Modena’s new corona vaccine has the highest effective rate of 100%, submit an emergency use request today

Original Title: Modena’s New Corona Vaccine Has Higher 100% Effective Rate and Submits Emergency Use Request Today

November 30, local time, Modena, United Statesthe companyHe announced that the effectiveness of the new mRNA-1273 coronavirus vaccine under development reached 94.1% and the effectiveness rate against new severe coronary pneumonia reached 100%. It will be reported to the US Food and Drug Administration today.administrationThe FDA (FDA) urgently requests the vaccineRight to use(USA) and the European Medicines Agency have submitted ongoing applications.

According to the official news published by Modena, the effective result of 94.1% is based on the analysis of 196 cases, of which 185 cases of new coronary pneumonia were observed in the placebo group and 11 cases in the mRNA-1273 group.

Previously, on November 16, Modena had released the news that the results of the evaluation of 95 cases showed that the effective rate of its new coronavirus mRNA-1273 vaccine in development reached 94.5%. Modena said the last major efficacy analysis from the phase III study confirmed the high efficacy seen in the first interim analysis.

As for the 100% efficiency, it is the analysis of the secondary end point of the analysis. The cases analyzed this time include 30 severe cases, all of which occurred in the placebo group, but none in the mRNA-1273 vaccination group. Therefore, Modena said that the vaccine is 100% effective in preventing a new severe coronary pneumonia.

Modena mentioned in the official statement that today it will submit an application for an emergency use right to the US FDA and to the FDA consultation on vaccines and related biologics.Committee(VRBPAC) Can be held on December 17 (Thursday)meeting, Review the safety and efficacy data package for mRNA-1273. Modena hopes that the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will make recommendations on immunization priorities.

Modena said the company’s new corona vaccine is expected to receive emergency use in the United States.AuthorizationSoon after, it will be shipped to the designated address.Distributionpoint.

Additionally, Modena also plans to submit ongoing applications to regulatory authorities in the European Union, Canada, Switzerland, Israel, the United Kingdom, Singapore, and other countries and regions, and seek approval from the World Health Organization.prequalification(PQ) or emergency use list.

Modena emphasized that by the end of 2020, the company is expected to prepare to ship around 20 million doses of the new corona vaccine to the United States, and is expected to produce 500 million to 1 billion doses at the level. worldwide in 2021.

The new Modena vaccine crown andPfizer/ BioNTech’s new corona vaccine belongs to the new mRNA corona vaccine, totransportThe conditions are demanding. Previously, Modena had stated that the vaccine can be stable for 30 days at 2 to 8 (36 ° to 46 ° F), the temperature of a standard household or medical refrigerator; and stable for up to six months at a temperature of -20 ° C; It can be stable for up to 30 days in refrigerated conditions and up to 12 hours at room temperature.

In her latest statement, Modena stressed that further progress has been made to ensure that the new corona vaccine can be distributed, stored and processed using existing infrastructure.

(Source: The Paper)

(Responsible editor: DF524)