U.S. Health Officials Question AstraZeneca Vaccine Trial Results

However, federal officials were stunned to discover on Monday that AstraZeneca had released those results, despite the fact that the monitoring body had been pushing for and eventually receiving updated data for days. Until then, Dr. Fauci publicly welcomed the results at a White House briefing, and the company had been showered with positive media coverage. AstraZeneca’s shares rose around 4 percent on Monday.

AstraZeneca on Tuesday defended its actions, saying the interim results appeared to be “consistent” with more recent data collected during the trial. The company announced that it would immediately share its latest data with the Monitoring Board and republish more comprehensive results within 48 hours.

The company’s shares fell 3.5 percent on Tuesday.

Dr. H. Cody Meissner, an infectious disease expert at Tufts University School of Medicine, said he had never seen such a series of events with a vaccine developer before. “They know the anti-vaccine community will use this as fodder to argue that drug companies are always fooling,” he said.

Dr. Meissner, who serves on a panel that advises the FDA on vaccine approval, predicted that if AstraZeneca were to apply for such approval, board members would examine the hundreds of pages of data even more carefully than usual.

“I’ll make sure I don’t skip a word,” he said.

Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego, said it was “very infrequent” to see such public friction between a supervisory board and a drug company.

“I’ve never seen anything like it,” he said. “It’s so, so unsettling.”

AstraZeneca’s relationship with the US authorities has been very strained almost since the clinical trial began last summer. Senior health officials complained that the company was not open about the design of its clinical trials, its results, and safety issues.

Last week, an apparent delay in the release of the vaccine’s interim results sparked suspicion among federal officials.

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