February 3, 2023

FDA puts strict limits on Johnson & Johnson Covid-19 vaccine

3 min read

The FDA said A statement This change is due to the risk of a rare and dangerous coagulation condition called thrombocytopenia syndrome (TTS) with thrombosis after receiving the vaccine.

“We are closely monitoring the presence of TTS following the Johnson COVID-19 vaccine and its administration and have used the latest information from our security surveillance system to review the EUA,” said Dr. Peter Marks, FDA. The director of the Center for Biological Diagnosis and Research, said in a statement. “We recognize that the Johnson COVID-19 vaccine still plays a role in the current epidemic response in the United States and around the world. … Today’s action is part of our commitment to strengthening our security surveillance system and Demonstrates the commitment that science and data guide our actions. “

The agency confirmed to CNN that the latest permit also applies to booster doses.

The FDA says it has determined that the benefits of the J&J vaccine far outweigh the risks for some people. Examples of people who can still get the vaccine:

  • People who had severe allergic reactions to the mRNA vaccine, such as Pfizer / Biotech or Moderna
  • Personal concerns about the MRNA vaccine that would not be available without the J&J vaccine
  • Who have limited access to the mRNA Covid-19 vaccine.

As of Thursday, more than 18.7 million doses of the J&J vaccine have been given in the United States, according to the US Centers for Disease Control and Prevention. Of those who are considered fully vaccinated, 7.7% have received the vaccine.

Following a meeting in December, the CDC’s Vaccine Advisory Committee issued an updated recommendation on the Johnson & Johnson vaccine, stating that it would “use the MRNA COVID-19 vaccine.” Therefore, Johnson recommends the Adeno Viral Vectorized COVID-19 vaccine in all individuals over the age of 18 years in the United States. “

The committee referred to the same concerns on TTS.

CDC recommends Pfizer, Moderna vaccine over J & Js

Both the CDC and the FDA have previously recommended stopping the use of the vaccine in TTS reports. The pause was lifted, but the move came with a warning about rare freezing events.

Johnson & Johnson said in a statement at the time, “The safety and well-being of those who use our products is our number one priority. A small number of people have received our COVID-19 vaccine. … We are working closely with medical professionals and health officials, and we are a healthcare professional. We strongly support the open communication of this information to individuals and the public. “

In one Updated fact sheet Regarding the vaccine, the FDA states that 15% of TTS cases are fatal.

The agency’s latest vaccine analysis includes cases reported in its Vaccine Adverse Events Reporting System (VAERS) database as of March 18. The FDA says it has confirmed 60 TTS cases, including nine deaths.

Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. The highest TTS rate is in women between the ages of 30 and 49. About eight cases out of 1 million doses of the vaccine have been found in women in this age group.

Cases of TTS usually start one or two weeks after vaccination. Symptoms include shortness of breath, chest pain, swelling in the legs, persistent abdominal pain, neurological symptoms such as headache or dizziness, or red spots under the skin beyond the vaccination site.

The new warning on the vaccine fact sheet states that “the Johnson Covid-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which can be fatal.”

CNN’s Brenda Goodman and Amanda Sally contributed to this report.

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