FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Booster Vaccines in Younger Age Groups

The FDA has amended the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a single booster dose in younger age groups.

The Moderna COVID-19 bivalent vaccine is authorized for administration at least 2 months following completion of primary or booster vaccination in children 6 years of age and older. The Pfizer-BioNTech bivalent vaccine is authorized for administration at least 2 months following completion of primary or booster vaccination in children 5 years of age and older.

The vaccines both include an mRNA component of the original strain for a broadly protective immune response against COVID-19, as well as an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA in the vaccines instructs cells to make a distinctive spike protein of the original virus strain and the BA.4 and BA.5 omicron lineages.

“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 of the Center for Biologics Evaluation and Research at the FDA, in a press release. “Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death.”

With this authorization, the monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized as a booster dose for individuals 5 through 11 years of age. Both the Moderna and Pfizer-BioNTech vaccines continue to be authorized for primary series administration in individuals 6 months of age and older.

Both EUA updates are based on immune response and safety data that the FDA previously evaluated from a clinical study in adults, using 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. The FDA has also evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups.

The data supporting Moderna’ COVID-19 bivalent vaccine for both the 6- through 11-year age group and the 12- through 17-year age group is based on a previous analysis of immune response and safety data from a study of adults who received a booster dose of the vaccine. For the 12- through 17-year age group, the authorization is also based on the efficacy of a single booster dose of the monovalent Moderna COVID-19 vaccine in this age group.

The safety of a single dose of the monovalent Moderna COVID-19 vaccine was evaluated in approximately 1300 participants aged 12 through 17 years who received a booster dose of the vaccine at least 5 months after the second dose of the primary series, as well as approximately 1300 participants aged 6 through 11 years who received a booster dose at least 6 months after the second primary dose.

The most commonly reported adverse effects (AEs) after a booster dose of the Moderna monovalent vaccine for both age groups were pain, redness, and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen underarm lymph nodes, nausea, vomiting, and fever.

The data supporting the Pfizer-BioNTech authorization for individuals 5 through 11 years of age are based in part on the FDA’s previous analysis of immune response and safety data from a trial in adults 55 years of age and older who received a booster dose. Additionally, the authorization is based on the FDA’s previous analysis of safety and efficacy data of a booster dose in children 5 through 11 years of age. AEs of the Pfizer-BioNTech vaccine are similar to those for the Moderna vaccine.

“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,” Marks said in the 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.”

REFERENCE

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups. News release. FDA; October 12, 2022. Accessed October 12, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines