The FDA Has Approved Moderna’s COVID-19 Booster Shots for Older People

Another booster program 'improved severe disease protection in people aged 40 and older.'
Brad Bergan
A syringe about to inject a COVID-19 vaccine.Chaz Bharj / iStock

We are entering another stage of the COVID-19 pandemic.

A panel of advisers to the United States' Food and Drug Administration (FDA) has voted unanimously to suggest the rollout of Moderna's COVID-19 booster shots to the initial vaccine for citizens who are 65 years or older, in addition to people with high-risk of serious illness or occupational proximity to the virus, according to an initial report from Reuters.

The vote for Moderna's booster was 19 to zero; in favor.

While the booster shot still needs formal approval from the FDA to go forward, we could begin seeing increased rollouts soon, despite the fact that "the data itself is not strong," according to Patrick Moore of the University of Pittsburgh's school of medicine, in the Reuters report.

Moderna's COVID-19 vaccine booster was approved

The FDA will still need to approve the booster shot from Moderna, but when this happens, the United States' Centers for Disease Control and Prevention (CDC) will move forward with concrete recommendations on who should and shouldn't receive the shots. The FDA's advisory panel, known as the Vaccines and Related Biological Products Advisory Committee, reached this agreement after a Thursday meeting to reflect on the idea of an additional dose of Moderna's vaccine. Further consideration is due to take place concerning Johnson & Johnson's vaccine on Friday.

"The data itself is not strong, but it is certainly going in the direction that is supportable of this vote," said Moore in the report, who added that he voted in favor of Moderna's booster shot to the vaccine based primarily on what he calls a "gut feeling rather than truly serious data." On Tuesday, FDA staff said in Tuesday documents that data for the vaccine supported the theory that it was linked to an increase of protective antibodies. But the FDA staff also said that, while antibodies did increase, they hadn't risen in number to a level sufficient for an FDA-specified measure of success, especially in people whose antibody levels stayed high for a long time.

Positive results in Israel lend credibility to booster shots in the US

Meanwhile, Moderna wants authorization of a booster that injects 50 micrograms of COVID-19 vaccine, which is half the dosage of the normative vaccine, but still higher than a similar shot from Pfizer, which is only 30 micrograms. Moderna's booster is designed to be administered to recipients at least six months following the first two shots. Health officials in the U.S. have faced mounting pressure from the White House to give full authorization to COVID-19 booster shots since the Biden administration said it aimed for a renewed vaccine campaign, of wider scope for the boosters than the initial two-shot dose, pending further approval from the CDC and FDA.

In September, both agencies approved the Pfizer booster shots for high-risk adults, and nearly 9 million people have received a third shot since then, said the CDC, according to the report. This comes on the heels of a presentation from health officials in Israel, who said boosters for Pfizer's vaccine helped to lower the latest wave of infections, adding that it improved severe disease protection for those older than 40 years old. It remains to be seen if the same will happen in the U.S., and whether similar results will obtain for Moderna's booster shot to the COVID-19 vaccine.