The pharmaceutical company Moderna has announced the results of its phase 3 trial in which it has tested the safety and efficacy of mRNA-1083, an experimental combination vaccine against influenza and COVID-19, which has met its main objectives, generating stronger immune responses against the flu virus and SARS-CoV-2 than the licensed flu and COVID vaccines in adults aged 50 and older that have been used in the trial, including an improved flu vaccine in adults 65 years or older.
“Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide greater protection against seasonal diseases.” , declared Stéphane Bancel, CEO of Moderna.
“Moderna is the only company with a positive phase 3 combination vaccine against flu and COVID. Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address important unmet medical needs and advance public health,” Bancel added.
A powerful immune response against flu and COVID-19
mRNA-1083 is composed of elements from mRNA-1010 – Moderna’s vaccine candidate for seasonal flu – and mRNA-1283, the next-generation vaccine candidate for COVID-19. Each of these experimental vaccines has independently demonstrated positive results in Phase 3 clinical trials.
The ongoing Phase 3 clinical trial is a study evaluating the safety, reactogenicity (presence of adverse effects), and immunogenicity of mRNA-1083 in two independent age groups of approximately 4,000 adults each. One group consisted of adults 65 years of age and older, in whom mRNA-1083 was compared with coadministration of Fluzone HD®, an enhanced flu vaccine, and Spikevax®, the COVID-19 vaccine. Modern. In the other group, adults ages 50 to 64, mRNA-1083 was compared to coadministration of Fluarix®, a standard-dose flu vaccine, and Spikevax.
Immune responses to a single dose of -1083 mRNA were found to be non-inferior compared to routinely recommended and licensed comparative vaccines. In both age cohorts, mRNA-1083 also generated significantly higher immune responses against three influenza virus strains (H1N1, H3N2 and B/Victoria) and against SARS-CoV-2.
“Co-administration of flu and COVID-19 vaccines has the potential to improve vaccine acceptance and convenience, and combination vaccines could take this a step further”
mRNA-1083 showed an acceptable safety and tolerability profile. The majority of adverse reactions recorded were grade 1 or 2 in severity and similar to those of the licensed vaccines used in the trial. The most frequently reported adverse reactions were pain at the injection site, fatigue, myalgia, and headache.
“Co-administration of flu and COVID-19 vaccines has the potential to improve vaccine acceptance and convenience, and combination vaccines could take this a step further. With coverage rates potentially increasing, the hope is that we can see those benefits reflected in broader public health advances, such as lower rates of serious outcomes,” wrote Dr. Francesca Ceddia, chief medical affairs officer at Moderna. , in a Moderna blog post.
“In addition to the convenience of fewer shots, combination vaccines could reduce the burden of a very intense respiratory virus season on doctors’ offices and pharmacies. With fewer individual COVID-19 and flu vaccines to administer, healthcare professionals can regain time to care for more patients better,” adds Ceddia.
Moderna representatives told the media that the company intends to present Phase 3 clinical data for mRNA-1083 at an upcoming medical conference, as well as submit it for publication. The company aims to have the new vaccine approved by the fall of 2025, so it will not be available for this flu season, but it could be available for the next one.
