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FDA advisory panel unanimously backs Moderna boosters 

By Brian Buntz | October 15, 2021

ModernaAll 19 members of the Vaccines and Related Biological Products Advisory Committee voted to expand emergency use authorization of the Moderna COVID-19 vaccine to include boosters.

The recommendation, however, limited its use to three main groups, including those 65 and older and individuals 18 to 64 with an elevated risk of developing severe COVID-19. In addition, the recommendation extended to individuals with a high risk of exposure to the virus in occupational or institutional settings that could lead to severe complications from COVID-19.

The conclusions mirrored the FDA’s current recommendations for the Pfizer-BioNTech vaccine, a similar vaccine that uses a lower dose of mRNA.

Regarding the dose level, Moderna requested a 50 microgram dose for the boosters, which is half the dose of the primary series of the same vaccine.

While the committee members supported the booster, several members had reservations about its potential use in populations outside of the three groups indicated in the voting question.

The Moderna vaccine booster is best suited for the elderly and “those that have the high risk of severe COVID,” said Dr. Michael Kurilla, a voting member and official at the NIH. “These are the ones who are most at risk. They’re relying extensively on their neutralizing titers to really prevent infections and have much more limited capacity to prevent this severe disease complication.”


Filed Under: Infectious Disease
Tagged With: coronavirus, covid-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines, FDA, Moderna
 

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