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The first interim analysis included 95 participants with confirmed COVID-19 cases
The initial results of the clinical trials of the American biotechnology company Moderna show that the vaccine they developed against COVID-19 showed an effectiveness of 94.5%. The results are from the third phase of clinical trials. The first interim analysis included 95 participants with confirmed COVID-19 cases, the company said.
In the coming weeks, Moderna intends to apply for an emergency use permit from the US Food and Drug Administration. The company expects the permit to be based on a final analysis of 151 cases and a median follow-up of more than 2 months.
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“This is a turning point in the development of our candidate for the COVID-19 vaccine. We have been chasing this virus since the first days of January to protect as many people as possible around the world. We have always been aware that every day mattered. This positive interim analysis from our phase 3 study gave us the first clinical confirmation that our vaccine can prevent COVID-19 disease, including severe disease, “said Stefan Bansel, CEO of Moderna.
The company has announced a longer shelf life for its refrigerated COVID-19 vaccine candidate. The vaccine is expected to remain stable between 2 and 8 degrees Celsius for 30 days, an increase from the previous prediction of 7 days.
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“We believe that our investment in mRNA delivery technology and in the development of a manufacturing process will allow us to store and transport our candidate COVID-19 vaccine at temperatures typical of widely available pharmaceutical freezers and refrigerators,” said Juan Andrés. , Director of Technical Operations and Quality at Moderna.
“We are pleased to be able to propose for regulatory approval these extended stability conditions for mRNA-1273. The ability to store our vaccine for up to 6 months at minus 20 degrees Celsius, including up to 30 days under normal refrigeration conditions after thawing, is a important advance and will allow a simplified distribution and more flexibility to facilitate vaccination on a larger scale in the United States and other parts of the world, ”he said.
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