Washington, Nov 16 (efe-epa).- A United States biotech firm on Monday announced that a coronavirus candidate vaccine it is developing has a 94.5 percent efficacy rate.
In a statement, Moderna said the clinical “trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 percent.”
The news follows a similar announcement made earlier this month by US pharmaceutical giant Pfizer and German firm BioNTech, who said their vaccine had 90 percent efficacy in fighting off the virus.
Public health officials around the world have pegged most of their hopes of fully overcoming the virus on a vaccine.
Moderna said that in the next few days it will present the documentation for its definitive approval from the Food and Drug Administration (FDA).
The trial, known as the COVE study, recruited more than 30,000 participants in the US and was conducted, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
Moderna has developed an “RNA vaccine,” which means that part of the genetic code of the coronavirus is injected into the body, enabling the production of sufficient antibodies in the host’s immune system.
As explained in Moderna’s statement, the study’s main assessment criterion is based on the analysis of confirmed Covid-19 cases and adjudicated from two weeks after the second vaccine dose.
“This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5 percent,” the statement said.
The statement added that the study had reported 11 severe cases of Covid-19, all of which occurred in the group who had been administered a placebo.
The 95 cases of COVID-19 included 15 older adults (65+) and 20 participants who identified themselves as belonging to diverse communities (including 12 Hispanic or Latino, 4 black or African-American, 3 Asian-American and 1 multiracial), the company says.
Moderna says that a review of the side effects concluded that “the vaccine was generally well tolerated” and that most of the “adverse events were mild or moderate in severity” as well as being short in duration.
“Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups,” the company said.
In Moderna’s statement, Executive Director Stéphane Bancil said: “This is a pivotal moment in the development of our Covid-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. 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.” EFE-EPA