Pfizer Inc PFE

PFE REPORT ADDITIONAL DATA FROM GERMAN COVID STUDY

[Humanist]

Pfizer, BioNTech report additional data from German COVID-19 vaccine study
Dec. 14, 2020 7:45 AM ETPfizer Inc. (PFE)By: Mamta Mayani, SA News Editor3 Comments

• Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announce additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany.
• Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and almost 92% of participants demonstrated strong expansion of CD8+ T cells of the early effector memory phenotype.
• All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. CD8+ T cell responses were directed against multiple regions of the spike protein, and several of the multiple epitopes recognized by BNT162b2-induced CD8+ T cells were molecularly identified.
• Overall, these results mirror previous findings from the U.S. trial demonstrating a favorable safety profile and robust induction of antibody responses with a longer follow-up period of 85 days.
• Antibodies generated efficiently neutralized 19 pseudo-viruses, indicating the potential for broad BNT162b2-elicited protection against reported mutations.
• The ongoing Phase 1/2 trial is being conducted in Germany in parallel to the Phase 1/2/3 trial that started in the U.S.
• As of today, BNT162b2 has been authorized or approved for emergency use for individuals 16 years of age and older in the U.S., U.K., Bahrain, Canada, Saudi Arabia, and Mexico.
• The companies have submitted a final Conditional Marketing Authorization Application following rolling submissions with the EMA and several other regulatory agencies.
• Vaccines are rolling out for delivery in the United States today.