy – First Severe COVID-19 Occurrence in Participants 16 Years of Age andOlder With or Without* Prior SARS-CoV-2 Infection Based on Protocol† or Centers for
Disease Control and Prevention (CDC)‡ Definition From 7 Days After Dose 2 – Evaluable
Efficacy (7 Days) Population During the Placebo-Controlled Follow-up
Vaccine Efficacy – First Severe COVID-19 Occurrence
COMIRNATY§
Placebo
Cases
Cases
n1a
n1a
Vaccine Efficacy %bcbcSurveillance Time (n2 ) Surveillance Time (n2 )(95% CId)
1
21
95.3
d
7 days after Dose 2
6.353 (20,540)
6.237 (20,629)(70.9, 99.9)
Vaccine Efficacy – First Severe COVID-19 Occurrence Based on CDC Definition
COMIRNATY§
Placebo
Cases
Cases
a
n1
n1a
Vaccine Efficacy %bcSurveillance Time (n2 ) Surveillance Timeb (n2c)(95% CId)
31100
06.225 (20,593)(87.6, 100.0)
7 days after Dose 2d
6.345 (20,513)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new orincreased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2) and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis.
† Severe illness from COVID-19 is defined in the protocol as confirmed COVID-19 and presence of at least 1 of the following: Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per
minute, saturation of oxygen ≤93% on room air at sea level, or ratio of arterial oxygen partial pressure to fractional inspired
oxygen <300 mm Hg);
 Respiratory failure [defined as needing high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal
membrane oxygenation (ECMO)]; Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or requiring vasopressors);
 Significant acute renal, hepatic, or neurologic dysfunction;
 Admission to an Intensive Care Unit; Death.
‡ Severe illness from COVID-19 as defined by CDC is confirmed COVID-19 and presence of at least 1 of the following: Hospitalization;
 Admission to the Intensive Care Unit; Intubation or mechanical ventilation;
 Death.
§ Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. n1 = Number of participants meeting the endpoint definition.
26

b. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint.
Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
c. n2 = Number of participants at risk for the endpoint.
d. Two-side confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to thesurveillance time.

14.3

Primary Series With COMIRNATY – Efficacy and Immunogenicity in Adolescents 12 Through15 Years of Age

A descriptive efficacy analysis of Study 2 has been performed in 2,260 adolescents 12 through 15 years of age
evaluating confirmed COVID-19 cases accrued up to a data cutoff date of September 2, 2021.
The vaccine efficacy information in adolescents 12 through 15 years of age is presented in Table 15.
Table 15: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidenceof Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Blinded
Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable
Efficacy (7 Days) Population
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without
evidence of prior SARS-CoV-2 infection*
COMIRNATY†
Placebo
Na=1057
Na=1030
Cases
Cases
n1b
n1b
Vaccine Efficacy %cdSurveillance Time (n2 ) Surveillance Timec (n2d)(95% CIe)
Adolescents
0
28
100.0
12 through 15 years of age
0.343 (1043)
0.322 (1019)(86.8, 100.0)
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age With orwithout evidence of prior SARS-CoV-2 infection
COMIRNATY†
Placeboa
N =1119
Na=1109
Cases
Cases
n1b
n1b
Vaccine Efficacy %cdcdSurveillance Time (n2 ) Surveillance Time (n2 )(95% CIe)fAdolescents
0
30
100.0
12 through 15 years of age
0.362 (1098)
0.345 (1088)(87.5, 100.0)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new orincreased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2) and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis.
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group at risk for theendpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-side confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted forsurveillance time.
f. The only SARS-CoV-2 variant of concern identified from COVID-19 cases in this age group from this data cutoff was B.1.1.7(Alpha).

27

In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly
selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing
adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or
virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 16).
Table 16: Summary of Geometric Mean Ratio for 50% Neutralizing Titer – Comparison of Adolescents
12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity
Subset) – Participants Without Evidence of Infection up to 1 Month After Dose 2 – Dose 2
Evaluable Immunogenicity Population
COMIRNATY*
12 Through 15 Years 16 Through 25 Years
12 Through 15 Years/
na=190na=17016 Through 25 Years
Met
Noninferiority
Time
GMTc
GMTc
GMRd
Objectivee
b
c
c
d
Assay
Point
(95% CI )(95% CI )(95% CI )(Y/N)
SARS-CoV-2
neutralization
1 monthassay - NT50
after1253.6708.1
1.77(titer)f
Dose 2(1117.7, 1406.1)(625.9, 801.1)(1.50, 2.09)
Y
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit ofquantitation; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory
syndrome coronavirus 2.
Note: Participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS-CoV-2
infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and2), and had negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 were included in the analysis.
* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. n = Number of participants with valid and determinate assay results for the specified assay at the given dose/sampling time point.
b. Protocol-specified timing for blood sample collection.
c. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (basedon the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
d. GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1[12 through 15 years of age] – Group 2 [16 through 25 years of age]) and the corresponding CI (based on the Student t
distribution).
e. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
f. SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay. The assay uses a
fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The
sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.

14.4

Booster Dose With COMIRNATY – Immunogenicity of a First Booster Dose in Individuals 18
Through 55 Years of Age

Effectiveness of a booster dose of COMIRNATY was based on an assessment of 50% neutralizing antibody
titers (NT50) against SARS-CoV-2 reference strain (USA_WA1/2020) in Study 2 participants 18 through55 years of age (n = 200 – 212) who had no serological or virological evidence of past SARS-CoV-2 infection
up to 1 month after the booster vaccination. Analyses of NT50 1 month after the booster dose compared to 1
month after the primary series demonstrated noninferiority for both geometric mean ratio (GMR) [3.26 (97.5%
CI: 2.76, 3.86)] and difference in seroresponse rates (percentage) [4.5% (97.5% CI: 1.0, 7.9)]. Seroresponse fora participant was defined as achieving a ≥4-fold rise in NT50 from baseline (before primary series).

28

14.5

Booster Dose With Pfizer-BioNTech COVID-19 Vaccine, Bivalent – Immunogenicity of a Second
Booster Dose in Individuals 12 Years of Age and Older

In an analysis of a subset from Study 5, 105 participants 12 through 17 years of age, 297 participants 18 through55 years of age, and 286 participants 56 years of age and older who had previously received a 2-dose primaryseries and 1 booster dose with COMIRNATY received a second booster dose of Pfizer-BioNTech COVID-19
Vaccine, Bivalent. In participants 12 through 17 years of age, 18 through 55 years of age, and 56 years of age
and older, 75.2%, 71.7% and 61.5% were positive for SARS-CoV-2 at baseline, respectively.
Analyses of NT50 against Omicron BA.4/BA.5 and against reference strain among participants 56 years of age
and older who received a second booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in Study 5compared to a subset of participants from Study 4 who received a second booster dose of COMIRNATY
demonstrated superiority of Pfizer-BioNTech COVID-19 Vaccine, Bivalent to COMIRNATY based on GMR
and noninferiority based on difference in seroresponse rates with respect to anti-Omicron BA.4/BA.5 response,and noninferiority of anti-reference strain immune response based on GMR (Table 17 and Table 18).
Analyses of NT50 against Omicron BA.4/BA.5 among participants 18 through 55 years of age compared toparticipants 56 years of age and older who received a second booster dose of Pfizer-BioNTech COVID-19
Vaccine, Bivalent in Study 5 demonstrated noninferiority of anti-Omicron BA.4/BA.5 response among
participants 18 through 55 years of age to participants 56 years of age and older for both GMR and difference inseroresponse rates (Table 17 and Table 18).
The study also assessed the level of NT50 against the anti-Omicron BA.4/BA.5 and original SARS-CoV-2
strains pre-vaccination and 1 month after vaccination in participants who received a second booster dose
(Table 19).
Table 17: Geometric Mean Titer Ratios – Study 5 COMIRNATY – Participants With or Without
Evidence of Infection – Evaluable Immunogenicity Population
Pfizer-BioNTech COVID-19
Vaccine, Bivalent*
Study 5

COMIRNATY†

Age Group
Vaccine Group
Comparison
Comparison
Pfizer-BioNTech
COVID-19
Vaccine,Bivalent*≥56 Years of Age
18 ThroughPfizer-BioNTech
55 Years of
COVID-19
18 Through
56 Years of Age 56 Years of Age and Age/≥56 Years of Vaccine, Bivalent*
and Older
Older
Age/ COMIRNATY†
SARS-CoV-2
Sampling 55 Years of Age
Neutralization
Time
GMTc
GMTc
GMTc
Assay
Pointanb (95% CIc) nb (95% CIc) nb(95% CIc) GMRd (95% CId) GMRd (95% CId)
Omicron4455.94158.1
938.9
0.98
2.91
BA.4/BA.5 1 Month 297 (3851.7, 284 (3554.8, 282(802.3, 1098.8)(0.83, 1.16)f(2.45, 3.44)geNT50 (titer)
5154.8)4863.8)16250.1
10415.5
Reference Strain –1.38
1 Month286 (14499.2, 289(9366.7,eNT50 (titer)(1.22, 1.56)h
18212.4)
11581.8)
Abbreviations: GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein–binding;
NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome
coronavirus 2.
* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages
BA.4 and BA.5 (Omicron BA.4/BA.5).
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. Protocol-specified timing for blood sample collection.
29

Subset of Study 4

b. n = Number of participants with valid and determinate assay results for the specified assay at the given sampling time point.
c. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (basedon the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
d. GMRs and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on
analysis of logarithmically transformed neutralizing titers using a linear regression model with terms of baseline neutralizing titer(log scale) and vaccine group or age group.
e. SARS-CoV-2 NT50 were determined using a validated 384-well assay platform (original strain [USA-WA1/2020, isolated in
January 2020] and Omicron B.1.1.529 subvariant BA.4/BA.5).
f. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
g. Superiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 1.
h. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67 and the point estimate of the
GMR is ≥0.8.

Table 18: Difference in Percentages of Participants With Seroresponse – Pfizer-BioNTech COVID-19
Vaccine, Bivalent from Study 5 and COMIRNATY from Subset of Study 4 – Participants With
or Without Evidence of Infection – Evaluable Immunogenicity Population
SARS-CoV-2
Neutralization
Assay

Sampling
Time
PointaPfizer-BioNTech COVID-19
Vaccine, Bivalent*
Study 518 Through
55 Years of Agenb
Nc (%)(95% CId)
OmicronBA.4/BA.5 NT50 (titer)g

1 Month294

56 Years of Ageand Oldernb
Nc (%)(95% CId)

COMIRNATY†
Subset of Study 4

56 Years of Ageand Oldernb
Nc (%)(95% CId)180 (61.2)
188 (66.7)
282
273(55.4, 66.8)(60.8, 72.1)

127 (46.5)(40.5, 52.6)

Age Group
Comparison

Vaccine Group
Comparison≥56 Years ofAge

Pfizer-BioNTech
COVID-19
Vaccine,Bivalent*
Pfizer-BioNTech
18 Through
COVID-19
55 Years of
Vaccine,Age/≥56 Years
Bivalent* /of AgeCOMIRNATY†
e
Difference
Differenceef(95% CI )(95% CIf)-3.03(-9.68, 3.63)h

26.77(19.59, 33.95)i

Abbreviations: LLOQ = lower limit of quantitation; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome
coronavirus 2.
Note: Seroresponse is defined as achieving a ≥4-fold rise from baseline. If the baseline measurement is below the LLOQ, a
postvaccination assay result ≥4 × LLOQ is considered a seroresponse.
* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages
BA.4 and BA.5 (Omicron BA.4/BA.5).
† Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).
a. Protocol-specified timing for blood sample collection.
b. N = Number of participants with valid and determinate assay results for the specified assay at both the pre-vaccination time point
and the given sampling time point. This value is the denominator for the percentage calculation.
c. n = Number of participants with seroresponse for the given assay at the given sampling time point.
d. Exact 2-sided CI, based on the Clopper and Pearson method.
e. Difference in proportions, expressed as a percentage.
f. 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline neutralizing titer category (<median, ≥ median)for the difference in proportions. The median of baseline neutralizing titers was calculated based on the pooled data in 2
comparator groups.
g. SARS-CoV-2 NT50 were determined using a validated 384-well assay platform (Omicron B.1.1.529 subvariant BA.4/BA.5).
h. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the difference in percentages of participants withseroresponse is >-10%.
i. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the difference in percentages of participants withseroresponse is >-5%.

30

Table 19: Geometric Mean Titers – Pfizer-BioNTech COVID-19 Vaccine, Bivalent Groups Subset ofStudy 5 – Prior to and 1 Month After Second Booster – Participants 12 Years of Age andOlder – Evaluable Immunogenicity Population
Pfizer-BioNTech COVID-19 Vaccine, Bivalent*
12 Through 17 Years of
18 Through 55 Years of 56 Years of Age and Older
Age
Age
SARS-CoV-2
Sampling
GMTc
GMTc
GMTc
a
b
c
b
c
b
Neutralization Assay
Time Pointn(95% CI )n(95% CI )n(95% CIc)
Pre1105.8
569.6
458.2
vaccination
104(835.1, 1464.3)
294(471.4, 688.2)
284(365.2, 574.8)
Omicron BA.4/BA.5 NT50 (titer)d8212.84455.94158.1
1 Month
105(6807.3, 9908.7)
297(3851.7, 5154.8)284(3554.8, 4863.8)
6863.34017.33690.6(5587.8, 8430.1)
296(3430.7, 4704.1)
284(3082.2, 4419.0)
Reference strain - NT50 Pre-vaccination 105(titer)d23641.3
16323.3
16250.1
1 Month105 (20473.1, 27299.8) 296 (14686.5, 18142.6) 286(14499.2, 18212.4)
Abbreviations: GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein–binding;
NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome
coronavirus 2.
* Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages
BA.4 and BA.5 (Omicron BA.4/BA.5).
a. Protocol-specified timing for blood sample collection.
b. n = Number of participants with valid and determinate assay results for the specified assay at the given sampling time point.
c. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (basedon the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
d. SARS-CoV-2 NT50 were determined using a validated 384-well assay platform (original strain [USA-WA1/2020, isolated in
January 2020] and Omicron B.1.1.529 subvariant BA.4/BA.5).

16 HOW SUPPLIED/STORAGE AND HANDLINGCOMIRNATY is a suspension for intramuscular injection and is supplied as follows:Glass Prefilled Syringes
o Carton of 10 single dose prefilled syringes: NDC 0069-2432-10
o Single dose prefilled syringe: NDC 0069-2432-01



Vials
o Carton of 10 single dose vials: NDC 0069-2403-10
o Single dose vial: NDC 0069-2403-01

Regardless of presentation, during storage, minimize exposure to room light, and avoid exposure to direct
sunlight and ultraviolet light.
Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials,
prefilled syringes, and cartons.
Storage Prior to Use
Glass Prefilled Syringes
Store COMIRNATY glass prefilled syringes refrigerated at 2°C to 8°C (35°F to 46°F). DO NOT FREEZE.
The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed
12 hours.
31

Single Dose Vials
COMIRNATY single dose vials may arrive frozen at ultra-cold conditions in thermal containers with dry ice.
Once received, frozen vials may be immediately transferred to the refrigerator at 2ºC to 8ºC (35ºF to 46ºF),
thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at
the time of transfer. Cartons of 10 single dose vials may take up to 2 hours to thaw at this temperature. Once
thawed, they should not be refrozen.
Alternatively, single dose vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF
to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F).
Cartons of COMIRNATY single dose vials may be received at 2°C to 8°C (35ºF to 46ºF), and they should be
stored at 2°C to 8°C (35ºF to 46ºF). Check that the carton has been previously updated to reflect the 10-weekrefrigerated expiry date.
The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed
12 hours.
17 PATIENT COUNSELING INFORMATION
Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling.
Inform the vaccine recipient or caregiver of the potential benefits and risks of vaccination with COMIRNATY.
Advise the vaccine recipient or caregiver to report any adverse events to their healthcare provider or to the
Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov.
This product’s labeling may have been updated. For the most recent prescribing information, please visit
https://dailymed.nlm.nih.gov/dailymed/.
Manufactured for
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany

Manufactured by
Pfizer Inc., New York, NY 10001
LAB-1490-9.0
US Govt. License No. 2229

32

INFORMATION FOR RECIPIENTS AND CAREGIVERS
COMIRNATY (Cuh-mir'-na-tee)(COVID-19 VACCINE, mRNA)(2024-2025 Formula)This summary is not intended to take the place of talking with your healthcare provider. If you havequestions or would like more information, please talk with your healthcare provider.
What is COMIRNATY?
COMIRNATY is a vaccine for use in people 12 years of age and older to protect against
COVID-19.
COMIRNATY may not protect all people who receive the vaccine.
COMIRNATY does not contain SARS-CoV-2, the virus that causes COVID-19. COMIRNATY
cannot give you COVID-19.
Who should not get COMIRNATY?
You should not get COMIRNATY if you had:
 a severe allergic reaction after a previous dose of COMIRNATY or any Pfizer-BioNTech
COVID-19 vaccine
 a severe allergic reaction to any ingredient in these vaccines (see What are theingredients in COMIRNATY?).
Before getting COMIRNATY, tell your vaccination provider about all of your medical
conditions, including if you: have any allergies
 had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
 have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of thelining outside the heart) have a fever have a bleeding disorder or are on a blood thinner are immunocompromised or are on a medicine that affects your immune system are pregnant or plan to become pregnant
 are breastfeeding have received another COVID-19 vaccine
 have ever fainted in association with an injection
How is COMIRNATY given?
COMIRNATY is given as an injection into the muscle.

1What are the possible risks of COMIRNATY?
There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe
allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For thisreason, your vaccination provider may ask you to stay at the place where you received yourvaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: Difficulty breathing Swelling of your face and throat
 A fast heartbeat
 A bad rash all over your body Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside
the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including
COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following
COMIRNATY have occurred most commonly in adolescent males 12 through 17 years of age. In
most of these individuals, symptoms began within a few days following vaccination. The chance of
having this occur is very low. You should seek medical attention right away if you or your childhave any of the following symptoms after receiving the vaccine, particularly during the 2 weeks
after receiving a dose of the vaccine: Chest pain
 Shortness of breath Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines
include: Severe allergic reactions
 Non-severe allergic reactions such as rash, itching, hives, or swelling of the face Myocarditis (inflammation of the heart muscle)
 Pericarditis (inflammation of the lining outside the heart) Injection site reactions: pain, swelling, redness, arm pain
 General side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea,
feeling unwell, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea,
vomiting, dizziness Fainting in association with injection of the vaccine
These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about
any side effects that concern you.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The
VAERS toll-free number is 1-800-822-7967 or report online tohttps://vaers.hhs.gov/reportevent.html.
In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or
www.pfizersafetyreporting.com.
What if you are pregnant or breastfeeding?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

2

What are the ingredients in COMIRNATY?
COMIRNATY contains the following ingredients:
 messenger ribonucleic acid (mRNA) lipids (((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate),
2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3phosphocholine, and cholesterol)
 tromethamine
 tromethamine hydrochloride
 sucrose
COMIRNATY does not contain preservatives.
This Information for Recipients and Caregivers may have been updated. For the most recent
Information for Recipients and Caregivers, please visit https://dailymed.nlm.nih.gov/dailymed/.
If you have questions, talk to your healthcare provider or visit www.COMIRNATY.com or call
1-877-VAX-CO19 (1-877-829-2619).
Manufactured for
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany

Manufactured by
Pfizer Inc., New York, NY 10001
LAB-1587-3.0
US Govt. License No. 2229
Revised: 8/20243