US FDA limits use of Johnson & Johnson COVID-19 vaccine over Blood Clot Risk - Today Quizzes

US FDA limits use of Johnson & Johnson COVID-19 vaccine over Blood Clot Risk



The US Food and Drug Administration (FDA) limited the authorized use of the Johnson & Johnson COVID-19 vaccine on May 5, 2022 saying that it can cause “life-threatening blood clots”. The J&J vaccine has been administered to more than 18 million people in the United States.

The US FDA took the decision after conducting an updated analysis, evaluation and investigation of reported cases. The FDA determined that the risk of thrombosis with thrombocytopenia syndrome (TTS) warrants limiting the authorized use of the vaccine.

Peter Marks, director of the FDA’s Center for Biologics said, “Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

Read: Bharat Biotech asked to provide additional data on Covaxin for use on children below 12 years

What is thrombosis with thrombocytopenia syndrome (TTS)?

The thrombosis with thrombocytopenia syndrome is a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets. The symptoms of the syndrome occur approximately one to two weeks following administration of the Janssen COVID-19 vaccine.

The US FDA has been closely monitoring the Janssen COVID-19 vaccine and the occurrence of the rare syndrome following its administration and used the updated information from its safety surveillance systems to revise the authorization and limit the vaccine’s use.

US FDA limits J&J COVID-19 Vaccine Use: Key Points

  • The US FDA has restricted the authorized use of the Janssen COVID-19 Vaccine to individuals above 18 years for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate.
  • It can also be administered to individuals 18 years of age and above who choose to receive the J&J Covid-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
  • The FDA has determined that the known and potential benefits of the COVID-19 vaccine outweigh the known and potential risks for individuals aged 18 years or above for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate.
  • However, the fact sheet for healthcare providers administering the vaccine has been updated with a warning statement for prominence which summarizes information on the risk for TTS. 
  • The Fact Sheet for Recipients and Caregivers has been updated with information on the risk of blood clots with low levels of blood platelets.

FDA’s Center for Biologics Director Peter Marks noted, “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. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

How many TTS cases were reported in US?

The FDA and the US Centers for Disease Control and Prevention (CDC) have identified 60 confirmed cases of thrombocytopenia syndrome, including nine fatal ones through March 18, 2022. 

The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

Read: What is Paxlovid Pill that WHO ‘strongly recommends’ against COVID-19?

How to identify TTS?

The symptoms of thrombocytopenia syndrome appear typically one or two weeks after vaccination. The main symptoms include shortness of breath, persistent abdominal pain, chest pain, leg swelling and neurological symptoms like headaches, blurred vision or red spots under the skin called petechiae beyond the vaccination site.

Background

The Johnson and Johnson COVID-19 vaccine was authorised for emergency use in February 2021. The CDC’s vaccine advisory committee had issued an updated recommendation on Johnson & Johnson’s vaccine in December 2021, 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 and above in the United States.

Read Also: Johnson & Johnson’s single dose vaccine approved in India for emergency use



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