FDA Authorizes Updated COVID-19 Boosters for Younger Children

The FDA has issued an emergency use authorization for both the Moderna and Pfizer updated COVID-19 vaccine boosters in children. These bivalent booster vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 and a component of omicron lineage BA.1.

Moderna’s updated booster is authorized for children six years of age and older. In August, the FDA had authorized Moderna’s updated booster for those 18 years and older. The BioNTech/Pfizer updated booster is authorized for children five years and older. In August, the agency had authorized the BioNTech/Pfizer updated booster for those 12 years and older.

Related: FDA Authorizes Pfizer, Moderna Updated COVID-19 Boosters

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER) said in a press release. “Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

For each of the bivalent COVID-19 vaccines authorized, the FDA relied on data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. In addition, the FDA has evaluated immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups.

In a press release, Pfizer indicated preclinical data showed a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus. A phase 1/2/3 pediatric study is currently under way to evaluate different dosing regimens and dose levels of the omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.

The company has manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations, Albert Bourla, chairman and chief executive officer, Pfizer, said.

Moderna indicated in a separate press release it is currently working to finalize its EUA application for children ages 6 months to 5 years old. The application is expected to be completed later this year.