“Our action reflects our updated risk analysis [thrombosis with thrombocytopenia syndrome] after administering this vaccine and restricting the use of the vaccine to certain individuals, “said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, in a statement.” We recognize that the Janssen COVID-19 vaccine continues to play a role in current the pandemic response in the United States and throughout 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 that they would continue to work with regulators around the world to ensure that consumers are “warned and fully informed about TTS reports”[ads1];.
“The Johnson & Johnson COVID-19 vaccine plays a crucial role in the global fight to end the COVID-19 pandemic,” said J&J. “The company continues to focus its efforts on ensuring that the 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, of which nine died. The updated prices for TTS are similar to previous prices; 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 risk factors for developing TTS, although the highest reporting rates have been among women aged 30 to 49.
What it means: A former senior FDA official, given anonymity to discuss the issue honestly, said the agency’s updated authorization for the J&J vaccine “places it in third place” compared to the other products available to U.S. adults.
While the CDC’s independent vaccine advisory panel gave a preferred recommendation of the mRNA vaccines over the J&J product in December, the FDA’s update mainly stated this preference on the vaccine’s label.
An administration official who provided 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. The FDA’s emergency standard of authorization allows the agency to appropriately market medical treatments when “there are insufficient, approved, and available alternatives” under a public health situation.
“If there were no mRNA vaccines available, this is still a very viable option. It could save lives,” the administration said. . I think you have to look globally where it is not. “
TTS is a rare side effect, but the condition can be disabling and life-threatening, said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
“It’s a fact about how serious the side effect is – not that it is extremely common in any way,” 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, those who do not have access to mRNA vaccines and those who are unwilling to receive mRNA vaccines and would otherwise remain unvaccinated.
J&J has not yet applied for a full license for its vaccine in the United States, and the former senior FDA official suggested that the product will receive even greater scrutiny if an application goes ahead.
It is “a realm of possibilities” for the vaccine, said the former official. The latest restrictions may preclude full approval, but the vaccine may also be approved along with restrictions or monitoring requirements. The FDA can give J&J the task of better identifying the subpopulations that may be predisposed to the blood coagulation 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 risk here, they say people should consider other options before coming to this one,” they said.
David Lim contributed to this report.