The pharmaceutical company Moderna has announced that the vaccine it is developing against the coronavirus has an effectiveness of 94.5 percent and that it meets the efficacy criteria required for its commercialization, as announced in a statement.
In the note, the company states that it is a “great day” in the fight against the coronavirus, says that it has met the criteria established in the protocol to study its effectiveness and that in the coming days it will present the documentation for final approval.
The study, known as the COVE study, recruited more than 30,000 participants in the US and has been conducted, the statement said, according to the National Institute of Allergy and Infectious Diseases (NIAID) and the US Institutes of Health. , part of the National Institutes of Health (NIH) and the Biomedical Institute.
The results come on the heels of similar results from Pfizer and increase confidence that vaccines can help end the pandemic. The two companies have used a novel approach to design their vaccines.
Moderna has developed an “RNA vaccine”, which means that part of the genetic code of the coronavirus is injected into the body, allowing the production of enough proteins to train the immune system.
As the Moderna statement explains, the study’s primary endpoint is based on analysis of confirmed and adjudicated COVID-19 cases starting two weeks after the second dose of vaccine.
“This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the group of people who received a placebo, compared to five cases observed in the group that received the vaccine,” he says. the notice.
As a second endpoint, it was included that the eleven severe cases all developed in the group that received the placebo and not the vaccine.
The 95 COVID-19 cases included 15 older adults (65 and older) and 20 participants who identified as belonging to diverse communities (including 12 Hispanics or Latinos, 4 Blacks or African Americans, 3 Asian Americans and 1 multiracial), says the company.
Moderna states that when reviewing the contraindications, it was concluded that “in general, the vaccine was well tolerated” and that most of the “adverse events were of mild or moderate severity”, in addition to being of short duration.
“Serious events with a frequency greater than or equal to 2% after the first dose included pain at the injection site (2.7%), and after the second dose they included fatigue (9.7%), myalgia ( 8.9%), headache and redness at the injection site.
In the company statement, Chief Executive Officer Stéphane Bancil said, “This is a crucial moment in the development of our COVID-19 candidate vaccine. Since the beginning of January, we have been pursuing this virus with the intention of protecting as many people as possible around the world. All along we have known that each day is important ”.
“This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” Stéphane Bancel said in a statement.