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The North American pharmaceutical company Modernista requested this Monday authorization for the use of its vaccine against covid-19, after confirming that the effectiveness is 94.1%.
In this regard, the company requested the US authorities (FDA) to use the vaccine in an emergency, as well as conditional approval by the European Medicines Agency.
Two weeks ago, preliminary results were published that put the effectiveness of the vaccine at 94.5%, but the American company now announces that no safety problems have been reported, so it has a 100% success rate in preventing severe 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 it will provide a powerful new tool that will change the course of this pandemic and help prevent serious cases, hospitalizations and deaths ”, justifies Stéphane Bancel, CEO of Moderna.
According to the statement issued by Moderna, the phase 3 primary efficacy analysis of the COVE study for the Covid-19 vaccine was carried out in 196 patients with confirmed cases of covid-19, 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 effectiveness of the vaccine “was consistent in terms of age, race, ethnicity, and gender,” with no cases with serious effects so far.
Once the authorization request for the use of 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 the safety and efficacy data will be reviewed, and according to the information provided. by the FDA to Moderna, the results will be communicated on December 17, 2020.
