FDA, CDC approve Moderna and Pfizer-BioNTech bivalent vaccines for booster use
Key Takeaways
The FDA has approved use of bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 vaccines as booster shots. Following the Sept. 1 approval by the CDC, these boosters can now be administered to a greater number of people, including younger patients.
The bivalent formulations target the Omicron variant’s BA.4 and BA.5 lineages, and were proven to be effective against the BA.1 strain in clinical trials.
The FDA is recommending that adults and adolescents receive the bivalent boosters. Physicians should consider encouraging patients—especially younger ones who may not have been previously eligible for boosters—to receive these vaccinations.
A new weapon against Omicron is right around the corner. The CDC voted on September 1, 2022, to approve emergency use authorizations (EUA) of the Moderna and Pfizer-BioNTech COVID-19 vaccines, authorizing bivalent formulations of both to be used as booster shots, as updated by the FDA on August 31.
The new formulations are designed to give broad protection against COVID-19, including better protection against the Omicron variants currently circulating.[]
These shots were approved by the CDC in a 13-to-1 vote after an almost 7-hour meeting. A few hours after the vote, CDC Director Rochelle Walensky, MD, MPH, signed off on the bivalent boosters.[]
Following the CDC approval, the bivalent shots are expected to be available in early September.
Available to young people
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
These bivalent vaccines combine the original vaccines with new ones that target the BA.4 and BA.5 lineages of the Omicron variant.
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.
Boosters recommended
"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 an August 31 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."
— Peter Marks, MD
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.
What this means for you
The FDA approval of bivalent COVID-19 booster shots for both Moderna (18 and older) and Pfizer-BioNTech (12 and older) vaccine recipients is big news that you should share with patients. The new formulations' efficacy against the Omicron variants, as shown in clinical studies, will further the effectiveness of COVID-19 vaccines. The FDA’s authorization of boosters for younger patients—in particular enabling those 12 and older to receive the Pfizer-BioNTech booster—should be of special note to patients in this age group and their guardians.