FDA Expands EUA for Bivalent COVID-19 Vaccines to Include Children as Young as Age 5 Years

The US Food and Drug Administration (FDA) on Wednesday amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent booster shots for use in children as young as age 5 years. Both company’s bivalent boosters can be administered at least 2 months after primary or booster vaccination, the Moderna shot in children aged 6 to 17 years and the Pfizer counterpart in those aged 5 to 11 years.

The Centers for Disease Control and Prevention followed with a recommendation to support the expanded use.

The updated booster vaccines are adapted to target the original strain of the SARS-CoV-2 virus as well as the omicron BA.4 and BA.5 subvariants, with the mRNA component of the former included to trigger a broadly protective COVID-19 immune response and a component shared by the 2 omicron variants to provide more specific protection against the lineages now in wide circulation.

Moderna received authorizations on 2 requests, for a 50-µg dose for adolescents aged 12 to 17 years and a 25-µg dose for children aged 6 to 11. The Pfizer omicron-adapted shot, already recommended for children aged ≥12 years, was authorized in a 10-µg dose, one-third the dose recommended for the older age group.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” said Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, in the FDA announcement. While cases of COVID-19 in children have tended to be less severe than in adults, Marks added, more children have gotten sick and been hospitalized as waves of the infection have occurred. Vaccination in people of all ages continues to provide the most effective protection against severe consequences of COVID-19, he emphasized.

Pfizer-BioNTech in their EUA application cited clinical data from a phase 2/3 trial that showed a booster dose of the 30-µg omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine. Additional preclinical data demonstrated 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.

Moderna’s pediatric and adolescent EUA application is based on clinical trial booster data for the company’s original vaccine, preclinical data for its omicron BA.4/BA.-5-targeting bivalent vaccine, and data from a phase 2/3 clinical trial studying a second booster that also targets the omicron subvariant, according to the company.

"We are proud to have received authorization for our updated, bivalent COVID-19 booster for children and adolescents 6 to 17 years of age," said Moderna chief executive officer Stéphane Bancel. "With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings.”

“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” said Pfizer chairman and chief executive officer Albert Bourla, in a company statement.

“This milestone is important to be able to provide access to variant-adapted vaccines to a broader population,” added BioNTech chief executive officer and founder Ugur Sahin, MD. Sahin also said the company has initiated a clinical trial to evaluate the omicron subvariant-adapted vaccine in children aged 11 months to 6 years, “aiming to offer all age groups the opportunity to immunize against Omicron variants and subvariants.”

With Wednesday’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals aged 5 to 11 years, said the FDA. Both vaccines do, however, continue to be authorized for primary series administration in individuals aged ≥6 months.

The fact sheets for both of the bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about potential side effects, as well as the risks of myocarditis and pericarditis.