September 6, 2022, 11:55 a.m. News Staff — Following an expedited review of the evidence, the AAFP has approved federal authorization of updated COVID-19 booster shots that target the original virus as well as a pair of omicron subvariants.
“The models predict that by starting the boosters in September, we will significantly decrease the number of deaths and hospitalizations associated with COVID over the rest of 2022,” said family physician Jamie Loehr, M.D., a voting member of the CDC’s Advisory Committee on Immunization Practices.
The FDA on Aug. 31 amended the emergency use authorizations of the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow use of bivalent formulations of the vaccines. These bivalent vaccines, also called updated boosters, contain an mRNA component of the original strain of SARS-CoV-2 that first emerged more than two years ago, and an mRNA component common to omicron subvariants BA.4 and BA.5, which have become the dominant strains in the United States.
On Sept. 1, the ACIP voted 13-1 on two separate questions to recommend use of the updated boosters, and CDC Director Rochelle Walensky, M.D., M.P.H., endorsed the recommendations.
The Academy’s Commission on Health of the Public and Science approved the CDC and FDA actions on Sept. 2. The AAFP has updated its COVID-19 Vaccine webpage to reflect the latest information.
Both updated boosters are authorized as single doses administered two months after either the primary COVID-19 vaccination series or the most recent COVID-19 booster. They are not intended to be used for initial vaccination.
The Pfizer/BioNTech booster is authorized for individuals 12 years and older, and the Moderna booster for adults 18 years and older.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes of COVID-19,” FDA Commissioner Robert Califf, M.D., said in a news release. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
It’s important to note that as a result of the amended EUAs, monovalent mRNA COVID-19 booster shots are no longer authorized for use as booster doses for individuals 12 years and older. However, the monovalent original vaccines may continue to be used for primary vaccination in patients who have never been vaccinated against COVID-19.
Loehr, owner of Cayuga Family Medicine in Ithaca, N.Y., described the booster development process to AAFP News.
“The bivalent boosters contain mRNA based on the original Wuhan strain as well as mRNA from the recent BA.4/5 variants,” he explained. “Omicron-variant mRNA has been shown to provide additional antibodies against omicron-variant COVID infections, plus it boosts the antibody response to the original strain, and other variants as well.”
He noted that while there’s not yet human data on the updated boosters, data from vaccines using BA.1 mRNA are useful.
“It is important to understand that the new bivalent boosters are made using the exact same process as the original boosters but with a different strain of mRNA added to the vaccine,” Loehr said. “Thus, the FDA and ACIP feel comfortable that new vaccines with BA.4/5 mRNA will behave in the exact same way as the vaccines in the studies with BA.1 mRNA.”
He drew comparisons between the approval for the updated COVID-19 boosters and annual influenza vaccines, which could ease concerns among vaccine-hesitant patients.
“This is very similar to the influenza vaccine ,where the strains might change on a yearly basis,” Loehr said. “We don’t do human studies on each new strain in the influenza vaccine every year before sending it out to the general public. That would take too long and we would always be late on delivering the needed vaccines. We have good data that trusting in the process when adding new strains is safe and effective.”
Similar federal action on updated COVID-19 boosters for younger people is expected in the coming weeks, followed by quick CDC action to make them available in the United States.
Make sure to visit aafp.org/covid19 for the latest information.