The European Medicines Agency (EMA) on Tuesday said that the overall benefit-risk for Johnson & Johnson’s COVID-19 vaccine “remains positive” despite six reports of extremely rare but severe clotting issues in the U.S.

In addition, the EMA — the top medical regulatory body of the European Union — recommended adding a warning label to the vaccines packaging that lists “very rare cases of unusual blood clots with low blood platelets” as a side effect of the vaccine.

The FDA and the CDC recommended a pause in the use of the Johnson & Johnson vaccine last week after a sixth person suffered the rare clotting disorder. About 7 million people in the U.S. safely received a dose of the vaccine before the pause.

Over the weekend, President Joe Biden’s top medical adviser, Dr. Anthony Fauci, said he expects the Johnson & Johnson pause to be lifted later this week.

This story is breaking and will be updated.