CDC and FDA urge pause in administration of J & J COVID-19 vaccine

April 14, 2021

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have recommended a brief pause in the administration of the Johnson & Johnson COVID-19 vaccine while the agencies review data involving cases of a rare and severe type of blood clot that occurred in six people after they received the vaccine.

The pause also will allow the CDC and FDA to “ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for proper recognition and management.” That’s because the type of treatment is different than what providers typically use for blood clots, the agencies said in a statement.

The six cases involved a type of blood clot called cerebral venous sinus thrombosis (CVST), which was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women 18-48 years old, with symptoms occurring 6 to 13 days after vaccination.

The agencies also stressed that the occurrence of the blood clots was rare, noting that more than 6.8 million doses of the vaccine had been administered in the United States as of April 12.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review the cases and assess their potential significance. The FDA will review that analysis as it also investigates these cases.

In a separate statement, Johnson & Johnson said it also is reviewing the cases with European health authorities and has delayed the rollout of the vaccine in Europe.

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