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

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

“Now we have intently monitored the Janssen COVID-19 vaccine and the incidence of TTS after administration and used up to date data from our security monitoring methods to evaluation the EUA,” Dr. Peter Marks, director of the FDA’s Middle for Biologics Analysis and Analysis, mentioned within the assertion. “We acknowledge that the Janssen COVID-19 vaccine continues to play a job within the present pandemic response in the US and all the world neighborhood. … In the present day’s motion demonstrates the robustness of our safety surveillance methods and our dedication to making sure make 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 its dangers for sure folks. Examples of people that can nonetheless obtain the vaccine embody:

  • Those that had a extreme allergic response to an mRNA vaccine, similar to these from Pfizer/BioNTech or Moderna
  • These with private considerations in regards to the mRNA vaccines who wouldn’t stay vaccinated with out the J&J vaccine
  • These with restricted entry to mRNA Covid-19 vaccines

Greater than 18.7 million doses of the J&J vaccine had been administered within the US on Thursday, in line with the US Facilities for Illness Management and Prevention. Of these thought-about absolutely vaccinated, 7.7% obtained this vaccine.

Following a December assembly, the CDC’s Vaccine Advisory Committee issued an up to date advice on Johnson & Johnson’s vaccine, stating that it makes a “preferential advice for the usage of mRNA COVID-19 vaccines over the adenoviral vectorized COVID-19 vaccine.” Janssen vaccine in all people aged ≥18 years in the US.”

The committee talked about the identical considerations about TTS.

Each the CDC and the FDA beforehand advisable a pause in the usage of this vaccine attributable to reviews of TTS. The pause was lifted, however that transfer got here with a warning in regards to the uncommon coagulation occasions.

Johnson & Johnson mentioned in an announcement 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 situation involving folks with blood clots together with low platelets in a small variety of people who’ve obtained our COVID-19 vaccine. … Now we have labored intently with medical specialists and well being authorities and strongly assist the open communication of this data to healthcare professionals and the general public.”

In an up to date vaccine factsheet, the FDA says 15% of TTS circumstances have been deadly.

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

Usually, the danger of TTTS is extraordinarily uncommon: about three circumstances for each million doses of vaccine administered. The best price of TTS was in ladies aged 30 to 49 years. About eight circumstances per 1 million doses of vaccine administered had been in ladies on this age group.

Circumstances of TTTS often begin one or two weeks after vaccination. Signs embody shortness of breath, chest ache, leg swelling, persistent stomach ache, neurological signs similar to headache or blurred imaginative and prescient, or crimson spots slightly below the pores and skin known as petechiae past the vaccination web site.

The brand new warning on the vaccine factsheet says: “The Janssen Covid-19 vaccine could cause thrombosis with thrombocytopenia syndrome (TTS), which might be life-threatening.”

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

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