FDA Enforces Strict Limits On Johnson & Johnson COVID-19 Vaccine
Coronavirus

FDA Enforces Strict Limits On Johnson & Johnson COVID-19 Vaccine

On Thursday, the FDA announced that it’s limiting the emergency use authorization of the Johnson & Johnson/Janssen COVID-19 vaccine for people 18 and older. They said in a statement that the new changes were made because of the risk of rare and dangerous clotting. The condition called thrombosis with thrombocytopenia syndrome (TTS) can occur after receiving the vaccine.

“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 EUA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “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…Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

The agency confirmed that the new authorization also applies to the booster doses.

Groups Of People Who May Still Get the Johnson & Johnson Vaccine

The FDA released the following groups may still get the vaccine:

  • 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
Related:
FDA Authorizes Second Booster Shot For Ages 50 And Up

According to the CDC, more than 18 million doses of the Johnson & Johnson vaccine have been administered in the U.S. However, of the fully vaccinated, only 7.7% received this vaccine. In December, the CDC’s vaccine advisory committee issued an updated recommendation on the vaccine. After a meeting in December, the CDC’s vaccine advisory committee issued an updated recommendation on Johnson & Johnson’s vaccine, 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.” They cited the same concerns over the blood clotting condition.

In the past, the CDC and FDA’s recommended a pause on the vaccine due to reports of TTS. Eventually, the pause was lifted, but a new warning of TTS was placed.

Johnson & Johnson released the following statement at the time:

“The safety and well-being of the people who use our products is our number one priority. We are aware of a rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine…We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.”

Related:
The U.S. COVID-19 Death Toll Reaches 900,000

TTS Percentages

The FDA claims that 15% of TTS cases have been fatal. Overall, the risk of TTS is scarce. There are about three cases for every million doses of the vaccine administered. The highest rate of TTS has been in women ages 30 to 49. About eight cases per million doses of vaccine administered have been in women in this specific age group. 

TTS has typically begun one or two weeks after vaccination. Symptoms include:

  • Shortness of breath
  • Chest pain
  • Leg swelling
  • Persistent abdominal pain
  • Neurological symptoms – headaches, blurred visions, etc.
  • Petechiae (red spots under the skin)

Like before, another updated warning will go on the vaccine’s fact sheet, “The Janssen Covid-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening.”  

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