US biotech firm Moderna said Monday their novel coronavirus vaccine is 94.5 percent effective in inhibiting the virus, become the second major player to announce promising results in the vaccine-development rat race.
Announcing the interim results of the large-scale Phase III clinical trials with over 30k participants, Moderna CEO Stephane Bancel said: “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.”
“This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2, and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus,” he added.
The study was done in collaboration with the the National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA).
The announcement came a week after another US-based pharma giant Pfizer and German partner BioNTech announced their COVID-19 vaccine was 90 percent effective in inhibiting the virus, although they did not reveal the effect on a severe form of the disease.
Moderna’s vaccine candidate, codenamed mRNA-1273, is based on a new-age mRNA technology that essentially overturns the body’s immune system to generate viral proteins to fight the infections.
Moderna’s promising results came after analyzing what they call the COVE Study, which is based on the COVID-19 cases confirmed and adjudicated two weeks after the participants were inoculated with the experimental jab.
Moderna researchers analyzed two endpoints in the study where participants contacted the virus after getting the experimental vaccine.
The primary endpoint was derived after 95 people contacted the disease — 90 from the placebo group, verser 5 from the ones who were given the experimental jab.
The secondary endpoint was derived from the analysis of severe cases of COVID-19. Researchers found none of the people who got the experimental jab had a severe COVID-19, but 11 cases sprouted from the placebo group.
Overall analysis tipped to the fact that people who were inoculated with Moderna’s vaccine were immune to the virus more than those who were given placebo in the study.
Moderna’s promising results also encompass diverse demography, but it remains unclear how long the effects last, and how well it sustains in a higher age-group who’s at the highest risk from the disease.
A prelim study published in the New England Journal of Medicine in September found Moderna’s SARS-CoV-2 vaccine appeared to have elicited an equally strong immune response in older adults as much as younger people.
Of the 95 people who contacted the COVID-19 from the participants, 15 older adults (ages 65+), and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans, and 1 multiracial), Moderna said.
The repost from Moderna also found the after-effects of the vaccine were in-general short-lived, with the major adverse events showing up in moderate severity.
Side-effects deemed severe after the second dose included ten percent of participants reporting fatigue, nine-percent myalgia, Five-percent arthralgia, four and half-percent headache, four-percent pain, and two-percent erythema/redness at the injection site.
Moderna says the firm will apply for the Emergency use Authorization in the US with the U.S. Food and Drug Administration (FDA) and other parts of the world in the coming weeks.
The company expects to hoard 20 million doses of the vaccine ready t ship in the US by the end of 2020 and is on track to manufacture 500 million – 1 billion doses globally in the coming year.
Peter Openshaw, a professor of experimental medicine at Imperial College London said Moderna’s vaccine news is ‘tremendously exciting’ and “considerably boosts optimism that we will have a choice of good vaccines in the next few months.”
Experts also noted Moderna Inc.’s COVID-19 jab is also logistically beneficial, at least more than rival Pfizer’s offering. Moderna’s vaccine can be stored in 36 – 46 degrees Fahrenite, or temperature in standard domestic or medical freezers, for up to 30-days, and up to six-months in minus 4 degrees Fahrenheit, CNBC reported.
But Pfizer x BioNTech’s vaccine requires a minimum storage temperature of negative 94-degree Fahrenite, which raises a number of logistical concerns, especially in third-word and less developed countries.