FDA cancels J&J COVID-19 vaccine approval.

Are you up-to-date with the latest COVID-19 vaccine news? The US Food and Drug Administration (FDA) recently revoked the authorization for the Johnson & Johnson vaccine, leaving only three vaccines available in the country.

“[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, wrote 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.

Why Was the Authorization Revoked?

The Johnson & Johnson vaccine was revoked because Janssen, the subsidiary that makes the vaccine, informed the FDA that the last lots of the vaccine purchased by the US government had expired, and there was no demand for new lots of the vaccine in the country. Janssen also stated that they did not intend to update the strain composition of the vaccine to address emerging variants.

As the effectiveness of the Moderna and Pfizer vaccines has been shown to decrease over time, the companies have updated the composition to try to recover some of the effectiveness. However, Janssen chose not to do so, perhaps because US officials limited the availability of the vaccine in 2022 after determining that 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. Janssen’s vaccine was an adenovirus vaccine, which means it used a modified type of common virus instead of messenger RNA. Its primary series was a single shot, compared with the two doses of the other vaccines. The vaccine became unavailable in the United States in May.

Emergency Authorizations

The emergency authorizations were enabled by then-Health Secretary Alex Azar, a Trump appointee who invoked the Public Readiness and Emergency Preparedness Act because of the COVID-19 pandemic in early 2020. The declaration meant vaccine manufacturers were largely shielded from liability and that regulators could authorize shots if, based on the scientific evidence, they were deemed safe and effective.

Available Vaccines

• Moderna
• Pfizer
• Novavax

Stay informed and stay safe!