FDA Authorizes Bivalent COVID-19 Vaccine Booster for Children 6 Months to 4 Years of Age


Booster shots updated for the Omicron variant BA.4 and BA.5 lineages cleared for children 6 months through 4 years of age.

The FDA has authorized expanded eligibility for the updated bivalent COVID-19 boosters for children between 6 months and 4 years of age, the agency announced today. Omicron variant-targeted booster shots made by Pfizer-BioNTech and Moderna were already available to individuals 5 years of age and older.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so—especially as we head into the holidays and winter months where more time will be spent indoors,” FDA Commissioner Robert M. Califf, MD, said in a press release “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

The FDA action authorizes children 6 months through 5 years of age who were administered the original monovalent Moderna COVID-19 vaccine to receive a single booster of the updated bivalent Moderna COVID-19 vaccine 2 months following completion of a primary series with the monovalent vaccine.

For children 6 months through 4 years of age who have yet to begin the 3-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or who have not yet received the third dose of the primary series, the updated bivalent Pfizer-BioNTech COVID-19 vaccine can now be administered as the third dose in the primary series after 2 doses of the original monovalent vaccine.

Notably, children 6 months through 4 years of age who completed the 3-dose Pfizer-BioNTech COVID-19 primary vaccine series with the original monovalent vaccine are not eligible for the updated bivalent booster dose at this time.

“Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant,” the FDA said in a press release. “The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.”

Both the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component that corresponds to the original COVID-19 strain to induce a broadly protective immune response against COVID-19. The updated bivalent vaccines also contain an mRNA component that corresponds to the Omicron variant BA.4 and BA.5 lineages to confer superior protection against Omicron, according to the FDA.

In terms of adverse events (AEs), those administered the updated bivalent vaccines may experience similar AEs to individuals who were previously administered the original monovalent mRNA COVID-19 vaccines, according to the FDA.

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”


Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. FDA. News release. December 8, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months

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