The U.S. likely won't authorize AstraZeneca's COVID-19 vaccine for emergency use until April, Operation Warp Speed Chief Moncef Slaoui, PhD, said, Politico reported.
Though Dr. Slaoui, head of the White House's initiative to speed COVID-19 vaccine and drug development, had estimated in December that AstraZeneca would file for emergency use authorization with the FDA as early as February, the U.S. still has questions about the vaccine's efficacy in certain groups, particularly the elderly. Dr. Slaoui said the efficacy of the vaccine in older people is "effectively unknown" because few older people enrolled early in the trial, according to Politico.
The U.S. has ordered 300 million doses of the vaccine.
A late-stage trial of the vaccine was paused in the fall to assess a serious reaction in one participant, and promising early results were attributed to a dosing mistake.
According to preliminary data, the vaccine is 62 percent effective when patients are given two full doses 28 days apart. Researchers also found, due to a dilution mistake in one arm of a late-stage trial, that the vaccine was 90 percent effective in patients receiving a half-dose of the vaccine, followed by a full dose 28 days later, Politico reported.
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