C4591001 COVID-19 BLA Safety and Efficacy Data For
C4591001 COVID-19 BLA Safety and Efficacy Data For ACIP
(Data Cutoff 13-Mar-2021) John L. Perez, MD, MBA, MA Vice President, Pfizer Vaccine Clinical Research & Development
30 Aug 2021
Breakthroughs that change patients' lives
Confidential 1
Agenda
1. High level overview of long-term safety analyses for individuals 16+ years of age 2. Adverse events of special interest 3. Efficacy update through 13-March-2021 4. Sequence data on COVID-19 cases through 13-March-2021 5. Pregnancy data through 13-March-2021
Not Covered in presentation but data available for: HIV+ participants, SARS-CoV-2 +/- at baseline, more than 1 episode COVID-19 cases in placebo group, placebo participants who developed COVID-19 then received BNT162b2, booster data
Worldwide Research, Development and Medical
Confidential 2
Phase 2/3 Safety Schema ? Started 27 July, 2020
Vaccination period
Follow-up period
21 days apart
7 days
Active surveillance
for potential COVID-19 symptoms TRIGGERING telehealth or in-person visit and nasal swab
7 days
Reactogenicity in subsets for 16 and above; all 12-15 year olds
One month post dose 2
Non-serious AE: all participants
Six months post dose 2 Through study
Serious AE: all participants Deaths: all participants
Up to 2 years
Worldwide Research, Development and Medical
Confidential 3
Original BNT162b2 Participants Original Placebo Participants
Blinded Placebo-Controlled Follow-Up Period:
Unblinding Date1
Blinded
Open-Label
Dose 1
1 month after Dose 2
Dose 1
Unblinding date2
Blinded Placebo-Controlled Follow-up Period and Open-Label Observational Follow-Up Period3:
Dose 1
6 months after Dose 2
Open-Label Observational Follow-Up Period:
Unblinding Date Original BNT162b2 Participants
Data cutoff date
Unblinding Date (Dose 3, Vaccination with BNT162b2)
Original Placebo Participants
Data cutoff date
1 Will vary by participant. Adverse event data analyzed from Dose 1 to unblinding date (on or after 14 December 2020), or from unblinding date to data cutoff date, are reported as incidence rates adjusted for exposure time.
2 Up to ~5 months after Dose 2. 3 Cumulative BNT162b2 follow-up to at least 6 months after Dose 2, N~3000/age group (16 to 55 years of
age, >55 years of age).
Worldwide Research, Development and Medical
Confidential 4
Follow-up Time After Dose 2: >16 year olds ? Safety Population
Total exposure from Dose 2 to cut-off date
BNT162b2 (30 g) (N=22026) nb(%)
Original blinded placebo-controlled follow-up period
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