On April 13, 2021, one of the nation’s biggest assets against the coronavirus was taken out of play.
Experts with the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) called for a pause to usage of the Johnson & Johnson (Janssen) COVID-19 vaccine. In response, several states, including New Jersey, announced that they would comply with the request. Residents who were scheduled for a J&J shot were either switched to a Pfizer vaccine or rescheduled for another date.
“Out of an abundance of caution and following the guidance of the U.S. Centers for Disease Control and Prevention (CDC) and the U. S. Food and Drug Administration (FDA), the New Jersey Department of Health this morning paused the administration of the Johnson & Johnson (Janssen) vaccine across all vaccination sites in the state,” New Jersey Health Commissioner Judith Persichilli said in a statement.
“The CDC and the FDA are reviewing the data involving six reported cases – among nearly 7 million doses administered in the U.S – in women between the ages of 18 and 48 who received the J&J vaccine. Symptoms occurred 6 to 13 days after vaccination. In these cases, a type of blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets. Both the CDC and FDA have said that these adverse events are extremely rare. According to the FDA and CDC, individuals who have received the vaccine and develop abdominal pain, leg pain, shortness of breath, severe headache or other unusual symptoms within three weeks after vaccination should contact their health care provider.
“All New Jersey vaccination sites have been told to cancel or put on hold appointments for the J&J vaccine until further notice. For individuals scheduled to receive the J&J vaccine, the Department will work with all vaccination sites to make arrangements for the administration of an alternative two-dose vaccine. We will work with all sites, as needed, to reschedule vaccination appointments.
“The Department will await further guidance from the federal government. The federal Advisory Committee on Immunization Practices (ACIP) is scheduled to hold an emergency meeting tomorrow to discuss these adverse events and make recommendations to the CDC on how to proceed.
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 (thrombo-cytopenia).
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) 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.
Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html
