The Food and Drug Administration on Thursday announced it was limiting access to Johnson & Johnson’s Covid-19 vaccine because of the risk of a clotting disorder that was discovered weeks after the vaccine was first put into use in the spring of 2021.
The agency said that a review of the available data on the risk of thrombosis with thrombocytopenia — or TTS — suggested limiting access to the vaccine is warranted. The condition, though rare, can be fatal.
Going forward, the single-dose vaccine will only be available to people 18 and older who would not otherwise agree to be vaccinated or who cannot take one of the other available vaccines for medical reasons. The vaccine is made by J&J’s vaccines division, Janssen.
“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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
The prospect of a single-dose vaccine was promising when J&J announced its approach. But the level of protection the vaccine offered was not as high as the level achieved by the messenger RNA vaccines made by Moderna and by Pfizer and its partner BioNTech. And when the clotting risk was identified, demand for the vaccine fell.
Of the 577 million doses of Covid vaccine administered in the United States, only 18.7 million were the J&J vaccine.