Pause on all administration of the Johnson & Johnson/Janssen COVID-19 vaccine
News Release, April 13, 2021 --The Texas Department of State Health Services is asking vaccine providers in Texas to pause all administration of the Johnson & Johnson/Janssen COVID-19 vaccine following today’s recommendation from the Centers for Disease Control and Prevention and the Food and Drug Administration.
The pause is recommended following reports of blood clots in six individuals 6 to 13 days after receiving the Johnson & Johnson vaccine. Right now, these adverse events appear to be extremely rare and are being further evaluated to ensure vaccine safety. People who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider.
None of the cases of blood clots reported at this time have occurred in Texas, where more than 500,000 doses of the Johnson & Johnson vaccine have been administered.
DSHS has not been notified of any change in vaccine distribution. Providers that have or receive the Johnson & Johnson vaccine should continue to store it in the proper conditions. Providers should report all adverse events following any vaccination to the Vaccine Adverse Events Reporting System at vaers.hhs.gov.
DSHS will provide updates as they become available.
Joint CDC and FDA Statement on Johnson & Johnson COVID-19
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. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.
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.
At this time, WCCHD is not administering Johnson & Johnson, and was not slated to receive any Johnson & Johnson vaccine.