FDA approves Moderna booster after 5 months, CEO says fourth dose could be next

People who have received two doses of the Moderna COVID-19 vaccine can now receive a booster dose after five months, the U.S. Food and Drug Administration announced on Jan. 7.

The previous wait time was six months, but the new guidance, which mirrors new recommendations for the Pfizer vaccine, was issued in response to the continued spread of the omicron variant of the coronavirus.

“Vaccination is our best defense against COVID-19, including the circulating variants, and shortening the length of time between completion of a primary series and a booster dose may help reduce waning immunity,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release.

The Moderna booster is available for people 18 and older who have completed the primary series of the vaccine, the release said.

The new guidance comes at a time when transmission of the omicron variant remains high; it accounted for about 95.4% of COVID-19 cases in the U.S. between Dec. 26 and Jan. 1, according to the Centers for Disease Control and Prevention. The delta variant, which peaked during the summer, made up about 4.6% of cases during that same window.

The updated guidelines came as Moderna CEO Stephane Bancel announced people may need a fourth dose of the vaccine this fall.

On Jan. 6, Bancel said in an interview at a Goldman Sachs healthcare conference that people who received boosters in the fall will likely be protected through the winter, but that the efficacy of the booster will likely wane over time, as it did with the first two doses, CNBC reported.

“I will be surprised when we get that data in the coming weeks that it’s holding nicely over time — I would expect that it’s not going to hold great,” Bancel said of the booster, according to CNBC.

Bancel added that the company is working on a vaccine tailored to the omicron variant of the coronavirus, but that it probably won’t be available in the next two months, Reuters reported.

“I still believe we’re going to need boosters in the fall of ‘22 and forward,” Bancel said, according to Reuters.

The omicron variant is believed to be more contagious than previous variants, likely because it seems to be much more transmissible among fully vaccinated adults than previous variants, like delta, were, NPR reported.

“This is a game-changing virus, especially in the vaccinated population where people have had a level of invincibility,” Sumit Chanda, a professor in the Department of Immunology and Microbiology at Scripps Research, told NPR.

Infections caused by the omicron variant are typically milder in vaccinated people than infections in unvaccinated people, demonstrating that vaccines are still highly effective in preventing severe illness and death, according to the CDC. But the symptoms can still be intense for some people, health experts warn.

Dr. Tedros Adhanom Ghebreyesus, chief of the World Health Organization, said on Jan. 6 that “while omicron does appear to be less severe compared to delta, especially in those vaccinated, it does not mean it should be categorized as mild,” BBC reported. “In fact, the tsunami of cases is so huge and quick, that it is overwhelming health systems around the world.”

That includes healthcare systems in the U.S., where community transmission is considered high in almost every county, according to the CDC.

To help protect against the omicron variant, the CDC recommends getting vaccinated, getting a booster at the appropriate time, wearing masks, and getting tested for the virus before gathering with other people.

This story was originally published January 7, 2022 at 1:01 PM with the headline "FDA approves Moderna booster after 5 months, CEO says fourth dose could be next."