Pfizer Presented 3rd Booster Dose Analysis for the Comirnaty Vaccine

On September 22, 2021, William C. Gruber, M.D., Senior Vice President Vaccine Clinical Research and Development Pfizer Inc., presented an updated 3rd dose (booster) analysis regarding the Comirnaty COVID-19 vaccine to the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) digital meeting on September 22, 2021.

The highlights from this Pfizer presentation are as follow:

• Data from Israel and the United States suggest vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.
• Comirnaty-elicited Sera Effectively Neutralize a Broad Range of SARS-CoV-2 Spike Variants After 2 Doses.
• Post-dose 3 BNT162b2 GMTs Indicate a Substantial Boost and Reduced Gap Between W.T. and Beta Neutralization.
• Geometric Mean Ratio of Neutralization Titers Non-inferiority Criterion (Post-dose 3 vs. Post-dose 2) was Met, with Titers ~3-fold Higher.
• Safety and Immunogenicity Data Meet FDA Criteria for Booster Dose ≥16 Years of Age.

In summary, Pfizer indicated 'Comirnaty (BNT162b2) demonstrated high efficacy (>90%) against COVID-19 and safety in the pivotal clinical trial after a 2-dose primary series. And while Vaccine Efficacy against severe disease and hospitalization remains high in most populations in the U.S., data from Israel predicts this may not be sustained.'

Israel has administered over 3.1 million 3rd vaccine doses since late July 2021 through today. Israel's COVID-19 data dashboard is available at this link.

The U.S. FDA issued Approval to BioNTech Manufacturing GmbH for Comirnaty on August 23, 2021. The Comirnaty vaccine is Approved for additional people, including individuals 12 through 15 years of age, and for administering the third dose in specific immunocompromised individuals.

The initial agenda of the ACIP meeting to review COVID-19 vaccines was published on Sept 20th.