FDA, CDC Urges Pause of J&J COVID Vaccine

This story was updated at 1:25 p.m.

April 13, 2021 — The FDA and CDC on Tuesday recommended that use of the Johnson & Johnson COVID-19 be paused after reports of blood clots in patients receiving the shot, the FDA and CDC announced Tuesday.

In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.

The pause is intended to give time to alert the public to this “very rare” condition, experts said during a joint CDC-FDA media briefing Tuesday.

“It was clear to us that we needed to alert the public,” Janet Woodcock, MD, acting FDA commissioner said. The move also will allow “time for the healthcare community to learn what they need to know about how to diagnose, treat and report” any additional cases.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to review the cases.

Of the six reported cases linked to the Johnson and Johnson vaccine, all are in women between the ages of 18 and 48 years, one woman died and another ended up in critical condition.

“I know the information today will be very concerning to Americans who have already received the Johnson and Johnson vaccine,” said Anne Schuchat, MD, principal deputy director at the CDC.

“For people who got the vaccine more than one month ago, the risk is very low at this time,” she added. “For people who recently got the vaccine, in the last couple of weeks, look for symptoms.”

Headache, leg pain, abdominal pain and shortness of breath were among the reported symptoms. All six cases arose within 6 to 13 days of receipt of the Johnson and Johnson vaccine.

April 13, 2021 — The FDA and CDC on Tuesday recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the FDA and CDC announced Tuesday.

In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to review the cases.

https://www.webmd.com/news/default.html

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