FDA Investigates Reports of Johnson & Johnson COVID-19 Vaccine Blood Clot Problems

Federal drug and disease experts are calling for health care providers to pause their use of the Johnson & Johnson COVID vaccine, following reports of at least six rare and severe cases of blood clot problems among women in the U.S. who received the single-shot vaccine.

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) issued a joint statement on April 13, announcing a review of six reported cases of blood clots following use of the J&J vaccine.

As states nationwide continue to push to get COVID vaccination shots in arms, the agencies have made the controversial decision to call for a halt on the use of the Johnson & Johnson vaccine, until they can review the potential health impacts and severity of these blood clots.

The J&J vaccine is one of three available COVID-19 vaccines approved for use in the United States, but is the only one administered with a shingle dose to provide protection against the coronavirus.

According to the FDA and CDC, more than 6.8 million doses of the J&J vaccine have already been administered in the U.S. However, the agencies have received data on six blood clot incidents, called cerebral venous sinus thrombosis (CVST), which have occurred among women who received the vaccine. This occurred alongside low levels of blood platelets; a condition known as thrombocytopenia.

Symptoms in all six cases occurred between one and two weeks after the patients were inoculated, and all were women between the ages of 18 and 48. Symptoms of the blood clots linked to the J&J vaccine may include severe headaches, abdominal pain, leg pain, and shortness of breath.

The low blood platelets make treating the blood clots complicated. Typically, patients suffering such a blood clot would be given a blood thinner known as heparin. However, the low blood platelet levels make giving patients heparin dangerous in these types of cases, the health experts warn.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the joint CDC and FDA press release states. “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 agencies urge anyone who experiences the symptoms listed above within three weeks of receiving the vaccine to contact their health care providers. The FDA and CDC are asking health care providers to report any adverse events to the Vaccine Adverse Event Reporting System.