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Moderna announces positive Phase III data for Covid-19/Influenza mRNA vaccine

Moderna has announced positive Phase III data for its Covid-19/influenza combination vaccine, mRNA-1083. The investigational combination messenger RNA (mRNA) vaccine generated statistically significant higher immune responses in relation to the licensed comparator vaccines used in the randomised, observer-blind, active control study among 8,000 adults ages 50 years and older. This development comes less than two weeks after Moderna received FDA approval for the first mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA, further demonstrating the potential of mRNA technology in combatting infectious diseases.

mRNA-1083 combines the mRNA-1010 seasonal influenza vaccine candidate with the mRNA-1283 next-generation Covid-19 vaccine candidate. At this time, mRNA-1083 is poised to be the first Covid-19/influenza combination vaccine and the first mRNA influenza vaccine on the market.

Moderna reported that a single dose of mRNA-1083 met immunogenicity non-inferiority criteria versus the licensed comparator vaccines: Sanofi’s Fluzone High-Dose and GSK’s Fluarix for influenza, and Moderna’s Spikevax for Covid-19. Furthermore, mRNA-1083 generated statistically significant higher immune responses against the influenza strains H1N1, H3N2, and B/Victoria, as well as SARS-CoV-2. In the study group of adults ages 50–64 years, the geometric mean ratios (GMRs) of mRNA-1083 compared to Fluarix were 1.414 (A/H1N1), 1.380 (A/H3N2), and 1.216 (B/Victoria). The GMR of mRNA-1083 compared to Spikevax was 1.308. In the study group of adults ages 65 years and older, the GMRs of mRNA-1083 compared to Fluzone High-Dose were 1.155 (A/H1N1), 1.063 (A/H3N2), and 1.118 (B/Victoria). The GMR of mRNA-1083 compared to Spikevax was 1.641. mRNA-1083 also met non-inferiority criteria against the B/Yamagata strain of influenza, but this strain is no longer recommended for the composition of seasonal influenza vaccines. The investigational combination vaccine displayed an acceptable safety and tolerability profile, with the most commonly reported adverse reactions being injection site pain, fatigue, myalgia, and headache.

The development of a Covid-19/influenza combination vaccine could be advantageous to patients, as it would decrease the number of injections needed to provide sufficient protection against multiple respiratory illnesses. Likewise, the development of a combination vaccine is strategic for pharmaceutical companies, as successful uptake of the vaccine can translate to significant market shares under multiple indications.

Key opinion leaders (KOLs) interviewed by GlobalData have expressed positive opinions on both the development of a Covid-19/influenza combination vaccine and the advancement of vaccines for infectious diseases due to mRNA technology. mRNA vaccines require a shorter production time and have the potential to incorporate large numbers of antigens. Therefore, they may be more efficacious than traditional vaccines.

According to GlobalData, there are over 90 mRNA vaccines for infectious diseases in late-stage development (Phases II–III) globally. These include vaccines for Covid-19, RSV, influenza, cytomegalovirus, tuberculosis, malaria, mpox, meningitis, norovirus, shingles, and Lyme disease. Among these are combination vaccines for Covid-19/influenza and COVID-19/RSV.

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If approved, Moderna’s Covid-19/influenza combination vaccine will be an important addition to the vaccine market. The positive Phase III data on the combination provides further validation of how mRNA technology is advancing the infectious diseases pipeline.