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

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The FDA mentioned in a press release that the change is being made due to the danger of a uncommon and harmful clotting situation referred to as thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.

“We have been intently monitoring the Janssen COVID-19 Vaccine and incidence of TTS following its administration and have used up to date data from our security surveillance methods to revise the EUA,” Dr. Peter Marks, director of the FDA’s Heart for Biologics Analysis and Analysis, mentioned within the assertion. “We acknowledge that the Janssen COVID-19 Vaccine nonetheless has a task within the present pandemic response in the USA and throughout the worldwide group. … In the present day’s motion demonstrates the robustness of our security surveillance methods and our dedication to making sure that science and knowledge information our actions.”

The company confirmed to CNN that the up to date authorization additionally applies to booster doses.

The FDA says it has decided that the advantages of the J&J vaccine outweigh the dangers for sure individuals. Examples of people that should still get the vaccine embody:

  • Those that had a extreme allergic response to an mRNA vaccine resembling these from Pfizer/BioNTech or Moderna
  • These with private considerations in regards to the mRNA vaccines who would stay unvaccinated with out the J&J vaccine
  • These with restricted entry to mRNA Covid-19 vaccines

As of Thursday, greater than 18.7 million doses of the J&J vaccine have been administered within the US, based on the US Facilities for Illness Management and Prevention. Of those that are thought of totally vaccinated, 7.7% bought this vaccine.

After a gathering in December, the CDC’s vaccine advisory committee issued an up to date advice on Johnson & Johnson’s vaccine, saying it makes a “preferential advice for the usage of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all individuals aged ≥18 years in the USA.”

The committee cited the identical considerations over TTS.

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

Each the CDC and the FDA beforehand really helpful a pause in the usage of this vaccine over reviews of TTS. The pause was lifted, however that transfer got here with a warning over the uncommon clotting occasions.

Johnson & Johnson mentioned in a press release on the time, “The security and well-being of the individuals who use our merchandise is our primary precedence. We’re conscious of an especially uncommon dysfunction involving individuals with blood clots together with low platelets in a small variety of people who’ve acquired our COVID-19 vaccine. … We now have been working intently with medical consultants and well being authorities, and we strongly help the open communication of this data to healthcare professionals and the general public.”

In an up to date reality sheet on the vaccine, the FDA says that 15% of TTS circumstances have been deadly.

The company’s up to date evaluation of the vaccine consists of circumstances reported to its Vaccine Adversarial Occasions Reporting System (VAERS) database via March 18. The FDA says it has confirmed 60 circumstances of TTS, together with 9 deaths.

Total, the danger of TTS is extraordinarily uncommon: about three circumstances for each million doses of vaccine administered. The best fee of TTS has been in ladies 30 to 49 years of age. About eight circumstances per 1 million doses of vaccine administered have been in ladies on this age group.

Circumstances of TTS sometimes start one or two weeks after vaccination. Signs embody shortness of breath, chest ache, leg swelling, persistent belly ache, neurological signs like complications or blurred imaginative and prescient, or purple spots just below the pores and skin referred to as petechiae past the positioning of vaccination.

The brand new warning on the vaccine’s reality sheet says “The Janssen Covid-19 vaccine may 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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