BRIEF—FDA revokes EUA for COVID-19 Vaccine Janssen

3 June 2023

The Food and Drug Administration (FDA) announced it had revoked the emergency use authorization (EUA) of the COVID-19 Vaccine Janssen.

On May 22, Janssen Biotech, a unit of US healthcare giant Johnson & Johnson, requested the voluntary withdrawal of the EUA for this vaccine, the FDA noted.

Janssen Biotech informed the FDA that the last lots of the vaccine purchased by the US government have expired, there is no demand for new lots of the vaccine in the USA, and the company does not intend to update the strain composition of this vaccine to address emerging variants.

First-quarter 2023 sales of the Janssen vaccine were $747 million, an increase of 63% compared with the like 2022 period, but with none coming from the USA, J&J’s financial report showed.

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