Health officials are considering simplifying COVID vaccine recommendations for children ages 2-4 years.
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) looked at the possibility of requiring only one dose for this group instead of two to three, although it did not make a final decision on Friday. The group also discussed studies on general vaccine safety and a new pentavalent meningococcal vaccine.
In the spring, health officials approved simplification of COVID vaccine dosing for most children and adults, calling for just one bivalent dose regardless of vaccination history.
However, children under 5 years continue to need two or three doses depending on which vaccine they receive.
ACIP’s COVID-19 vaccine work group said Friday it would support a single, potentially annual, dose for children ages 2 years and older, while maintaining multiple doses for those under 2. The group noted children ages 2-4 years have similar hospitalization rates as those 5-17 years, while rates for children under 2 are significantly higher. Children 2-4 years also are more likely to have been exposed through vaccination or infection compared to children under 2 years.
“The hospitalization rate among our children 6 months to 23 months of age is relatively high and resembles that of older adults, so maintaining multiple doses makes a lot of sense to me,” 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. “I also respect that with the data we have … and with the lower hospitalization rate in children over 2, I do think now is a very good time to consider simplifying to a single dose.”
Simplifying the recommendations also may lead to more children getting vaccinated. Among children ages 2-4 years, just 11% have had one dose and 0.6% had received at least one bivalent dose as of May 10, according to CDC data. Among children under 2 years, 9% have had at least one dose and 0.6% have had a bivalent dose.
The Food and Drug Administration (FDA) recently requested that vaccine manufacturers prepare a new monovalent COVID vaccine containing omicron XBB.1.5, the most commonly circulating strain. It is expected to be authorized in the next few months. The CDC then would make recommendations on who should get it and how many doses would be needed.
The CDC also is preparing for commercialization of COVID vaccines this fall. It expects to publish guidance for partners this summer.
ACIP members reviewed data on Friday regarding the safety of aluminum in vaccines, which improves the immune response.
ACIP member Matthew F. Daley, M.D., FAAP, senior investigator at the Institute for Health Research at Kaiser Permanente Colorado, on Friday presented a study he co-authored last fall that found a possible link between aluminum and asthma in children. After the study was published, the AAP, CDC and study authors said it has important limitations, and the findings do not prove causation. They did not recommend changing the vaccine schedule.
The findings have not been replicated in other studies. A researcher from Denmark presented data Friday from a study of more than 470,000 children that found no evidence of an association between aluminum in vaccines and asthma by age 5 years.
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., called the data “reassuring.”
“What I’m taking away from this is, looking at both studies together, that it doesn’t seem there is an association that I’m concerned about at the moment,” Dr. Lee said. “ … (I) really appreciate the investment, the time and the care that is spent with regard to ensuring that our vaccination program is as safe as possible for our entire childhood population.”
U.S. researchers plan to perform a follow-up study with a larger group of children and longer follow-up time.
ACIP also discussed a new pentavalent meningococcal vaccine that combines Pfizer’s MenACWY vaccine used in other countries and the serogroup B meningococcal disease (MenB) vaccine used in the U.S.
An ACIP work group has been analyzing benefits, harms, whether it would be a reasonable allocation of resources, feasibility of administering it and its impact on equity. It presented a draft proposal Friday saying the pentavalent vaccine could be used as an alternative to MenACWY and MenB for people ages 10 and older only when both are indicated to be given at the same time. Committee members did not vote on the proposal at Friday’s meeting.
Pneumococcal, influenza and respiratory syncytial virus vaccines
In the first two days of its meeting, ACIP also recommended a 20-valent pneumococcal conjugate vaccine and changes to precautions for people with allergies to eggs getting a flu vaccine. The CDC director will make final recommendations. In addition, it discussed unanswered questions and logistical hurdles around a respiratory syncytial virus (RSV) vaccine for pregnant women and an RSV monoclonal antibody product for infants.