Children as young as 6 months old should be eligible for COVID-19 booster shots, the Food and Drug Administration (FDA) said yesterday.
The FDA’s recommendation still needs to be approved by the Centers for Disease Control and Prevention (CDC).
FDA Commissioner Robert Califf, M.D., said in the announcement that “as this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”
At least one expert questions the process by which the FDA reached its decision.
“I think these decisions should be vetted through the FDA and CDC advisory committees first,” Paul Offit, M.D., the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told Fierce Healthcare.
He sits on the Vaccines and Related Biological Products Advisory Committee, a panel of experts that makes recommendations to the FDA. He was one of two experts on the 15-member panel to vote against approval of the bivalent vaccines this summer. The Advisory Committee on Immunization Practices is the panel of experts that advises the CDC.
Yesterday’s FDA recommendation comes with caveats about just who and who shouldn’t get the mRNA COVID-19 booster, one being the exclusion of children who’ve already received three doses of the Pfizer-BioNTech vaccine. Those children will still have protection against the omicron BA.4 and BA.5 subvariants now in circulation.
But this could change, as the FDA in its announcement added that “the data to support giving an updated bivalent booster dose for these children are expected in January.”
Here’s who can receive the booster:
- Children aged 6 months old through 4 years old who haven’t gotten a three-dose primary series of the Pfizer-BioNTech vaccines. Also, in the same age group, those who haven’t yet gotten the third dose in the series will now be given the bivalent booster as their third dose.
- Children aged 6 months old through 5 years old who’ve gotten the monovalent Moderna vaccine will be eligible for the Moderna bivalent booster shot two months after they’ve completed the monovalent dosing.
The booster shots will be “broadly protective” against COVID-19 because they contain a component that should ward off the original COVID-19 strain, as well as BA.4 and BA.5, according to the FDA. Some individuals who receive the bivalent shot could experience side effects like those that affected people who’d gotten the original monovalent vaccines.
The CDC reported last month in its Morbidity and Mortality Weekly Report that data collected by the government’s Vaccine Adverse Event Reporting System (VAERS) said side effects “for persons aged ≥12 years after a bivalent booster dose were nonserious (95.5%) and were usually similar to those after first booster vaccination and second booster vaccination among adults aged ≥50 years (3–5). Vaccination errors were among the most common events reported to VAERS (34.5%); most (88.2%) of which did not list an adverse health event. Continued education of vaccine providers could help reduce administration errors.”
In approving the Moderna bivalent vaccine for children 6 months through 5 years old, the FDA analyzed data comparing the immune response among 56 individuals 17 months through 5 years old, finding that “the immune response … was comparable to the immune response to the two-dose primary series in the adult participants.”
The FDA’s recommendation of the Pfizer-BioNTech vaccine for children 6 months through 4 years old “is supported by the FDA’s previous analyses of the effectiveness of primary vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older and individuals 6 months through 4 years of age.”
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement that “parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”