The vaccine candidate from the US company Moderna demonstrated 94.1% efficacy against Covid-19, and has also demonstrated 100% efficacy in severe cases.
This was announced by the company, announcing the results of phase 3 tests on 196 cases.
Today Moderna will apply to the US drug authority FDA for emergency use authorization, and to the European Medicines Agency EMA for conditional authorization.
The Vaccines Committee of the US Medicines Authority Fda is expected to meet on December 17 to review the efficacy and safety data of the Moderna company 's Covid vaccine candidate mRNA-1273.
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 will be ensured.
By 2020, the Moderna company expects to have approximately 20 million doses available in the United States, and plans to produce 500 million-1 billion doses globally in 2021. Moderna also announced further advances aimed at ensuring that distribution , storage and handling of the vaccine can be done using existing infrastructure.
THE STUDY -
THE STUDY -
The results are related to the phase 3 COVE study for the RNA-1273 vaccine candidate which involved a total of 30 thousand participants in the US, including 196 cases of Covid-19 of which 30 were severe cases.
The vaccine candidate has shown to be generally well tolerated, with no serious concerns identified to date in relation to its safety.
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 vaccine efficacy of 94.1%.
Severe cases of Covid-19 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 placebo-treated group of volunteers.
The effectiveness of the vaccine is judged to be constant for age, race, ethnic groups and gender.
The 196 cases of Covid-19 included 33 elderly adults (over 65).
The COVE study has exceeded two months of post-vaccination follow-up as required by the FDA for the Authorization for Emergency Use (Eua).
Moderna announces that it plans to apply for Eua to the FDA for today, in order to request a conditional trade authorization from the European Medicines Agency EMA and to continue with the 'rolling reviews' analyzes already started with international regulatory agencies.