Maine Public Health Alert
Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine
April 13, 2021 – 1:30 PM EDT
Maine CDC is not aware of any reports of these cases in Maine residents. The State of Maine is advising that providers pause administration of the Johnson & Johnson vaccine until the U.S. CDC’s scientific advisory committee has further reviewed the safety data. Maine CDC is working with administration partners to provide an alternative supply of the mRNA vaccines to clinics already scheduled so they can continue operations.
For Public Health
- Pause the use of the J&J COVID-19 vaccine in public health clinics until the ACIP is able to further review these CVST cases in the context of thrombocytopenia and assess their potential significance.
- Encourage healthcare providers and the public to report all serious and life-threatening adverse events and deaths following receipt of COVID-19 vaccines to VAERS as required under the EUAs for COVID-19 vaccines.
- Disseminate this alert to healthcare providers in your jurisdictions.
For the Public
- If you have received the J&J COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination, contact your healthcare provider, or seek medical care.
- Report adverse events following receipt of any COVID-19 vaccine to VAERS.
- If you are scheduled to receive the J&J vaccine, please contact your healthcare provider, vaccination location, or clinic to learn about additional vaccine availability.
For More Information
- Resources on thrombotic thrombocytopenia after AstraZeneca COVID-19 vaccine: https://www.nejm.org/doi/full/10.1056/NEJMoa2104840, https://www.nejm.org/doi/full/10.1056/NEJMoa2104882
- Frequently asked questions about VAERS reporting for COVID-19 vaccines VAERS – FAQs (hhs.gov)
- How to report to VAERS
- CDC materials on stroke and NIH materials on thrombocytopenia
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
4/13/21 – The following statement is attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research
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. 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.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. 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.
Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
ADVISORY: Maine Advises Pause for Johnson and Johnson COVID-19 Vaccine
04/13/2021 08:57 AM EDT
AUGUSTA — Governor Janet Mills, Maine Department of Health and Human Services Commissioner Jeanne Lambrew and Maine Center for Disease Control and Prevention Director Dr. Nirav D. Shah issued the following statement today:
“This morning, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine out of an abundance of caution following reports of six cases of a rare and severe type of blood clot in recipients in the United States. Maine CDC is not aware of any reports of these cases in Maine residents. Given this recommendation, the State of Maine is advising that providers pause administration of the Johnson & Johnson vaccine until the U.S. CDC’s scientific advisory committee has further reviewed the safety data.”
Tuesday, April 13, 2021, 8:45 AM EDT
MDI Hospital has learned this morning that the Johnson & Johnson vaccine for COVID-19 has been paused by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control out of an abundance of caution related to several adverse events reported. To date, MDI Hospital and Health Centers have administered 900 doses of the Johnson & Johnson vaccine. The hospital is monitoring the situation and will provide updates as new information is available.