EU regulator backs J&J vaccine, despite risk

Europe's drug regulator continues to back Johnson & Johnson's COVID vaccine, despite confirming on Tuesday that it had found possible links to rare blood clot issues in adults who received doses.

The European Medicines Agency - or EMA - maintains that the vaccine's benefits outweighs the risk.

The EMA's safety committee had concluded that a warning about unusual blood clots must be added to the vaccine's labels.

This was also required for its rival vaccine maker AstraZeneca.

EMA's Executive Director, Emer Cooke:

"When vaccines are rolled out to large numbers of people, it is possible that very rare side effects can occur and these will not necessarily have been identified in the clinical trials. But because we have a very good pharmacovigilance system in place in Europe we can spot these events very quickly and we can take action to make sure that healthcare professionals and patients are aware and can take necessary actions, so it's really showing that the system works."

The EMA found that all instances of clotting had occurred in adults under 60 years old, mostly women, within three weeks of their Johnson & Johnson shot.

It said all available evidence, including eight reported cases in the U.S., had formed part of its assessment.

Over 7 million doses have been administered in that country as of April 13, according to the EMA.

The U.S. health regulators last week recommended pausing the use of this particular vaccine.

Despite the official backing, the findings are a still a blow to the European Union, which is battling major hurdles to its immunization campaign.

Several nations have suspended or limited the use of AstraZeneca's vaccines.

Johnson & Johnson is one of four that has been authorized for use in Europe.

Video Transcript

- Europe's drug regulator continues to back Johnson & Johnson's COVID vaccine despite confirming on Tuesday that it had found possible links to a rare blood clot issues in adults who received doses. The European Medicines Agency, or EMA, maintains that the vaccine's benefits outweighs the risk. That EMA's safety committee had concluded that a warning about unusual blood clots must be added to the vaccine labels. This was also required for its rival vaccine maker AstraZeneca. This is EMA Executive Director Emer Cooke.

EMER COOKE: When vaccines are rolled out to a large number of people, it is possible, but very rare side effects can occur. And these will not necessarily have been identified in the clinical trials. But because we have a very good pharmacovigilance system in place in Europe, we can spot these events very quickly. And we can take action to make sure that health care professionals and patients are aware and can take necessary action. So it's really showing that the system works.

- The EMA found that all instances of clotting had occurred in adults under 60 years old, mostly women within three weeks of their Johnson & Johnson shot. It said all available evidence, including eight reported cases in the US, had formed part of its assessment. Over 7 million doses have been administered in that country as of April 13th according to the EMA.

The US health regulators last week recommended pausing the use of this particular vaccine. Despite the official backing, the findings are still a blow to the European Union, which is battling major hurdles in its immunization campaign. Several nations have suspended or limited the use of AstraZeneca vaccines. Johnson & Johnson is one of the four that has been authorized for use in Europe.