However, federal officials were stunned to learn on Monday that AstraZeneca had released those results, even as the monitoring board spent days pushing – and eventually updating – the data. Until then, Drs. Fauci had publicly praised the results at the White House briefing, and the company was bombarded with positive media coverage. Shares of AstraZeneca rose nearly 4 percent on Monday.
AstraZeneca defended its actions on Tuesday, saying the interim results appeared to be “consistent” with recent data collected during the trial. The company said it would immediately share its latest figures with the monitoring board and reissue Fuller’s results within 48 hours.
The company’s shares fell 3.5 percent on Tuesday.
An infectious-pathologist from Tufts University School of Medicine, Drs. H. Cody Meisner said he had never seen such a sequence of events with the vaccinator. “You know that the anti-vaccine community is going to use it as bait to argue that pharmaceutical companies are always fraudulent,” he said.
Dr. Meisner, who serves on a board that advises the FDA to approve the vaccine, predicted that if AstraZeneca sought such authorization, board members would examine the data on its hundreds of pages Would be more careful than usual to do.
“I’ll make sure I don’t miss a word,” he said.
Dr., a clinical trial specialist at Scripps Research in San Diego. Eric Topol said it was “very irregular” to see such a public display of friction between the Board of Monitoring and the pharmaceutical company.
“I haven’t seen anything like this,” he said. “It’s very disturbing.”
AstraZeneca’s relations with US officials have deteriorated almost since he began his clinical trial last summer. Senior health officials complained that the company was not being clarified Design of its clinical trials, its results and safety issues.
Last week, an apparent delay in releasing the results of an interim trial of the vaccine created new suspicions among federal authorities.