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European Medicines Agency Finds No Link Between AstraZeneca Vaccine And Blood Clots

A MARTINEZ, HOST:

The Biden administration says it plans to send millions of doses of the AstraZeneca COVID-19 vaccine to Canada and Mexico. That vaccine isn't yet authorized for use here in the U.S. Here's White House press secretary Jen Psaki.

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JEN PSAKI: The pandemic knows no borders. And ensuring our neighbors can contain the virus is a mission-critical step to ending the pandemic.

MARTINEZ: But in Europe, the AstraZeneca vaccine has been a source of concern. More than a dozen countries had suspended use of that vaccine over worries about a possible link to blood clots. NPR's global health correspondent Jason Beaubien has been following this. Jason, why is the Biden administration now changing course on what to do with its AstraZeneca stockpile?

JASON BEAUBIEN, BYLINE: Well, there are a couple of reasons. First, these doses can't yet be used in the U.S., as you mentioned, because they haven't been authorized by the FDA. Also, the U.S. might not need them in the short term, given production that we're seeing from other manufacturers. And finally, it looks good. The U.S. is way out ahead of a lot of other countries in terms of how many people have actually gotten vaccinated. There's been some criticism that Washington is hoarding doses. So it looks good to be sharing, particularly with your neighbors.

MARTINEZ: Yeah, why not share? Now, The European Medicines Agency, the EMA, just wrapped up its investigation into whether the vaccine could have caused these clots and if it's still safe. What did they determine?

BEAUBIEN: Well, the head of the EMA, Emer Cooke - she was very definitive and said the review committee came to a clear conclusion.

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EMER COOKE: This vaccine is a safe and effective option to protect citizens against COVID-19.

BEAUBIEN: And she said particularly given the sharp rise in cases right now in Europe, vaccination campaigns should restart. And, in fact, right after those remarks, many countries did resume vaccinating with the AstraZeneca product.

MARTINEZ: But how is the EMA backing up its conclusion that this vaccine is safe?

BEAUBIEN: Well, what they're saying is that there's no evidence that these rare blood clotting conditions that we're seeing - and they occurred in a few people after getting vaccinated - there's no link right now to the vaccine. That link might be proven later. But right now, they're saying they don't have evidence to support that. Sabine Straus - she led the safety committee - she points out that even under normal circumstances, a sizable number of people develop blood clots.

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SABINE STRAUS: Approximately 100,000 people develop blood clots every month in the European Union.

BEAUBIEN: So seeing 25 blood clots among the nearly 20 million people in Europe who've been vaccinated so far with AstraZeneca is actually fewer than they would have expected to see in the general population.

MARTINEZ: Are they taking any additional steps around this?

BEAUBIEN: Yeah. So despite what they're saying, they are adding additional warnings that will go along with the vaccines. They're telling people to be on the lookout for severe headaches, unusual bruising, other symptoms that may indicate that there's one of these rare blood clots. And they're telling people if that happens, then to seek help immediately.

MARTINEZ: This is happening at a time when the AstraZeneca vaccine is starting to get distributed all over the world. So even with the all clear from European regulators, I mean, does an incident like this end up damaging the broader effects to just get people vaccinated?

BEAUBIEN: Yeah, I mean, it could. There's concern about the ripple effect of this entire thing that happened in Europe. Remember, AstraZeneca is expected to be the most used immunization globally this year. Some 2 billion doses, more than any other manufacturer, are expected to be administered in 2021. I was talking with Jennifer Nuzzo, who studies vaccines and global health at the Johns Hopkins Center for Health Security.

JENNIFER NUZZO: These national decisions to stop using the vaccine, even temporarily, casts a shadow over the vaccine itself.

BEAUBIEN: And she says in a moment in this pandemic when the goal is to get as many people vaccinated as quickly as possible, these questions about safety, even if they're resolved, as they seem to be here - you know, they can still affect vaccination efforts.

NUZZO: We are always worried about people's willingness to be vaccinated. It doesn't have to be that people are just full-out opposed to getting vaccinated. It could also be deadly if people just decide to wait too long to get it. We know that a lot of people probably fall on the wait-and-see camp.

BEAUBIEN: And just looking at Europe, we've got 20,000 people dying on the continent every week from COVID. She says the focus right now needs to be on getting people immunized.

MARTINEZ: That's NPR's Jason Beaubien. Jason, thanks.

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