J&J Vaccine Pause

Why we’ve suspended use of Johnson & Johnson vaccine

April 13, 2021

This morning, out of an abundance of caution, the Centers for Disease Control and the Food and Drug Administration have recommended a pause to the distribution of the Johnson & Johnson vaccine following six cases of rare and severe blood clots reported after receiving the vaccine. This recommendation is to halt distribution while the CDC, FDA, and other agencies work together to fully understand these events and get the appropriate vaccine education out to vaccine providers and recipients. Following this recommendation, the Coquille Indian Tribe has halted its use of the Johnson & Johnson vaccine, including the scheduled vaccine clinic on Friday, April 16. 

Out of the more than 6.8 million doses of Johnson & Johnson vaccine that have been distributed, there have been six reported U.S. cases of a rare and severe type of blood clot. 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). CVST occurs when a blood clot forms in the brain’s venous sinuses. This prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming a hemorrhage. 

All six cases of adverse reactions following receipt of vaccine have occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. As treatment of this specific type of blood clot is different from the treatment that might typically be administered it is important that the health care system is ready to appropriately diagnose and treat these specific reactions. 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.

While these adverse events are extremely rare, only affecting 0.0000923% of the population who has received the vaccine, the safety of our community is our top priority, and we take all reports of health problems following COVID-19 vaccination very seriously. People who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the Johnson & Johnson vaccination should contact their health-care provider immediately. These symptoms are different from the mild flu-like symptoms that have been experienced by many who have received any one of the available COVID-19 vaccines.

Again, while these events are extremely rare, the health and safety of tribal members and our patients is our main concern. We are working to learn more about the vaccine and the overall risks and benefits associated with it. We will share with you what we know as we know it, and do our best to ensure that you have all of the education and tools needed to protect your health.

Sources:

Marks, P. M.D., PhD. (2021). Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

Joint Media Call: FDA & CDC to Discuss Janssen COVID-19 Vaccine – 4/13/2021

Johns Hopkins Medicine

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