FDA, CDC call for pause on Johnson and Johnson COVID-19 vaccine

April 13, 2021
Keith A. Reynolds

U.S. regulators is taking a pause on administering the vaccine while experts study a small number of blood clots.

The federal government is recommending a pause to the use of the Johnson and Johnson COVID-19 vaccine after a small number of recipients developed dangerous blood clots.

According to a joint statement from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) there have been six cases where women between the ages of 18 and 48 developed cerebral venous sinus thrombosis (CVST) along with low levels of blood platelets six to 13 days after receiving the Johnson and Johnson vaccination. As of April 12, more than 6.8 million shots of the single-dose vaccine had been administered in the U.S.

Complicating the issue, the anticoagulant drug heparin, which is usually used to treat clots, can be dangerous in this setting necessitating alternative treatments, the statement says.

The CDC is convening a meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14 to further review the cases and assess their significance. The FDA will review the committee’s analysis in its own investigation of the cases, according to the statement.

“Right now, these adverse events appear to be extremely rare,” the statement says. “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. 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.”

Health care providers are asked to report adverse vaccine reactions here.

In response, Johnson and Johnson says in a separate statement that they will delay the rollout of the 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 company says in the statement.