European Union regulator links J&J vaccine to clots

We clarify 4 doubts about the Johnson & Johnson vaccine 4:11

London (CNN) -

Europe's drug regulatory body said it found a possible link between Johnson & Johnson's covid-19 vaccine and rare blood clots, but stressed that the overall benefits of getting the injection outweigh the risks.

The news, announced on Tuesday, represents a new complication in the deployment of the vaccine in the European Union.

It also represents a severe blow for the company, a week after the suspension of its vaccine in the United States.

The European Medicines Agency (EMA) concluded that "a warning about unusual blood clots with low platelets should be added to the product information."

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The agency said it had analyzed all currently available evidence, including eight reports of serious and unusual blood clots from the United States.

More than 7 million Johnson & Johnson vaccines have been administered in the country.

One of those cases was fatal.

"All the cases occurred in people under 60 years of age in the three weeks after vaccination, the majority in women," said the EMA.

"Based on the currently available evidence, the specific risk factors have not been confirmed."

The agency said that "the combination of blood clots and low platelets is very rare, and the overall benefits of the Janssen COVID-19 vaccine outweigh the risks of side effects."

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Johnson & Johnson vaccine: these are the symptoms of a rare case of blood clots 1:24

The agency's findings are, however, a setback for the pharmaceutical giant.

They also come as the company awaits the results of similar investigations from regulators in the United States.

The vaccine was suspended in the country on April 13 after the reports became known, and Johnson & Johnson decided to "proactively delay" the launch of the injection in Europe on the same day.

Johnson & Johnson's Response on Clots

Following the European Medicines Agency's assessment, Johnson & Johnson said it will resume shipments of its COVID-19 vaccine to the European Union, Norway and Iceland.

The company said in a statement that it will update the COVID-19 vaccine insert to include information on how to diagnose and treat rare blood clots.

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"We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this rare event to ensure correct diagnosis and appropriate treatment," said Dr. Paul Stoffels, Chief Scientific Officer of Johnson & Johnson, referring to the EMA committee responsible for evaluating and monitoring drug safety.

It's not just Europe

The US Centers for Disease Control and Prevention (CDC) is studying a "handful" of adverse events reported after people received the vaccine, they said Monday.

They are expected to announce their own findings on Friday.

Johnson & Johnson further complicated matters after initial reports of blood clots came to light on April 9 by also pointing to the Pfizer and Moderna vaccines, issuing a press release saying a study showed that there were also reports of blood clots with their vaccinations.

The study author they cited said that's not what their research found.

The company will try to regain the trust of both the United States and Europe.

Vaccination programs have intensified in both regions in recent weeks;

millions of people are being vaccinated in the US every day, while deployment in the EU has improved after a rocky start.

Second vaccine suspended

Johnson & Johnson's vaccine had been cleared for use by the EMA on March 11, but was not yet in widespread use.

The vaccine has been touted as a potential game changer in the pandemic because it is given in a single injection.

Most of the other vaccines approved worldwide are given in two doses, with an interval of at least a few weeks.

However, it has become the second vaccine to be discontinued in Europe for fear that it could lead to rare blood clots.

The Oxford-AstraZeneca vaccine rollout was delayed for several days in many EU countries after an equally small number of clotting reports came to light.

Experts fear that confidence in that vaccine has waned as a result.

Multiple health regulatory bodies have stressed that the overall benefits of the AstraZeneca vaccine continue to outweigh the risks.

However, some European countries are restricting the use of the injection to older age groups.

UK authorities, instead, advised that those under the age of 30 receive other vaccinations.

- CNN's Jen Christensen contributed to this report.

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