FDA Recommends Moderna Covid-19 Booster Shot

A 19-member committee has voted unanimously in favor of advising the FDA to recommend booster shots for people who have previously been vaccinated with Moderna’s COVID-19 vaccine. It’s now up to the FDA to make a final decision, which the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices will then consider shortly in coming up with the final recommendation for who should get the Moderna booster.

The COVID-19 vaccine made by Moderna is the second to get the greenlight from a panel of experts assigned to advise the Food and Drug Administration (FDA). Moderna follows Pfizer-BioNTech, which, in September, received FDA authorization for its booster. The CDC followed up with a booster recommendation for anyone over 65 years old who received their last Pfizer-BioNTech vaccine dose at least six months earlier; and anyone aged 18 to 64 who is more vulnerable to complications of COVID-19 because of underlying health conditions or because they work in a higher risk setting including a hospital, grocery store or school.

The advisory committee unanimously voted in support of a booster of the Moderna vaccine; however, in a discussion following the vote members raised concerns about whether the data the committee and FDA have been reviewing so far are adequate to justify boosters for the wider population. Several committee members voiced their support of a booster dose for vulnerable populations, including those over age 65 and people with compromised immune systems, who are at greater risk of developing severe COVID-19 and its complications, but noted the dearth of data supporting the benefit among younger people, even those in jobs that might put them at risk of exposure. 

Still, the members voted to recommend the Moderna shot for a population that mirrors that currently eligible for the Pfizer-BioNTech booster. (The same FDA committee had voted against recommending the Pfizer-BioNTech booster for these groups, but CDC director Dr. Rochelle Walensky decided to include them so those who find themselves in high-risk settings have the option of getting an additional dose.)

Moderna booster dose would give younger people who mount adequate immune responses after the initial shots any extra protection. Indeed, FDA scientists presenting to the committee emphasized that the immunity from the original two doses remains strong enough to protect most people from getting sick enough to need hospitalization, or from dying of COVID-19. 

Dr. Patrick Moore, another committee member and a professor at the University of Pittsburgh Cancer Institute, said he voted in favor of the booster “more from a gut feeling rather than based on really, truly serious data. The data itself is not strong, but [is] certainly going in the direction that is supportive of this vote.”

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