Moderna kicks off Phase I/II trial of quadrivalent mRNA flu vaccine

Moderna said Wednesday that its first seasonal influenza vaccine candidate, mRNA-1010, has advanced into clinical testing, with dosing now under way in a Phase I/II trial. "We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines," commented CEO Stéphane Bancel.

The randomised, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010 in approximately 180 healthy US participants aged 18 and older. According to the company, the quadrivalent vaccine targets A H1N1, H3N2 and the influenza B Yamagata and Victoria lineages. The overarching aim of the programme is to test multiple candidates, exploring different antigen combinations against seasonal influenza viruses, it added.

Second clinical-stage mRNA vaccine against flu

The news comes shortly after Sanofi and partner Translate Bio announced the initiation of a Phase I study evaluating an mRNA-based investigational vaccine against seasonal influenza, in what the companies suggested was the first clinical trial of a seasonal mRNA influenza vaccine candidate. Sanofi subsequently said that it will invest around €400 million ($472 million) annually to develop mRNA vaccines, with the aim of having a minimum of six clinical candidates by 2025.

Meanwhile, Moderna recently posted its first-ever profitable quarter, thanks to sales of $1.7 billion generated by its COVID-19 vaccine mRNA-1273 in the first three months of this year. That vaccine, Moderna's only authorised product, is currently greenlighted for emergency use in multiple markets, but last month the company began the process of trying to secure full US approval.

Combinations targeting range of respiratory viruses

Moderna said it envisions developing a respiratory vaccine for adult and elderly populations combining seasonal influenza, a COVID-19 variant booster and respiratory syncytial virus (RSV), adding that it intends to explore potential combinations of those three, as well as human metapneumovirus.

"The advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses, such as influenza, SARS-CoV-2 and RSV," Bancel remarked, adding that the goal is to create "an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses."

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