FDA Calls for Pause on Johnson & Johnson COVID Vaccine

The Food and Drug Administration requested a brief pause of the use of Johnson & Johnson’s COVID-19 vaccine, citing 6 cases of rare blood clots among the 7 million doses administered.

The Food and Drug Administration requested a brief pause of the use of Johnson & Johnson’s COVID-19 vaccine, citing cases of a rare blood clot disorder that six people developed within two weeks of receiving the shot.

Acting FDA Commissioner Janet Woodcock said Tuesday that she expects the pause to only last “a matter of days,” as health officials investigate the data surrounding the “extremely rare” blood clots.

The FDA’s recommendation was issued “out of an abundance of caution” and to prepare health providers to recognize and treat patients appropriately, since these types of blood clots require a different kind of treatment.

As of Monday, nearly 7 million doses of the J&J vaccine have been administered in the United States. The CDC and FDA are reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

New York State Health Commissioner Howard Zucker said “New York State will follow the CDC and FDA recommendation and pause the use of the Johnson & Johnson vaccine statewide immediately today while these health and safety agencies evaluate next steps.”

According to Governor Andrew Cuomo, New Yorkers who signed up for appointments to receive the Jonhson & Johnson at state-run vaccination centers will instead be able to get the Pfizer vaccine.

“The CDC will convene a meeting of the Advisory Committee to further review these cases and assess their potential significance,” the FDA wrote. “Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”