(WPRI) — The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of the Johnson & Johnson vaccine “out of an abundance in caution.”
Both the FDA and the CDC issued a joint statement Tuesday morning regarding the single-dose vaccine.
Both agencies are currently reviewing data involving six reported cases of a rare and severe type of blood clot. it is not being treated like typical blood clots which is what prompted the pause.
All six patients who developed the blood clots were women between the ages of 18 and 48. One woman died and another is in critical condition, according to the Director of the FDA Center for Biologics Evaluation and Research Peter Marks.
At this time, the FDA says these adverse events appear to be extremely rare.
The FDA notes that it is not clear there is any indication the women with the reported blood clots were on oral contraceptives.
Listen to the full joint media call below:
As of Monday more than 6.8 million doses of the J&J vaccine have been administered in the U.S.
Principal Deputy Director of the CDC Anne Schuchat says anyone who had the vaccine more than a month ago likely faces no risk.
The CDC says they will “convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance.” The FDA says they then will review the analysis as they continue to investigate these cases.
“Until that process is complete, we are recommending this pause,” the FDA wrote on Twitter. “This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
Both agencies say COVID-19 vaccine safety is a top priority for the government and will take all reports of health problems following vaccination seriously.
Anyone who has received the J&J vaccine and develop a 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 any adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.