AstraZeneca plans to apply for US emergency nod for Covid-19 jab in April
Mar 22, 2021
Cambridge [UK], March 22 : AstraZeneca said on Monday that the company plans to apply for emergency use authorization from the US Food and Drug Administration for its Covid-19 vaccine in the first half of April.
"We are thrilled by the results we have disclosed this morning," AstraZeneca's biopharmaceuticals business unit president Ruud Dobber told CNBC's Meg Tirrell as quoted by CNN.
The company released its Phase 3 trial results earlier Monday that showed the vaccine was 79 per cent effective against symptomatic disease and 100 per cent effective against severe disease and hospitalization.
The results are based on 32,449 participants in the United States, Peru and Chile.
"The plan is to file in the first half of April for the emergency use authorization... Of course, then it's in the hands of the FDA, how fast they can decide about the approval," Dobber said.
CNN reported that assuming that the authorization takes place quickly, AstraZeneca hopes to deliver 30 million doses for use "instantly after the EUA," Dobber said.
The Oxford-AstraZeneca vaccine became the subject of controversy earlier in the month when more than a dozen European countries paused their rollouts due to reports of blood clotting in patients post-vaccination.
Europe's medicines regulator, the European Medical Authority (EMA), investigated the concerns and on Thursday declared the Oxford-AstraZeneca vaccine to be "safe and effective." EMA executive director Emer Cooke said the group did not find that the vaccine causes clotting, though it could not definitively rule out a link to a rare blood clotting disorder.
She added that the benefits of the vaccine outweigh the risks, a message previously stressed by both the EMA and the World Health Organization (WHO) earlier in the week.
