| 20 April 2024, Saturday |

J&J to resume rollout of COVID-19 vaccine in Europe with safety warning

Johnson & Johnson announced on Tuesday that it will resume rolling out its coronavirus vaccine in Europe after the region’s medical regulator said the benefits of the jab outweigh the risk of very rare, potentially lethal blood clots.

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

J&J shares jumped more than 2%.

Last week, use of the J&J vaccine was temporarily suspended by U.S. regulators after rare brain blood clots combined with a low blood platelet count were reported in 6 women, prompting the company to delay its rollout in Europe.

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

J&J said a new package label is to 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 Norway, Iceland and the European Union, 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.

The Netherlands announced that it would use the vaccine starting on Wednesday.

The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are also reviewing the rare blood clots reported in people who received the jab. An advisory committee to is slated to meet Friday and may make a recommendation.

“The outcome of the vaccine review is important for overall global vaccination efforts, given J&J’s vaccine does not have the extreme cold storage requirements of the mRNA vaccines,” said Edward Jones analyst Ashtyn Evans, referring to vaccines from Moderna Inc and Pfizer Inc with partner BioNTech SE.

The J&J vaccine can be stored at normal refrigerator temperatures and is expected to be used worlwide.

Similar rare blood clot issues were reported with use of AstraZeneca’s coronavirus vaccine, which is also expected to be widely used globally.

  • Reuters