The National Institute of Allergy and Infectious Diseases said in an unusual statement that it had concerns about the validity of the efficacy data for AstraZeneca’s coronavirus vaccine, Politico reports.
The statement came after the Data and Safety Monitoring Board (DSMB), which is overseen by NIAID Chief Anthony Fauci, raised “concerns” just one day after AstraZeneca announced that its vaccine had 79% efficacy against infection and was 100% effective at preventing severe disease and hospitalization.
The rate midnight statement said that the pharmaceutical giant "may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data."
"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," the statement said.
The company said on Tuesday that the "numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of 17 February."
"We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis," AstraZeneca said, vowing to share updated data within 48 hours.
Fauci says “unforced error” for “good vaccine”:
AstraZeneca already faced problems getting approval in the US after it released efficacy data earlier that combined data from differing trials. It was later briefly banned by some European countries after unfounded reports that it may be linked to blood clots. Though the vaccinations have resumed in Europe, trust in the vaccine has plummeted.
Fauci told Good Morning America on Tuesday that the situation was "really what you call an unforced error because the fact is this is very likely a very good vaccine."
"This kind of thing does, as you say, do nothing but really cast some doubt about the vaccines and maybe contribute to the hesitancy," he added.
Fauci told Politico that the DSMB “wrote a rather harsh note” to AstraZeneca that prompted the statement.
“The issue that the DSMB had is straightforward and very simple: The DSMB had data that they know the company had. When they saw the press release, they said ‘wait a minute—the data in the press release do not reflect the most recent data that we know you have,'" he said.