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Reports of a rare, severe type of blood clot in 6 women in the US led the agencies to halt use of the J&J product, out of an abundance of caution.
The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on Tuesday recommended immediate suspension of use of the Johnson & Johnson COVID-19 vaccine. The recommendation follows reports of a "rare and severe type of blood clot" in individuals receiving the vaccine.
The 6 reported cases of cerebral venous sinus thromboses (CVST) occurred among women between the ages of 18 and 48 years. Symptoms manifested 6 to 13 days after vaccination and occurred in combination with thrombocytopenia, according to a joint FDA/CDC statement.
The pause in use comes as more than 6.8 million doses of the J&J vaccine have been administered in the US.
"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," said the joint statement. "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."
Treatment of CVST is different than for the more common venous thromboembolism, often treated with heparin. Administration of heparin in a case of CVST may be dangerous, notes the statement
The FDA/CDC counsel any patient who has received the J&J vaccine and develops severe headache, abdominal pain, leg pain, or shortness of breath within 3 weeks after vaccination to 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.
In a statement on Tuesday, J&J noted that the company has decided to "proactively delay the rollout" of its vaccine in Europe.