Now that the U.S. Food and Drug Administration has granted full authorization to the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older, expect a fuller rollout of vaccinations — and more mandates from business and organizations that anticipate large crowds.
The FDA made that announcement Monday morning making the Pfizer's product the first coronavirus vaccine fully approved by the FDA for ages 16 and up. It had been authorized for emergency use in the United States since the start of 2021 for adults, and extended to those 12 and older prior to the beginning of summer.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Per a press release sent Monda morning the FDA reviewed updated data from the clinical trial which supported the emergency use authorization and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. Based on results from the clinical trial, the vaccine was 91 percent effective in preventing COVID-19 disease, a figure that led to Monday's announcement
The FDA is already allowing emergency use of a third dose for those who have received Pfizer or Moderna vaccine and have severely weakened immune systems, or who have comorbidities that prevent them from responding as strongly to the vaccine. Per FDA and CDC authorization, the Biden administration is planning for a booster rollout for the general population for eight months after their second shot. Study is also ongoing for the effectiveness of the Pfizer and Moderna vaccines for children under 12, with feedback expected this fall.
