A joint press release from the Federal Drug Administration and the Centers for Disease Control was released today, April 13, to announce their recommendation to pause the administration of the Johnson & Johnson (Janssen) COVID-19 vaccine.
Six (6) instances of a rare and severe type of blood clot called cerebral venous sinus thrombosis have been reported in individuals after receiving the one-shot Johnson & Johnson vaccine. “All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to thirteen days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered.” Heparin is an anticoagulant that is commonly used to treat blood clots but, “in this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” says the statement attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC.
“The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday, April 14, to further review these cases and assess their potential significance.” The FDA will review the analysis as it undertakes an investigation into these cases as well.
Pausing the administration of the vaccine “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.”
If you have received the Johnson and Johnson vaccine and have developed severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination you should contact your health care provider. These adverse reactions appear to be extremely rare but could have life threatening consequences if not treated.
From the California Department of Public Health, “California is following the FDA and CDC’s recommendation and has directed health care providers to pause the use of the Johnson & Johnson vaccine until we receive further direction from health and safety experts. Additionally, the state will convene the Western States Scientific Safety Review Workgroup to review the information provided by the federal government on this issue. As the federal government has said, we do not expect a significant impact to our vaccination allocations. In California, less than 4% of our vaccine allocation this week is the Johnson & Johnson vaccine.”
A similar investigation of the Moderna COVID-19 vaccine was completed in Jan. 2021. That investigation was spurred on by a cluster of patients at a single clinic who experienced a “possible allergic reaction” after receiving their first dose. That investigation was completed in less than a week and did not significantly impact vaccine distribution.