Coronavirus, Ema begins Modern vaccine approval process. The company: "94.5% effective"

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November 16, 2020After that of AstraZeneca and the University of Oxford, the EMA (European Medicines Agency) has begun to analyze the data of the mRna-1273 anti-Covid vaccine developed by Moderna Biotech Spain, a subsidiary of the American Moderna.

As the EMA specifies on its website, it was decided to start with the rolling review procedure, the first step of the approval process, based on the preliminary results of the non-clinical studies and the first clinical studies done on adults, which seem that the vaccine stimulates the production of antibodies and immune T cells against the SarsCov2 virus.

The vaccine with messenger RNA developed by the US company Moderna (mRNA-1273) has shown an efficacy against Covid-19 equal to 94.5%.

The same company announces it in a statement a few days after Pfizer's announcement of a 90% effective vaccine.

The findings emerge from a phase 3 study called Cove "that enrolled more than 30,000 participants in the United States," conducted in collaboration with the National Institute of Allergy and Infectious Diseases, the National Institutes of Health (NIH), and Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health.

"The security analysis - adds Moderna - has not reported any significant security problems".

The vaccine is "safe and well tolerated".

The vaccine developed by the US company Moderna, "94.5% effective", remains stable at a temperature between 2 ° and -8 ° C "the temperature of a normal household or medical refrigerator, for 30 days".

This was announced by the same company in a statement underlining that the mRNA-1273 vaccine "remains stable at -20 ° C for up to six months" while at room temperature "the maximum duration of effectiveness is equal to 12 hours".

"We believe our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our candidate COVID-19 vaccine at temperatures commonly found in readily available pharmaceutical freezers and refrigerators," he said. stated Juan Andres, Chief Technical Operations and Quality Officer at Moderna.