Axios Vitals: Why the credibility of AstraZeneca's vaccine data matters

1 big thing: Why the credibility of AstraZeneca's data matters | Wednesday, March 24, 2021

Open in app View in browser   Presented By Blue Cross Blue Shield Association   Vitals By Caitlin Owens ·Mar 24, 2021 Good morning. Join Axios' Kim Hart and Erica Pandey tomorrow at 12:30pm ET for a virtual event on the safe return to in-person learning, featuring Rep. Bobby Scott (D-Va.) and California State Superintendent of Public Instruction Tony Thurmond. Register here. Today's word count is 790, or a 3-minute read.     1 big thing: Why the credibility of AstraZeneca's data matters Illustration: Aïda Amer/Axios   The world desperately needs to be able to believe in AstraZeneca's coronavirus vaccine, and the never-ending confusion over its clinical data isn't helping, Axios' Sam Baker reports. The big picture: The extraordinary public dispute between the company and independent experts risks undermining patients' trust, experts said, even if the vaccine turns out to work well. Driving the news: The independent review board overseeing clinical trials for AstraZeneca's vaccine, developed in partnership with Oxford University, protested to the NIH after the company said in a press release that the product had proven 79% effective. Those experts told federal officials they thought the company had sliced the data in a way that overstated the vaccine's effectiveness. The other side: AstraZeneca has said it will release a fuller analysis soon, and that it'll show results consistent with what it claimed in its press release. What they're saying: "I think everybody is sort of stunned," said Jennifer Nuzzo, an epidemiologist at Johns Hopkins. "There are billions of eyeballs on these data." The public rift between a drug company and independent reviewers is highly unusual. And it's all the more frustrating, experts noted, because this particular trial was designed in part to help quell some of the uncertainty AstraZeneca caused with its other studies. "It's one thing for a drug company or sponsor to bungle this on the first go but this is the second time this company has released information that was inaccurate and confusing, and it's incredibly frustrating," said Jonathan Kimmelman, a bioethicist at McGill University. Between the lines: If AstraZeneca oversold its findings, it'll create a perception that it needed to juice the numbers. If outside experts overreacted to a minor statistical issue, it'll keep a cloud hanging over an effective vaccine. Either way, it's bad news. Go deeper.     2. What happened just gets muddier So what exactly is the issue with AstraZeneca's data? It's still evolving, but the bottom line is that an independent data monitoring board believes the company reported an efficacy number from February that, in real life, decreased in March. Between the lines: Multiple outlets yesterday reported that the board and AstraZeneca had been going back and forth about the data before the company issued Monday's press release. The data the board was reviewing showed efficacy of around 70% to 79%, which shifted daily based on new data, WSJ reports. The board had recently told AstraZeneca that it should not report an efficacy rate above 75%. With another month of data taken into account, the effectiveness ranged from 69% to 75%, the Washington Post reported. The other side: AstraZeneca executives still see the data acquired since mid-February as needing further review, per WSJ. The company's internal view is that the efficacy numbers it will present to U.S. regulators will be within one or two percentage points of what AstraZeneca announced this week, sources told the Journal. What we're watching: This isn't going to be a mystery forever. The company will release more data very soon, and then we'll see the data that it submits to the FDA when it applies for authorization.     3. More good hospitalization news Data: Centers for Disease Control and Prevention; Chart: Michelle McGhee/Axios Older adults' share of coronavirus hospitalizations is shrinking, per the CDC's COVID-NET, a surveillance network representing about 10% of the U.S. population. Why it matters: Americans 65 and older are significantly more likely to be vaccinated than younger Americans. Their shrinking share of hospitalizations is yet another suggestion that the vaccination effort is working. Older Americans are also at higher risk of dying from the virus, making it extra important to keep them out of the hospital in the first place. Go deeper: Nursing home COVID cases have drastically declined     A message from Blue Cross Blue Shield Association Connecting vulnerable seniors with vaccines     Blue Cross and Blue Shield companies nationwide are using data and local relationships to help vaccinate millions of at-risk seniors living in underserved and vulnerable communities where COVID-19 vaccines are most inequitable. See how.     4. COVID infections among the vaccinated are rare Illustration: Aïda Amer/Axios   Fully vaccinated people can still get COVID, but it's pretty rare, according to a pair of studies published in the New England Journal of Medicine. By the numbers: One study published Tuesday found that only four out of 8,121 fully vaccinated employees at the University of Texas Southwestern Medical Center in Dallas became infected, Axios' Marisa Fernandez reports. The other study found that seven out of 14,990 vaccinated health care workers at Los Angeles hospitals tested positive. Some of the positive health workers showed mild symptoms, but some were asymptomatic, suggesting that the vaccines were protective, Francesca Torriani, lead researcher on the study, told the New York Times. What they're saying: "Currently, there is no evidence that COVID-19 after vaccination is occurring because of changes in the virus," Kristen Nordlund, spokesperson for the CDC, tells Axios. "Based on what we know about vaccines for other diseases and early data from clinical trials, experts believe that getting a COVID-19 vaccine might also help keep you from getting seriously ill, even if you do get COVID-19."     5. Catch up quick Illustration: Aïda Amer/Axios   The special enrollment period for Americans to sign up for Affordable Care Act health plans will continue through Aug. 15, the Biden administration announced Tuesday. The FDA issued an Emergency Use Authorization for a Catalent Pharma plant in Bloomington, Indiana, allowing it to produce and ship doses of Johnson & Johnson's coronavirus vaccine, the company announced Tuesday. People around the world spent 148% more time in meetings and sent 45% more chats in February 2021 than in February 2020, per an analysis of aggregate Microsoft Teams data.     A message from Blue Cross Blue Shield Association Taking action to fight the pandemic     Blue Cross and Blue Shield companies have committed more than $7 billion to help the nation address the COVID-19 outbreak by: Providing premium relief. Enhancing access to telehealth. Investing to support people in need. Learn more.   This newsletter is written in Smart Brevity®. Learn how your team can communicate in the same smart, clear style with Axios HQ.   Axios thanks our partners for supporting our newsletters. Sponsorship has no influence on editorial content. 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