FDA: J&J Will Need To Monitor Vaccine For Link To Thrombotic Events

By Beth Wang / February 25, 2021 at 7:45 PM
Johnson & Johnson will need to monitor its COVID-19 vaccine for any potential link to thromboembolic events if it gets emergency use authorization from FDA and the vaccine is distributed to a larger population beyond those included in the clinical trials, FDA says in briefing materials released ahead of its Friday (Feb. 26) vaccine advisory committee meeting. FDA says J&J’s safety analysis through the Jan. 22, 2021, data cutoff date support a favorable safety profile with no specific safety concerns...


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