With an updated analysis, evaluation, and investigation of reported cases in its hands, the U.S. Food and Drug Administration (FDA) has decided to limit the emergency use authorization of the Janssen (Johnson & Johnson) COVID-19 vaccine to two demographic groups.
Those groups include people 18 and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and individuals 18 and older who choose to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
The FDA said its decision is based on the determination that the Johnson & Johnson COVID-19 vaccine comes with a higher risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but serious condition that produces blood clots.
Where does this leave Johnson & Johnson?
This doesn’t mean the end for Johnson & Johnson’s participation in the vaccine pipeline.
“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. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., Ph.D., and director of the FDA’s Center for Biologics Evaluation and Research.
Marks said the FDA will continue to monitor the safety of the Janssen vaccine – as it will all other vaccines – and will thoroughly evaluate any new safety information that emerges.
Johnson & Johnson said it has updated its U.S. COVID-19 vaccine fact sheet in an effort to make the public aware of the risk of thrombosis with thrombocytopenia syndrome. However, the company reinforced its belief that the benefits of its vaccine outweigh the risks.
“Our number one priority is the safety and well-being of those who use the Johnson & Johnson COVID-19 vaccine,” the company said in a press release. “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”
Company officials stated that they will continue to collaborate with health authorities, regulators, and vaccine recipients to make sure everyone is kept up to date about reports of TTS.