COVID Omicron Shots Now Authorized for Kids 6 Months and Up

Bivalent COVID-19 vaccines from Pfizer and Moderna are now authorized for use in children as young as 6 months old, the FDA announced on Thursday.

Under an updated emergency use authorization (EUA), Pfizer’s updated vaccine is now authorized as the third dose of the primary series for kids ages 6 months to 4 years, following two doses of the monovalent vaccine. Under the terms of the EUA, Pfizer’s monovalent vaccine is no longer authorized as a third dose for this age group.

Moderna’s bivalent vaccine is now authorized as a booster dose for kids ages 6 months to 5 years, at least 2 months following the two-dose primary series.

The bivalent mRNA vaccines — which were authorized for older children and adults earlier this year — target both the ancestral SARS-CoV-2 strain and the Omicron BA.4/5 subvariants, the dominant circulating strains earlier this year.

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said in a statement.

The updated EUAs were based in part on immune response data from clinical studies in adults and children who received previous BA.1-targeting bivalent vaccines or additional vaccinations with the companies’ monovalent shots. Side effects with the new vaccines are likely to be similar to those experienced after doses of the monovalent vaccines, the agency said.

“Parents and caregivers can be assured that the FDA has taken a great deal of care in our review,” said Marks. “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.”

In its announcement, the FDA noted that children ages 6 months to 4 years who have completed their primary series with the three monovalent doses of Pfizer’s vaccine “would still be expected to have protection against the most serious outcomes from the currently circulating Omicron variant,” and that data to support a bivalent booster dose in this population are expected early next year.

“More children now have the opportunity to update their protection against COVID-19,” said FDA Commissioner Robert Califf, MD, in the agency’s press release. “We encourage parents and caregivers of those eligible to consider doing so — especially as we head into the holidays and winter months where more time will be spent indoors.”

Califf added 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.”