Federal officials are recommending a spring booster dose of the updated bivalent SARS-CoV-2 vaccine for certain types of patients. But who should get it and when?
Eligibility applies to adults 65 or older, as well as adults and children with immunocompromising conditions, according to AMA Board Chair Sandra Adamson Fryhofer, MD. She is AMA’s liaison to the Advisory Committee on Immunization Practices (ACIP) and a member of ACIP’s COVID-19 Vaccine Workgroup.
The Food and Drug Administration (FDA) authorized this update in April. To simplify the schedule, the FDA also recommended using the mRNA bivalent vaccine for all vaccine doses. Monovalent vaccines no longer apply.
“An additional vaccine dose restores immunity. Some people are now at least six months out from their last bivalent vaccine dose. But many people have not yet had even a single bivalent vaccine dose,” said Dr. Fryhofer, an internist in private practice in Atlanta.
ACIP, a panel of the Centers for Disease Control and Prevention (CDC), followed up by reviewing FDA's amended authorizations and updates for vaccine safety and vaccine efficacy. “There was no formal ACIP vote,” said Dr. Fryhofer. CDC director Rochelle Walensky, MD, MPH, immediately signed off on the changes.
In an episode of “AMA Update,” Dr. Fryhofer discussed eligibility and regimens, offering a preview of future recommendations for additional populations.
Eligibility and timing
The new recommendation only applies to mRNA vaccines—not Janssen's viral vector vaccine or for Novavax's protein-based SARS-CoV-2 vaccine, Dr. Fryhofer explained.
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Adults 65 or older may now get an additional bivalent booster dose at least four months after their last dose.
Adults with immunocompromising conditions can get their additional booster at least two months after their last dose. For this category of patients, clinicians may administer additional doses based on clinical circumstances, and set dosing intervals.
“These options add flexibility for this group of people at higher risk of severe COVID complications,” added Dr. Fryhofer.
The situation is less cut and dried for very young children with compromised immune systems. Eligibility depends on the type and number of vaccines they have previously received. Children aged 6 months to 4 years old, for example, need two to three bivalent mRNA doses. But 5-year-olds just need one or two bivalent doses.
“Although the overarching theme of these new recommendations is flexibility and simplification, dosing for young children remains a little complicated,” Dr. Fryhofer noted.
The CDC is compiling step-by-step flowcharts to help physicians and other health professionals determine which dose and formulation children need and when, she added.
Spring meetings determine fall vaccination
The World Health Organization’s Technical Advisory Group on COVID-19 Vaccine Composition will be meeting in May to discuss SARS-CoV-2 vaccine antigen composition.
The FDA’s Vaccines and Related Biological Products Advisory Committee will likely address the WHO panel’s recommendations at its June meeting, as it considers additional boosters for those younger than 65.
The “FDA will also address any needed changes and the strains included in the vaccine. Changing the strains for a vaccine that's already been studied isn't new. We do this for flu vaccine every year,” said Dr. Fryhofer. This will afford vaccine manufacturers some time to make any recipe changes and update vaccines for the fall.
Booster uptake must improve
Patients are up to date on COVID vaccination if they received a single dose of the bivalent COVID-19 vaccine. “But, overall, only 16.7% of the U.S. population has received a dose of the updated booster. And only about 43% of those 65 and older have received the bivalent booster,” said Dr. Fryhofer.
It’s important to stay current with vaccination. COVID-19 vaccines protect from severe disease and death and can keep you out of the hospital, she said, noting that the virus continues to kill about 1,300 people each week.
“AMA Update” covers health care topics affecting the lives of physicians and patients. Hear from physicians and experts on public health, advocacy issues, scope of practice and more—because who’s doing the talking matters. You can catch every episode by subscribing to the AMA’s YouTube channel or the audio-only podcast version, which also features educational presentations and in-depth discussions.
