FDA Review Finds Johnson & Johnson’s One-Dose Covid Vaccine Effective

The vaccine shows strong efficacy in trials and could soon receive emergency authorization in the US.

Johnson & Johnson’s single-dose Covid-19 vaccine has been found to be safe and effective, according to a review by the US Food and Drug Administration (FDA) published on Wednesday. The vaccine is now on track for emergency authorization, pending a recommendation from an advisory panel of independent experts scheduled for Friday.

In trials involving over 44,000 participants, the vaccine showed a 72% effectiveness rate in the United States, 66% in Latin America, and 57% in South Africa, where the more transmissible B1351 variant is prevalent. Furthermore, the vaccine demonstrated an 85% effectiveness rate in preventing severe cases of Covid-19. Notably, the vaccine’s efficacy was consistent across different ethnic groups, including Asian, Black, white, and Latino participants.

The FDA’s briefing documents pave the way for the potential authorization of the vaccine, joining the previously authorized Pfizer and Moderna vaccines.

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