FDA LIMITS use of Johnson & Johnson’s one-shot COVID vaccine due to risk of life-threatening blood clots
- The FDA is limiting the use of the Janssen COVID-19 vaccine
- It is now only authorizing the jab to people 18 or older for whom other COVID vaccines aren’t available or aren’t appropriate
- Those 18 and older who otherwise would not get a COVID vaccine are also authorized to use the Janssen jab
- The decision comes after an investigation revealed those who got the vaccine were at increased risk for thrombosis and thrombocytopenia syndrome
- The syndrome creates blood clots and decreases blood platelet levels
- Symptoms started in those cases just one to two weeks after receiving the jab
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.’
Johnson and Johnson’s stock price is now down 1.9 percent, to close the day at $176.76 per share.
The FDA announced Thursday it is limiting the use of the Jansen COVID-19 vaccine
Shares of Johnson and Johnson were down 1.9 percent to close the day at $176.76 per share
The FDA has been aware of the risk for TTS for about two years.
It first authorized the Johnson and Johnson vaccine for emergency use on February 27, 2021.
Since then, data shows, 18.7 million people have received the vaccine.
But on April 13, 2021, the FDA and the Centers for Disease Control announced a pause in the administration of the vaccine to investigate six reported cases of TTS and to help ensure that health care providers were aware of the risk, and could plan for proper diagnosis and management.
Later that month, following two meetings with the CDC’s Advisory Committee on Immunization Practices, the FDA and CDC lifted the pause – even as they continued to investigate the level of risk.
The agencies determined at the time that a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System, including the six reported cases, out of 8 million doses administered.