MOSCOW, November 26 - RIA Novosti. Even the minimal study-based efficacy of the AstraZenec vaccine of 62% meets the threshold for its approval, said Mene Pangalos, executive vice president of research and development for biopharmaceuticals, in response to criticism of the developed drug, according to the Wall Street Journal.
On Monday, researchers released preliminary results from a Phase III clinical trial of the vaccine. Researchers estimated an average vaccination efficacy of 70.4%, with a minimum efficacy of 62% and a maximum of 90%. Scientists were surprised that the effectiveness of the vaccine was higher in the case when the patients were first given half and then the full dose of the vaccine - in this case, the developers estimated the effectiveness of the vaccine at 90%. However, with the introduction of two full doses, the efficacy was 62%. Bloomberg news agency on Wednesday, referring to the adviser to the administration of the incumbent US President Donald Trump, Monsef Sloughi, said that the dosage of the vaccine, which showed great effectiveness, was tested on volunteers no older than 55 years.
According to Pangalos, the vaccine dosing error in the trials came after a researcher noticed that the volunteers did not have such an inflammatory response to the vaccine. Researchers analyzed the vaccine stock and found they were in the wrong dosage. AstraZenec has informed regulators in the UK, US and EU and amended its research agenda to include a half-dose group in its analysis.
"The error doesn't really matter … Whichever way you look at the data, even if you only believe the full dose, the (vaccine study results - ed.) Full dose data. We still have efficacy that meets the thresholds for vaccine approval, the efficiency of which exceeds 60% ", - said Pangalos.
He also said that the reasons why half the dose of the vaccine was more effective has not yet been clarified, and AstraZene plans to test half the dose in a large study in the United States, in which more than 30 thousand volunteers are expected to participate.
Earlier, the chief researcher at the World Health Organization Sumiya Swaminathan noted that preliminary data on the vaccine being developed by the University of Oxford and the pharmaceutical company AstraZeneca is based on a study among "a very small number of patients." Jeffrey Porges, an analyst at investment bank SVB Leerink, suggested that the US Food and Drug Administration (FDA) is unlikely to approve a coronavirus vaccine from British pharmaceutical company AstraZenec due to the testing conditions.
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