“Our action reflects our updated analysis of the risk of [thrombosis with thrombocytopenia syndrome] following administration of this vaccine and limits 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 has 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 other vaccines.”
Johnson & Johnson said in a statement it will continue to work with regulators worldwide to ensure consumers “are warned and fully informed about reports of TTS.”
“The Johnson & Johnson COVID-19 vaccine plays a crucial role in the global fight to end the COVID-19 pandemic,” J&J said. “The Company continues to focus its efforts on ensuring its vaccine is available during the pandemic where people are most in need.”
Background: Updated figures reported through the Vaccine Adverse Event Reporting System through March 18 showed that 60 people developed TTS after receiving the Johnson & Johnson shot, nine of whom died. The updated rates of TTS are similar to previous rates; FDA said in December that about 15 percent of TTS cases post-J&J vaccination were fatal.
FDA and the Centers for Disease Control and Prevention have not been able to determine risk factors for developing TTS, though the highest reporting rates have been among women ages 30 to 49.
What it means: A former senior FDA official, granted anonymity to discuss the issue candidly, said the agency’s updated authorization for the J&J vaccine “puts it in third place” compared to the other products available to U.S. adults.
While the CDC’s independent vaccine advisory panel made a preferential recommendation of the mRNA vaccines over the J&J product in December, FDA’s update essentially enshrined that preference on the vaccine’s label.
An administration official granted anonymity to discuss the FDA action noted that if mRNA vaccines did not exist, the J&J risk benefit profile would justify having it on the market. FDA’s emergency use authorization standard lets the agency allow expedient marketing of medical treatments when “there are no adequate, 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 U.S., the benefit risk profile changes because there’s other options. I think you have to look globally where there is not.”
TTS is a rare side effect, but the condition can be debilitating and life-threatening, said Walid Gellad, director for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
“It’s the fact of how serious 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 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 U.S., and the former senior FDA official suggested the product will receive even greater scrutiny should it move forward with an application.
There’s “a realm of possibilities” for the vaccine, the former official said. The latest restrictions could preclude full approval, but the vaccine also could receive approval alongside restrictions or monitoring requirements. FDA may task J&J with better identifying the subpopulations who 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 FDA still sees a benefit in making it available to Americans.
“But given the risks here, they’re saying people should consider other options before they get down to this one,” they said.
David Lim contributed to this report.