FDA Recommends Pause In Use Of Johnson & Johnson's COVID-19 Vaccine On Blood Clot Concerns

The Food and Drug Administration and the Centers for Disease Control and Prevention are recommending a pause in the use of Johnson & Johnson's JNJ COVID-19 vaccine, the agencies said in a Tuesday statement, sending the drugmaker's stock lower in premarket trading. 

What Happened: Over 6.8 million doses of the vaccine have been administered in the U.S., and there have been reports of six cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

These adverse events are rare, and the treatment for this specific type of clot is different from what is typically used for clots, the agencies said.

The decision is being made out of an abundance of caution.

In late February, J&J's single-shot vaccine became the third coronavirus vaccine to receive FDA emergency use authorization.

Related Link: The Week Ahead In Biotech (April 11-17): Avenue Therapeutics FDA Decision and Conference Presentations In The Spotlight

"Vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously," the FDA said.

What's Next: The statement is a recommendation to practitioners, and the federal government is expected to pause administration of Johnson & Johnson vaccines at federally run sites as a result, according to The New York Times

State officials are likely to follow suit, the report said. 

The CDC plans to convene a meeting of the Advisory Committee on Immunization Practices Wednesday to further review these cases and assess the potential significance.

The FDA said it will review that analysis as it investigates the blood clot cases.

The FDA has scheduled an audio press conference at 10 a.m. ET Tuesday to update the public on the development.

JNJ Price Action: In premarket trading Tuesday, J&J shares were down 2.57% to $157.48. 

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Posted In: CoronavirusCovid-19vaccineBiotechNewsHealth CareFDAGeneral

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