The Food and Drug Administration announced Thursday it is limiting the use of the Johnson & Johnson one-shot COVID-19 vaccine after an investigation revealed that those who got the jab were at increased risk of developing life-threatening blood clots.
It is now only authorizing the brand’s COVID vaccine to people 18 or older for whom other authorized or approved vaccines are not accessible or clinically appropriate, and to those 18 years or older who otherwise would not get a COVID vaccine.
The decision comes following an investigation into reports of thrombosis and thrombocytopenia syndrome (TTS) – 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.
They have found 60 confirmed cases, including nine fatal cases, through March 18, 2022. It has determined that the reporting rate of TTS is 3.23 per million doses of the vaccine administered, and the reporting rate of TTS deaths is 0.48 per million doss of vaccines administered.
Symptoms began in the confirmed cases about one to two weeks after the individual received the 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,’ Peter Marks, the director of FDA’s Center for Biologic Evaluation and Research said in a statement.
‘We’ve been closely monitoring the Janssen COVID-19 vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the [Emergency Use Authorization,’ he continued.
‘The agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all other vaccines and, as has been the case throughout the pandemic, will thoroughly evaluate new safety information.’
The FDA announced Thursday it is limiting the use of the Jansen COVID-19 vaccine
