Pfizer Vaccine Update
On Monday August 23, the US Food and Drug Administration (FDA) gave its full approval of the Pfizer-BioNTech COVID-19 vaccine.
According to their press release: “ ‘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.”
Pfizer’s vaccine is fully approved for people ages 16 and older. For those who are ages 12 to 15, and for those who are immunocompromised and may need a booster shot, the vaccine is still available under the FDA’s emergency use authorization (EUA).
Pfizer and BioNTech applied for full approval of their vaccine in May 2021. The process of final approval requires an analysis of the drug’s benefits, its risks, and six months worth of peer reviewed data from the manufacturer’s clinical trials (in this case, over 40,000 individuals around the world).
Much of this process was already done as a prerequisite when the FDA authorized the vaccine’s emergency use. Due to the urgent health risks to individuals caused by the pandemic, the full approval process then fell into what the FDA refers to as a “Priority Review.” The typical length of time for products falling under Priority Review is six months. With much of the data analysis done on the front end, the full approval process took four months.
The FDA’s announcement comes as the COVID-19 Delta Variant continues to spread across the globe. Many communities are hitting record high numbers for infection rates and hospitalizations, including the Virgin Islands.
The vaccine remains the most effective way for individuals to protect themselves and others against the ill-effects of COVID-19. To learn more about the COVID-19 vaccine, visit the VI Department of Health’s resource page; the CDC’s Vaccine FAQ page, and the Johns Hopkins guide for fully vaccinated individuals.
You can also check out our vaccine Q&A with Sandy Colasacco, a Board Certified Family Nurse Practitioner and the Clinical Executive Director of Island Health and Wellness.