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FDA advisory committee votes to approve Moderna vaccine booster shots for vulnerable groups

The outside panel of experts voted unanimously in favor of offering Moderna boosters to specific groups of people, at least six months after their second dose.
The outside panel of experts voted unanimously in favor of offering Moderna boosters to specific groups of people, at least six months after their second dose.

The Food and Drug Administration’s vaccine advisory voted in favor of recommending booster doses of the Moderna vaccine Thursday for people age 65 and older, people ages 18-64 at high risk for severe COVID-19 and people ages 18-64 with frequent institutional or occupational exposures.

Related: FDA unlikely to rule on Merck’s COVID pill before December

The outside panel of experts voted unanimously in favor of offering Moderna boosters to those specific groups of people, at least six months after their second dose.

The recommendation will go before the FDA, which will make the official decision.

While some data suggests Moderna’s protection isn’t declining as much as Pfizer’s, the experts were sufficiently convinced that a booster dose would be beneficial for those at a higher risk.

Related: Pfizer booster shots now available in Metro Detroit

Moderna gave a higher relative dose initially, which may help explain why its protection has held up a little better. The company said its research found a half-dose would deliver the same boost in protection with a lower risk of side effects and would stretch the global supply of its vaccine.

The Food and Drug Administration’s vaccine advisory voted in favor of recommending booster doses of the Moderna vaccine Thursday for people age 65 and older, people ages 18-64 at high risk for severe COVID-19 and people ages 18-64 with frequent institutional or occupational exposures.
The Food and Drug Administration’s vaccine advisory voted in favor of recommending booster doses of the Moderna vaccine Thursday for people age 65 and older, people ages 18-64 at high risk for severe COVID-19 and people ages 18-64 with frequent institutional or occupational exposures.

Moderna said the highly transmissible delta variant has spurred the need for a booster dose. The company highlighted data that found breakthrough cases were happening more often in those who had been vaccinated longer.

“We observed a 36.4% decrease in the incidence of cases in those who were vaccinated more recently, as compared to those who were vaccinated at an earlier time,” said Dr. Jacqueline Miller.

Overall side effects with the booster dose were similar to those seen after the second dose. There was a higher rate of swollen lymph nodes in those under 65 after the booster.

The panel also discussed whether booster doses should be considered for those not in the higher risk groups.

Moderna’s booster dose will come from the same vials already widely available, but vaccine providers will need to draw up a half-dose for the boosters.

Immuno-compromised people will still get a third full-dose. It has not yet been determined if they will need a booster six months after the third dose.

Panelists expressed concern there may be confusion over who needs a full-dose and who should receive the half-dose. Moderna plans to launch an educational campaign for vaccine providers as well as a 24-hour call center for support.

The FDA raised some serious questions about Johnson & Johnson’s data and one of the tests the company used. Panelists expressed concern in the past that the Johnson & Johnson recipients don’t have the same level of protection as those who received the MRNA vaccines, so the desire to recommend a booster dose may be higher.


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About the Authors:

Dr. McGeorge can be seen on Local 4 News helping Metro Detroiters with health concerns when he isn't helping save lives in the emergency room at Henry Ford Hospital.

Dane is a producer and media enthusiast. He previously worked freelance video production and writing jobs in Michigan, Georgia and Massachusetts. Dane graduated from the Specs Howard School of Media Arts.