FDA, CDC Recommend Halting J&J COVID-19 Vaccine ‘Out of an Abundance of Caution’
The Food and Drug Administration and the Centers for Disease Control have announced they are recommending a pause in the use of Johnson & Johnson’s single-shot Janssen COVID-19 Vaccine “out of an abundance of caution,” following reports of blood clots, according to a joint statement.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance, and the 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,” Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the joint statement.
As of April 12, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S.
The issues under review involve six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.
“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination,” according to the statement.
Johnson & Johnson said in a statement today that it is aware of the “extremely rare disorder” and that “the safety and well-being of the people who use our products is our number one priority.”
“In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe. We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” according to the statement.
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