FDA withdraws approval for COVID-19 vaccine.

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 shot, 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, 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).

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 due to 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, it was deemed necessary.

Executives from Janssen have said that they do not anticipate any more COVID-19 vaccine sales moving forward, as their contractual commitments are complete. 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.

Stay Informed

It’s important to stay informed about the latest COVID-19 vaccine news. With only three vaccines available in the US, it’s crucial to understand the differences between them and make an informed decision about which one is right for you.

• Moderna
• Pfizer
• Novavax

Make sure to consult with your healthcare provider and do your own research to make the best decision for your health.

Stay safe and stay informed!