[메디컬투데이=김동주 기자] Moderna announced on the 8th that it has completed administration of its seasonal influenza vaccine candidate mRNA-1010 to the first participants in Phase 3 clinical trial.
The clinical trial will be conducted on approximately 6,000 adults living in southern hemisphere countries.
Moderna CEO Stefan Bansel said: “We are pleased to begin the phase 3 clinical trial of mRNA-1010, a seasonal influenza vaccine and our fourth mRNA vaccine candidate. “This is the first candidate among many of Moderna’s influenza vaccine candidates, which are being developed to continuously improve existing influenza vaccines.”
He continued, “We believe Moderna’s mRNA platform technology, with its flexibility and speed in the manufacturing process, will be able to address significant unmet needs related to seasonal influenza. It is an important element in our respiratory vaccine development strategy, including the development of a combination vaccine.”
This phase 3 clinical trial, designed to evaluate the safety and immunological non-inferiority of mRNA-1010 compared to an already licensed seasonal influenza vaccine in adults 18 years of age and older, is a randomized, observer-blind, randomized trial.
Participants were randomly assigned to a dose group and an active control group in a 1:1 ratio to receive either a single dose of mRNA-1010 or a single dose of the current seasonal influenza vaccine.
mRNA-1010 is hemagglutinin (HA) of four influenza strains recommended by the World Health Organization (WHO) for influenza prevention, including influenza A/H1N1, A/H3N2, influenza B/Yamagata and B/Victoria strains. It is a vaccine candidate that encodes a glycoprotein.
Hemagglutinin (HA) is an influenza surface glycoprotein that is considered an important target for generating broad-spectrum protection against influenza, and is a major target for currently used influenza vaccines.
Moderna is actively preparing a final validation study for mRNA-1010 as early as the 2022 and 2023 flu seasons in northern hemisphere countries.
Meanwhile, influenza (influenza A and B) epidemics occur seasonally, vary in severity each year, and cause several respiratory diseases, placing a significant burden on the health care system. Despite the availability of influenza vaccines, 3 to 5 million cases of severe influenza occur worldwide each year, and 290,000 to 650,000 die from influenza-related respiratory diseases.
Influenza A and B both cause seasonal epidemics, of which influenza A is associated with more than 95% of influenza-related adult hospitalizations.
Medical Today reporter Kim Dong-ju (ed30109@mdtoday.co.kr)
[저작권자ⓒ 메디컬투데이. 무단전재-재배포 금지]