While the U.K. will begin using AstraZeneca’s coronavirus vaccine, it likely won’t be authorized for use in the U.S. until April, Politico reports.
Moncef Slaoui, head of Operation Warp Speed, shared the updated timeline during a Wednesday press call.
Earlier this month, Slaoui predicted the British drugmaker would seek an emergency use authorization with the Food and Drug Administration as early as February. The date has been pushed back because of outstanding questions about the vaccine’s effectiveness in certain groups. U.K. regulators signed off on using the vaccine on Wednesday.
“We project, if everything goes well, that the readout and emergency use authorization may be granted somewhere early in the month of April,” Slaoui said.
The U.S. has already ordered 300 million doses of the vaccine candidate, which is administered in two shots. A late-stage trial was put on hold in September after reports of serious reactions to the shot emerged.
Slaoui said there is concern over how effective the vaccine is among the elderly because not many older people participated in early trials.
British health officials are also taking a different approach when it comes to vaccinating people. Instead of holding back doses to make sure people get a second shot, officials said they would opt to broadly vaccinate the country with the first doses and provide the second within three months. In doing so, they hope to provide some form of protection to more people quickly. Slaoui said their approach is based more on theory than evidence.
AstraZeneca’s vaccine so far shows 62% efficacy when used as two full doses administered 28 days apart. But after a dilution mistake in one arm of a phase 3 trial, scientists found that the vaccine was 90% effective when a small group received a half-dose first.
The drugmaker claims the vaccine has a 70% efficacy. Slaoui hinted that U.S. regulators would not be satisfied by that conclusion.
“As far as the American people are concerned, I think it’s important to say one vaccine has 95% efficacy, another vaccine has X percent, whatever that number,” Slaoui told reporters, referring to the high efficacy rates for the Pfizer and BioNTech and Moderna vaccines that the FDA has currently authorized. “We need a clear and concrete number more than a number that is accumulated by adding together different trials with different schedules and different materials.”
Marisa Herman ✉
Marisa Herman, a Newsmax senior reporter, focuses on major and investigative stories. A University of Florida graduate, she has more than a decade of experience as a reporter for newspapers, magazines, and websites.
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