Moderna has become the second US company to publish the full results of its experimental vaccine, which, as it was advanced in the preliminary study, points out that it is 94.1% effective against Covid 19. After these data, the The pharmaceutical company will request emergency use authorization from the US drug regulator this Monday and will also request conditional approval for distribution in the European Union. Their analysis was based on 196 cases of Covid-19 infection, of which 185 received a placebo and 11 received the mRNA-1273 vaccine. Hence the estimate of 94.1% effectiveness.
Regulators will now analyze the data provided by the company on the vaccine and decide if it is safe and effective enough to recommend its implementation. In this regard, US President Donald Trump has called on the FDA for speed in its action to give the green light to Moderna’s vaccine, which has been part of Operation Warp Speed, an ambitious plan championed by the president to accelerate in the States United the race to obtain a vaccine against the coronavirus and to which some 12,000 million dollars was destined.
According to the company, the efficacy analysis of the phase 3 study of the vaccine included 30,000 participants with an efficacy of 94.1%, generally good tolerability, and no serious safety concerns identified to date. The percentage of effectiveness increases to 100% in cases of severe Covid.
Within the group of 196 Covid infections, there were 30 serious cases among the participants, all of them injected with placebo and none among those who received the vaccine, for which the company has announced 100% protection efficacy against the most cases severe SARS-CoV-2. The company maintains that effectiveness is consistent by age, race and ethnicity, and gender. The 196 cases of contagion included 33 adults 65 years of age and older, and 42 participants from various communities, including 29 people of Hispanic origin, 6 African-American and 4 Asian.
To support applications for distribution in the US and Europe, the company has reported that it intends to obtain prequalification (PQ) for its vaccine from the World Health Organization (WHO) and to have it included in its List of Emergency Use.
The first injections can be administered from December 21 if the process runs smoothly and approval is granted, said Stéphane Bancel, executive director of Moderna, in an interview with The New York Times.
The success rate was slightly lower than the initial analysis result of 94.5%, but Moderna said the difference was statistically insignificant. The study’s publication comes after Pfizer and its German partner BioNTech pointed out that their experimental vaccine, also based on RNA, was 95% effective.
Moderna, which went public in 2018, has received nearly $ 1 billion in research and development funding from the US government and has a $ 1.5 billion deal to supply 100 million doses. The Administration also has an option for another 400 million doses.