FDA advisory committee endorses booster dose of Moderna's COVID-19 vaccine for specific groups

Posted at 7:35 AM, Oct 14, 2021
and last updated 2021-10-14 17:31:18-04

TAMPA, Fla. — An FDA advisory committee endorsed boosters of Moderna's COVID-19 vaccine for certain groups on Thursday.

“By the end of the week, we’ll have an idea of what the FDA’s advisory council thinks about booster shots,” said Dr. Michael Teng, a Virologist and Associate Professor for USF Health.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) came to the decision to unanimously recommend boosters of Moderna's COVID-19 vaccine for specific groups:

  • 65 and older
  • Individuals 18 through 64 years of age at high risk of severe COVID-19
  • Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

Advisors looked at if available data supported the safety and effectiveness of Moderna's COVID vaccine for use under EUA as a booster dose at least six months after the primary two-dose series. A difference between the first two Moderna shots and the booster is the booster would be a single, half dose.

"We chose the 50 microgram dose for the booster because we believe we should vaccinate with the lowest amount of antigen needed to induce an immune response at least equal to that in Study 301, which was linked to vaccine efficacy of 93 percent," said Dr. Jacqueline Miller with Moderna.

Miller went on to say reducing the dosage would also increase the worldwide supply of its vaccine. Dr. Miller also explained the booster has the potential to address waning antibody levels and reduce breakthroughs due to the Delta variant.

“Moderna is a half dose booster shot, and apparently that’s what they found is sufficient to induce enough of an immune response to give you a boost in immunity,” said Teng.

According to CDC data, more than 69 million people are fully vaccinated in the US with Moderna's COVID vaccine. Moderna presented data on Thursday that showed side effects were generally similar for a booster dose compared to the second dose people received.

Before this meeting, Pfizer’s COVID-19 vaccine was the only one that’s been given emergency use authorization for a booster dose in these groups.

“I think for the people who got the two doses of Moderna, they should feel really pretty good because the data that Moderna are showing, you do get a little boost of antibodies, but those first two doses of Moderna seem to be really good," said Teng.

The recommendation from Thursday's meeting will go to the FDA, who will make a final decision on authorization.

On Friday, October 15, the same FDA advisory committee will discuss Johnson & Johnson booster shots.