The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention and 1 no vote that based upon the available scientific evidence, the benefits of the Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 outweigh the risks in people 16 years of age and older.
Now, the FDA has to consider the discussion heard today at the advisory committee meeting and then make a decision on whether to approve an Emergency Use Application (“EUA”) to allow the product to be administered to the public. Based upon the discussion today, we expect FDA to approve the EUA in the very near future.
The data presented at the advisory committee meeting and analyzed by FDA demonstrate that in individuals without prior SARS-CoV-2 infection, the Observed Vaccine Efficacy (“OVE”) against COVID-19 occurring at least 7 days after Dose 2 was 95%.
Some members of the advisory committee expressed concern that there is an insufficient amount of clinical data from 16 and 17-year old age group to ascertain whether the vaccine would help them. Both FDA and Pfizer stated that the safety and efficacy data could be extrapolated to this patient population and that by the time that the vaccine would be available to this age group, additional data would be generated in the ongoing clinical trial and other future trials. Ultimately, the committee voted that the benefits for that group outweighed the risks.
Another question raised is whether pregnant and lactating women should be vaccinated. While there are currently no data on which to base such a recommendation, FDA has requested companies to conduct developmental and reproductive toxicity studies in animals before they could conduct clinical trials to test if these vaccines are safe to use in pregnancy and while breastfeeding.
We will be following FDA deliberations on the EUA and conditions for the storage and administration of the Pfizer and BioNTech’s COVID-19 vaccine over the next days.
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