U.S. FDA authorizes bivalent COVID shots for kids as young as 6 months old
Source: Reuters
December 9, 2022 3:53 AM EST Last Updated 2 hours ago
(Reuters) - The U.S. health regulator has authorized COVID-19 shots from Moderna (MRNA.O) and Pfizer (PFE.N) and its partner BioNTech (22UAy.DE) that target both the original coronavirus and Omicron sub-variants for use in children as young as 6 months of age.
The amended authorization on Thursday from the Food and Drug Administration allows use of Moderna's bivalent shot as a booster in children 6 months through 5 years of age, two months after their initial vaccination.
Pfizer/BioNTech's updated shot can now be given as a third dose to those aged 6 months through 4 years, who have not completed their primary vaccination series or are yet to receive the third dose.
Children who have completed their initial three-dose vaccination with Pfizer's original shot are not yet eligible to receive the bivalent booster, the agency said. The regulator added that data supporting use of Pfizer/BioNTech's bivalent shot as a booster in this age group is expected in January.
Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-authorizes-moderna-pfizer-updated-covid-boosters-6-months-old-2022-12-08/
This still needs CDC review/sign off and then done.