“Our actions reflect our updated risk analysis [thrombosis with thrombocytopenia syndrome] after the introduction of this vaccine and restricts the use of the vaccine to certain individuals, “- Peter Marx, director of the Center for Evaluation and Research of Biological Substances of the FDA, the statement said. “We recognize that the Janssen COVID-19 vaccine continues to play a role in the ongoing response to the pandemic in the United States and around the world … The Agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all other vaccines.”

Background: Updated figures reported through the vaccine’s adverse event reporting system up to March 18 showed that 60 people developed TTS after vaccination with Johnson & Johnson, nine of whom died. The updated TTS rates are similar to previous bets; The FDA said in December that about 15 percent of TTS cases after J&J vaccination were fatal.

The FDA and the Centers for Disease Control and Prevention have been unable to identify risk factors for TTS, although the highest number of reports was among women aged 30 to 49 years.

What it means: A former senior FDA official, who was given anonymity for an open discussion of the issue, said the agency’s updated permission for the J&J vaccine “puts it in third place” compared to other products available to US adults.

Although the independent CDC Vaccine Advisory Group recommended mRNA vaccines over the J&J product in December, the FDA update essentially enshrined this advantage on the vaccine label.

A spokesman for the administration, who was given anonymity to discuss the FDA’s actions, said that if mRNA vaccines did not exist, the risk and benefit profile of J&J would justify their availability on the market. The FDA’s Emergency Permit Standard allows the agency to allow appropriate marketing of medical treatments when “there are no adequate, approved, and available alternatives” during a health emergency.

“If there were no mRNA vaccines, this is still a very viable option. It can save lives, ”a spokesman for the administration said. “But in places where there are large numbers of mRNA vaccines, such as the United States, the risk profile changes because there are other options. I think we need to look globally where there is none. “

TTS is a rare side effect, but the condition can be debilitating and life-threatening, said Walid Gelad, director of the Center for Pharmaceutical Policy and Prescription at the University of Pittsburgh.

“The question of how serious the side effect is is not that it is extremely common in any case,” he said.

What’s next: The J&J Covid-19 vaccine will remain available to those who have experienced severe allergic reactions to mRNA vaccines, to those who cannot access mRNA vaccines, and to those who do not wish to receive mRNA vaccines and otherwise remain would be unvaccinated.

J&J has not yet applied for a full license for its vaccine in the U.S., and a former senior FDA spokesman has suggested that the product will receive even more attention if it moves forward with the application.

The former official said there was a “kingdom of opportunity” for the vaccine. Recent restrictions may prevent full approval, but the vaccine may also receive approval along with restrictions or monitoring requirements. The FDA may set the task of J&J to better identify subpopulations that may be prone to blood clotting, they said.

The updated permit does not remove the J&J vaccine from the market, a former official said, meaning the FDA still sees benefits in making it available to Americans.

“But given the risks, they say people need to consider other options before embarking on it,” they said.

David Lim contributed to this report.


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