That study, being run by the researchers at the University of Oxford who developed the vaccine, has enrolled more than 11,000 people in the U.K., South Africa and Brazil. Those overseas trials started in June and are on track to wrap up later this year, the company said. AstraZeneca is planning a similar trial in the United States that it hopes will enroll 30,000 people.
The company struck a $1.2 billion deal in May to provide the U.S. with 300 million initial doses of the shot.
Why it matters: The rumors about imminent authorization of the AstraZeneca vaccine come at a tricky time for the FDA. President Donald Trump is urging the FDA to move faster on coronavirus shots, and FDA Commissioner Stephen Hahn is working to build up the public’s confidence that it won’t sacrifice safety or efficacy for speed.
But it’s not clear whether the agency is bearing up under White House pressure. The FDA held off last week on authorizing emergency use of blood plasma for coronavirus patients over concerns that data supporting its use was thin. Days later, the agency reversed itself — after Trump accused it of slow-walking the authorization to harm his reelection chances.
“Data is driving the development of all COVID-19 countermeasures. Careless talk about career F.D.A. experts somehow approving an unsafe and ineffective vaccine just for politics only undermines confidence in the public health system,” HHS spokesperson Michael Caputo said in a statement Monday.