CNN (CNN) – The US Food and Drug Administration announced Thursday that the Johnson & Johnson/Janssen Covid-19 vaccine’s emergency use authorization will be limited to people 18 and older for whom other vaccines aren’t appropriate or accessible, as well as those who choose J&J because they wouldn’t otherwise get vaccinated.
The FDA stated in a statement that the adjustment was made due to the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare and hazardous clotting disorder that can occur after getting the vaccination.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement, “We’ve been closely monitoring the Janssen COVID-19 Vaccine and the occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.” “We acknowledge that the Janssen COVID-19 Vaccine continues to play a role in the ongoing pandemic response in the United States and throughout the world….” Today’s action underscores the reliability of our safety monitoring systems and our dedication to making decisions based on science and facts.”
The amended permission also applies to booster dosages, according to the FDA.
For certain patients, the FDA has judged that the advantages of the J&J vaccination exceed the dangers. People who may still receive the vaccination include:
- Those who had a severe allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna
- Those with personal concerns about the mRNA vaccines who would remain unvaccinated without the J&J vaccine
- Those with limited access to mRNA Covid-19 vaccines
According to the US Centers for Disease Control and Prevention, more than 18.7 million doses of the J&J vaccine have been provided in the US as of Thursday. 7.7% of those who are deemed completely immunised received this vaccination.
The CDC’s vaccine advisory committee updated its recommendation on Johnson & Johnson’s vaccine after a meeting in December, saying it makes a “preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged 18 years in the United States.”
Concerns about TTS were raised by the committee.
The CDC and the FDA have previously advised against using this vaccination due to TTS incidents. The halt was lifted, but with a cautionary note about the uncommon clotting incidents.
“The safety and well-being of the people who use our products is our number one priority,” Johnson & Johnson said at the time. A very unusual illness involving blood clots and low platelets has been reported in a tiny percentage of persons who have received our COVID-19 vaccination… We’ve been collaborating extensively with medical specialists and health authorities, and we strongly believe that this knowledge should be shared with healthcare professionals and the public.
The FDA claims that 15% of TTS episodes are deadly in a revised fact sheet on the vaccination.
Cases submitted to the Vaccination Adverse Events Reporting System (VAERS) database through March 18 are included in the agency’s latest review of the vaccine. According to the FDA, 60 cases of TTS have been confirmed, with nine deaths.
TTS symptoms usually appear one or two weeks following inoculation. Shortness of breath, chest discomfort, leg swelling, persistent abdomen pain, neurological symptoms such as headaches or confused vision, or red patches just beneath the skin called petechiae beyond the immunisation site are all possible symptoms.
“The Janssen Covid-19 vaccine can induce thrombosis with thrombocytopenia syndrome (TTS), which can be life-threatening,” according to a new warning on the vaccine’s information page.
TTS is exceedingly uncommon, with just approximately three occurrences per million vaccination doses delivered. TTS has been shown to be most common in women aged 30 to 49. Women in this age range have had about eight cases per million vaccination doses delivered.