Goodbye, BA.4 and BA.5 COVID-19 Omicron bivalent booster. A new COVID-19 vaccine is taking its place.
The Food and Drug Administration (FDA) approved—and authorized—emergency use of an updated monovalent mRNA COVID-19 vaccine, which specifically offers protection against the XBB.1.5 strain. The authorization applies to vaccines for 2023–2024 manufactured by Moderna and Pfizer-BioNTech. An updated protein vaccine manufactured by Novavax is still under FDA review.
Additionally, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommends the updated vaccine for everyone 6 months or older to protect against COVID-19 this winter.
“Given that COVID-19 infections, hospitalizations and deaths continue to impact the U.S. population and an increase in infections is expected this fall and winter, the updated COVID-19 vaccines increase the immune response against the currently circulating variants,” said Sandra Fryhofer, MD, an Atlanta general internist and immediate past chair of the AMA Board of Trustees. Dr. Fryhofer also serves as the AMA’s liaison to ACIP.
The updated COVID-19 vaccine is anticipated to prevent 400,000 hospitalizations and 40,000 deaths over the next two years.
In an “AMA update” episode, Dr. Fryhofer drilled down the specifics on administration, eligibility and safety data.
Those who are 6 months or older are eligible to receive the vaccine and should get it as soon as possible, said Dr. Fryhofer. This is a universal recommendation, similar to the flu vaccine.
For those 5 or older, a single dose of the updated vaccine is all they need, regardless of previous vaccination status and even if they’ve never had any previous COVID-19 vaccinations, she explained. This is because anyone 5 or older likely has some COVID-19 immunity, either through previous vaccination, infection or both.
Those who are immunocompromised need a three-dose prime and at least one updated shot. They can also get additional doses if their physician recommends it.
Younger children—6 months to 4 years old—may need a multi-dose regimen, with two doses of Moderna, or three doses of Pfizer. The updated vaccine may be an addition to or part of that initial series. The same vaccine brand should be used in children for all doses, Dr. Fryhofer emphasized.
If you recently had a COVID infection, you no longer need to wait at least three months to get a dose of the updated vaccine, she added.
Vaccine manufacturers and the FDA say the updated vaccines should protect against circulating strains, based on recent study data.
Ninety percent of all circulating strains are XBB lineage viruses with a few substitutions, Dr. Fryhofer said. EG.5, a variant closely related to XBB, is currently the dominant variant in the U.S. It has mutations to help it evade antibodies from previous vaccines as well as prior infections from earlier variants. FL.1.5.1 is second on the list of dominance.
There’s also BA.2.86—known as Pirola—which has been detected in at least seven states and has more than 30 different substitutions in the spike protein, said Dr. Fryhofer. But preliminary studies show the updated COVID-19 vaccines seem to provide sufficient protection against Pirola and EG.5.
The updated COVID-19 vaccine can be administered with other seasonal vaccines, including the flu shot and respiratory syncytial virus (RSV) vaccines for adults. It can also be co-administered with nirsevimab, the monoclonal antibody given to babies to prevent RSV.
Monkeypox vaccines are the one exception and should not be administered in conjunction with a COVID-19 vaccine.
Post authorization studies show that myocarditis and anaphylaxis events are rare. Even in men, a population at higher risk for myocarditis, the benefits of vaccination outweigh risk, Dr. Fryhofer said.
Another silver lining: New data shows (PDF) that previous vaccines and boosters can reduce risk of long COVID. With new COVID-19 variants emerging and vaccine immunity waning, physicians should urge patients to get the updated vaccine.
“There is no group that clearly has no risk from COVID,” Dr. Fryhofer said.
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