The mRNA influenza vaccine developed by Moderna demonstrates promising results. In a late-stage trial, Moderna’s influenza vaccine elicited a more excellent immune response than existing vaccines, paving the way for the Boston-based biotech firm to access the $6bn annual market.
Initial data on antibody levels from the company, whose first approved vaccine was for COVID-19, suggested that it could compete with GSK’s Fluarix. With regulators, it is discussing the approval procedure.
In a separate study, the vaccine evoked a more excellent antibody response than the French pharmaceutical company Sanofi’s Fluzone high-dose, commonly administered to older individuals.
Stéphane Bancel, the CEO of Moderna, stated that the results, which followed successful trials of vaccines for COVID-19 variants and respiratory syncytial virus, demonstrated that the messenger RNA platform is effective. The technology, which employs genetic code to teach the body to recognize pathogens, was initially implemented in Covid-19 vaccinations.
By 2028, Moderna intends to launch products in oncology, rare, and latent diseases. In the five years following the launch of these treatments, the company anticipates annual sales of $10 billion to $15 billion, in addition to the $8 billion to $15 billion previously projected for respiratory vaccines in 2027. Between 2024 and 2028, it intends to invest approximately $25 billion in R&D.
Investors had hoped that mRNA would be a valuable technology for improving flu vaccines, which are frequently only about 50% effective because they can rapidly adapt to seasonal strain changes.
In February of this year, a Moderna study revealed that an earlier version of the company’s flu vaccine was inferior to current vaccinations for two of the four most common flu strains.
Moderna reformulated it, and the new formulation is superior to Fluzone against three strains. According to the corporation, it is equally capable of targeting the fourth strain. After releasing the results, Moderna’s stock climbed 6.6% to $112.19.
Stephen Hoge, the president of Moderna, told the Financial Times that the company had rapidly learned how to improve the shot over the past year. He added, “We did not disclose this information for competitive reasons.”
Pfizer and BioNTech are also attempting to enter the influenza vaccine market with a phase 3 trial of an mRNA vaccine. Existing manufacturers, such as GSK, which is collaborating with German biotech CureVac on a phase 2 trial this winter, and CSL Seqirus, which has licensed a version of mRNA technology from San Diego-based Arcturus Therapeutics, are also employing mRNA.Sanofi stated in June that its early efforts with using mRNA for influenza had shown a similar pattern to Moderna’s earlier trial results, with two of the four strains falling short. Additionally, it is working on updated versions.
Some analysts are concerned that the market for influenza vaccines will not withstand the same level of “reactogenicity” or short-term adverse effects such as swelling and fever that some individuals experienced after receiving COVID-19 mRNA vaccines.
According to Moderna, the trial demonstrated the vaccine’s “acceptable” safety profile. Hoge stated that the reactogenicity of the new flu injection was comparable to that of existing, higher-dose flu vaccines.
“We do not believe it will be a disadvantage,” he said, “but others will ultimately determine that.”