Federal health officials are casting doubts about AstraZeneca’s vaccine data just hours after the company announced that its shot is safe and effective, leading the drugmaker to promise updated data within two days.
The National Institute of Allergy and Infectious Diseases said in a rare statement late Monday that its Data and Safety Monitoring Board, the independent panel overseeing coronavirus vaccine trials, that it was concerned AstraZeneca had included “outdated information” in an announcement touting its shot’s 79 percent effectiveness against the virus.
The DSMB “wrote a rather harsh note” to AstraZeneca with NIAID Director — and Biden medical adviser — Anthony Fauci copied in, he told POLITICO. “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.
Fauci also discussed the issue during an appearance Tuesday morning on Good Morning America. The data board felt the data released by AstraZeneca “might, in fact, be misleading a bit, and wanted them to straighten it out,” he said.
AstraZeneca said on Tuesday morning that its results were based on an interim analysis of data before February 17, more than a month ago. But the company defended its decision to release those findings, saying that it reviewed a “preliminary assessment” of the final results and found them consistent with the earlier data.
Fauci oversees the DSMB that assess trials results for AstraZeneca and other vaccine makers; he ratifies the board’s decisions but is not involved directly in its assessments. All results will still need to go before the Food and Drug Administration, which authorizes drugs and vaccines for use.
The trial confusion and public reprimand from federal scientists comes after a series of PR blunders that have eroded public confidence in AstraZeneca’s vaccine and aggravated government officials across the world. Thirteen countries in Europe suspended use of the shot after unsubstantiated blood clot concerns this month; meanwhile in the U.S., the authorization timeline has dragged on after the company admitted a dosing mistake in their British trial.
AstraZeneca plans to file with FDA by mid-April, but their timeline relies on the DSMB clearing its trial results. Fauci said there is not necessarily a delay to the primarily analysis — the data the DSMB says is actually the most up-to-date — but that ” it’s just data coming in, additional cases coming in.”
The drugmaker meanwhile is promising that it can set things right soon.
“We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours,” AstraZeneca said.