The U.S. Food and Drug Administration has announced that it will be limiting the emergency use authorization of the Johnson & Johnson COVID-19 vaccine because of a “rare and dangerous” blood clotting condition. The FDA says the vaccine will be only authorizing the Johnson & Johnson COVID vaccine to people 18 or older when other approved vaccines are not accessible.
In a statement, the FDA said, “We’ve been closely monitoring the Janssen [Johnson & Johnson] COVID-19 vaccine and occurrence of Thrombosis Thrombocytopenia Syndrome (TTS) following its administration and have used updated information from our safety surveillance systems to revise the EUA. We recognize that the Janssen [Johnson & Johnson] COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community. Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”
The FDA says they have identified sixty cases (nine fatal) of people experiencing blood clots TTS. They claim that the rate of TTS is 3.23 per million doses of vaccines administered.
Thrombosis and Thrombocytopenia syndrome (TTS) is a rare and potentially life-threatening syndrome that creates blood clots and creates low levels of blood platelets – from those who have received the vaccine.
Johnson & Johnson has not released a statement regarding the news. This story is developing, more to come.
Official FDA statement attached (3 pages)