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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