The vaccine maker is preparing to apply for emergency authorization from the Food and Drug Administration. But the vaccine may not be needed in the United States.
If AstraZeneca wins authorization for emergency use in the U.S. based on the new results, the vaccine will likely not become available until May, when federal officials predict that three other authorized vaccine manufacturers will be producing enough doses for all the nation’s adults.
The announcement comes at a deeply fraught moment for AstraZeneca. More than a dozen countries this month briefly suspended inoculations with the shot over concerns about possible rare side effects, the latest in a series of problems for AstraZeneca that have undermined confidence among both the public and some government officials.
AstraZeneca said on Monday that it would continue to analyze the new data to and prepare to apply for emergency authorization from the Food and Drug Administration. The vaccine has already been authorized in more than 70 countries, but clearance from American regulators, if the company can secure it, would be a boost to the firm.
The U.S. trial also recruited participants from Chile and Peru. It found AstraZeneca’s vaccine to be 79 percent efficacious in preventing symptomatic infections. The vaccine was particularly good at preventing severe disease, with 100 percent efficacy in that regard among trial participants who got the vaccine — a major selling point for the shot.
Its overall efficacy was higher than that observed in the vaccine’s previous clinical trials, despite being used on a dosing schedule that may not be optimal. Oxford said that figure could be affected by the thresholds it set for symptomatic Covid-19 cases.
The regulators found that the vaccine did not increase overall risk of blood clots, but said they could not rule out the possibility of a link between the vaccine and a rare complication leading to bleeding in the brain. A new warning label will be added to the shot so health practitioners will be on the lookout for possible indications of that illness.
Source: New York Times