FDA Authorizes Updated COVID-19 Boosters Despite Lack of Clinical Data

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U.S. drug regulators on Aug. 31 authorized COVID-19 vaccine booster shots despite no clinical trial data being available for the updated formulations.

The U.S. Food and Drug Administration (FDA) granted emergency use authorization to Moderna and Pfizer for their updated boosters.

The original vaccines were based on components of the Wuhan strain of the virus that causes COVID-19. The updated shots contain components of the Wuhan strain and of the BA.4 and BA.5 subvariants of the Omicron variant.

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