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Vaccine advisers to the Centers for Disease Control and Prevention (CDC) expressed support Friday for using bivalent COVID-19 vaccines in both the primary series and booster doses for all ages.
If federal regulators adopt the change backed by the CDC’s Advisory Committee on Immunization Practices (ACIP), vaccine recommendations would be simplified. The change would be especially impactful for children, the group least likely to have been vaccinated.
“We have made this vaccination schedule so complicated for providers that it becomes so difficult to even give, even if you want to do right thing and you have the kid in your office,” said ACIP Chair Grace M. Lee, M.D., M.P.H., associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital in Palo Alto, Calif. “I have a strong request and plea for simplification, so that’s why I am supportive of this transition.”
However, there also was debate about whether some people who are unvaccinated would continue to need a primary series or just a single annual dose.
ACIP did not take any formal votes Friday, but there was clear consensus for transitioning away from monovalent mRNA vaccines in favor of the updated bivalent mRNA vaccines. A Food and Drug Administration (FDA) vaccine committee also supported that move when it met earlier this year. However, no changes will go into effect immediately. The FDA would need to authorize the move, and ACIP and the CDC then would provide formal recommendations.
Experts said Friday the transition could mean reducing the number of COVID vaccine products from 11 to five and eliminating look-alikes that cause confusion. It also could improve storage space, reduce administration errors and allow continued access to the primary series.
“In talking to my pediatric and family medicine colleagues as well as other vaccinators throughout the state, the number of doses in the refrigerator and the look-alikes are a major source of safety concerns, so simplifications will improve the logistics, the feasibility and the confidence of families in receiving the vaccine,” said ACIP member Katherine A. Poehling, M.D., M.P.H., FAAP, professor of pediatrics and epidemiology and prevention at the Wake Forest University School of Medicine in North Carolina.
The bivalent vaccine consists of the original strain and omicron BA.4/5. ACIP member Sarah S. Long, M.D., FAAP, professor of pediatrics at Drexel University College of Medicine in Philadelphia, said she has seen children with severe illness from omicron.
“There is urgency for these bivalent vaccines, these newer strain vaccines to be available for a primary series in children down to at least 6 months,” she said.
About 92% of children under 2 years, 90% of children 2-4 years, 60% of children ages 5-11 years and 28% of children ages 12-17 are unvaccinated, according to CDC data. The CDC also noted about 1,500 children have died of COVID since the start of the pandemic, and half of hospitalized children and adolescents did not have underlying medical conditions.
Data on a bivalent primary series in children are limited. Moderna has been studying an omicron BA.1 bivalent primary series in children 6 months to 5 years. The vaccine induced an immune response, and safety data are encouraging.
As the pandemic evolves, health officials have been discussing the possibility of transitioning to an annual COVID-19 vaccine to protect against new variants and address waning effectiveness. This raises questions about whether people who have never been vaccinated would need a primary series or if they would get a single annual shot given the likelihood they already had some protection from a previous infection.
The CDC is looking at the possibility of continuing to recommend a primary series for young children, since those under 2 years have higher hospitalization rates than older children and those under 4 years are less likely to have protection from a prior infection and vaccination than those who are older.
Some ACIP members said they would prefer basing the need for a primary series on whether a person has a previous infection instead of on age. Others said doing so would make recommendations more complicated.
ACIP also discussed the possibility of older adults and people who are immunocompromised needing more than one annual dose. Several members stressed the need for flexibility with these populations.
“If the FDA decides there can be some enhanced flexibility around recommendations, I think that that will be helpful,” said ACIP member Camille N. Kotton, M.D., FIDSA, FAST, clinical director, transplant and immunocompromised host infectious diseases at Massachusetts General Hospital. “It has been really terrific over the course of the pandemic when we saw the disease rates were higher in immunocompromised, we were able to give an additional dose of the vaccine based on that. So we will need to be responsive to upcoming increases in disease activity or viral strains, viral variants, etc., so I think flexibility will be key.”
- CDC clinical considerations for administering COVID-19 vaccines
- AAP COVID vaccination resources
- AAP pediatric COVID-19 vaccine dosing quick reference guide
- CDC COVID Vaccination Field Guide
- AAP/Health and Human Services COVID vaccine toolkit
- Information for parents on COVID vaccines from HealthyChildren.org