FDA clears updated Omicron boosters for youngest children

09 Dec 2022
www.biopharmadive.com
VaccineEmergency Use AuthorizationmRNADrug Approval
The U.S. has cleared children as young as 6 months old to receive updated COVID-19 vaccinesCOVID-19 vaccines from Pfizer and Moderna that target both the original form of the coronavirus and widely circulating omicron variant sub-strains.
The Food and Drug Administration announced on Thursday it expanded the emergency use authorizations of the two-pronged, or “bivalent,” vaccine shots to include the youngest age groups. The updated shots were cleared as boosters for adults in August and in children as young as 5 in October.
“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccineCOVID-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 on the authorizations.
Moderna’s updated shot can now be given as a booster to children 6 months to 5 years of age, at least two months after they complete the company’s two-dose primary shot series.
Pfizer’s updated vaccine is cleared as the last shot of its three-dose regimen for children 6 months to 4 years of age. Children in this age group who have already received the three-dose series are not eligible for Pfizer’s updated bivalent shot as an additional booster dose, however.
The FDA said it expects data supporting the use of Pfizer’s updated shot as a booster in this age group in January, adding children who have completed the series “are still be expected to have protection against the most serious outcomes from the currently circulating omicron variant.”
Children in the U.S. aged 6 months to 5 years were the last group cleared to receive COVID-19 vaccineCOVID-19 vaccine shots in June.
Uptake of the vaccine remains slow in the youngest age groups. Less than 3% of children under 2 years old and less than 5% of those aged 2 to 4 years old have completed a primary COVID-19 vaccine series, according to data from the Centers for Disease Control and Prevention.
The updated shots include messenger RNA for the spike proteins found on both the original coronavirus strain and the BA.4/BA.5 omicron strains.
The FDA said its authorization is based on safety and efficacy data from clinical trials that tested other versions of the companies’ updated boosters, as well as data for their original booster shots, which the agency said are “relevant” because the updated vaccines are made using the same process.
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