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The Effects Of The Johnson & Johnson Vaccination Interruption

MARY LOUISE KELLY, HOST:

After weeks of good news about vaccines in this country, today brings a more concerning development. It was a call by scientists at the Food and Drug Administration and the Centers for Disease Control and Prevention, a call for a pause in using the Johnson & Johnson COVID vaccine while they investigate rare but serious side effects. So what does this mean for the pace of vaccination and for confidence in vaccines? Joining me now, NPR health reporter Pien Huang and White House correspondent Tamara Keith.

Hey there, you two.

TAMARA KEITH, BYLINE: Hello.

PIEN HUANG, BYLINE: Hi.

KELLY: So, Pien, you start. Tell us more about why the FDA and CDC are hitting pause.

HUANG: Yeah. Well, the Johnson & Johnson vaccine has been in use for a little over six weeks in this country, and today CDC and FDA officials called for a pause in using it here. That's because there have been six reported cases of severe blood clots in people who have gotten that vaccine, including one death.

Now, these are six cases out of 6.8 million J&J vaccines given out, so it's a very rare reaction - less than one in a million. But health officials say they're putting a hold on the vaccine out of an abundance of caution. And right now they're working to figure out what's happening. You know, they're looking for links between those six cases, seeing if there are additional safety warnings or restrictions they should put on who gets it. And they're also alerting doctors to the problem and making sure they know what to look for. You know, one thing they're saying, for instance, is that these cases should not be treated with a typical blood thinner called heparin, which could make the situation worse.

KELLY: Can I pause you on one thing you just said, Pien - that there has been one death? What do we know about the woman who died?

HUANG: Yeah. So there is a listing in the CDC's Vaccine Adverse Events database, and it appears to describe the woman who developed these complications and died after getting the J&J vaccine. The report describes a 45-year-old woman in Virginia. She got the vaccine in early March. And a week after getting the shot, she got a really bad headache and ended up going to the hospital for it. She had blood clotting and low platelet count and died about two weeks after getting the vaccine.

FDA officials said earlier that their best guess as to what's happening is that it's a rare autoimmune reaction that happens somewhere between a few days to no more than three weeks after getting the shot. And Dr. Peter Marks - he's a top FDA official - emphasized that it's very rare and explained the symptoms to look for.

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PETER MARKS: If someone ends up with a very severe headache or any type of shortness of breath, pain in their legs, pain in their abdomen that's severe, that they would want to seek medical attention.

KELLY: OK, so a view there from the FDA. Tam, let's bring you in. What does the White House have to say about all this?

KEITH: The White House coronavirus coordinator Jeff Zients and Dr. Anthony Fauci both came to the regularly scheduled press briefing today, which tells you that they are taking this very seriously. They made it clear that the FDA and CDC made this decision to call for the pause without consulting the White House. And Zients says that's exactly how it should be, that science should be leading the way.

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JEFF ZIENTS: I think it's important that, you know, we have here the FDA, and the FDA is the gold standard for ensuring the safety and the effectiveness of the vaccines. And today's action, I think, is clear evidence that they're taking every step necessary to ensure the American people have clear and transparent information.

KEITH: But there is no question that this is inconvenient for the White House for any number of reasons. Running a successful vaccine rollout is important for the president politically. Of course, it is also incredibly important from the perspective of public health and the economy. The Biden team is betting that letting the scientists lead, even if it is politically inconvenient - you know, not publicly badgering them or complaining about the decision - will help build trust that there isn't interference - political interference - and that the only priority of the FDA and CDC is keeping people safe.

KELLY: And what about the president's goal, Tam? He has established a goal of 200 million shots in arms by the end of this month. How does this pause on the J&J vaccine affect that?

KEITH: Well, Zients insisted it wouldn't affect that. He said that the number of doses going out to states this week will rise even without J&J in the mix. And the reality is that only about 5% of doses administered so far have been the Johnson & Johnson, and Zients insisted that they have ordered enough of the Pfizer and Moderna vaccine for every adult who wants it to have it by the end of May. Now, that said, there's a lot of confusion right now for people who have J&J appointments on the books. Some are going to get Pfizer or Moderna instead. Some are being rescheduled. But there's just going to be a lot of logistical challenges and frustration as this pause continues.

KELLY: Well, and to the point about every adult who wants it, as we know, there are parts of the country already where there are actually enough supplies. There are enough shots. But the challenge has been persuading people to go get those shots. Will this development scare some of those people off?

KEITH: It's not clear, but people who specialize in public health think that this sort of transparency is important, that, yes, this could create a temporary cloud of uncertainty but that if J&J is restarted at some point, there should be confidence in the public that it is safe. But this is another bad headline for a vaccine that has already had its share of bad headlines, including problems at a production facility in Baltimore.

You know, with or without these J&J challenges, there is a lot of work to be done to convince some share of the public - white conservatives and evangelicals, some African Americans and Latinos - you know, that any of these vaccines are safe and worth the effort to get vaccinated.

KELLY: So many challenges ahead. Pien, I'm going to give you the last word. In terms of what comes next, what happens with this pause? Do we know how long this pause might last?

HUANG: Yeah. Well, it's not completely clear right now how long it's going to last. Dr. Anthony Fauci said earlier today that that might be a few days, a few weeks. But currently, the FDA and the CDC are both independently reviewing the risks. And tomorrow the CDC's Vaccine Advisory Committee is meeting, and they'll be discussing what's known about these cases and voting to update the recommendations for how the Johnson & Johnson vaccine is used.

FDA officials have said that while it's not completely clear what's causing the problem, it does appear similar to some blood clotting cases in Europe, which was linked to a similar COVID vaccine made by the drug company AstraZeneca. That also appeared to be happening in younger women, so some countries ended up putting age restrictions around who gets that vaccine. So something like that could happen here, and it's the type of thing the CDC group will consider on Wednesday.

KELLY: That is NPR's Pien Huang and Tamara Keith.

Thanks, you two.

KEITH: You're welcome.

HUANG: Thank you.

(SOUNDBITE OF CORRE'S "TWO") Transcript provided by NPR, Copyright NPR.