FDA Approves Bivalent COVID-19 Vaccines for Children as Young as 6 Months

WASHINGTON — The Food and Drug Administration on Thursday amended its emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines, saying the shots are safe to administer to children as young as 6 months old.

“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,” said FDA Commissioner Dr. Robert M. Califf, in a written statement. 

“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,” Califf said.

Parents are advised that children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 vaccine two months after completing a primary series with the monovalent Moderna COVID-19 vaccine.

Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original Pfizer-BioNTech COVID-19 vaccine.

Additionally, the agency says parents should be aware that children 6 months through 4 years of age who have already completed their three-dose primary series with the original Pfizer-BioNTech COVID-19 vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. 

That’s because 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 Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component corresponding to the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. 

Individuals who receive the updated (bivalent) vaccines may experience similar side effects reported by individuals who received previous doses of the original (monovalent) mRNA COVID-19 vaccines, the agency said.

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death,” said Dr. Peter Marks, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” he continued. “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.”

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