FDA recommends pause in use of Johnson & Johnson COVID-19 vaccine

Washington [US], April 13 : The US Centers of Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have recommended "pause" in the use of Johnson and Johnson COVID-19 vaccine "out of an abundance of caution" over six reported cases in the US of a "rare and severe" type of blood clot.
In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.
The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.
All six cases occurred among women ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to Dr Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
"CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance," the statement said.
"FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot," it added.
On February 27, The FDA issued Emergency Use Authorization (EUA) for single-dose Johnson & Johnson COVID-19 vaccine.