FDA sets strict limits for Johnson & Johnson Covid-19 vaccine

The FDA said in a statement that the change is being made because of the risk of a rare and dangerous coagulation condition called thrombosis with thrombocytopenic syndrome (TTS) after receiving the vaccine.

“We have been closely monitoring the Janssen COVID-19 vaccine and the occurrence of TTS after administration and have used up-to-date information from our pharmacovigilance systems to review the EUA,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. in the statement. “We recognize that the Janssen COVID-19 vaccine continues to play a role in the current pandemic response in the United States and across the global community … Today̵[ads1]7;s action demonstrates the robustness of our security monitoring system and our commitment to ensuring that science and data govern our actions. . “

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

The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks to certain people. Examples of people who can still get the vaccine 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

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

Following a meeting in December, the CDC’s Advisory Committee on Vaccines issued an updated recommendation on Johnson & Johnson’s vaccine, stating that it provides a “preferred 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. “

The Committee cited the same concerns for TTS.

The CDC recommends Pfizer, Moderna vaccines over J & J's

Both the CDC and the FDA previously recommended a halt in the use of this vaccine over reports of TTS. The pause was canceled, but that move came with a warning about the rare coagulation events.

Johnson & Johnson said in a 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 an extremely rare disorder that involves people with blood clots combined with low platelets in a small number of individuals. has received our COVID-19 vaccine … We have worked closely with medical experts and health authorities, and we strongly support open communication of this information to healthcare professionals and the general public. “

In an updated fact sheet about the vaccine, the FDA says that 15% of TTS cases have been fatal.

The agency’s updated analysis of the vaccine includes cases reported to the Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says they have confirmed 60 cases of TTS, including nine deaths.

Overall, the risk of TTS is extremely rare: approximately three cases for every million doses of vaccine administered. The highest frequency of TTS has been in women aged 30 to 49 years. Approximately eight cases per 1 million doses of vaccine administered have been in women in this age group.

Cases of TTS usually begin 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 blurred vision, or red spots just under the skin called petechiae outside the vaccination site.

The new warning on the vaccine’s fact sheet states “The Janssen Covid-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which can be life threatening.”

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

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