FDA dramatically reduces use of Johnson & Johnson Covid-19 vaccine
“Our action reflects our updated analysis of the risk of [thrombosis with thrombocytopenia syndrome] after the administration of this vaccine and limits the use of the vaccine to certain people,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We recognize that the Janssen COVID-19 vaccine continues to play a role in the current pandemic response in the United States and in the global community…The agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all other vaccines.
Johnson & Johnson said in a statement it would continue to work with regulators around the world to ensure consumers “are aware and fully informed of TTS reports.”
“The Johnson & Johnson COVID-19 vaccine plays a critical role in the global fight to end the COVID-19 pandemic,” said J&J. “The company continues to focus its efforts to ensure its vaccine is available during the pandemic where people need it most.”
Background: Updated figures reported by the Vaccine Adverse Event Reporting System through March 18 showed 60 people developed TTS after receiving Johnson & Johnson’s vaccine, nine of whom died. TTS’s updated fares are similar to previous fares; The FDA said in December that about 15% of TTS cases after the J&J vaccination were fatal.
The FDA and Centers for Disease Control and Prevention have not been able to determine risk factors for developing TTS, although the highest reporting rates are among women ages 30 to 49.
What this means: A former senior FDA official, who spoke on condition of anonymity to candidly discuss the issue, said the agency’s updated clearance for the J&J vaccine ‘puts it in third place’ over other products. available for US adults.
While the CDC’s independent vaccine advisory committee made a preferential recommendation of mRNA vaccines over the J&J product in December, the FDA update essentially put that preference on the vaccine label.
An administration official on condition of anonymity to discuss the FDA action noted that if mRNA vaccines did not exist, J&J’s benefit-risk profile would justify bringing it to market. The FDA’s Emergency Use Authorization Standard allows the agency to authorize rapid commercialization of medical treatments when “there are no adequate, approved, and available alternatives” during an emergency. public health.
“If there were no mRNA vaccines available, this is still a very viable option. It can save lives,” the administration official said. “But in places where there is an abundance of mRNA vaccines, like the United States, the benefit-risk profile changes because there are other options. I think we have to look globally where there is none.
TTS is a rare side effect, but the condition can be debilitating and life-threatening, said Walid Gellad, director of the Center for Drug Policy and Prescribing at the University of Pittsburgh.
“It’s the fact of the severity of the side effect – not that it’s extremely common in any way,” he said.
And after: The J&J Covid-19 vaccine will remain available to those who have experienced severe allergic reactions to mRNA vaccines, those who cannot access mRNA vaccines, and those who do not wish to receive mRNA vaccines and would otherwise remain unvaccinated.
J&J has yet to apply for a full license for its vaccine in the United States, and the former top FDA official suggested the product would face even greater scrutiny if it goes ahead. forward with a request.
There is “an area of possibility” for the vaccine, the former official said. The latest restrictions could prevent full approval, but the vaccine could also be approved alongside restrictions or monitoring requirements. The FDA could task J&J to better identify subpopulations that may be predisposed to blood clotting, they said.
The updated authorization does not remove the J&J vaccine from the market, the former official said, meaning the FDA still sees benefit in making it available to Americans.
“But given the risks here, they say people should consider other options before embarking on this one,” they said.
David Lim contributed to this report.
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