FDA advisers vote to replace original COVID vaccine with bivalent boosters despite lack of clinical trial data

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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 …read more

Source: Sott health news feed

    

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