The Food and Drug Administration (FDA) announced Thursday that the Omicron-adjusted COVID vaccines developed by Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) are authorized in the U.S. for use as boosters in children as young as six months old.
Accordingly, children aged six months – 5 years and six months – 4 years will be eligible to receive a single booster of Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) bivalent COVID-19 vaccines, respectively, after completing the primary vaccine series.
However, the updated booster shots are not indicated for children who have already completed the three-dose primary series with the original Pfizer (PFE)/BioNTech (BNTX) vaccine. The data supporting an additional bivalent vaccine dose for this age group are expected in January, the FDA said.
Announcing the decision, FDA Commissioner Robert Califf highlighted the importance of being up to date with COVID vaccines as holidays and winter months approach.
“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,” he said.
In August, the FDA initially greenlighted the redesigned COVID-19 booster shots adapted for the Omicron BA.4 and BA.5 subvariants of the virus.