FDA limits J&J vaccine use to people with no other options – Boston News, Weather, Sports

The U.S. Food and Drug Administration has restricted approved use of the Janssen COVID-19 vaccine, also known as the J&J vaccine, to a small patient pool.

The initial single-dose vaccine was restricted to use in people aged 18 and over “for whom other licensed or licensed COVID-19 vaccines are not accessible or clinically appropriate, and to people aged 18 and over who are interested in obtaining the Janssen COVID vaccine decide. 19 vaccine because otherwise they would not receive a COVID-19 vaccine,” the FDA said.

The FDA made this decision after evaluating the risk of thrombocytopenia syndrome, or TTS, which can cause rare and potentially life-threatening blood clots and low platelet counts, with symptoms appearing one to two weeks after receiving the vaccine.

However, the FDA determined that the vaccine’s benefits outweigh the known and potential risks for adults who cannot obtain any other COVID-19 vaccine.

“We recognize that Janssen’s COVID-19 vaccine continues to play a role in the current pandemic response in the United States and throughout the global community. Our actions reflect our updated analysis of the risk of TTS following administration of this vaccine and restrict use of the vaccine to certain individuals,” said Dr. Peter Marks, director of the FDA Center for Biological Agent Evaluation and Research.

The vaccine was originally approved for emergency use on February 27, 2021, although use of the vaccine was suspended less than two months later after six cases of TTS were reported. The FDA and CDC lifted the pause 10 days later. Since then, a total of 15 TTS cases have been reported out of approximately 8 million doses administered.

In December 2021, after reviewing updated vaccine efficacy and safety data, the CDC’s Advisory Committee on Immunization Practices issued a preferred recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine in all adults 18 and older years from The United States.

(Copyright (c) 2022 Sunbeam Television. All rights reserved. This material may not be published, broadcast, transcribed or redistributed.)

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https://whdh.com/news/fda-limits-use-of-jj-vaccine-to-people-with-no-other-options/ FDA limits J&J vaccine use to people with no other options – Boston News, Weather, Sports

Nate Jones

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