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CDC Backs FDA’s Call for Second COVID Booster for Those at High Risk

The Centers for Disease Control and Prevention (CDC) has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the US Food and Drug Administration’s (FDA’s) authorization Tuesday of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP) that met earlier Wednesday. While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot — which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 — should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, said Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, during the meeting Wednesday.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Twentyman said.

If an individual has already received a bivalent mRNA booster — made by either Pfizer/BioNTech or Moderna — “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.

“Unnecessary Drama” Over Kids’ Recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University College of Medicine, Philadelphia, Pennsylvania, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.”

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with healthcare professionals to discuss the updated recommendations on May 11.

New Vaccine by Fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

Acknowledging that there is continued confusion over COVID-19 vaccination, ACIP Chair Grace M. Lee, MD, MPH, said, “We all recognize this is a work in progress.”

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Lee, professor of pediatrics, Stanford University School of Medicine, California.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist, whose work has appeared in publications including JAMA and You can find her on Twitter @aliciaault.

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