Trial finds latest version elicited better immune response than existing jabs
Moderna’s flu vaccine elicited a better immune response than existing jabs in a late-stage trial, paving the way for the Boston-based biotech company to enter the $6bn annual market.
The company — whose first approved vaccine was for Covid-19 — reported initial data on antibody levels that suggested its vaccine could compete against GSK’s Fluarix. It is discussing the approval process with regulators.
In another trial, the vaccine elicited a higher antibody response than French drugmaker Sanofi’s Fluzone high-dose, which is often used to vaccinate older people.
Stéphane Bancel, Moderna’s chief executive, said the results, coming after successful trials of vaccines for Covid-19 variants and the respiratory syncytial virus, showed the messengerRNA platform works. The technology, which uses genetic code to teach the body to recognise pathogens, was first used in Covid-19 jabs.
Moderna plans to launch products in oncology, rare and latent diseases by 2028. In the five years after these launches, it expects $10bn-$15bn of annual sales from these treatments, on top of its previously announced $8bn-$15bn of expected sales from respiratory vaccines in 2027. It plans to invest about $25bn in research and development from 2024 to 2028.
Investors had hoped mRNA would be a good technology to improve flu vaccines, which are often only about 50 per cent effective, because they can be quickly adapted to new strains each winter.
But in February this year, shareholders were disappointed when a Moderna study reported that an earlier version of its flu vaccine was no better than current jabs for two of the four most common flu strains.
Moderna reformulated it, and the new version is better than Fluzone at tackling three of the strains. It is just as able to target the fourth strain, the company said. Moderna’s shares rose 6.6 per cent to $112.19 after the results were published.
Stephen Hoge, Moderna’s president, told the Financial Times that in the past year, Moderna had quickly learned how to improve the shot. “We didn’t disclose what that is for competitive reasons,” he added.
Pfizer and BioNTech are also trying to enter the flu market with an mRNA vaccine, which is in a phase 3 trial. Existing manufacturers are also adopting mRNA, including GSK, which is partnering 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.
Sanofi said in June that its early efforts with using mRNA for flu had shown a similar pattern to Moderna’s previous trial results, missing the mark on two of the four strains. It is also working on updated versions.
Some analysts have been concerned that the flu market will not tolerate the same level of “reactogenicity”, short-term side effects such as swelling and fever that some people experienced after taking Covid-19 mRNA vaccines.
Moderna said the trial showed the vaccine had an “acceptable” safety profile. Hoge said the new flu shot’s reactogenicity was similar to that of existing higher-dose flu vaccines.
“We do not believe that it’s going to be a disadvantage,” he said, “but that’s really will be for others to decide.”
