mRNA flu vaccine shows promising results – 09/14/2023 – Health

Moderna’s flu vaccine elicited a better immune response than existing vaccines in a late-stage trial, paving the way for the Boston-based biotechnology company to enter the $6 billion annual market.

The laboratory, whose first approved vaccine was for Covid-19, reported early data on antibody levels that suggested its vaccine could compete with GSK’s Fluarix. It is discussing the approval process with regulatory bodies.

In another trial, the vaccine provoked a higher antibody response than French drugmaker Sanofi’s high-dose Fluzone, which is often used to vaccinate elderly people.

Stéphane Bancel, chief executive of Moderna, said the results, obtained after successful vaccine trials for variants of Covid-19 and respiratory syncytial virus, showed that the messenger RNA platform works. The technology, which uses genetic code to teach the body to recognize pathogens, was used for the first time in vaccines against the new coronavirus.

Moderna intends to launch products in oncology and rare and latent diseases by 2028. In the five years after these launches, it anticipates annual sales of between US$10 billion and US$15 billion from these treatments, in addition to US$8 billion to US$15 billion of previously announced expected sales of respiratory vaccines in 2027. It intends to invest around US$25 billion in research and development from 2024 to 2028.

Investors had hoped that mRNA would be a good technology to improve flu vaccines, which are often only about 50% 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 vaccines for two of the four most common flu strains.

Moderna reformulated it, and the new version is better than Fluzone in combating three of the varieties. It is equally capable of reaching the fourth, the company said. Moderna shares rose 6.6% to $112.19 after the results were published.

Stephen Hoge, president of Moderna, told the Financial Times that last year the company quickly learned how to improve the vaccine. “We don’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 phase three testing. Existing manufacturers are also adopting mRNA, including GSK, which is partnering with German biotech CureVac in a phase two trial this winter, and CSL Seqirus, which licensed a version of Arcturus Therapeutics’ mRNA technology, with Headquarters in San Diego (California).

Sanofi said in June that its initial efforts using mRNA for flu showed a similar pattern to Moderna’s previous trial results, missing the mark on two of the four strains. Also working on updated versions.

Some analysts are 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 have experienced after taking Covid-19 mRNA vaccines.

Moderna said the trial showed the vaccine had an “acceptable” safety profile. Hoge said the reactogenicity of the new flu vaccine is similar to that of existing, higher-dose flu vaccines.

“We don’t believe this is a disadvantage,” he said, “but it’s really up to others to decide.”

^{Translated by Luiz Roberto M. Gonçalves}