BNT162b2 [COMIRNATY (COVID-19 Vaccine, mRNA)] Booster ...

[Pages:20]BNT162b2 [COMIRNATY? (COVID-19 Vaccine, mRNA)] Booster (Third) Dose

William C. Gruber, MD, FAAP, FIDSA, FPIDS

Senior Vice President Vaccine Clinical Research and Development Pfizer Inc

September 22, 2021

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Data to Support Public Health Need for Booster

Data from Israel and the United States suggest vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose

VACCINE EFFICACY WANES

1

2

3

3 weeks

6-8 months after D2

Data Source Kaiser Permanente Southern California (KPSC)

FDA requested analysis

Type Retrospective Cohort Study

Post-hoc

C4591001 substudy

RCT

Israeli booster vaccination program

RWE

Result

? Reduction in VE is likely due to waning effectiveness rather than to Delta escaping vaccine protection

? Waning effectiveness over time

? A booster dose of BNT162b2 has an acceptable safety profile and elicits robust immune responses

? Reactogenicity profile similar or better to that seen after the second primary series dose

? Restores high levels of protection against COVID-19 outcomes

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Overview of Clinical Program

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BNT162b2-elicited Sera Effectively Neutralize a Broad Range of SARS-CoV-2 Spike Variants After 2 Doses

Viruses are isogenic, recombinant SARS-CoV-2 strains, with variant spike coding sequences on a common, USA-WA1/2020 genetic background

194

Circles: 2 weeks PD2 Triangles: 4 weeks PD2 Data from Liu et al., 2021, Nature DOI: ; L10.1038/s41586-021-03693-y; Liu et al., 2021 NEJM, DOI: 10.1056/NEJMc2102017; Delta-AY.1, Lambda data submitted for publication

LLOD

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3rd Dose Evaluated in Both Phase 1 and Phase 3 Participants from Original Pivotal Trial

Vaccination period

21 days apart

Vaccination 1 and 2

Follow-up period

Active Surveillance

for Potential COVID-19 symptoms TRIGGER telehealth or in-person visit and nasal swab

PHASE 1 BOOSTER Reactogenicity

~8 months PD2

(N=23)

7

1

DAYS PD3 AE

SAE

PHASE 3 BOOSTER Reactogenicity

~7 months PD2

(N=312)

7

1

DAYS PD3 AE

SAE

6

MONTH PD3

6

MONTH PD3

18 18

UP TO 2-YEARS through study DEATHS: all participants

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Summary of Data for BNT162b2 Booster (3rd Dose) Administered in C4591001: Phase 1

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Post-dose 3 BNT162b2 GMTs Indicate a Substantial Boost and Reduced Gap Between WT and Beta Neutralization

50% Serum Neutralizing Titer

18-55 Years Old

n=11/group

65-85 Years Old

n=12/group

GMRBeta/WT

1.0

0.30

0.27

0.48

0.69

0.73

1.0

0.27

0.29

0.49

0.67

0.77

(95% CI) (1.00, 1.00) (0.20, 0.45) (0.18, 0.39) (0.36, 0.66) (0.52, 0.91) (0.52, 1.02) (1.00, 1.00) (0.16, 0.45) (0.17, 0.49) (0.34, 0.69) (0.53, 0.84) (0.51, 1.16)

10,000 1,000 100

1202 2119

1754

1546

497

387 150

103 83

40

538 147

261 76

1318 879

2032 1567

41 20

10 10

10

10 10

Before 7 Days 1 Month Before 7 Days 1 Month Before 7 Days

Dose 1

after

after

Dose 3

after

after

Dose 1

after

Dose 2 Dose 2

Dose 3 Dose 3

Dose 2

PRNTWT

PRNTBeta

SARS-CoV-2 Neutralization with BNT162b2 Vaccine Dose 3 | NEJM (), DOI: 10.1056/NEJMc2113468

1 Month after

Dose 2

Before Dose 3

7 Days after

Dose 3

1 Month after

Dose 3

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Post-dose 3 BNT162b2 GMTs Indicate a Substantial Boost to the Delta Variant Similar to Wild Type

GMRDelta/WT

(95% CI)

10,000

18-55 Years Old

n=11/group

0.78

(0.63, 0.96)

0.85

(0.71, 1.03)

1546 1321

65-85 Years Old

n=12/group

0.63

(0.46, 0.86)

0.92

(0.71, 1.18)

1613 1479

50% Serum Neutralizing Titer

1,000

310

241

196 123

100

10 1 Month After Dose 2

1 Month After Dose 3

1 Month After Dose 2

PRNTWT

PRNTDelta

SARS-CoV-2 Neutralization with BNT162b2 Vaccine Dose 3 | NEJM (), DOI: 10.1056/NEJMc2113468.

1 Month After Dose 3

LLOD

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