CDC Backs Extra Bivalent Booster for High-Risk Groups, Simplifies Vax Recs

The CDC on Wednesday endorsed an additional dose, or doses, of the bivalent COVID vaccine for high-risk groups, while streamlining recommendations for most other groups.

In step with the FDA's updated emergency use authorizations (EUAs) for Moderna and Pfizer/BioNTech's bivalent mRNA products, which incorporate the original strain plus components targeting Omicron BA.4/BA.5, the new CDC recommendations allow for an extra vaccine dose for adults ages 65 years and older, starting at least 4 months from their prior bivalent dose.

And the CDC says additional doses can be given to people who are immunocompromised as needed, starting at 2 months from their last bivalent dose, and in consult with a healthcare provider.

For immunocompetent adults and kids ages 6 years and up, people are considered up to date if they've had a single bivalent mRNA vaccine, even if they have not had any prior vaccination with the monovalent products beforehand, which are no longer authorized in the U.S. as of Tuesday.

Younger children still need multiple doses (two or three depending on the vaccine), with recommendations varying by age.

"This is an important milestone in the evolution of the program," said CDC's Melinda Wharton, MD, MPH, the associate director for vaccine policy, during a meeting of the agency's Advisory Committee on Immunization Practices (ACIP) on Wednesday, where the changes were discussed.

"We are not completely across the finish line in terms of the simple program we would like to have, but we are definitely moving closer," she added.

The CDC is hopeful that the simpler recommendations will increase vaccine uptake. Currently, only 17% of people in the U.S. have received a bivalent vaccine, and just 43% of those age 65 and older have received one.

ACIP members showed support for the changes, but expressed concerns that the recommendations for children were still too complex.

"For age 6 [years] or older, we have simplified -- but for less than 6, I don't see the difference," said Sybil Cineas, MD, of the Warren Alpert Medical School of Brown University in Providence, Rhode Island.

"Immunologically there is not a difference between a 4-, 5-, and 6-year-old," said Sarah Long, MD, of St. Christopher's Hospital for Children in Philadelphia. "There isn't really any reason to have all this unnecessary drama around those ages."

Young children ages 6 months to 4 years receiving Pfizer's vaccine are now considered up to date if they have had at least three doses (including one bivalent dose). For unvaccinated kids, all three doses would be with the bivalent product going forward. For 5-year-olds, a single bivalent dose of the Pfizer vaccine is necessary to be considered up to date.

For Moderna's two-dose regimen for those ages 6 months to 5 years, kids are now up to date if they have had at least two vaccine doses, including one bivalent dose. Going forward, both doses for this group would be with the bivalent product.

Absent are specific recommendations for young children who are immunocompromised, and for adults under age 65 with chronic conditions, individuals who may be at high risk for severe disease.

"The gaps -- some of which we talked about today -- cause confusion, and then they also cause consternation," said Matthew Daley, MD, of Kaiser Permanente Colorado in Aurora.

Nearly a year without a booster is a problem for adults with chronic conditions who aren't immunocompromised, he said. "What can we do to fill the gaps?"

No further recommendations were issued for the Novavax and Johnson & Johnson's monovalent vaccines, neither of which have gained broad use in the U.S.

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