FDA authorizes Moderna, Pfizer’s bivalent omicron boosters for children, adolescents

The FDA has granted an emergency use authorization for booster doses of Moderna and Pfizer-BioNTech’s omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines for children and adolescents, both companies announced today.

The news comes just over 2 weeks after both Moderna and Pfizer said they were seeking an emergency use authorization (EUA) for boosters.

Moderna applied for and received authorizations on its request for a 50 µg dose for adolescents aged 12 to 17 years, and another EUA request on a 25 µg dose for children aged 6 to 11 years. Their formula is derived from their omicron-targeting bivalent booster vaccine, messenger RNA-1273.222, which contains mRNA encoding for the spike protein of BA.4/BA.5 as well as mRNA encoding for the original strain of the SARS-CoV-2 virus.

“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 Stéphane Bancel, CEO of Moderna, in a press release. “With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings. We are grateful for the FDA for their thorough and timely review.”

Pfizer’s booster, which is already recommended for children aged 12 years and older, was authorized for children aged 5 to 11 years. Its adapted vaccine targets the original strain of SARS-CoV-2 and the omicron BA.4 and BA.5 subvariants, but in a 10 µg dose — one-third the size of the vaccine recommended for the older age group.

Pfizer chairman and CEO Albert Bourla, DVM, PhD, said in a release that the manufacturers were ready to ship “millions of booster doses” in the coming days.

“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.,” Bourla said. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”

[Editor’s note: CDC Director Rochelle P. Walensky, MD, MPH, later signed off on recommending the boosters.]

Pfizer cited clinical data from a phase 2/3 trial which showed that a booster dose of their 30 µg omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the omicron BA.1 subvariant when compared with the companies’ original COVID-19 vaccine.

Pfizer also said it will be launching a phase 1/2/3 clinical study of the booster’s safety, immunogenicity and effects among children aged 6 months through 11 years of age. Four substudies will group children by age and COVID-19 vaccination status: ages 6 through 13 months who are COVID-19 vaccine naive; aged 6 months through 4 years who have received two to three doses of the original COVID-19 vaccine; ages 6 months through 4 years who have previously received three doses of original COVID-19 vaccine; and ages 5 through 11 years who have received two to three doses of COVID-19 vaccine.

As of Oct. 6, the CDC reported that approximately 8.8 million children aged 5 to 11 years in the U.S. had received a full multidose regimen of COVID-19 vaccine, representing just 31% of that population. An additional 2 million received one dose.

According to the AAP, 40,656 new pediatric COVID-19 cases were reported in the U.S. during the week ending Oct. 6, bringing the total number of child cases reported to 14,817,723.

References:

• AAP. Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Published Oct. 6, 2022. Accessed Oct. 12, 2022.
• AAP. Summary of data publicly reported by the Centers for Disease Control and Prevention. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/. Published Oct. 5, 2022. Accessed Oct. 12, 2022.
• Moderna. Moderna receives FDA authorization for emergency use of omicron-targeting bivalent COVID-19 booster vaccine for children and adolescents 6 to 17 years of age. https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Authorization-for-Emergency-Use-of-Omicron-Targeting-Bivalent-COVID-19-Booster-Vaccine-for-Children-and-Adolescents-6-to-17-Years-of-Age/default.aspx. Published Oct. 12, 2022. Accessed Oct. 12, 2022.