CDC and FDA Call for Pause on Johnson & Johnson Vaccine
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UPDATE: As of Friday, April 23, the CDC and FDA approved the J&J vaccine for use again, after an 11 day pause.
Today, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) released a recommendation to pause the distribution of the Johnson and Johnson vaccine in the United States due to reported cases of a rare blood clot called cerebral venous sinus thrombosis (CVST) linked to low platelet counts following vaccination. Janet Woodcock, MD, acting FDA commissioner stresses in a CDC and FDA joint media call that adverse reactions to vaccines are extremely rare and the advisory reflects the CDC and FDA’s abundance of caution they have around vaccine safety. “Right now, I like to stress these events appear to be extremely rare,” Woodcock states. “COVID-19 vaccine safety is a top priority for the federal government and we take all reports of adverse events following vaccination seriously.”
As of April 12, more than 6.8 million doses of the Johnson and Johnson vaccine have been administered and the CDC and FDA are currently investigating the matter further to provide guidance not only to health professionals, but for current recipients of the Johnson and Johnson COVID-19 vaccine.
“We’re recommending this pause while we work together to fully understand these events and also, so we can get information out to healthcare providers and vaccine recipients,” Woodcock says.
So far, what is known about the reported cases is that all occurred six to 13 days post Johnson and Johnson vaccination among women between the ages of 18 and 48. Peter Marks, MD, PhD, director for the FDA Center for Biologics Evaluation and Research notes that treatment for the CVST blood clot is different compared to treatments for other types of blood clots, which usually involves an anticoagulant drug called heparin.
“With cerebral venous sinus thrombosis, heparin may be dangerous and alternative treatments need to be given preferably under the guidance of physicians experienced in the treatment of blood clots,” Marks says in the FDA and CDC joint media call.
Anne Schuchat, MD, CDC’s principal deputy director says that for people who have gotten the vaccine over a month ago, the risk is very low. “For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” Schuchat says in the FDA and CDC joint media call. She says if people begin to experience symptoms such as severe headache, abdominal pain, leg pain, or shortness of breath, to seek out medical treatment.
Tomorrow, April 14, the CDC will meet with the Advisory Committee on Immunization Practices (ACIP) to further investigate these cases and inform next steps. Once more information is known, Mark says that the two organizations will update the fact sheet for both healthcare providers and vaccine recipients. The fact sheets will inform benefit risk determinations for healthcare providers administering the vaccines.
While the pause is not permanent, the CDC and FDA’s pause is part of the regulatory process to keep recipients of the COVID-19 vaccines informed and safe. The CDC and FDA encourages all Johnson and Johnson vaccine recipients to monitor the aforementioned symptoms and report any adverse effects to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.
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