FDA, CDC call for pause on Johnson & Johnson vaccinations due to clotting cases
U.S. regulators are calling for Johnson & Johnson vaccinations to pause after reports and severe blood clots in six individuals.
The Food and Drug Administration [FDA] and the Centers for Disease Control and Prevention [CDC] confirmed that the agencies are reviewing data involving six reported US cases of women suffering from blood clots called cerebral venous sinus thrombosis [CVST].
The 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, the agencies are recommending a pause in the use of this vaccine out of an abundance of caution, the agencies said in a statement on Tuesday.
The FDA and the CDC will be holding a joint media call at 10 a.m. to discuss the Johnson & Johnson vaccine.
“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,” the agencies said.
The cases occurred in women between the ages of 18 and 48. Symptoms occurred between 6 and 13 days after vaccination, officials reported.
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, the agencies said. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System here.
Johnson & Johnson also released a statement on Tuesday:
“The safety and well-being of the people who use our products is our number one priority. We share all adverse event reports about individuals receiving our COVID-19 vaccine, along with our assessment of these reports, with health authorities in compliance with regulatory standards. We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public.”
A CVS Pharmacy spokesperson confirmed the company is immediately pausing its use of the Johnson & Johnson COVID-19 vaccine, per agency recommendation.
As of April 12, more than 6.8 million doses of the Johnson & Johnson [Janssen ] vaccine have been administered in the U.S.
The agencies will be holding in news conference at 10 a.m. ET on Tuesday to discuss next steps.
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