AstraZeneca COVID-19 

Vaccine 

(AZD1222) 

ACIP COVID-19 Emergency Meeting 

January 27, 2021 

Tonya Villafana 

VP Global Franchise Head, Infection 

1 
 

 

 

 

 

 

Forward-Looking Statements 

In order, among other things, to utilize the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter ’the Group’) provides the following cautionary statement: this document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, 

margins, earnings per share or other financial or other measures. Although the Group believes its expectations are based on reasonable 

assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could 

cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar 

expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking 

statements, certain of which are beyond the Group’s control, include, among other things: the risk of failure or delay in delivery of pipeline or launch of new medicines; the risk of failure to meet regulatory or ethical requirements for medicine development or approval; the risk of 

failure to obtain, defend and enforce effective intellectual property (IP) protection and IP challenges by third parties; the impact of competitive pressures including expiry or loss of IP rights, and generic competition; the impact of price controls and reductions; the impact of economic, 

regulatory and political pressures; the impact of uncertainty and volatility in relation to the UK’s exit from the EU; the risk of failures or delays in the quality or execution of the Group’s commercial strategies; the risk of failure to maintain supply of compliant, quality medicines; the risk of 

illegal trade in the Group’s medicines; the impact of reliance on third-party goods and services; the risk of failure in information technology, data protection or cybercrime; the risk of failure of critical processes; any expected gains from productivity initiatives are uncertain; the risk of 

failure to attract, develop, engage and retain a diverse, talented and capable workforce; the risk of failure to adhere to applicable laws, rules 

and regulations; the risk of the safety and efficacy of marketed medicines being questioned; the risk of adverse outcome of litigation and/or governmental investigations; the risk of failure to adhere to increasingly stringent anti-bribery and anti-corruption legislation; the risk of failure 

to achieve strategic plans or meet targets or expectations; the risk of failure in financial control or the occurrence of fraud; the risk of 

unexpected deterioration in the Group’s financial position; and the impact that the COVID-19 global pandemic may have or continue to have on 

these risks, on the Group’s ability to continue to mitigate these risks, and on the Group’s operations, financial results or financial condition. 

Nothing in this document, or any related presentation/webcast, should be construed as a profit forecast. 

2 
AGENDA 

AZD1222 Adenoviral Platform, Clinical 

Development Plan & Phase I/II Data 

US Phase III Study 

Non-IND Phase III Efficacy and Safety 

Trials (Interim Analysis) 

Vaccine Storage & Handling 

Summary 

Q&A 
 

AZD1222 COVID-19 Vaccine - Executive Summary 

AstraZeneca committed to a partnership with Oxford University to ensure broad and equitable vaccine access 

globally, not for profit during the pandemic. 

Vaccine immunogenicity, efficacy and safety were demonstrated in four Phase I-III non-IND trials in UK, Brazil 

& South Africa. Data from these trials supported MHRA (UK) Authorization for Temporary Supply. 

Phase III trial in the US is ongoing, enrollment is complete. This trial will be the primary basis for the EUA 

application with supporting data from the non-IND trials conducted outside the US. 

Vaccine is supplied in 5 ml preservative free, non-latex multidose vials to be stored at 2-8°C for at least 6 

months. 

4 
AZD1222 Adenoviral Platform 

Clinical Development Plan & 

Phase I/II Data 
 

AZD1222: The Technology 

Penton 

base 

Hexon 

Fiber 

DNA 

Non-replicating chimp adenovirus-vectored vaccine expressing 

nCoV-19 spike1 

Non-replicating due to E1 (and E3) gene deletion2 

Chimp adenovirus avoids issues with pre-existing immunity to human 

adenoviruses2 

Vaccine antigen encoded in the viral genome – not a structural part of the 

virion3 

Induces strong B- and T-cell responses after a single vaccination1 

Prior to April 2020, 12 Phase I studies, 330 subjects vaccinated 

Dose is 5 x 1010 viral particles (vp) as an IM injection, 0.5 ml1 

DNA = deoxyribonucleic acid; IM = intramuscular. 

1. Folegatti PM, et al. Lancet 2020;396:467–478; 2. Dicks MDJ, et al. PLoS One 2012;7:e40385; 3. Guo J, et al. Hum Vaccin Immunother 2018;14:1679–1685. 

6 
 

 

 

AZD1222 Clinical Development Plan 

28 August 2020

Phase 3 N=32,459*

(USA, Chile, Peru, Sponsor:

AstraZeneca)5

23 April 2020 

Phase 1/2 N=1,077 

(UK; Sponsor: 

University of Oxford)1 

23 June 2020 

Phase 3 N = 10,300 

(Brazil; Sponsor: 

University of Oxford)3 

28 May 2020 

Phase 2/3 N=12,330 

(UK; Sponsor: University of 

Oxford)2 

24 June 2020 

Phase 1/2 N=2020 

(South Africa; Sponsor: 

University of Oxford)4 

02 September 2020 

Phase 3 N=100 

(Russian Federation; Sponsor: 

AstraZeneca)6 

23 August 2020 

Phase 1/2 N=256 

(Japan; Sponsor: 

AstraZeneca)7 

25 August 2020 

Phase 2/3 N=1,600 

(India; Sponsor: 

SIIPL/ICMR)7 30 October 2020 

Phase 1 N=360 

(Kenya; Sponsor 

University of Oxford)8 

Started 

*Planned; AZ sponsored Phase 3 trial 

*Planned; Sponsored by BioKangtai 

1. Study NCT04324606. ClinicalTrials.gov website; 2. Study NCT04400838. ClinicalTrials.gov website; 3. Study NCT04536051. ClinicalTrials.gov website 4. Study NCT04444674. 

ClinicalTrials.gov website, 5. Study NCT04516746. ClinicalTrials.gov website; 6. Study NCT04540393 ClinicalTrials.gov website; 7. AstraZeneca. Data on File; 8. University of Oxford 

press release. (Accessed 05 November 2020).*Participants enrolled by January 15, 2021. 7 
 

 

Neutralizing activity against SARS-CoV-2 in 91% vaccines after a single d

and 100% after two doses in micro-neutralisation assay (IC80) 

Neutralising antibody titres inducing 

80% virus neutralisaion (log scale) 

256 

64 

16 

0 28 42 

Dose 1 Dose 2 

Single dose Two dose 

Baseline 

Days after vaccination 

 ose 

 

10,000 

Spike antibody titres 

(ELISA units log scale) 1000 

100 

10 

Single dose Second dose Convalescent 

sera 

0 14 28 56 28 35 56 Severe 

Dose 1 Dose 2 Mild 

Asymptomatic Days after vaccination 

SARS-CoV-2 spike antibodies peaked one month after injection and were 

elevated after two doses in a similar range to convalescent sera 

8 

AZD1222 Induced Robust Antibody Responses At Levels In A 

Similar Range To Those Seen In Convalescent COVID-19 

Patients In Phase I/II Study COV001 

Folegatti P et al. The Lancet. 2020. 
 

Neutralizing activity against the SARS-CoV-2 virus is boosted 

after a second dose in older adults 

Normalised MNA80 

300 

100 

30 

10 

18-55 yrs, SDSD 

56-69 yrs, SD 

56-69 yrs, SDSD 

70+ yrs, SD 

70+ yrs, SDSD 

D0 D28 D42 D56 

Days post vaccination 

Robust Humoral Response In Older Adults Receiving AZD1222 

In COV002 

Ramasamy M et al. Lancet. 2020 9 
Th1 cytokines were induced following stimulation with overlapping SARS-CoV-2 peptides 

AZD1222 

Control 

 

 

 

Limited Th2 cytokines were induced following stimulation with overlapping SARS-CoV-2 peptides 

AZD1222 

Control 

 

AZD1222 Induced A Robust Th1 Biased T-Cell Response In 

COV001 And COV002 Participants 

D28 P1 = Day 28 post 1st Dose, D28 P2 = Day 28 post 2nd Dose. Boxplots display the median and 1st and 3rd quartiles. Th1 data result indicates percentage of CD69+ cells expressing 

IFNγ, IL-2, TNFα (or any Th1 cytokine) after stimulation with SARS-CoV-2 S1 peptide pool (similar results were seen with S2 peptide pool). Th2 data result indicates percentage of 

CD69+ cells expressing IL-4, IL-13 (or either Th2 cytokine). Background percentage was subtracted from the stimulated percentage prior to analysis. Stimulated percentages less than 

10 the background percentage were set to 0%. Exploratory analysis, Unpublished results 
 

AZD1222 Was Well Tolerated In Phase I/II Studies 

Local and systemic reactions ~20% less frequent after the 2nd dose 

Most AEs were mild to moderate in severity and majority resolved within 1 to 7 days 

AEs were similar in nature to those previously reported 

Injection site pain, feeling feverish, muscle ache and headache 

Local and systemic reactions were more common in participants given AZD1222 than MenACWY 

Less reactogenicity (local and systemic) in older adults 

>70 years about 30% fewer mild/moderate local reactions than <55 years 

>70 years about 20% fewer systemic reactions than <55 years 

Ramasamy MN et al. Lancet. 2020. https://doi.org/10.1016/S0140-6736(20)32466-1. Accessed January 21, 2021. 

11 
US Phase III Trial 

D8110C00001 

Design, Objectives, Diversity 
 

 

Phase III Study D8110C00001 To Evaluate Safety And Efficacy 

Of AZD1222 In Over 30,000 Volunteers 

Start: 28 August 2020 

• Given by intra-muscular injection, 0.5 ml 

• Study ongoing in the US, Chile and Peru 

(NCT04516746. ClinicalTrials.gov website) 

AZD1222 

5x1010 viral particles 

2 IM doses 

N=20,000 

Saline Placebo 

2 IM doses 

N=10,000 

Randomized (2:1) 

N >30,000 

• Subjects 18+ yo 

• 25% subjects 65+ yo 

• Study enrollment diversity targets were selected in agreement with US Government/OWS recommendations. 

IM = intramuscular; yo = years old. 

1. Study NCT04516746. ClinicalTrials.gov website; 2. AstraZeneca Pharmaceuticals LP. Clinical Study Protocol (D8110C00001). 13 
 

 

 

 

 

 

 

 

 

 

 

 

 

Phase III Study D8110C00001 Case Definition Of Symptomatic 

COVID-19 Disease 

Primary efficacy endpoint: Symptomatic illness 

• First case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring > 14 days post administration of study 

intervention. Participants included if they meet following criteria at any point from Day 1 (initial visit) through Day 14 

Subjects will be counted as a case if they have: 1) One or more category A findings OR 2) Two or more category B 

symptoms 

Specificity Category A: Lower respiratory tract involvement (one Category B: Systemic/ other symptoms (two or 

(Pathogen Confirmation) or more) more) 

SARS-CoV-2 confirmed • Pneumonia diagnosed by chest x-ray, or CT scan • Fever > 37.8 ̊ C (100 ̊ F) or feverishness

• Positive RT-PCR • O2 sat of ≤ 94% on room air or 2 percentage point • New or worsening cough 

drop from baseline • Myalgia/ muscle pain 

• New or worsening dyspnea/ shortness of breath • Fatigue that interferes with activities of daily living 

• Vomiting or diarrhea 

• Anosmia or ageusia 

Safety endpoint: 

• Occurrence of adverse events : 

1) Incidence of AEs for 28 days post each dose 

2) Incidence of AEs, MAAEs, and AESIs from Day 1 post treatment throughout study 

AE = adverse event; AESI = adverse event of special interest; MAAE = medically attended adverse events. 

AstraZeneca Pharmaceuticals LP. Clinical Study Protocol (D8110C00001). 

14 
 

Phase III Study D8110C00001 Diversity And Enrollment 

Race Enrolleda 

Hispanic/Latin 11.2% 

Black or African American 9.8% 

Asian 5.3% 

American Indian 1.8% 

Hawaiian or Pacific Islander 0.4% 

White 71.5% 

Age groups and 

comorbiditiesb Enrolled 

65+ years old 23.6% 

<65 years old 76.4% 

Has comorbidity 57.8% 

No comorbidity 42.2% 

bComorbidities include: Chronic Kidney Disease, COPD, 

Heart Failure, Coronary Artery Disease, Diabetes, Asthma, 

High Blood Pressure, Liver Disease, BMI 30+. 

aUS enrollment only 

32,459 participants enrolled; 26,327 received second dose by Jan 21, 2021 

15 
 

 

 

Phase III Study D8110C00001 Clinical Hold Summary 

• Study was initiated on 28 Aug and paused by AstraZeneca on 6 Sep. Clinical hold was issued on 9 Sep and 

lifted on 23 Oct; study restarted on 28 Oct 

• The study was paused due to an event of transverse myelitis reported in the Phase II/III study conducted 

by the University of Oxford in the UK 

• Information provided to FDA: 

• Additional details on neurological events in studies sponsored by AstraZeneca and University of 

Oxford 

• Analyses of available clinical safety data from AZD1222 and ChAdOx-1 viral vector platform studies 

• Changes in study conduct implemented 

• Updated risk language in Informed Consent Form (ICF) and Investigator Brochure (IB) 

• Protocol changes 

• Establishment of independent expert neurology panel 

• Accelerated/increased safety reporting 

16 
Non-IND Phase II/III Program 

Interim Results 

(Data Cut: November 4th) 
 

 

 

=

Interim Analysis Provided For Regulatory Approval: 

23,745 Participants Across Four Studies 

UK COV001 (N 1,077)1 UK COV002 (N=12,390)1 Brazil COV003(N=10,300)1 S. Africa COV005 (N=2,070)1 

Phase I/II single-blinded, 

adults aged 18–55 yrs 

Phase II/III single-blinded, ≥18

years (including elderly) 

Phase III single-blinded, ≥18

years (including elderly) 

Phase I/II double-blinded, 

adults aged 18–65 yrs 

Primary endpoint: Efficacy (number of virologically confirmed symptomatic cases of COVID-19 [NAAT positive])1 

2 2 

•

•

Global statistical analysis plan for pooling 

data developed 

Prespecified analyses that would contribute to 

assessment of efficacy 

The cutoff date for inclusion in the analysis was November 4, 2020, and the data lock date was November 21, 2020 

NAAT = nucleic acid amplification test. 

1. Voysey M, et al. Article and supplementary appendix. Lancet. 2020. http://dx.doi.org/10.1016/S0140-6736(20)32661-1. Accessed January 21, 2021; 2. COVID-19 Vaccine AstraZeneca, solution for injection in 

18 multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]). 

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949772/UKPAR_COVID_19_Vaccine_AstraZeneca_05.01.2021.pdf. Accessed January 8, 2021. 
 

 

Summary of Phase III Interim Pooled Efficacy Analyses For 

AZD1222 

In a diverse cohort (geographically and ethnically) pooled analysis demonstrated 

70.4% (95.8% CI: 54.8% to 80.6%) efficacy at preventing symptomatic COVID-19 

• Subgroup analysis with SD/SD demonstrated efficacy at preventing symptomatic 

COVID-19 of 62.1% (41.0% to 75.7%) 

There were no hospitalizations or severe COVID-19 in vaccinated participants from 21 

days after first dose 

MenACWY = meningococcal group A, C, W, and Y conjugate vaccine; SAE = severe adverse event. 

Voysey M, et al. Lancet. 2020. http://dx.doi.org/10.1016/S0140-6736(20)32661-1. Accessed January 21, 2021. 19 
 

 

Across Four Studies, AZD1222 Exhibited A Favorable Safety 

Profile 

Across all four studies, SAEs occurred in 168 participants (<1%) 

79 of whom received AZD1222 (0.7%) and 89 of whom received MenACWY or saline control (0.8%) 

There were 175 SAEs, of which 4 were considered possibly related to intervention 

(either the experimental vaccine or the control) 

AZD1222 group 

• Pyrexia: 2 days after dose 1; treated with 

paracetamol and resolved the same day 

• Transverse myelitis: 14 days after dose 2 

Control group 

• Autoimmune hemolytic anemia: 10 days 

after MenACWY 

• Transverse myelitis: 2 months after first 

control dose 

Solicited Adverse Events, the majority usually resolved within a few days of vaccination. 

• Reactogenicity; the most frequently reported AEs were mild to moderate in severity including injection site 

tenderness (>60%); injection site pain, headache, fatigue (>50%); myalgia, malaise (>40%); pyrexia, chills 

(>30%); and arthralgia, nausea (>20%). 

• Generally milder and reported less frequently after second dose and in older adults (≥65 years old)

MenACWY = meningococcal group A, C, W, and Y conjugate vaccine; SAE = severe adverse event. 

Voysey M, et al. Lancet. 2020. http://dx.doi.org/10.1016/S0140-6736(20)32661-1. Accessed January 21, 2021. 

20 
Vaccine Storage And Handling 
AZD1222 Storage And Administration 

Storage 

Refrigerator 

• Store in 

refrigerator (2 to 

8°C) 

• Shelf life = 6 

months 

• Do not freeze 

• Keep vials in outer 

carton to protect 

from light 

Administration 

Multi-dose Vial 

• After first puncture 

cumulatively store 

up to 6 hours at 

room temperature 

or up to 48 hours 

at 2-8°C with total 

storage time not to 

exceed 48 hours. 

• No dilution or 

reconstitution 

22 
Summary 
 

Summary: AZD1222 offers a potential to address the 

Global COVID-19 Crisis 

• AZD1222 induces robust immune responses against the SARS-CoV-2 S protein: 

• Spike Antibodies increased after a second dose with GMTs comparable to convalescent 

sera 

• Neutralizing Antibodies titers observed in all participants following 2nd dose 

• Strong Th-1 biased CD4+ T Cell response observed 

• US Phase III study ongoing with 32,459 participants enrolled with co-morbidities, older 

adults and diverse backgrounds 

• 26,327 received second dose by Jan 21, 2021 

• Efficacy and safety were demonstrated in four Phase I-III studies in UK, Brazil and South 

Africa 

• AZD1222 has the potential to address the SARS-CoV-2 pandemic and has been 

authorized in 18 countries (under emergency use or full approval as of January 25, 2021) 

GMT = geometric mean titer. 

24 
Thank You 

to our collaborators, investigators and subjects: 

•

•

•

•

•

•

•

University of Oxford 

BARDA 

NIAID 

DoD 

The AstraZeneca Team 

Clinical trial sites personnel and investigators 

All our trial participants 
Q&A 
Back-Up 
 

 

General selection criteria:

Phase II/III Program to evaluate safety and efficacy of 

AZD1222 in over 20,000 volunteers 

Primary endpoints: 

Efficacy endpoint: 

SARS-CoV-2 RT-PCR-positive 

symptomatic illness ≥ 15 days post

second dose 

Safety endpoint: 

Occurrence of adverse events : 

1) Incidence of AEs for 28 days 

post each dose 

2) Incidence of AEs, MAAEs, and 

AESIs from Day 1 post 

treatment throughout study 

Experimental: 

AZD1222 

5x1010 viral particles 

Control: 

MENACWY OR Saline 

General selection 

criteria: 

Key inclusion criteria: 

• Adults age ≥ 18 years 

• Healthy or have medicallystable chronic diseases 

• At increased-risk for 

exposure to SARS-CoV-2 

and COVID-19 

Key exclusion criteria: 

• History of laboratoryconfirmed COVID-19 

infection 

R 

AE = adverse event; AESI = adverse event of special interest. 

Voysey M, et al. Article and supplementary appendix. Lancet. 2020. http://dx.doi.org/10.1016/S0140-6736(20)32661-1. Accessed January 21, 2021. 28 
 

 

 

Efficacy Based On Symptomatic, Virologically-Confirmed 

COVID-19 Cases > 14 Days Post 2nd Dose 

Total number 

of cases 

AZD1222 

n/N (%) 

Control 

n/N (%) 

VE (95% CI) 

unless indicated 

All LD/SD and SD/SD recipients 131 30/5807 (0.5%) 101/5829 (1.7%) 70.4% (54.8%, 80.6%)a 

COV002 (UK) 

LD/SD recipients 

SD/SD recipients 

86 

33 

53 

18/3744 (0.5%) 

3/1367 (0.2%) 

15/2377 (0.6%) 

68/3804 (1.8%) 

30/1374 (2.2%) 

38/2430 (1.6%) 

73.5% (55.5%, 84.2%) 

90.0% (67.4%, 97.0%)b,c 

60.3% (28.0%, 78.2%) 

COV003 (Brazil) SD/SD 45 12/2063 (0.6%) 33/2025 (1.6%) 64.2% (30.7%, 81.5%)b 

All SD/SD recipients 98 27/4440 (0.6%) 71/4455 (1.6%) 62.1% (41.0%, 75.7%) 

a95.8% CI used for primary analysis. bVaccine efficacy calculated from a reduced robust Poisson model that was not adjusted for age. All other models included an adjustment for age. c

P value for 

interaction term comparing LD/SD with SD/SD is P=0.010. 

CI = confidence interval; LD = low dose (2.2×1010 vp); SD = standard dose (5×1010 vp); vp = virus particles. 

Voysey M, et al. Lancet. 2020. http://dx.doi.org/10.1016/S0140-6736(20)32661-1. Accessed January 21, 2021. 

29 
Subgroup Baseline 

GMT (95% CI) 

28 days after 

dose 1 

GMT (95% CI) 

28 days after 

dose 2 

GMT (95% CI) 

(N=106) 

34754.10 

(30287.2, 39879.8) 

(N=154) 

63181.59 

(55180.1, 72343.4) 

Dose interval 

<6 weeks (N=481) (N=479) (N=443) 

60.51 8734.08 22222.73 

(54.1, 67.7) (7883.1, 9676.9) (20360.5, 24255.3) 

Subgroup Baseline 28 days after 28 days after 

GMT (95% CI) dose 1 dose 2 

GMT (95% CI) GMT (95% CI) 

Dose interval 

<6 weeks (N=3) (N=3) (N=3) 

50.92 7496.44 22121.36 

(3.9, 669.2) (1461.4, 38454.7) (8547.7, 57250.2) 

6–8 weeks 

- - -

9–11 weeks (N=30) (N=30) (N=29) 

64.09 4803.21 36928.89 

(40.4, 101.6) (3255.7, 7086.4) (24509.6, 55641.2) 

≥12 weeks (N=35) (N=35) (N=35) 

52.42 6750.27 66274.91 

(37.7, 72.9) (4184.6, 10889.0) (49546.6, 88651.1) 

6–8 weeks (N=137) (N=99) (N=116) 

58.02 7295.54 24363.10 

(46.3, 72.6) (5857.4, 9086.7) (20088.5, 29547.3) 

9–11 weeks (N=110) (N=87) 

48.79 7492.98 

(39.6, 60.1) (5885.1, 9540.2) 

≥12 weeks (N=154) (N=152) 

52.98 8618.17 

(44.4, 63.2) (7195.4, 10322.3) 

Longer Dose Interval Was Associated With Increased Spike-Binding 

Antibody Responses in Participants Seronegative At Baseline 

SD/SD LD/SD 

 

 

Similar results were seen with the nAb responses by pseudoneutralisation assay 

nAb = neutralizing antibody. 

COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]). 

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949772/UKPAR_COVID_19_Vaccine_AstraZeneca_05.01.2021.pdf. Accessed January 8, 2021. 

30 
 

 

 

 

 

Vaccine Efficacy Is Higher With a Longer Interval Between Doses 

Subgroup analyses of vaccine efficacy as a function of dose interval showed a trend for 

increasing vaccine efficacy associated with longer dose interval 

Vaccine efficacy by dose interval at interim analysis: COVID-19 cases: ≥15 days post second dose 

Case definition: 

Primary – any COVID-19 

Participants with events, n (%) Vaccine 

efficacy 

(%) 

95% CI (%) P-value AZD1222 

n / N (%) 

Control 

n / N (%) 

Dose interval 

8–11 weeks 9 / 1444 (0.62) 34 / 1488 (2.28) 72.85 (43.45, 86.97) <0.001 

> 11 weeks 7 / 2093 (0.33) 39 / 2116 (1.84) 81.90 (59.53, 91.90) <0.001 

CI – confidence interval. 

COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]). 

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949772/UKPAR_COVID_19_Vaccine_AstraZeneca_05.01.2021.pdf. Accessed January 8, 2021. 

31 
 

 

 

Vaccine Efficacy: Single Dose And In Subjects With 

Co-Morbidities 

Single Dose: Participants were censored from the analysis at the earliest time point of when they received 

a second dose or at 12 weeks post dose 1 

Total Events 

AZD1222 

n (%) 

N=7998 

Control 

n (%) 

N=7982 

Vaccine 

efficacy (%) 

(95% CI) 

p-value 

Occurring 22 days after 1st dose through 

2nd dose up until 12 weeks 56 12 (0.15) 44 (0.55) 73.00 (48.79, 85.76) <0.001 

Co-morbidities 

Vaccine efficacy (%) 95% CI 

Comorbid populationa 73.4 48.5, 86.3 

aComorbidity was defined as BMI ≥30 kg/m2, cardiovascular disorder, respiratory disease or diabetes. The proportion of subjects with comorbidities at baseline was substantial (36%): Obesity 

(20%); Cardiovascular disease (11%) - Mainly hypertension (5%); Respiratory disease (12%) - Mainly asthma (8%); Diabetes (2%). 

COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]). 

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949772/UKPAR_COVID_19_Vaccine_AstraZeneca_05.01.2021.pdf. Accessed 8 Jan 2021. 

32 
Phase III Study D8110C00001 Inclusion/Exclusion Criteria 

Key inclusion criteria: 

• Adults age ≥ 18 years

• Healthy or have medically-stable chronic diseases 

• At increased-risk for exposure to SARS-CoV-2 and COVID-19 

• Able to understand and comply with study requirements/procedures 

Key exclusion criteria: 

• History of laboratory-confirmed COVID-19 infection 

AstraZeneca Pharmaceuticals LP. Clinical Study Protocol (D8110C00001). 

33