While its phase-three trial is still awaiting peer review, Moderna’s preliminary analysis shows promise for a potential Covid-19 vaccine.
Following last week’s news of promising results from the Pfizer-BioNTech Covid-19 vaccine trial, US biotech company Moderna has announced that the trial of its Covid-19 vaccine candidate, mRNA-1273, has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5pc.
The trial is still ongoing and results are being analysed by an external, independent data monitoring committee. Data from the phase-three trial has yet to be submitted for peer review.
The study enrolled more than 30,000 participants in the US, with half of the people receiving two injections of the vaccine and the other half receiving two placebo injections of saltwater.
The primary endpoint of the trial is based on the number of Covid-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 confirmed Covid-19 cases, of which 90 cases were observed in the placebo group compared to five cases observed in the vaccine group.
The study also analysed what were deemed severe cases of Covid-19 as defined in the study protocol. There were 11 severe cases in this first interim analysis, all of which occurred in the placebo group.
According to Moderna, preliminary data suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.
Moderna’s CEO, Stéphane Bancel, said it is a “pivotal moment” in the development of the company’s vaccine candidate.
“This positive interim analysis from our phase-three study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease,” he said. “This milestone is only possible because of the hard work and sacrifices of so many.”
Like the Pfizer vaccine, Moderna’s candidate is based on messenger RNA (mRNA) technology. It acts by sending viral mRNA into the body, which is used by the body’s cells to create a fragment of a SARS-CoV-2 viral particle that should not cause an infection, but is enough for the immune system to recognise as a foreign antigen.
The company intends to submit for an Emergency Use Authorization with US Food and Drug Authority (FDA) in the coming weeks. The FDA states that a coronavirus vaccine must have an effectiveness rate of at least 50pc.