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Will the FDA Endorse COVID Boosters? Here’s What to Expect

The FDA could weigh in on COVID-19 booster shots soon, which the White House has backed. But what does it mean?

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Update: As of mid-day September 17, the FDA overwhelmingly rejected the value of giving boosters to all Americans 16+. They will likely make a second vote on whether or not they will recommend boosters for more targeted groups such as the elderly or immunocompromised people.

In mid-August, the Biden administration announced that they, alongside government medical officials, recommended booster shots for people who were already fully vaccinated against COVID-19

The recommendation of a booster was targeted in order of people who had been vaccinated first. The Biden administration suggested that Americans get another dose around 8 months after their second dose. But since the recommendation, the FDA has yet to weigh in on whether or not they will recommend the boosters for Americans.

Per The Wall Street Journal, the group of 20 scientific advisers will meet to discuss data about the boosters and whether or not the COVID-19 Pfizer vaccine becomes less effective as time passes. The data the panel will look at will show immunity over time in different parts of the world and data that shows if the third dose significantly boosts the efficacy of the COVID-19 Pfizer vaccine. 

Pfizer says that the FDA already said the third dose was safe and effective. So the hearing will mainly be about whether or not the third dose will significantly boost immunity or if it’s necessary.  

While in the past, FDA authorization of vaccines has felt more like a certainty than a possibility, given the data on how safe and effective all three COVID-19 vaccines being offered to the public are, there’s a legitimate possibility that the FDA might not approve the booster shots due to their potential lack of medical necessity.

After all, the data has to show that the vaccine’s efficacy does wane for everyone at around the 8-month mark for full, blanket approval. The WSJ suggests that a possible outcome of the meeting could be that the boosters are approved on a targeted level, like for people who work in health care and are therefore at greater risk of contracting COVID, or for people who are older than 65, who are at greater risk of dying from the virus.

This potential FDA endorsement comes at a time when the Biden administration has already put its full weight behind the booster plan.

Meanwhile, experts have fallen on both sides of the issue, some suggesting that the vaccine is still effective and that the data doesn’t yet support the need for a booster; while others have said that data shows that offers much-needed protection against a growing number of increasingly aggressive variants of COVID-19. 

This comes at a time when global health organizations like the World Health Organization (WHO) have begged otherwise healthy people to not get booster shots as the global population has struggled to get access to COVID-19 vaccines. The decision from the FDA should come fairly soon. It’s not clear what they will say, for now.