The North American pharmaceutical Modernist requested this Monday the authorization for the use of its vaccine against the covid-19, after having been confirmed that the effectiveness is of 94,1%.
In this regard, the company asked the American authorities (FDA) to use the vaccine in an emergency, as well as conditional approval by the European Medicines Agency.
Preliminary results were published two weeks ago that put the vaccine’s effectiveness at 94.5%, but the American company now announces that no safety problem has been reported, which is why it has a 100% success rate in preventing serious cases , with more severe symptoms.
“This positive primary analysis confirms the ability of our vaccine to prevent covid-19 disease with 94.1% effectiveness and, more importantly, the ability to prevent severe cases of covid-19. We believe that our vaccine will provide a new and powerful tool that will change the course of this pandemic and help prevent serious cases, hospitalizations and deaths “, justified Stéphane Bancel, executive director of Moderna.
According to the statement released by Moderna, the COVE Study’s Phase 3 Primary Effectiveness Analysis for the Covid-19 vaccine was performed on 196 patients with confirmed covid-19 cases, of which 30 were severe. In this sense, it was found that the vaccine was effective in 94.1% of cases, with severe cases being 100% effective in severe cases.
Moderna’s note adds that the vaccine’s efficacy “was consistent with regard to age, race, ethnicity and gender”, with no cases with serious effects recorded so far.
After the application for authorization to use the vaccines has been made, Moderna’s next step will be to hold the meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) where safety and efficacy data will be reviewed, and according to information given by FDA to Moderna, the results will be communicated on December 17, 2020.
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