Resource: Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
Source: U.S. Food and Drug Administration
Synopsis: The FDA and Centers for Disease Control and Prevention (CDC) issued a Statement regarding the Janssen (Johnson & Johnson) COVID-19 Vaccine. Out of an abundance of caution, the FDA and CDC recommended a pause in the use of this vaccine while we review the data from six reported cases in the U.S. of a rare and severe type of blood clot in people who received the vaccine. This pause was recommended, 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.
The FDA and CDC are reviewing data involving six cases reported to the Vaccine Adverse Event Reporting System (VAERS) of a low level of platelets in the blood in combination with a rare and severe type of blood clot called cerebral venous sinus thrombosis (CVST) in individuals who had received the Janssen COVID-19 Vaccine. One individual died. All cases occurred in females ranging in age from 18 through 48 years. In some of the reported cases of CVST, blood clots also involved large veins in the abdomen.
Out of an abundance of caution, the FDA and CDC are recommending a pause in the use of the Janssen COVID-19 Vaccine while the FDA and CDC, including through its Advisory Committee on Immunization Practices investigate these reports of serious adverse events. This is important, in part, to help ensure that health care providers are aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required for CVST with low levels of platelets.
Comment: The safety monitoring program that is in place to monitor COVID-19 vaccines is working, as we were able to detect the reports of these very rare, serious adverse events early and take action to assess them. The FDA and CDC will continue to fully investigate all reports to determine if a causal relationship exists.
