Johnson & Johnson's single-dose Covid-19 vaccine has been limited for use by U.S. regulators due to a rare but serious risk of blood clots.
The stock was down 1% in premarket trading Friday to $174.99. Coming into the session, shares have risen 3.3% year to date.
The Food and Drug Administration said in a statement that although the potential benefits of the J&J (ticker: JNJ) vaccine outweigh the risks, the shot should only be given to adults aged 18 and over who are medically ineligible for a different vaccine or for those who specifically request the J&J one.
The FDA said it made the decision after conducting an updated analysis which confirmed a total of 60 cases, including nine deaths of the clotting condition known as thrombosis with thrombocytopenia syndrome, or TTS, that occurred in people one or two weeks after receiving the J&J shot.
"Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said Thursday.
J&J's vaccine, which received U.S. clearance in February 2021, is one of three shots available in the U.S. The other two are from Pfizer,(PFE) and its partner BioNTech, (BNTX), and the one made by Moderna (MRNA).
J&J said it has updated the fact sheet for its vaccine to increase awareness of the risk of TTS. "Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine," the company said in a statement .