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Brazilian pediatric doctor Monica Levi, one of the volunteers who received the COVID-19 vaccine, works at the Specialized Clinic in Infectious and Parasitic Diseases and Immunizations (CEDIPI), in Sao Paulo, Brazil.
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The U.S. Food and Drug Administration is unlikely to authorize AstraZeneca’s Covid-19 vaccine candidate prior to the completion of a large U.S. trial in the coming months, a top government adviser said on Wednesday.
Last week, AstraZeneca AZN, +0.77% and the University of Oxford reported results from trials in the U.K. and Brazil showing that their vaccine was 62% and 90% effective in preventing infections depending on the dose given to volunteers. The higher protection rate occurred in patients who mistakenly received a half-dose of the vaccine followed by a full dose a month later, an unexpected result that has puzzled some scientists and AstraZeneca executives.
“Frankly, unless there is a very clear explanation based on facts and data for what’s behind those two numbers, it’s very likely that that package would not be sufficient for an approval–I’ll be the first one to say it,” Moncef Slaoui, chief scientific adviser to the U.S. government’s Operation Warp Speed, told reporters. The operation is a $10 billion initiative aimed at speeding development of coronavirus vaccines. “But of course the FDA will make their own decision.”
In addition, by the time AstraZeneca is able to submit to U.S. regulators detailed data from the overseas studies on the vaccine’s effectiveness, safety and manufacturing processes, results from a large, continuing U.S. trial are likely to be available, said Dr. Slaoui.
An expanded version of this story appears on WSJ.com.
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