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European Union Regulator Says Benefits Outweigh Risks Of Johnson & Johnson Vaccine

NOEL KING, HOST:

The European Union's Drug Regulatory Agency says it found a, quote, "possible link between Johnson & Johnson's COVID-19 vaccine and extremely rare blood clots." That agency says a warning should be added to the vaccine's label, but experts there also stress that the benefits of this vaccine outweigh the risks. NPR's Jason Beaubien is following this one. Good morning, Jason.

JASON BEAUBIEN, BYLINE: Good morning.

KING: So, as I understand it, the vaccine was on hold in Europe. Does this mean it will be used again now?

BEAUBIEN: Yeah. So basically, they are now giving this the green light to go ahead. This was a review that was being done by a safety committee of the European Medicines Agency. And Dr. Sabine Straus, she chaired that committee, and this is what she had to say.

(SOUNDBITE OF ARCHIVED RECORDING)

SABINE STRAUS: The careful review of the cases and other available evidence have led the committee to the conclusion that these blood clotting disorders are very rare side effects of the vaccine.

BEAUBIEN: And they have decided that those rare side effects actually shouldn't stop the rollout, that they should be moving forward, and that now they're going to give member states in the European Union the information they need. And it'll be based on each individual country to decide whether or not to go forward with Johnson & Johnson. But basically, the regulatory agency's giving them the green light right now.

KING: And, of course, as everyone knows, the CDC and the FDA ordered a pause of its use in the United States. Does this mean anything for the U.S.?

BEAUBIEN: In a way, it doesn't. It's kind of interesting because the Europeans are actually looking at some of the same data that the U.S. regulators are looking at. This may signal what we can see from from the U.S. regulators, but it actually doesn't have much impact. And if the U.S. decides to go in a different direction, certainly it has every right to do that.

KING: If they're all looking at the same data, why are the Europeans going ahead before the U.S.?

BEAUBIEN: Because they have a bigger problem with COVID right now in terms of trying to get their vaccines rolled out. They've had problems in a lot of different countries. The U.S. is actually doing quite well. We have other vaccines we can turn to. They really want to get this vaccine into the pipeline and being used. And so they're basically saying, we see the problems. We - this is the solution that we see. We're going to put a label on it, warn people that this is a possible side effect and move forward from there and try to get this thing going sooner rather than later.

KING: OK. That's in Europe. And when will we know if the pause in the U.S. has been lifted?

BEAUBIEN: So that is still under review. We actually expected it to happen earlier, but that has gotten pushed back. But we do expect to hear soon from the CDC and the FDA that - what their exact decision is going to be. It's quite likely that it's going to be something similar here, that - they - as I said, the data is the same that they're looking at. The Europeans are saying that they've looked at this and said, if we put labels on this, if we warn health care providers that these are the possible side effects and this is what you can do if you have these side effects, then this can be used safely. And it's probably going to be a similar outcome from the United States regulators, but obviously we're still waiting on that.

KING: NPR's Jason Beaubien. Thanks, Jason.

BEAUBIEN: You're welcome. Transcript provided by NPR, Copyright NPR.

Jason Beaubien is NPR's Global Health and Development Correspondent on the Science Desk.

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