FDA authorizes updated Covid-19 boosters for youngest children

The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.

Previously, the bivalent boosters, which protect against two different strains of the SARS-CoV-2 virus, were only available to children 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 Califf said in a 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.”

Vaccination rates in children under the age of 5 are the lowest for any age group in the country. Only 10% of kids under the age of 5 have received even a single dose of Covid vaccine.

With the amended EUA, children 6 months to 5 years of age who received the Moderna vaccine for their primary series can get a bivalent booster, so long as at least two months have elapsed since they completed the two-shot primary series.

Children aged 6 months to 4 years of age who have started the three-dose Pfizer primary series will get Pfizer’s bivalent booster as the third shot in their series, if they haven’t already received three shots. And going forward, children in this age group who start the Pfizer primary series will receive two doses of monovalent vaccine followed by a third dose of the bivalent vaccine.

Children who have received all three shots in the Pfizer primary series will not be eligible for an updated booster at this time, the FDA statement said, suggesting more data are needed before a fourth shot for this age group can be authorized.

“The data to support giving an updated bivalent booster dose for these children are expected in January,” the statement said. “The agency is committed to evaluating those data as quickly as possible.”