The emergency use authorization amendments extend availability of the bivalent booster to young children.
The FDA’s emergency use authorizations (EUAs) for the Moderna and Pfizer/BioNTech COVID-19 vaccines have been amended to authorize a bivalent booster dose for younger age groups. The Moderna EUA now authorizes the booster dose for children aged 6 years and older, when administered 2 months after either the primary series or booster dose and the Pfizer EUA now allows for a bivalent booster in children aged 5 years and older. These boosters, like the one for older patients, will contain the mRNA component for the original strain as well as one for the Omicron variant BA.4 and BA.5 lineages.
The authorizations were dependent on the safety data and immune response from a clinical study of adults for a bivalent vaccine with an original strain component and a component of Omicron lineage BA.1, which is considered supportive by the FDA for vaccines with a component of the Omicron variant BA.4 and BA.5 lineages.
When asked why this news is welcome Peter Marks, MD, PhD said, “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. 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.”
As a result of this move, the monovalent Pfizer-BioNTech COVID-19 vaccine is not authorized for use as a booster dose for children aged 5 to 11 years.
1. FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups. News Release. FDA. Published October 12, 2022. Accessed October 13, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines