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AstraZeneca scrambles to address concerns about vaccine efficacy data

AstraZeneca is facing new questions today after a highly unusual reprimand from a board overseeing the company’s clinical vaccine trials.The company is scrambling to respond to allegations that it used misleading data when claiming its vaccine was 79 percent effective against COVID-19 symptoms. Nick Schifrin breaks down the latest with epidemiologist Dr. Jennifer Nuzzo of Johns Hopkins University.

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  • Judy Woodruff:

    As we reported earlier, AstraZeneca is facing new questions today, after a highly unusual reprimand from a board overseeing the company's clinical trials.

    Just yesterday, AstraZeneca announced its COVID-19 vaccine was highly effective. But, today, it is scrambling to respond to allegations it used misleading data. Nick Schifrin reports.

  • Nick Schifrin:

    AstraZeneca, it's one of the world's most important COVID vaccines, inexpensive, easy to administer, and a primary vaccine not only for Europe, but also for the U.N.'s program for low-and middle-income countries.

    But the independent American panel of experts that oversees the company's trials accused the company in a letter seen by The New York Times of a selectively positive analysis of its own data. And the organization led by Dr. Anthony Fauci blamed the company and acknowledged its actions would increase vaccine hesitancy.

  • Dr. Anthony Fauci:

    This is really what you would call an unforced error, because the fact is, this is very likely a very good vaccine. And this kind of thing does, as you say, do nothing but really cast some doubt about the vaccines and maybe contribute to the hesitancy.

    It was not necessary. If you look at it, the data really are quite good. But when they put it into the press release, it wasn't completely accurate.

  • Nick Schifrin:

    Today, AstraZeneca acknowledged it had released an interim analysis of data from before February 17, and would release a primary analysis of the most recent data by Thursday.

    To discuss, I'm joined by Dr. Jennifer Nuzzo, an epidemiologist and senior scholar at Johns Hopkins Center for Health Security.

    Dr. Nuzzo, welcome to the "NewsHour."

    What did AstraZeneca do wrong? And how unusual is this pushback?

  • Dr. Jennifer Nuzzo:

    Well, the whole situation is quite unusual. And I don't fully understand why this happened.

    Essentially, there is a difference interpretation of the data in just a few percentage points. And the DSMB, the group from the NIH that put out the letter, wanted a slightly lower range of numbers to be presented, and AstraZeneca put in as slightly higher number.

    The difference is really marginal, and why they would have done this is quite unclear. Unfortunately, what it does then is raise questions about a vaccine that we don't need to have right now. We don't need to be having these questions that are not related to real issues of safety or efficacy.

    It is just an unfortunate situation, in that it could increase people's hesitancy about receiving this vaccine.

  • Nick Schifrin:

    But this isn't the first time that there have been questions about AstraZeneca. The company had a dosing error during clinical trials that it didn't disclose initially.

    The company promised about three times what it has delivered to Europe. Does all this increase the hesitancy, and does the company have more questions to answer?

  • Jennifer Nuzzo:

    I mean, it could. And that's really the worry here.

    To be clear, I don't think there is any reason in any of these stories to doubt the safety and efficacy of this vaccine. However, the perhaps even perceived lack of full transparency or the perception that the company isn't disclosing everything it needs to will unnecessarily raise questions about the vaccine, at a time when we're deeply concerned about people's willingness to be vaccinated.

    So, it is unfortunate that this has happened. It didn't need to happen. I think Dr. Fauci's assessment of it as being an unforced error is a correct one. And it is just unfortunate. The company had a setback last week, where a number of European countries had wanted to pause the use of the vaccine for real, legitimate concerns about safety.

    Those have been resolved, in the sense that the European Medicines Agency has reviewed the data, has spoken in favor of it. So has the WHO. And it was thought that this press release that they issued could help restore some confidence in a much-needed way for this vaccine, but now the stories today, I think, are only going to add some more question marks, which is just quite unfortunate.

  • Nick Schifrin:

    How can those question marks be answered?

    I'm thinking about three very public world leaders who got AstraZeneca just in the last few days, Moon of South Korea, Boris Johnson of the U.K. last week, Thailand's prime minister as well.

    What can be done to address the issues of hesitancy?

  • Jennifer Nuzzo:

    Well, I think national leaders have to do just that, continue to show support for the vaccine.

    Obviously, we're going to wait the full review of the AstraZeneca data in the United States. And I think — I'm guessing that the review will be quite favorable. That will be important.

    But, crucially, the company needs to answer for what happened here. They said they would come back in 48 hours with new data. It's really unfortunate. We shouldn't have to wait 48 hours to understand why they released 79 percent in their press release yesterday, when the DSMB had advised them to look at a different set of data.

    There's some questions that they have to answer, and I think they have to answer it quite soon and quite completely. And it's really important for them to disclose as much information as possible to just answer these questions, because, in a pause, in a gap of information, unfortunately, people can fill that gap with the wrong information.

  • Nick Schifrin:

    And, finally, the U.S. produces about a quarter of the world's COVID-19 vaccines, but so far has exported zero percent.

    The Biden administration points out it is the leading investor of the U.N.'s COVAX program. But do you believe the U.S. government needs to do better at exporting vaccines around the world?

  • Jennifer Nuzzo:

    So, I understand national leaders' dilemma. Their first responsibility is to the people who elected them. And I understand the pressure to get Americans vaccinated as quickly as possible and to focus on that, before we think about sharing vaccines with the rest of the world.

    But the pragmatic answer is that the United States is not going to be fully safe from COVID-19 until all countries are protected. And when we have a situation like we have now, where there are deep discrepancies in which countries have access to vaccines, and how much, it really does call for countries to share some of what they have, particularly countries like the United States that have much more than many, many other countries.

  • Nick Schifrin:

    Dr. Jennifer Nuzzo, thank you very much.

  • Jennifer Nuzzo:

    Thanks so much.

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