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J&J vaccine paused due to risk of rare blood clots

by Judy Reed

The CDC and FDA announced on Tuesday, April 13, that they are recommending a “pause” on administering the one-dose Johnson & Johnson vaccine for COVID-19 due to the risk of a rare and severe type of blood clot.

On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. In a joint press release and a media briefing on April 13, the CDC and FDA said they have recommended a pause on administering the vaccine because they are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot that occurred in individuals after they received the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. One case was fatal, and one person is still in critical condition.

Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

According to Peter Marks, M.D., Ph.D., Director FDA Center for Biologics Evaluation and Research, this type of blood clot (CVST) usually only occurs in 2 to 14 people per million in those with a normal blood platelet count. “The notable thing here is their occurrence together (CVST and low platelet count). It is similar to what has been seen in Europe in another vaccine (Astra-Zeneca),” he said.

Marks said they have not seen the same problem with the Pfizer or Moderna vaccine, which has had 180 million doses administered.

For clarification, it is a recommended pause and not a mandate. They explained that if a provider and patient have a conversation about the risks, and then agree that the J&J vaccination is the best fit, the provider may still administer it.

The CDC and FDA emphasized that the reason for the pause is to give them time to review the data and to get the health community prepared to diagnose and treat patients with the correct protocol.

“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. 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,” they said in their press release.

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 at https://vaers.hhs.gov/reportevent.html external icon.

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