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March 22, 2021 – AstraZeneca today announced interim results from its phase III study in the USA showing 79% overall efficacy against symptomatic COVID-19, 80% efficacy in people 65 years of age and older and 100% efficacy against serious or critical illness and hospitalization. .
Company officials and clinical trial researchers also addressed recent concerns about blood clots, how well the variant vaccine will work, and provided a timeline for seeking regulatory approval.
With 30 million doses ready, the company plans to apply for emergency use authorization from the FDA “in a few weeks,” said Menelas Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca, during a press conference on March 22. .
Regarding the highly publicized reports of problems with blood clots from the AstraZeneca vaccine, the World Health Organization found that the vaccine does not create increased risks, as does the European Medicines Agency.
“We have had absolute confidence in the efficacy of the vaccine. Looking at this data now, I hope that others have more confidence that it is a very safe and effective vaccine,” said Pangalos.
“We’re glad this is being really thoroughly investigated,” said Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University in New York City. “It is incredibly reassuring that regulatory agencies have analyzed the data thoroughly and there is no enhanced signal above what is seen in the population.
“There were no worrisome signs in the US data,” he added.
The vaccine was well tolerated, the company reported, with no serious adverse events. Temporary pain and tenderness at the injection site, mild to moderate headaches, fatigue, chills, fever, muscle aches. and malaise are among the reported reactions.
Interim Phase III results show 141 cases of symptomatic COVID-19 in the study of 32,449 adults. “We don’t have the full breakdown yet … these are the high-level results that we just got this week,” Pangalos said. For example, no further information is yet available on rates of mild to moderate COVID-19 illness among the groups.
The company explained that the participants were randomly assigned to either the vaccine or the placebo, with twice as many receiving the actual vaccine.
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