'Out of an abundance of caution': FDA requests temporary pause for Johnson & Johnson vaccine amid rare blood clot issue

13 April 2021

A person, wearing gloves and a surgical mask, handles a COVID-19 Vaccine vial and syringe.

The Food and Drug Administration (FDA) is asking states to temporarily halt usage of the Johnson & Johnson COVID vaccine. According to CNBC, the FDA made the request "out of an abundance of caution" after several vaccine recipients in the United States developed rare blood clots.

On Tuesday, the FDA released a joint statement with the Centers for Disease Control and Prevention (CDC) raising awareness about the vaccine complications while noting the importance of COVID vaccine safety.

"COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously," the FDA said in its statement with the CDC.

The statement went on to issue a warning to vaccine recipients who have experienced any of the symptoms mentioned in the statement. "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider," the FDA and CDC said.

With the release of the statement, federal health regulators also noted that the CDC would reconvene with the Advisory Committee on Immunization Practices on Wednesday, April 14.

"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," the statement added.

Johnson & Johnson has also released a statement following the FDA and CDC announcement.

"We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines," the statement read. "At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine."

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