European regulator says Johnson & Johnson vaccine benefits outweigh risks

Europe’s drug regulator said Tuesday that it’s recommending a warning be added to the Johnson & Johnson COVID-19 vaccine about a possible link to blood clots, but noted they are “very rare” and the benefits still outweigh the risks.

In response, the company said it will resume its vaccine rollout in Europe.

J&J had decided to delay its rollout in the EU’s member states last week, after U.S. regulators called for a pause on the vaccine following concerns about the potential serious side effect.

“The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects,” the European Medicines Agency (EMA) said in a statement.

Just eight cases of the blood clots out of about 7 million people who received the single-dose vaccine have been identified in the U.S., the agency noted.

Next move? The EMA’s decision could foreshadow what U.S. regulators will decide on Friday, when a Centers for Disease Control and Prevention (CDC) advisory committee meets again. The panel of experts previously met last week, but they put off a decision on what to do about the vaccine until another meeting this Friday because of a lack of evidence. That delay drew criticism from some experts, who said there was no good reason to prolong the pause.

Seen it before: The EMA noted that similar instances of rare blood clots have been linked to a different COVID-19 vaccine, from AstraZeneca. Use of that vaccine has resumed after pauses in some countries in Europe, though some nations have added age restrictions.

The clotting cases with the Johnson & Johnson vaccine have mostly been in women under 60 years of age.