“Our action reflects our up-to-date risk analysis of [thrombosis with thrombocytopenia syndrome] after administering this vaccine and restricts the use of the vaccine to certain individuals, “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 still plays a role in the current pandemic response in the United States and across the global community … The agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all others. vaccines. “
Background: Updated data reported through the Vaccine Adverse Event Reporting System through March 18 showed that 60 people developed TTS after receiving the Johnson & Johnson stroke, nine of whom died. The updated rates of TTS are similar to the previous rates; 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 not been able to determine the risk factors for developing TTS, although the highest reporting rates have been among women between the ages of 30 and 49.
What does it mean: A former senior FDA official, who was granted anonymity to candidly discuss the matter, said the agency’s updated clearance for the J&J vaccine “puts it third” over other products available for adults. Americans.
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 enshrined that preference on the vaccine label.
An administration official granted anonymity to discuss the FDA’s action noted that if mRNA vaccines did not exist, J&J’s benefit-risk profile would justify having it on the market. The FDA’s Emergency Use Authorization Standard allows the agency to enable the timely commercialization of medical treatments when “there are no suitable, approved, and available alternatives” during a public health emergency.
“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 you 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 Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
“It’s the fact of how severe the side effect is, not that it’s extremely common in any way,” he said.
What’s next: The J&J Covid-19 vaccine will remain available for those who have experienced severe allergic reactions to mRNA vaccines, those who cannot access mRNA vaccines, and those who are unwilling 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 senior FDA official suggested the product will receive even greater scrutiny if it goes ahead with an application.
There is “a realm of possibility” for the vaccine, the former official said. The latest restrictions may preclude full approval, but the vaccine may also receive approval along with restrictions or monitoring requirements. The FDA could instruct J&J to better identify subpopulations that may be predisposed to the blood-clotting condition, they said.
The updated authorization does not remove the J&J vaccine from the market, the former official said, meaning the FDA still sees an advantage in making it available to Americans.
“But given the risks here, they are saying that people should consider other options before moving on to this one,” they said.
David Lim contributed to this report.