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The announcement of the American biotechnology company: result of a phase 3 study with more than 30,000 participants in the United States. Ema begins the approval process
The announcement of the American biotechnology company: result of a phase 3 study with more than 30,000 participants in the United States. Ema begins the approval process
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After Pfizer, the announcement of another anti-Covid vaccine comes this time by Moderna: The American biotechnology company has published phase 3 human experimentation data for the mRNA-1273 vaccine showing an efficacy of almost 95% (94, 5). Furthermore, the vaccine can be stored at a temperature between 2 and 8 degrees (values guaranteed by a domestic refrigerator) for 30 days (compared to the 7 estimated in a previous study phase), without the need to keep it in the freezer. the “stability” of the drug is instead of 12 hours at room temperature.
This confirms the provisions of virologists and industry experts: the availability of two vaccines to stop the Covid breed within the year. “We believe that our investments in mRNA delivery technology and manufacturing process development – Juan Andrés, Director of Technical Operations and Quality at Moderna – will allow us to store and ship our candidate COVID-19 vaccine at temperatures commonly found in freezers and refrigerators. readily available pharmaceuticals ”.
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Phase 3
Moderna had completed the enrollment of 30,000 volunteers in the United States for phase 3 on October 22. such as people over 65 or people under that age group but with chronic diseases (diabetes, obesity, heart disease).
Ema starts the approval process
Data from the anti-Covid mRna-1273 vaccine developed by Moderna Biotech Spain (a subsidiary of American Moderna) is being examined by the European Medicines Agency. This was announced by Ema herself, who explained how the approval process will begin with the “continuous review” procedure, the first step in the approval process, based on the preliminary results of non-clinical studies and the first clinical studies conducted in adults. . which seems to indicate that the vaccine stimulates the production of antibodies and immune T cells against the SarsCov2 virus.
