The FDA's full approval has been granted to the Pfizer-BioNTech Covid-19 vaccine

August 23, 2021
But what does "FDA full approval" mean and why does it matter?

The Food and Drug Administration has today granted full approval to Pfizer-BioNTech’s Covid-19 vaccine, making it the first in the US to receive the coveted designation.

Up until now, the vaccine has been under an emergency use authorization that was granted by the FDA in December. More than 204 million shots have been administered across the US since then, according to data from the CDC.

How did the FDA decide to grant full approval?

For vaccines, the FDA grants an emergency use authorization after reviewing at least two months of follow-up results for clinical trial participants who received the actual injection. For full approval, known in FDA-speak as a “biologics license application,” the agency wants to see six months of data to ensure there are no widespread problems or to detect any adverse reactions. 

Both reviews examine safety and efficacy while also studying what the best national distribution strategy might be.

Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet Woodcock said in a statement released last week. “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.”

Monitoring clinical trial participants over six months also yields more information about how the efficacy of the vaccine might change over time and gives the FDA an opportunity to see how well it holds up against new virus variants.

Full vaccine approval may help convince the vaccine hesitant.

At this point, a majority of US adults have received at least one dose of a Covid-19 vaccine under an emergency use authorization. However, there remain pockets of the country with much lower rates of vaccination which are driving up the rates of hospitalizations and deaths.

According to polling from the Kaiser Family Foundation, almost one-third of unvaccinated people said they would be more inclined to get a shot when it graduates to an FDA full approval. 

This suggests that full approval could be psychological more than anything else–with millions of doses already out there, an additional checkmark from the FDA doesn’t fundamentally change the fact that the vaccine already has enormous safety and efficacy. 

Our public health messengers and trusted primary care physicians can now seize the opportunity to convince people that getting their shots are our best–and safest–chance to bring us all back to something closer to pre-pandemic normal.

This article is for informational purposes only and is not intended to be a substitute for medical advice, diagnosis or treatment. Always seek the advice of your physician or other healthcare provider with any questions you have regarding a medical condition or treatment, or before starting a new healthcare regimen and never disregard medical advice or delay in seeking it because of something you've read on this website.

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