A new weapon against Omicron is right around the corner. On August 31, 2022, the FDA updated the emergency use authorizations (EUA) of the Moderna and Pfizer-BioNTech COVID-19 vaccines, authorizing bivalent formulations of both to be used as booster shots. They are designed to give broad protection against COVID-19, including better protection against the Omicron variants currently circulating.

Coronavirus (COVID-19) update: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose. FDA. August 31, 2022.

One of the big changes under the revised EUA is the availability of the boosters to younger people who were ineligible for an additional booster during the recent wave of variants.

According to the FDA’s announcement, the Moderna vaccine is authorized as a single booster for individuals 18 and older, while the Pfizer-BioNTech vaccine is authorized as a single booster for individuals 12 and older. Both can be administered 2 months after the recipient’s most recent vaccination or booster. People under those age cutoffs will still be able to get monovalent boosters.

Targeting variants

The FDA wrote that these lineages are “currently causing most cases of COVID-19 in the US and are predicted to circulate this fall and winter.” Stemming from this concern, in June 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to include an Omicron component in boosters.

In studies of approximately 600 individuals each for recipients of the Moderna and Pfizer-BioNTech vaccines, the FDA found that recipients of the bivalent boosters had better immune response to Omicron B.1 than those who got the monovalent versions.

Pending approval

These shots await approval from the US Centers for Disease Control and Prevention (CDC), which was scheduled to vote on September 1, 2022, as this article went to press.

Thomas N, Goodman B. FDA authorizes Pfizer and Moderna's updated Covid-19 boosters. CNN. Updated August 31, 2022.

"We want to make sure that adults and the adolescents covered by this authorization are able to get the most up-to-date version of a booster vaccine, and that's why we are no longer authorizing the monovalent—the original—booster for administration as a booster dose to those populations," stated Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, in a press briefing.

If you've not yet received a booster dose, or it's been several months since your last booster dose, now's the time to consider getting one.

Along these lines, physicians should encourage patients—particularly younger individuals who may not have been eligible for boosters—to take advantage of this new provision and receive the bivalent boosters as soon as possible, following CDC approval.