CDC, FDA call for pause in use of J&J's COVID-19 vaccine over blood clot concerns

The Centers for Disease Control and Prevention, and the Food and Drug Administration today issued a recommendation to pause the use of Johnson & Johnson (Janssen) COVID-19 vaccine out of an abundance of caution, following six reported cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

Anne Schuchat, principal deputy director of the CDC, and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, issued a joint statement, noting that as of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the United States, and that the agencies are reviewing data from six reported U.S. cases of a severe type of blood clot in individuals that developed after receiving the J&J vaccine. 

In these cases, a type of blood clot called cerebral venous sinus thrombosis, or CVST was seen in combination with low levels of blood platelets. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.

The CDC will meet with the Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. 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. Right now, these adverse events appear to be extremely rare. 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 statement said.

The statement went on to advise 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 events to the Vaccine Adverse Event Reporting System.

J&J issued a statement, which said, “The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The CDC and FDA are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.

J&J said it has been reviewing these cases with European health authorities and have made the decision 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 CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot."

J&J reiterated the CDC's and FDA's advice that people who have received its COVID-19 vaccine and develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.

Following the FDA’s request, CVS Health, Walgreens, and Wegmans began sharing their response, according to a CNBC report.

CVS Health said it has paused all Johnson & Johnson’s Covid-19 vaccines at its stores. Company spokesman Mike DeAngelis said affected customers will receive an email to notify them that their scheduled appointments are canceled. He said it will follow up with those customers to reschedule, as it continues to offer shots developed by other manufacturers.

Walgreens said in a statement that it was suspending J&J vaccines at its stores and off-site clinics, too. It said it would reach out to people with appointments and reschedule them with another shot, as supply allows. 

Wegmans said in a statement on its website that it has canceled all J&J vaccine appointments.