Are Combination Respiratory Virus Vaccines the Way of the Future?
With the recent phase 3 data results of the Moderna COVID-19-influenza combination vaccine, the company is working towards regulatory approval and opens the door to possible protection against multiple viruses with less immunizations.
Respiratory virus vaccines have witnessed a flurry of activity related to COVID-19, RSV, influenza, and pneumococcal disease—especially in the last year. A few vaccine manufacturers including Pfizer-BioNTech, Novavax, and Moderna all have investigational, combination COVID-19-influenza vaccines in development. Earlier this month, Moderna reported phase 3 trial data on its mRNA-1083 combination vaccine.
Moderna’s Phase 3 Data
This late-stage trial is a randomized, observer-blind, active control study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age group cohorts of approximately 4000 adults each. One cohort, consisting of adults 65 years and older, compared mRNA-1083 to co-administered Fluzone HD, an enhanced influenza vaccine, and Spikevax, Moderna's currently licensed COVID-19 vaccine.1
The other cohort of adults 50 to 64 years of age compared mRNA-1083 to co-administered, Fluarix, a standard dose influenza vaccine, and Spikevax. The immune responses from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered, routinely recommended, licensed comparators.1
In both age cohorts, the Moderna vaccine also elicited statistically significantly higher immune responses against 3 influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2. In the 65 years and older cohort, overall Geometric Mean Ratios (GMRs) of the mRNA-1083 group compared to the Fluzone HD group for the influenza strains were 1.155 (95% CI: 1.094, 1.220) for A/H1N1, 1.063 (95% CI: 1.007, 1.122) for A/H3N2 and 1.118 (95% CI: 1.070, 1.167) for B/Victoria. The GMR of mRNA-1083 compared to Spikevax for the SARS-CoV-2 variant Omicron XBB.1.5 was 1.641 (95% CI: 1.526, 1.765).1
In the 50 to 64 years of age cohort the GMRs of the mRNA-1083 group compared to the Fluarix group for the influenza virus strains were 1.414 (95% CI: 1.333, 1.500) for A/H1N1, 1.380 (95% CI: 1.310, 1.454) for A/H3N2, and 1.216 (95% CI: 1.163, 1.270) for B/Victoria. The GMR of mRNA-1083 compared to Spikevax for the SARS-CoV-2 variant Omicron XBB15 was 1.308 (95% CI: 1.219, 1.404).1
Learn more: Special Report: Clinical Insights on Moderna's RSV Vaccine
Viability of Combination Vaccines
Although there are no FDA approved combination respiratory vaccines yet, the manufacturers are working towards it. And in thinking about vaccines historically, James Mansi, PhD, vice president of Medical Affairs, North America, Moderna reminds everyone that combination vaccines for the pediatric population are already being utilized.
“When we look at pediatrics, the number of vaccines that a young infant receives in those pivotal and formative early years of life are mostly all combination vaccines,” said Mansi. “It's recognized that the more that we can give in 1 injection—facilitates the acceptability, the ease of administration, and the feasibility of ensuring that those individuals maintain compliance with vaccination recommendations.”
Will RSV Protection be Included?
Moderna’s RSV vaccine was just FDA approved recently and theoretically leads to the question of including protection against this virus in their COVID-19-influenza combination vaccine. Seniors are some of the most vulnerable patient populations when it comes to respiratory viruses, so the potential to get immunized for multiple respiratory viruses with 1 vaccine can be attractive to both clinicians and the general public.
For Moderna, inclusion of RSV protection is not yet included in their plan, explains Mansi, but he does leave open the door for its potential inclusion in future combination vaccines.
“I think it's too soon to tell for RSV—should it be included in the annual COVID-influenza vaccine—but the opportunity does exist,” Mansi stated. “And we are exploring other combination vaccines for exactly this reason to facilitate the acceptability, the feasibility, and ultimately raise vaccination rates within this adult population and throughout the age range as well.”
