US Safety Board Asks If AstraZeneca Used ‘Outdated Information’ On Vaccine Results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overnight issued an unusual statement raising concerns from an independent safety committee that AstraZeneca included outdated or incomplete data in recently announced covid vaccine trial results.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."
AP:
US: AstraZeneca May Have Used Outdated Info In Vaccine Trial
Results from a U.S. trial of AstraZeneca’s COVID-19 vaccine may have included “outdated information” and that could mean the company provided an incomplete view of efficacy data, American federal health officials said early Tuesday.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 “looking into it.” (3/23)
Stat:
AstraZeneca May Have Used ‘Outdated Information’ In Announcing Results From Covid-19 Vaccine Trial, U.S. Officials Say
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,” NIAID said.
NPR:
AstraZeneca COVID-19 Vaccine Trial Data Questioned By Safety Board
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 —
AP:
Reputation Of AstraZeneca's COVID Vaccine Marred By Missteps
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. “I doubt it was (U.S. officials’) intention to deliberately undermine trust in the AstraZeneca vaccine,” said Dr. Paul Hunter, a professor of medicine at the University of East Anglia. “But this will likely cause more vaccine hesitancy.” (Cheng, 3/23)
Axios:
The U.S. May Not Need AstraZeneca's Coronavirus Vaccine
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)
Axios:
Europe Divided Over Two Vaccines: AstraZeneca And Sputnik V
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’s reputation in Europe, with majorities in France (61%), Germany (55%) and elsewhere now deeming it unsafe, according to a YouGov poll. (Lawler, 3/22)
