The Director of the NIH’s National Institute of Allergy and Infectious Diseases, Anthony Fauci, speaks at the daily press conference at the White House in Washington, January 21, 2021.
Jonathan Ernst | Reuters
AstraZeneca is likely to issue a modified statement about its Covid-19 vaccine after the accuracy of the company’s clinical trial results was questioned earlier this week, White House chief medical advisor Dr. Anthony Fauci said on Wednesday.
The company announced on Monday the long-awaited results of its phase three clinical trial of the Covid-19 vaccine it developed with the University of Oxford, saying it was 79% effective in preventing symptomatic diseases and 100% effective against serious illnesses. and hospitalization.
The next day, the National Institute of Allergy and Infectious Diseases issued an unusual statement that said it had been informed by the data and safety monitoring board, or DSMB, which was overseeing the study, that the UK-based company may have included information in their US results that provided an “incomplete view of the effectiveness data.”
Fauci, director of NIAID, said the DSMB raised concerns about the U.S. agency because it considered the results in the AstraZeneca press release to appear more favorable than the latest data from the vaccine study showed, according to STAT News.
The company is now working with the DSMB and “will likely come out with a modified statement,” Fauci told reporters on Wednesday during a press conference at the White House about the pandemic.
Public health and vaccine experts told CNBC that the AstraZeneca data hiccup is just the latest example of a series of mistakes made by the company that could affect people’s willingness to get the vaccine, which can be authorized for use in the U.S. next month.
President Joe Biden’s senior pandemic advisor Andy Slavitt tried to reassure Americans about vaccines on Tuesday, telling CNN: “The public must be sure nothing will pass unless the FDA does a thorough analysis. of that data. “
When the AstraZeneca vaccine goes through the FDA review, the agency “will make a judgment on what the data says or what it says, and also whether or not it will be approved. And so, until that moment, all of this is just material that will be happen in the background, “said Slavitt. “We believe that this transparency and scientific independence are vital to public trust.”
The AstraZeneca vaccine is already authorized for use in other countries. The company said in a statement on Tuesday that it intended to disclose the results of its primary analysis of the Covid-19 vaccine “within 48 hours”.