J&J to resume rolling out COVID-19 vaccine in Europe with safety warning

Johnson & Johnson (JNJ.N) said on Tuesday it will resume rolling out its COVID-19 vaccine in Europe after the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots, Reuters reports.

Europe’s health regulator, the European Medicines Agency (EMA), on Tuesday recommended adding a warning about rare blood clots with low blood platelet count to the vaccine’s product label and said the benefits of the one-dose shot outweigh its risks.

J&J shares rose more than 2%

Use of the J&J vaccine was temporarily halted by US regulators last week after rare brain blood clots combined with a low blood platelet count were reported in six women, prompting the company to delay its rollout in Europe.

Nearly 8 million people in the United States have received the J&J vaccine.

J&J said a new package label will include a warning on the risk of the rare side effect and instructions on how to recognize and treat it. The company said it would restart shipments to the European Union, Norway and Iceland, and is working on restarting clinical trials.

"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 conference call to discuss the company earnings.