Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases at the NIH, speaks about the daily press conference at the White House in Washington on January 21, 2021.
Jonathan Ernst | Reuters
AstraZeneca is likely to release a modified statement on its Covid-19 vaccine after questioning the accuracy of the company’s clinical trial results earlier this week, said Dr. Anthony Fauci, Chief Medical Advisor of the White House, on Wednesday.
The company announced on Monday the long-awaited results of its Phase 3 clinical trial of the Covid-19 vaccine it was developing at Oxford University. It is 79% effective in preventing symptomatic diseases and 100% effective against serious illness and hospitalization.
The next day, the National Institute of Allergy and Infectious Diseases released an unusual statement informing it from the Data and Safety Monitoring Board (DSMB) overseeing the study that the UK-based company may have included information in its US results which provided an “incomplete view of the efficacy data”.
Fauci, director of NIAID, said the DSMB has raised concerns with the U.S. agency because it believes the results in AstraZeneca’s press release are more favorable than more recent data from the vaccine study showed, according to STAT News.
The company is now working with the DSMB and “is likely to make a modified statement,” Fauci told reporters Wednesday during a White House press conference on the pandemic.
Public health and vaccines experts told CNBC that AstraZeneca’s data problem is just the latest example of a series of mistakes by the company that could affect people’s willingness to take the vaccine, which may be approved in the US as early as next month becomes.
President Joe Biden’s senior advisor on the pandemic, Andy Slavitt, attempted to reassure Americans about the vaccines on Tuesday, telling CNN: “The public should be confident that nothing will be approved if the FDA gets this data not thoroughly analyzed. “
When the AstraZeneca vaccine is reviewed by the FDA, the agency will “judge what the data says or what it says and whether or not it is approved. Until then, this is all just stuff that will do it.” happen in the background, “said Slavitt.” We believe this transparency and scientific independence are critical to public trust.
AstraZeneca’s vaccine is already approved for use in other countries. The company said in a statement Tuesday that it intends to release results of its primary analysis of the Covid-19 vaccine “within 48 hours”.