Johnson & Johnson’s vaccine safe and effective, FDA review concludes

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

Johnson & Johnson’s single-shot COVID-19 vaccine is effective and has a “favorable safety profile,” according to scientists at the Food and Drug Administration.

The endorsement comes out of a review released by the regulatory agency Wednesday. The FDA has been looking over data on Johnson & Johnson’s vaccine since February 4, when the company applied for Emergency Use Authorization. The agency’s green light is a positive sign ahead of this Friday, February 26, when the FDA will convene an advisory committee to make a recommendation on whether the FDA should grant the EUA. The FDA isn’t obligated to follow the committee’s recommendation, but it usually does.

If Johnson & Johnson’s vaccine is granted an EUA, it will become the third COVID-19 vaccine available for use in the US. The other two vaccines are both two-dose, mRNA-based vaccines, one made by Pfizer and its German partner BioNTech and the other from Moderna, which developed its vaccine in collaboration with researchers at the US National Institutes of Health.

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