The modern biotechnology company announced, on Monday (30), the completion of the phase 3 tests of the vaccine against covid-19. The pharmaceutical company reported that the vaccine is 94.1% effective. On November 16, Moderna had already announced preliminary results of phase 3 tests with 94.5% effectiveness. With the result, the company announced that it will now apply for urgent authorization from the FDA (Food and Drugs Administration), the United States regulatory agency (similar to Anvisa do Brasil).
“The results of the positive primary analysis confirm the ability of the mRNA-1273 vaccine to prevent Covid-19 disease with 94.1% effectiveness and, importantly, the ability to prevent serious disease,” said the executive director of Moderna, Stéphane Barcel, in a press release.
The design of phase 3 of the clinical trials indicated that the analysis would be complete when 151 volunteers became infected. The test surpassed that mark and ended with 196 volunteers with covid-19, of which 185 received the placebo and only 11 received the vaccine. With that, Moderna announced 94.1% effectiveness. The company also reported that the vaccine was 100% successful in preventing severe cases of the disease, as the 11 infected vaccinees showed only mild symptoms.
Among the 196 volunteers who were infected, 33 (16.8%) were over 65 years old, and 42 (21.4%) represent some racial minority (including 29 Hispanics or Latinos, six blacks or African-Americans, four Asians, and three multiracial). The study had a total of 30,000 volunteers, with 37% of them representing a minority ethnic-racial group.
Named mRNA-1273, Moderna’s immunizer is a messenger RNA vaccine, the sequence of the virus’s genetic material responsible for encoding the virus’ S protein and inducing the production of antibodies and defense cells. Upon contact with the new coronavirus, SarsCov-2, the immune system will be prepared to prevent infection and viral replication.
In the statement this Monday, the American company said the FDA will present an assessment of the vaccine on December 17. There is an expectation that vaccination in the United States may begin shortly thereafter. The company said it could produce 20 million doses in December for use in the United States. For 2021, the estimated production capacity is up to 1 billion doses for global distribution – considering that the vaccine is applied in two doses, there will be up to 500 million people who can be vaccinated by Moderna’s immunizer. The United States government has already secured the purchase of the first 100 million doses.
