Moderna, one pharmaceutical company inextricably linked to the pandemic vaccination response, has announced it will take its new seasonal influenza and COVID-19 combination shot to Phase 3 trials after "strong" results in Phase 1/2 stages of testing. It'll be somewhat of a relief for the biotech business, which had disappointment with an earlier combination shot, mRNA-1010, at this stage of trials.
"With today's positive results from our combination vaccine against flu and COVID-19, we continue to expand our Phase 3 pipeline," said Stéphane Bancel, Chief Executive Officer of Moderna on Wednesday, October 4. "Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems. We are excited to move combination respiratory vaccines into Phase 3 development."
The vaccine, mRNA-1083, underwent testing for comparative safety and immunogenicity performance. In a randomized, observer blind study, mRNA-1083 was compared to standard influenza vaccine Fluarix, in adults aged 50-64, and enhanced influenza vaccine, Fluzone HD, in adults aged 65-79. For both age groups, mRNA-1083 was compared to Moderna's latest COVID-19 shot, the Spikevax booster.
It "achieved hemagglutination inhibition antibody titers similar to or greater than both licensed quadrivalent influenza vaccines and achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster," Moderna claimed.
In terms of adverse side effects, they were similar to the stand-alone COVID-19 vaccine cohort in the trial, with minor (grade one or two) issues; just under 4% reported more serious grade three side effects, yet no new safety concerns were identified in the new combo shot.
Moderna plans to begin a Phase 3 trial of mRNA-1083 before the end of the year, and is aiming for regulatory approval for the vaccine in 2025.
"We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses," Bancel added.
Source: Moderna
