J&J will resume vaccine in Europe. New package to include blood clot warning.
▪ J&J said on Tuesday it will resume rolling out the Covid-19 vaccine in Europe; the rollout had stopped after the US recommended a pause.
▪ The European Medicines Agency (EMA) – Europe’s health regulator, recommended the addition of a warning about rare blood clots to the label and confirmed that the overall benefit-risk profile remains positive.
▪ J&J will update its Covid-19 vaccine Summary of Product Characteristics and Package leaflet to include important information on the diagnosis and management of the rare blood clots.
▪ The US CDC and FDA are also reviewing the rare blood clots in some people who got the shot; a recommendation is expected Friday.
▪ Nearly 8 million people in the US have received the J&J shot.
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