Various updates for Pfizer, BioNTech COVID-19 vaccine post-EUA

By The Science Advisory Board staff writers

December 14, 2020 -- Various announcements and updates regarding the Pfizer-BioNTech COVID-19 vaccine were made during the weekend and on Monday, December 14. These included publishing immune data from the phase I trial in Germany, new recommendations from Health Canada, and an independent U.S. Centers for Disease Control and Prevention (CDC) committee recommending the vaccine for use.

Health Canada issued recommendations in light of two reports of anaphylactoid reactions to the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in the U.K., which occurred in individuals with a history of severe allergic reactions. Health Canada recommends that people with allergies to any of the ingredients of the vaccine should not receive the vaccine. The agency is working with U.K. Medicines and Healthcare products Regulatory Agency and with the manufacturer to monitor the situation.

The CDC Advisory Committee on Immunization Practices voted on Saturday, December 12 to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). The decision was made based on data from the phase III clinical trial published in the New England Journal of Medicine on December 10 and interim guidance given by the committee on December 1. Vaccine distribution in the U.S. began on Monday, December 14.

Finally, the companies announced that additional data on neutralizing antibody and T-cell responses from the phase I/II clinical trial with BNT162b2 in Germany were published on the MedRxiv preprint server. The results showed that the vaccine elicits combined humoral and cellular responses against SARS-CoV-2. Analysis of 37 participants showed SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and strong expansion of CD8+ T cells of the early effector memory phenotype.

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