The US Centers for Disease Control and Prevention and the US Food and Drug Administration recommend that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.
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 between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement on Tuesday from 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 recommend 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.”
Johnson & Johnson stated on Tuesday noting that the company has decided to “proactively delay the rollout” of its 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,” the statement said in part.
The AstraZeneca vaccine isn’t in use in the United States but has been authorized in more than 70 countries. The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as “infrequent side effects” of the AstraZeneca vaccine. While advising the public to look out for the signs of clots, the regulators said the shot’s benefits were still worth the risk.
