Following an investigation that revealed an increased risk of a rare, potentially fatal disease that lowers blood platelets and forms blood clots, the FDA announced Thursday that it will limit the use of Johnson & Johnson’s one-shot Janssen COVID-19 vaccine to select portions of the population.
“Today, the US. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine,” the FDA statement reads.
The restriction is in response to “the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine.”
The Janssen jab was authorized for emergency use in late February 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention (CDC) recommended a pause in the administration of the vaccine after six reported cases of TTS were reported to the Vaccine Adverse Event Reporting System (VAERS).
Ten days later, “following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the pause was lifted. At that point, the agencies confirmed a total of 15 cases of TTS were reported to VAERS, “out of approximately 8 million doses administered”
The investigation continued, and by December 2021, the ACIP announced that mRNA vaccines were to be preferred over the Jannsen vax “in all person 18 years of age and older in the United States.”
However, the ACIP recommended — and the CDC agreed — that the Jannsen shot “may be considered in some situations: when a person has a contraindication to receipt of mRNA COVID-19 vaccines, when a person would otherwise remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines, and when a person wants to receive the Janssen COVID-19 Vaccine despite the safety concerns identified.”
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As of March 18, 2022, 60 confirmed cases of TTS have been identified by the FDA and the CDC, including nine fatal cases.
“The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.
The FDA admits that “the factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown.”
The FDA also warns that those who do contract TTS “may rapidly deteriorate, despite prompt diagnosis and treatment” and that TTS “has a high death rate.”
Despite that, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, says there is still a place for the Jannsen vaccine in the world’s response to the pandemic.
“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,” Marks said in the statement. “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.”
“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” Marks continued. “We’ve been closely monitoring the Jannsen COVID-19 Vaccine and occurrences of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA [Emergency Use Authorization]. 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.”
Still, it seems social media has yet to catch up with the science.
On Twitter, the FDA announcement of the Jannsen restriction was flagged by those oh-so-reliable fact-checkers as “misleading.”
So, @Twitter literally flagging reports about the FDA announcement limiting Johnson & Johnson vaccines as misinformation is hilarious and perfectly captures the current zeitgeist pic.twitter.com/iyjOpubu2T
— Andrew Thornebrooke (@AThornebrooke) May 5, 2022
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