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EMA Says Benefits Outweigh The Clots Potentially Linked To Johnson & Johnson Vaccine

MARY LOUISE KELLY, HOST:

The Johnson & Johnson COVID-19 vaccine got a green light today from European drug regulators. The vaccine has been on pause. The vaccine had been put on pause last week in both Europe and the U.S. over concerns about a possible link to rare but serious blood clots. The J&J vaccine is still on hold here in this country. NPR's Jason Beaubien joins me now.

Hey, Jason.

JASON BEAUBIEN, BYLINE: Hey, Mary Louise.

KELLY: OK, so how did officials in Europe explain their decision today to say, green light; go ahead, Johnson & Johnson vaccine?

BEAUBIEN: Yeah, so this safety committee from the European Medicines Agency - they looked at all the data they could find on these blood clots. And that included eight cases from the United States, one of which was fatal. And they determined that, yes, there does appear to be a link between these unusual clots and the Johnson & Johnson vaccine. But it's really rare. The rate is about one clot occurring in every 1 million people who get vaccinated. Emer Cooke - she's the head of the European Medicines Agency. She pointed out today that the world has just passed 3 million deaths from COVID, and tens of thousands of people are getting infected with it every day in Europe.

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EMER COOKE: I don't need to tell you that there is untold human suffering behind all of these cases, and these vaccines play an immensely important role in combating this pandemic.

BEAUBIEN: And that was really their central argument. She says the benefits of getting people vaccinated against COVID far outweigh the risks from the Johnson & Johnson vaccine from what they've seen.

KELLY: OK. Now, some of the concern here was we mentioned these eight cases of blood clots in the U.S...

BEAUBIEN: Yeah.

KELLY: ...Which have affected women - young women. Are European regulators looking at that, saying, maybe we should only use this vaccine in certain people, certain groups of people?

BEAUBIEN: Yeah, and they talked about that, and they're looking at that. And it's true that of these eight cases, seven of the eight are women. The median age was 33. The regulators, however, said, you know, at this point, this is just too small of a data set. They just don't have enough numbers, they feel, to be able to say, look; it should only be used with this group, or this vaccine should only be used with men. But they did say that they are seeing some clear patterns with these clots. They tend to hit a week or two after vaccination. The person shows stroke-like symptoms, so they're recommending the clotting condition be listed as a side effect of this vaccine. And they're saying health care workers should be monitoring for these rare symptoms. And if they do occur, they have guidance on how to treat the clots, which they say can greatly improve a person's recovery.

KELLY: Meanwhile, here in the U.S., the Johnson & Johnson vaccine is still paused.

BEAUBIEN: Right.

KELLY: Any movement on that?

BEAUBIEN: So at the moment, both the FDA and the CDC - they're looking at this, and they're looking at exactly the same data as the European regulators because for the most part, this vaccine has only been given extensively in the United States. So they're both looking at the same sets of data. A CDC advisory committee is expected on Friday to meet, review this issue. So far, the CDC says they haven't confirmed any additional cases of clots from J&J beyond the eight that we already mentioned, so that's really good news. I think the U.S. regulators will probably come to a similar conclusion as the Europeans, but we'll really have to wait and see.

KELLY: Definitely good news that there are no reported cases of new blood clots here or anywhere else.

Jason Beaubien, NPR's global health correspondent, thanks for your reporting.

BEAUBIEN: It's my pleasure to be with you. Transcript provided by NPR, Copyright NPR.