“Even after it has completed its clinical trials, a vaccine still must be monitored in the real world,” she said. Yale Medicine infectious diseases specialist Jaimie Meyer, MD, MS, said the pause on the Johnson & Johnson vaccine was not an unusual step. All of these cases were reported to the Vaccine Adverse Events Reporting System (VAERS), a national early reporting warning system to detect safety problems with U.S.-licensed vaccines. But blood clots became a concern starting in April 2021, when the government put a pause on the J&J shot after six women who received it developed rare blood clots-and one died. While there are three vaccines authorized for use in the United States, there was hope that Johnson & Johnson’s would be an important one, partly because experts believed its one-shot dose could help with those who didn’t have access to mRNA vaccines. In terms of timing, all of these cases were identified within two weeks of the person receiving the vaccine. If you got the J&J shot, your risk of TTS would be expected to be low.
The FDA, which has updated its fact sheet on the shot, still says that the risks of the virus are greater than the risks of the J&J vaccine. The risk appears to be greatest-1 in 100,000-in women ages 30 to 49. The analysis was based on suspected cases of TTS reported to the government’s Vaccine Adverse Event Reporting System (VAERS). The clotting disorder is called thrombosis with thrombocytopenia syndrome (TTS), and it is rare-an updated safety analysis showed that, as of March 18, out of more than 18 million people who got J&J, 60 cases of TTS were reported and nine people died. The latest decision restricts access of the vaccine to adults 18 and older who specifically request the J&J shot or who cannot have the other available vaccines for medical reasons. This was five months after the Centers for Disease Control and Prevention (CDC) endorsed a decision to give a preferential recommendation to the Pfizer-BioNTech and Moderna vaccines. In May, the Food and Drug Administration (FDA) put new restrictions on who can get the J&J vaccine, based on a fresh review of data on the life-threatening blood clots that have been associated with the vaccine. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information.Ĭoncern has continued to grow over a small, but growing number of cases of a rare, but serious blood clotting disorders associated with the Johnson & Johnson coronavirus vaccine. Information in this article was accurate at the time of original publication. In May 2023, existing doses of the J&J vaccine expired and the Centers for Disease Control & Prevention (CDC) directed providers to dispose of any that had gone unused.
Note: The Johnson & Johnson (Janssen) COVID-19 vaccine is no longer available in the U.S.
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