The FDA has decided to limit the use of the COVID-19 vaccine to individuals at least 18 years old who cannot receive other authorized or approved COVID-19 vaccines. The agency also will authorize its use for individuals who would “otherwise not receive a COVID-19 vaccine.”
FDA came to the conclusion after reviewing data related to a rare clotting disorder known as thrombosis with thrombocytopenia syndrome (TTS) in a number of Janssen vaccine recipients roughly one or two weeks after vaccination.
FDA has added a warning describing the risk of TTS to the fact sheet for healthcare providers administering the Janssen vaccine.
“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 Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.The FDA temporarily suspended the Janssen vaccine’s use on April 13, 2021, after receiving TTS reports after authorizing its use on February 27 of that same year. After lifting the pause later in April 2021, FDA recommended mRNA vaccines over Janssen’s adenovirus-vectored vaccine in December 2021.
The European Medicines Agency uncovered a possible link between the AstraZeneca Vaxzevria COVID-19 vaccine and rare blood clots last year.
The AstraZeneca COVID-19 vaccine has not been authorized in the U.S.
The AstraZeneca and Janssen vaccines both rely on a viral-vector platform, whereas the vaccines from Pfizer and Moderna are mRNA-based.
To date, U.S. authorities have identified 60 cases of TTS, including nine that were fatal.
FDA concluded that there were 3.23 reports of TTS per million vaccine doses administered.
Janssen notes that current data indicate that the vaccine maintains a favorable benefit-risk profile given its ability to protect against COVID-19.
Unlike the FDA-approved COVID-19 vaccines from Pfizer and Moderna, the Janssen vaccine remains only available under emergency use authorization.
In early afternoon trading, JNJ shares were down about 1% to $175.38.