April 18, 2023: The FDA on Tuesday approved a second bivalent COVID-19 Booster for Americans at higher risk, hoping to increase public protection and encourage more people to get vaccinated, which targets both the original strain of the SARS-CoV-2 virus and two Omicron variants.
Moderna and Pfizer-BioNTech’s monovalent (single strain) mRNA COVID vaccines will no longer be available as the agency withdrew emergency use authorizations for both.
The FDA recommended an additional bivalent booster for:
- People 65 years of age or older who have received a bivalent dose, provided 4 months have passed after the initial injection
- Most unvaccinated people, who can now receive a single dose of the bivalent vaccine, instead of multiple doses of the original monovalent mRNA vaccines.
- Most people who have received a monovalent injection
- Immunocompromised people who have received a bivalent vaccine. Another booster may be given 2 months later, and more doses may be given at the discretion and at times determined by your healthcare provider.
For immunocompromised individuals 6 months to 4 years of age, eligibility will depend on the prior vaccine received. - Children 6 months to 5 years of age who have been vaccinated, but the number of boosters they receive depends on previous vaccinations.
The FDA said that unvaccinated children 6 months to 5 years of age can receive a two-dose series of the Moderna bivalent vaccine; or they may receive a three-dose series of the Pfizer-BioNTech bivalent vaccine (up to age 4). Unvaccinated children who are 5 years old can receive two Moderna bivalent boosters or a single Pfizer booster.
The decision was expected
the backing of a second reinforcement was expectedespecially since the CDC Advisory Committee on Immunization Practices (ACIP) meets Wednesday to formally recommend who should receive the bivalent booster.
In February, the panel recommended against another push, saying the nation should move toward a annual shot in the fall. At the same time, the CDC published data showing that having an updated booster reduced the risk of death.
The CDC reports that only 17% of Americans have had a bivalent reinforcement; only 43% of those over 65 years of age have been injected with two strains. Meanwhile, there are around 100,000 cases of COVID and more than 1,300 deaths in the US every week, according to the agency. While most of those deaths are in people over the age of 65, the FDA continues to urge people to get a boost.
“Americans under the age of 65 have largely missed out on receiving a bivalent booster,” Peter Marks, MD, PhD, director of the FDA’s Center for Biological Research and Evaluation, in a briefing with reporters. He estimated that 75% of people between the ages of 12 and 65 “could be taking a bivalent booster right now and haven’t taken it.”
Those people “could go out and get the bivalent boost now to improve their protection,” he said.
People under 65 who have already received a single bivalent dose should not receive another, the agency said.
Simplifying the process
The agency said it wants to simplify the COVID vaccination schedule to stop confusion and better prepare for emerging variants. To that end, the FDA’s advisory panel will meet in June to discuss which strains and variants of SARS-CoV-2 are most likely to circulate in the fall and winter of 2023-24.
The committee will recommend which of them should be included in a vaccine, and then drugmakers will prepare the new shot to be given in the fall, Marks said.
It’s similar to the process the FDA and drug manufacturers use to determine the composition of the flu vaccine each year, he said.
As with the flu vaccine, the agency and health officials will encourage people to receive the most recent vaccinations. “As we move into future seasons, particularly if the vaccine strain composition needs to be updated, it may be important for everyone to get an updated vaccine to provide protection against future variants that emerge,” Marks said.
The FDA judged how safe a bivalent vaccine alone would be, based on previous data from various age groups who received the Moderna and Pfizer monovalent and bivalent vaccines.
“We feel comfortable making some extrapolations here, based on our understanding of these vaccines, given the hundreds of millions of doses administered and what we’ve seen with real-world evidence with both monovalent and bivalent vaccines,” he said. marks. .
Neither Moderna’s nor Pfizer’s monovalent or bivalent vaccines have been formally approved, but they do have emergency use authorization. But Marks said the FDA still wants to put the products through a longer full approval process.
“We know that people are generally more comfortable with licensed products,” he said. But “we stand behind their safety, efficacy and quality just as we do licensed products.”