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The candidate vaccine from the American company Modern is 94.1% effective against Covid and 100% in severe cases. This was announced by the company, announcing the results of phase 3 tests in 196 cases. Hoy Moderna will apply to the US pharmaceutical authority FDA for an emergency use authorization and to the European Medicines Agency EMA for a conditional authorization.
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The United States Drug Authority (FDA) Vaccine Committee is expected to meet on December 17 to review the efficacy and safety data of the company’s Covid candidate mRNA-1273 vaccine candidate Moderna. This was announced by the same company, specifying that the distribution of the vaccine in the US will take place immediately after an authorization for emergency use is granted.
The CEO: “Powerful New Tool”
This positive analysis confirms the ability of our vaccine to prevent Covid-19 with an effectiveness of 94.1% and, above all, the ability to prevent serious forms. We believe that our vaccine will provide a powerful new tool that could change the course of this pandemic and help prevent serious illness, hospitalizations, and deaths. This was stated by Stéphane Bancel, CEO of Moderna, when reporting the latest data from the phase 3 trial of the candidate vaccine. “We will submit an emergency use authorization request to the Food and Drug Administration today and continue to move forward with ongoing reviews that have already begun with various regulatory agencies around the world,” he adds. «I want to thank – adds Bancel – to the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the personnel of the clinical trial sites at the forefront of the fight against the virus. I would like again to thank our partners at Nih, Niaid, Barda and Operation Warp Speed who assisted us in the clinical development of mRna-1273. Finally, I want to thank the Moderna team and our suppliers and partners for their tireless work in the research, development and production of our vaccine.
Twenty million doses in the US by 2020
By 2020, Moderna expects to have approximately 20 million doses of the Covid mRNA-1273 vaccine available in the United States and plans to produce between 500 million and 1 trillion doses globally by 2021. Moderna also announced new advancements aimed at ensuring that the distribution, storage, and handling of vaccines can be done using existing infrastructure.
A death in the volunteer group
The results are related to the COVE phase 3 study for the RNA-1273 vaccine candidate that involved a total of 30,000 participants in the US, including 196 Covid-19 cases of which 30 were severe cases. The candidate vaccine has proven to be well tolerated in general, and to date no serious problems with its safety have been identified. The analysis presented today by Moderna is based on 196 cases of Covid: of these, 185 cases were observed in the group of volunteers treated with placebo, compared to 11 cases observed in the group of volunteers vaccinated with mRNA-1273. This resulted in an estimate of the efficacy of the vaccine of 94.1%. Severe Covid-19 cases were also analyzed, and 30 of these cases were considered in the analysis: all 30 severe cases occurred in the placebo group and none in the vaccinated group. There has also been one Covid-19 related death in the study to date, which occurred in the group of volunteers treated with placebo. The efficacy of the vaccine is considered constant for age, race, ethnic groups, and gender. The 196 Covid-19 cases included 33 older adults (over the age of 65). The COVE study has exceeded two months of post-vaccination follow-up as required by the FDA for Emergency Use Authorization (Eua). Moderna announces that it plans to apply for the US to the FDA for today, in order to request a conditional commercial authorization from the European Medicines Agency EMA and to continue with the analyzes of ‘continuous reviews’ already initiated with international regulatory agencies.
Last updated: 13:51
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