FDA clears updated COVID-19 vaccines for kids under age 5
Federal regulators have cleared doses of the updated COVID-19 vaccines for use in children down to 6 months of age.
Omicron-targeted booster shots made by both Moderna and Pfizer already are urged for everyone 5 and older. On Thursday, the U.S. Food and Drug Administration amended the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines for use in certain groups of children.
The FDA says younger children who’ve had two original Moderna shots qualify for an updated booster.
Pfizer’s vaccine requires three doses for kids under 5, and the FDA said the updated version will be substituted for the third shot.
But children 6 months through 4 years of age who have already completed their three-dose primary series with the original Pfizer vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time, the FDA says.
The FDA says children who received a three-dose series of the Pfizer shot would still be expected to have good protection against the most serious outcomes of the virus. Data to support the use of an updated bivalent booster shot for those children are expected in January.
“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 Robert M. Califf, M.D., in a statement.
The Centers for Disease Control and Prevention is expected to agree. Few U.S. tots have gotten their initial vaccinations.
The Associated Press contributed to this report.