FDA authorizes updated COVID-19 boosters

The Food and Drug Administration (FDA) has authorized Pfizer-BioNTech’s and Moderna’s updated COVID-19 boosters, which target the Omicron subvariants responsible for more than 90% of new cases. 

A Centers for Disease Control (CDC) advisory committee still needs to recommend the shots before they can be distributed, but vaccinations could begin as soon as the first week of September.

The details: While the currently available mRNA vaccines only target the original coronavirus, first identified in January 2020, the new boosters have been updated to target both the original strain and two highly contagious subvariants of the Omicron strain: BA.4 and BA.5.

The updated COVID-19 boosters could be widely available just after Labor Day.

The FDA has authorized the updated COVID-19 boosters for people who have been fully vaccinated or boosted at least two months prior. Pfizer-BioNTech’s booster is authorized for people ages 12 or older, while Moderna’s is authorized for ages 18 and up.

The CDC advisory committee is expected to decide whether or not to recommend the updated COVID-19 boosters on September 1. CDC Director Rochelle Walensky could then sign off on them the same day, meaning the shots could be widely available just after Labor Day.

The data: Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines were highly effective against the original coronavirus, but substantially less effective against Omicron. Updating the shots to match the strain in circulation is expected to provide better and potentially longer-lasting protection.

Shots that target the latest Omicron subvariants, BA.4 and BA.5, are also expected to be more effective than the first Omicron variant.

However, we don’t actually know if that’ll be the case. While the shots targeting Omicron BA.1 were tested in human trials, the FDA requested earlier this year that the companies tweak the shots to target BA.4 and BA.5. Those have only been tested in animals so far.

Human trials are underway, but some worry that people might not bother to get boosted if we release the shots now.

“With a very skittish public that has voted with its feet about taking boosters, if we could add layers of reassurance that [the shot] has gone into humans for some level of studies, that would help,” Peter Hotez, a vaccine scientist and global health expert, told the Washington Post.

On the clock: BA.4 and BA.5 were responsible for fewer than 10% of new cases just three months ago, and if the FDA were to wait the expected month or two for the results of these human trials, a new subvariant might emerge by the time the shots were released.

Given that the updated COVID-19 boosters are very similar to the already approved vaccines, and to the BA.1 shot tested in earlier trials, few experts are worried about any safety issues, and many seem to believe making the boosters available as soon as possible is the right call.  

“It’s a race against an evolving virus at a time when you are being asked to go back into the office and winter is coming,” Jeanne Marrazzo, director of the infectious-diseases division at the University of Alabama at Birmingham, told the WaPo. “There is really no right answer, but with stakes being high, it’s better to err on [the] side of offering the protection.”

We’d love to hear from you! If you have a comment about this article or if you have a tip for a future Freethink story, please email us at [email protected].