The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have issued a joint statement recommending a pause in the use of the Johnson & Johnson (Janssen) anti-COVID vaccine.
The statement comes after reports of instances of blood clots among those who had received the vaccine. FDA and CDC said, “As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving 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.”
The agencies raised concerns over the particularly serious nature of the blood clots saying, “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.”
The CDC is all set to hold a meeting with the Advisory Committee on Immunization Practices (ACIP) to further review cases. Meanwhile, the FDA will not only review the analysis, but also continue to investigate these cases. “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” said the agencies adding, “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.” However, FDA and CDC do not want this news to cause people to avoid vaccination all together. They clarified, “Right now, these adverse events appear to be extremely rare.” They have also urged people “who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination” to immediately contact their doctors.
Johnson & Johnson has issued a statement in response to the above saying, “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 pharma major said that it was also reviewing blood clot cases with European authorities and has “made the decision to proactively delay the rollout of our vaccine in Europe.”
*Feature image: Janssen vaccine from official website.