Emergency U.S. authorization for AstraZeneca COVID-19 vaccine likely in April

(Reuters) -The COVID-19 vaccine developed by British drugmaker AstraZeneca Plc and Oxford University will likely be authorized for emergency use in the United States in April, the chief adviser for the U.S. COVID-19 vaccine program said on Wednesday.

FILE PHOTO: Former GlaxoSmithKline pharmaceutical executive Moncef Slaoui, who will serve as chief adviser on the effort to find a vaccine for the coronavirus disease (COVID-19) pandemic, waits to speak as President Donald Trump holds a coronavirus disease response event in the Rose Garden at the White House in Washington, U.S., May 15, 2020. REUTERS/Kevin Lamarque

Operation Warp Speed chief adviser Dr. Moncef Slaoui said recruitment for the British drugmaker’s late-stage U.S. trial is almost complete with over 29,000 participants enrolled.

“We project, if everything goes well with readout and emergency use authorization may be granted somewhere in April,” Slaoui said.

British regulators approved AstraZeneca’s vaccine Wednesday, the first country in the world to do so, based in part on unpublished data.

Several scientists have raised doubts about the robustness of results from its British and Brazilian trials, showing the shot was 90% effective in a sub-group of trial participants. That group, by error initially, received a half dose followed by a full dose. But the efficacy was 62% if the full dose was given twice, as it was for most participants.

Slaoui said it would ultimately be up to the U.S. Food and Drug Administration as to how to evaluate the vaccine for U.S. authorization.

Slaoui was also cautious about whether the United States should implement similar guidance as the U.K. regulators to space out the second dose of Pfizer Inc’s by as much as 12 weeks, longer than what was studied in clinical trials.

While early data suggests that people have some protection against the virus after receiving their first dose, the length of time that protection lasts has not been studied, Slaoui said.

Officials said that 14 million doses of Pfizer’s and Moderna’s have been distributed to states, short of their goal to send enough doses to vaccinate 20 million Americans this month.

Only about 2 million Americans have been vaccinated thus far and officials said they were still studying why immunizations were slower than they anticipated.

Reporting by Mrinalika Roy in Bengaluru and Rebecca Spalding in New York; Editing by Arun Koyyur