U.S. FDA advisers back Moderna COVID booster shots
Washington, D.C. – A panel of expert advisers to the United States Food and Drug Administration (FDA) unanimously voted on Thursday to recommend booster shots of Moderna’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. Centres for Disease Control and Prevention (CDC) 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,” Dr. Patrick Moore of the University of Pittsburgh School of Medicine said.
Moore said he voted in favour of Moderna boosters based largely on a “gut feeling rather than truly serious data”.
Moderna shares were up nearly three per cent at U.S. $330.71 after the vote.
FDA staff said in documents posted on Tuesday 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 authorisation of a booster that contains 50 micrograms of vaccine, half of the strength of its regular dose, but still higher than the Pfizer/BioNTech shot using similar technology at 30 micrograms.
U.S. health officials have been under pressure to authorise 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 nine million people have received a third shot, the CDC reported on Wednesday.
The panel heard presentations from Israeli health officials that boosters of the Pfizer/BioNTech vaccine helped curb the latest wave of infections in their country.
In the presentation on Thursday, they said the booster programme in Israel improved severe disease protection in people aged 40 and older.
“What we’re seeing is a break in the epidemic curve in Israel,” Dr. Sharon Alroy-Preis, director of public health services at the Ministry of Health in Israel, said.
She said the booster programme, which now includes 50 per cent of the population among all age groups, is starting to reduce infections even among the unvaccinated in Israel.