Children's Health Defense By
Advisers to the U.S. Food and Drug Administration on Thursday voted to replace the original Pfizer and Moderna primary series mRNA COVID-19 vaccines with the bivalent boosters designed to target Omicron variants, despite concerns about insufficient clinical trial data to support safety and efficacy.
Advisers to the U.S. Food and Drug Administration (FDA) on Thursday voted unanimously to replace the original Pfizer and Moderna primary series mRNA COVID-19 vaccines with the bivalent boosters designed to target Omicron variants.
The bivalent mRNA boosters — authorized in September with no human clinical trials — contain components of the original COVID-19 ancestral strain plus the BA.4 and BA.5 Omicron subvariants. They are currently available for children as young as 6 months old.
The recommendation by the 21-member Vaccines and Related Biological Products Advisory Committee (VRBPAC) moves the FDA one step closer to its goal, announced Monday, of creating a single annual COVID-19 shot.
