FDA Revokes Authorization for COVID-19 Vaccine

FDA Revokes Authorization for COVID-19 Vaccine
A sign for the Food And Drug Administration (FDA) outside of its headquarters in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)

Just three different 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).

Janssen did not respond to a request for comment.

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.

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 “reasonable to believe” that the vaccine “may be effective” in preventing or treating COVID-19.

While the Moderna and Pfizer vaccines were later approved, or granted licensure, by the FDA, the Johnson & Johnson and Novavax vaccines have remained available under emergency authorization.

As of May 10, of approximately 665 million COVID-19 vaccine doses administered in the United States, just 19 million were from Johnson & Johnson, according to data reported by the U.S. Centers for Disease Control and Prevention.

Another 12 million Johnson & Johnson vaccines had been delivered to jurisdictions and not administered, forcing health care workers to throw them out.

The U.S. government agreed in 2020 to purchase 100 million doses of the Johnson & Johnson vaccine for over $1 billion, through the Trump administration’s Operation Warp Speed program. Manufacturing delays and, later, concerns about TTS led to fewer doses being delivered.

Health Secretary Xavier Becerra, a Biden appointee, updated the Public Readiness and Emergency Preparedness Act most recently on May 11, extending liability protections for those who manufacture, distribute, and administer vaccines available under emergency authorization. The extension was made through Dec. 31, 2024.

Becerra said that while the COVID-19 public health emergency had ended, “I have determined there is a credible risk that COVID–19 may in the future constitute such an emergency and am thus amending this declaration to prepare for and mitigate that risk.”

From The Epoch Times

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