The use of Johnson and Johnson’s COVID-19 vaccine, also known as Janssen, has been limited to “certain individuals” over rare blood clot risks, the U.S. Food and Drug Administration announced Thursday, May 5.
It’s now limited to those 18 and older “for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate,” the FDA’s statement said. Additionally, those 18 and older can opt to get the J&J shot if “they would otherwise not receive a COVID-19 vaccine.”
Janssen Pharmaceuticals said “our number one priority is the safety and well-being of those who use the Johnson & Johnson COVID-19 vaccine,” in a statement provided to McClatchy News and noted its fact sheet on the single-dose shot has been updated in coordination with the FDA.
“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, warrants limiting the authorized use of the vaccine,” the FDA said.
The agency noted this determination followed an analysis and investigation into blood clot cases that have occurred in people after receiving the J&J vaccine.
The numbers
Roughly “15% of TTS cases have been fatal,” according to a fact sheet updated by the FDA and J&J.
In the U.S, over 18 million vaccine doses of J&J have been given to date, according to the CDC, CNN reported.
About eight TTS cases have occurred for every one million J&J vaccine doses administered, the fact sheet said. Most of these cases were in women ages 30-49.
Out of 17 million people who got the J&J shot in the U.S. through April 2021, a total of 54 TTS cases were identified, Yale Medicine reported in December. At the time, at least nine people died after receiving the shot and 36 people had to be treated in an intensive care unit.
‘Favorable benefit-risk’
“Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine,” J&J’s statement said.
The company noted that it is continuing to “collaborate with health authorities and regulators around the world to ensure healthcare professionals and individuals are warned and fully informed about reports of TTS.”
“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,” Dr. Peter Marks, the 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 occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the emergency-use authorization," Marks added.
What now?
Americans can get the Pfizer or Moderna COVID-19 vaccines, which both require two doses.
They can also get the J&J vaccine if they don’t want to get any other vaccine.
The Pfizer vaccine is approved for individuals 12 years and older; and there’s a version available for children 5 to 11 years old as well.
The Moderna vaccine is approved for adults 18 years and older.
Both Moderna and Pfizer vaccines also have booster shots available for individuals who have completed both shots, and a second booster shot is recommended for those 50 years or older or immunocompromised.
The first COVID-19 booster is recommended after five months, according to the CDC, and a second booster is encouraged after four months.
The updated FDA authorization for the J&J shot also applies to booster doses, CNN reported.
No COVID vaccine has been approved for children younger than 5 years old.
