A healthcare worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in Manhattan in New York City, New York, U.S., January 29, 2021. REUTERS/Mike
A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Thursday to recommend booster shots of Moderna Inc's COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus.
If the FDA signs off on Moderna's booster, the U.S. Centers for Disease Control and Prevention will make specific recommendations on who should get the shots. CDC advisers are scheduled to meet next week.
The FDA's Vaccines and Related Biological Products Advisory Committee met on Thursday to consider the additional dose of the Moderna vaccine and will weigh whether to make a similar recommendation for Johnson & Johnson's vaccine on Friday. The vote to back Moderna's booster was 19-0.
"The data itself is not strong, but it is certainly going in the direction that is supportable of this vote," said Dr. Patrick Moore of the University of Pittsburgh School of Medicine. Moore said he voted in favor of Moderna boosters based largely on a "gut feeling rather than truly serious data."
Moderna shares were up nearly 3% at $330.71 after the vote.
FDA staff in documents posted on said data for Moderna's vaccine showed that the booster does increase protective antibodies.
But they also said the difference in antibody levels before and after the shot was not wide enough by one measure of success specified by the FDA, particularly in those whose antibody levels had remained high.
Moderna is seeking authorization of a booster that contains 50 micrograms of vaccine, half of strength of its regular dose but still higher than the Pfizer/BioNTech shot using similar technology at 30 micrograms.
The booster would be administered to people at least six months after the initial two-shot inoculation.
U.S. health officials have been under pressure to authorize COVID-19 vaccine booster doses after the White House announced in August it planned a widespread booster campaign pending approvals from the FDA and the CDC.
Both agencies signed off on Pfizer/BioNTech boosters for certain high-risk adults last month. Since then, nearly 9 million people have received a third shot, the CDC reported on Wednesday.
In the United States, the Delta surge already has been begun to ease, with the seven-day average of daily COVID-19 cases falling 12% from the previous week, and the seven-day average of daily deaths down 5%. That is still more than 1,250 COVID-19 deaths a day, however, primarily among the unvaccinated.
