Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine (April 13, 2021)

Summary

A joint media statement of the CDC and FDA on the Johnson & Johnson COVID-19 vaccine, for release Tuesday, April 13, 2021, 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. It states that as of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S., and that CDC and FDA are reviewing six reported U.S. cases of a rare and severe type of blood clot. It states the agencies are recommending a pause in the use of this vaccine out of an abundance of caution, and that CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday.

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Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

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

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Media Statement

For Immediate Release: Tuesday, April 13, 2021 Contact: Media Relations (404) 639-3286

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. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html .

CDC and FDA will provide additional information and answer questions later today at a media briefing . A recording of that media call will be available on the FDA’s YouTube channel.

### U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

Last Reviewed: April 13, 2021

Source: Centers for Disease Control and Prevention

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