Andrew DunnTue, 23 March 2021, 2:15 pm
- Dr. Anthony Fauci says an AstraZeneca statement on its COVID-19 shot wasn’t “completely accurate.”
- “This is really what you call an unforced error,” Fauci said Tuesday on “Good Morning America.”
- AstraZeneca on Monday announced success in a large trial and is planning to seek an emergency OK.
- See more stories on Insider’s business page.
In a rare public rebuke, the top US infectious-disease doctor is criticizing the pharmaceutical company AstraZeneca for statements it recently made about its coronavirus vaccine.
Dr. Anthony Fauci said on Tuesday that AstraZeneca’s Monday press release about its COVID-19 vaccine “wasn’t completely accurate.”
On Monday, AstraZeneca announced success in a 32,000-person clinical trial conducted mainly in the US. The news was supposed to provide a much-needed moment of clarity on the two-dose vaccine. Instead, the announcement has become the latest controversy facing the program, which has already faced a string of confusion from public missteps by the company.
The National Institutes of Health’s infectious-disease unit, which Fauci leads, issued an extraordinary statement shortly after midnight on Tuesday. The board of independent experts that oversees the study “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the statement said.
AstraZeneca on Tuesday said it would release the “most up to date efficacy data” within 48 hours.
In Tuesday-morning interviews, Fauci elaborated on the late-night statement from US health authorities. He told the health-news publication STAT that he was “sort of stunned” by AstraZeneca’s press release.
“This is really what you call an unforced error,” Fauci said in a “Good Morning America” interview Tuesday.
AstraZeneca’s release said the study showed the vaccine was 79% effective at preventing symptomatic disease and 100% effective at stopping severe disease. That interim analysis included 141 cases of COVID-19 among trial participants and five cases of severe disease.
The expert panel took issue with the company announcing interim results based on data that was current as of February 17. Fauci, the nation’s top infectious-disease expert, said that the full data set still showed the shot was safe and effective at preventing COVID-19.
By basing its release on an early view of the data, AstraZeneca may have made its vaccine appear better, leading the data and safety monitoring board to write “a rather harsh note” to the company saying the release was misleading, copying Fauci on the letter, he said.
“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,” Fauci told “Good Morning America.” “We have to keep essentially trying as hard as we can to get people to understand there are safeguards in place.”
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