FDA Revokes Emergency Use Authorization for COVID-19 Vaccine

Just three COVID-19 vaccines are available in the United States after the U.S. Food and Drug Administration (FDA) on June 1 revoked the authorization for the Johnson & Johnson shot.

Regulators made the move because of a request from Janssen, a Johnson & Johnson’s subsidiary that makes the vaccine.

Janssen “has informed the FDA that the last lots of the Janssen COVID-19 vaccine purchased by the United States government have expired, that there is no demand for new lots of the Janssen COVID-19 vaccine in the United States, and that Janssen Biotech, Inc does not intend to update the strain composition of this vaccine to address emerging variants,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a letter to Janssen executive Ruta Walawalkar.

The FDA granted emergency authorization for shots from four companies during the pandemic: Moderna, Pfizer, Johnson & Johnson, and Novavax. Johnson & Johnson was authorized in February 2021, giving Americans an alternative to the messenger RNA vaccines from Moderna and Pfizer.

As those vaccines have proven increasingly unable to protect against infection and severe disease, the companies have updated the composition to try to recover some of the effectiveness.

But Janssen chose not to do so, perhaps because U.S. officials limited the availability of the vaccine in 2022 after determining it causes a life-threatening combination of blood clotting and low platelet levels, a condition called thrombosis with thrombocytopenia syndrome (TTS).

Executives said in an earnings call in April that they expected no more COVID-19 vaccine sales moving forward.

“We do not anticipate material sales beyond that which were recorded in the first quarter as our contractual commitments are complete,” Joseph Wolk, the company’s chief financial officer, said on the call.

Janssen’s vaccine was an adenovirus vaccine, or based on a modified type of common virus, as opposed to using messenger RNA. Its primary series was a single shot, compared to the two doses of the other vaccines. The vaccine had become unavailable in the United States in May.

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