Dr. Anthony Fauci, President Joe Biden’s chief medical advisor, again sought to reassure Americans that AstraZeneca PLC’s still-experimental COVID-19 vaccine is a strong candidate even though the drug maker reportedly miscommunicated findings from a clinical trial earlier this week.
U.S.-listed shares of AstraZeneca
were down 1.0% in afternoon trading on Wednesday.
“At the end of the day, you know, when you look at the data, this is going to turn out to be a good vaccine,” Fauci said during Wednesday’s White House COVID-19 briefing.
AstraZeneca on Monday announced in a press release that its coronavirus vaccine candidate, which is already authorized in the U.K. and the European Union, had a 79% efficacy rate when it comes to preventing symptomatic disease, according to interim findings from the U.S. arm of a late-stage clinical study. A news release issued that same day by the National Institute of Allergy and Infectious Diseases, which provided financial support for the clinical study, also cited the same efficacy figure.
However, much later that night, the NIAID, which is run by Fauci, said the clinical trial’s data safety and monitoring board had expressed concern that AstraZeneca had shared “outdated information” when it announced the interim results from the clinical trial.
(A data and safety monitoring board is a group of independent medical experts that oversee clinical trials. The board evaluates ethical issues that may arise and can make recommendations about whether a clinical trial should continue. Earlier this week, for example, a data and safety monitoring board recommended that Ionis Pharmaceuticals Inc.
and Roche Holding AG
halt a Phase 3 clinical trial for an investigational Huntington’s disease treatment.)
“The data and safety monitoring board was quite concerned that the data that was reflected in the press release was not the most recent updated data that was more accurately reflective of what the vaccine efficacy point was,” Fauci said Wednesday. “AZ is getting back with the data and safety monitoring board and will likely come out with a modified statement.”
AstraZeneca said Tuesday it plans to issue results of “a primary analysis with the most up-to-date efficacy data” sometime on Thursday.
As part of the emergency-use authorization process, the Food and Drug Administration will then evaluate the data submitted by AstraZeneca and is expected to share its own assessment of the vaccine in documents traditionally released about a day or two before a public meeting is convened by a vaccines advisory committee. (This also happened before the U.S. authorizations of vaccines developed by Pfizer Inc.
and Johnson & Johnson
“Everything is going to be open and transparent and hopefully that will dispel any hesitancy that was associated with this little bump in the road,” Fauci said.
AstraZeneca’s U.S.-listed stock has gained 19.6% over the past 12 months, while the broader S&P 500
is up 60.3%.