The FDA and US Centers for Disease Control and Prevention (CDC) have recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine after the reporting of six rare blood clots.
Covid US
The company’s vaccine, which is manufactured by its subsidiary Janssen, has been administered to over 6.8 million people in the US. The decision by the FDA and the CDC was made after reports of six cerebral venous sinus thrombosis (CVST) blood clots, which occurred in combination with low levels of blood platelets (thrombocytopenia). All six reports occurred in women between the ages of 18 and 48, with symptoms occurring six to 13 days after vaccination.
Whereas blood clots are usually treated with an anticoagulant drug called herapin, the FDA and CDC have stated that that in this case the use of that drug may be dangerous.
The CDC are now convening a meeting of the Advisory Committee on Immunization Practices (ACIP) on 14 April to review the potential significance of these cases. The FDA is also investigating the reported 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,” the FDA and CDC said in a joint statement.