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Morning Briefing

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Tuesday, Mar 23 2021

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US Safety Board Asks If AstraZeneca Used 'Outdated Information' On Vaccine Results

The National Institute of Allergy and Infectious Diseases overnight issued an unusual statement raising concerns from an independent safety committee that AstraZeneca included outdated or incomplete data in recently announced covid vaccine trial results. The company told AP it is "looking into it."

Results from a U.S. trial of AstraZeneca鈥檚 COVID-19 vaccine may have included 鈥渙utdated information鈥 and that could mean the company provided an incomplete view of efficacy data, American federal health officials said early Tuesday. A spokesman from the drug company said Tuesday it was 鈥渓ooking into it.鈥 (3/23)

In a statement issued soon after midnight Tuesday morning, the National Institute of Allergy and Infectious Diseases said it had been informed about the data questions by the data and safety monitoring board auditing the trial. DSMBs consist of independent medical experts who provide an extra screen of data produced from clinical trials. "We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,鈥 NIAID said.

It's unclear what, if any, impact this development could have on a possible future rollout of an AstraZeneca vaccine in the U.S. It's also still unknown what this news could mean for the vaccine's alleged efficacy. The pharmaceutical company had just released preliminary results from its late-stage COVID-19 vaccine trial earlier on Monday. Those results showed two doses of the vaccine administered four weeks apart had an efficacy of 79% at preventing symptoms of COVID-19 and an efficacy of 100% at preventing severe illness and hospitalization. (Diaz, 3/23)

In related news about the AstraZeneca vaccine 鈥

Coupled with earlier missteps in reporting data and a recent blood clot scare, experts said the new stumble could cause lasting harm to the shot that is key to global efforts to stop the pandemic and erode vaccine confidence more broadly. 鈥淚 doubt it was (U.S. officials鈥) intention to deliberately undermine trust in the AstraZeneca vaccine,鈥 said Dr. Paul Hunter, a professor of medicine at the University of East Anglia. 鈥淏ut this will likely cause more vaccine hesitancy.鈥 (Cheng, 3/23)

Public health experts are divided over whether the U.S. should add AstraZeneca's coronavirus vaccine to its arsenal, or let the rest of the world have it. By the time the AstraZeneca vaccine is authorized for distribution, the U.S. may already have more than enough supply. Meanwhile, most of the world is still waiting for shots. (Owens, 3/23)

Long-awaited data from the Oxford/AstraZeneca U.S. trial suggests the vaccine is safe, 79% effective at preventing symptomatic COVID-19, and fully effective at preventing hospitalizations and deaths. The suspension of the vaccine in at least 13 countries due to blood-clotting concerns has severely damaged the shot鈥檚 reputation in Europe, with majorities in France (61%), Germany (55%) and elsewhere now deeming it unsafe, according to a YouGov poll. (Lawler, 3/22)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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