In a joint statement issued early Tuesday, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) say experts are reviewing data showing six cases of a “rare and severe” type of blood clot.
"All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination," the agencies said. "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."
As of Monday, more than 6.8 million doses of the J&J vaccine have been administered, according to the CDC.However, a production bottleneck has slowed recent flow of the vaccine to Texas, the Texas Tribune reports. The state expected to get about 500,000 doses of the vaccine this week but was allotted just 130,000 through state and federal programs.
The CDC will hold a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, and the FDA will review the findings as it continues to investigate the cases.
Pfizer and Moderna vaccines are not included in the CDC’s and FDA’s recommended pause and continue to be viewed as safe to distribute, according to available information.The CDC and FDA urges caution for anyone who received the J&J vaccine recently.
"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," according to the CDC's statement. "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."
Johnson & Johnson responded to concern, saying it's working with regulators to assess the data, according to ABC News.
"We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines," says the corporation. "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."
The CDC asks health care providers to report adverse events to the Vaccine Adverse Event Reporting System at vaers.hhs.gov/reportevent.html.
Sanford Nowlin contributed to this report.
This story first appeared in CityBeat Cincinnati, an affiliated publication.
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