AstraZeneca’s COVID-19 vaccine provided strong protection against sickness and eliminated hospitalizations and deaths from the disease, including in older adults, in final-stage U.S. testing, the company announced Monday.
AstraZeneca said its experts did not identify any safety concerns related to the vaccine, including finding no increased risk of rare blood clots identified in Europe. The question now is whether the findings will help rebuild public confidence in the vaccine around the world, as the company seeks to win clearance in the United StatesIn a statement, AstraZeneca said its COVID-19 vaccine was 79% effective at preventing symptomatic COVID-19 and was 100% effective in stopping severe disease and hospitalization, though it has not yet published full data so it’s unclear if there were enough severe cases to make that finding significant. Investigators said the vaccine worked across adults of all ages, including older people — something experts wanted better data on.
AstraZeneca’s interim results are based on 141 COVID-19 cases, but officials declined to tell reporters during a news conference Monday how many were in study volunteers who received the vaccine and how many in those who received dummy shots.
“These findings reconfirm previous results observed,” said Ann Falsey, of the University of Rochester School of Medicine, who helped lead the trial. “It’s exciting to see similar efficacy results in people over 65 for the first time.”
AstraZeneca will apply for authorization for use of the vaccine in the United States from the Food and Drug Administration in the first half of April, Ruud Dobber, a company executive vice president, told reporters Monday. An FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether to allow emergency use. Dobber said that, if the FDA OK’s the vaccine, the company will deliver 30 million doses immediately — and another 20 within the first month.The AstraZeneca shot, which has been authorized in more than 70 countries, is a pillar of a U.N.-backed project known as COVAX that aims to get COVID-19 vaccines to poorer countries, and it has also become a key tool in European countries’ efforts to boost their sluggish vaccine rollouts. But confidence in the shot has taken repeated hits because of concerns about how data was reported from some previous trials, confusion over its efficacy in older adults and a recent scare over clotting.Stephen Evans, of the London School of Hygiene & Tropical Medicine, said the new data could help to allay concerns about the vaccine.
“The benefits of these results will mainly be for the rest of the world where confidence in the AZ (AstraZeneca) vaccine has been eroded, largely by political and media comment,” he said.
The study comprised more than 30,000 volunteers, of whom two-thirds were given the vaccine while the rest got dummy shots. Two doses were given to people four weeks apart.
Dr. Paul Hunter, a professor of medicine at the University of East Anglia, said the results were reassuring but that more details were needed to back up AstraZeneca’s claim that the vaccine was completely effective at preventing severe disease and hospitalization.