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.

“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.

The move could foreshadow what U.S. regulators will decide on Friday, when a Centers for Disease Control and Prevention (CDC) advisory committee meets again. The use of the vaccine is currently paused in the United States.

The European regulator said people getting the vaccine should simply be aware of the very rare possible side effect.

“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination,” the agency said.

Johnson & Johnson said in a statement that it will add the recommended information to alert providers about the symptoms and treatment of the “very rare adverse event,” and will resume shipments of the vaccine in the European Union, Norway and Iceland

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.

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.

In the United States, a CDC panel of experts last week put off a decision on the vaccine until another meeting this Friday. That delay drew criticism from some experts, who said there was no good reason to prolong the pause.

While the Johnson & Johnson vaccine does not represent a major share of the overall supply in the U.S., it can be important for vaccinating underserved communities, given that it is just one dose and is easier to store. It is also important on a global basis for lower-income countries.

No serious safety problems have been found in the other two vaccines in use in the U.S., from Pfizer and Moderna.

–Nathaniel Weixel contributed to this report, which was updated at 1:06 p.m.