March 22, 2021 – AstraZeneca announced interim results for its Phase III The American study today that show 79% overall effectiveness against symptomatic COVID-19, 80% effectiveness in people 65 years of age and older, and 100% effectiveness against severe or critical illness and hospitalization.
Company officials and clinical trial investigators also addressed recent concerns about blood clots, the performance of the variant vaccine, and provided a timeline for obtaining regulatory approval.
With 30 million doses ready, the company plans to file an emergency use authorization application with the FDA “within a few weeks,” said Menelas Pangalos, executive vice president of research and development. biopharmaceuticals at AstraZeneca, during a press briefing on March 22.
Regarding the high profile reports of blood clot problems due to the AstraZeneca vaccine, the World Health Organization found that the vaccine does not create greater risks, just like the European Medicines Agency
“We had absolute confidence in the effectiveness of the vaccine. Seeing this data now, I hope others will further confirm that it is a very safe and effective vaccine,” Pangalos said.
“We are pleased that this is being investigated fully,” said Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University in New York. “It is incredibly reassuring that the regulatory agencies have examined the data thoroughly and that there is no improved signal above what is seen in the population.”
“There was no worrying signal noted in the US data,” she 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 headache, fatigue, chills, fever, body aches. and discomfort were among the reactions reported.
Phase III interim results show 141 symptomatic COVID-19 cases in the study of 32,449 adults. “We don’t have the full breakdown, but these are the top results we just got this week,” Pangalos said. For example, further information on the rates of mild to moderate COVID-19 between groups is not yet available.
The company explained that participants were randomly assigned to either the vaccine or the placebo, with twice as many receiving the actual vaccine.
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