Johnson & Johnson will resume its COVID-19 vaccine rollout in Europe, the company announced Tuesday, with added packaging labels warning of a rare risk of blood clots.
The announcement came after Europe’s health regulator, the European Medicines Agency, said the vaccine’s benefits outweigh the risk of the rare, potentially lethal side effect.
J&J’s vaccine rollout in Europe was put on hold after US regulators last week halted use of the company’s shot after it was reported six women suffered blood clots.
“It’s an extremely rare event. We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore the confidence in our vaccine,” J&J Chief Scientific Officer Paul Stoffels said during a Tuesday conference call.
Nearly 8 million people in the US have received the J&J vaccine.
The Centers for Disease Control and Prevention and the Food and Drug Administration are reviewing the rare blood clots reported in people who got the shot.