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Tuesday, April 23rd, 2024

First participants dosed in Phase 1/2 study of new mRNA-based, Moderna seasonal flu vaccine

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The first healthy adult participants of the Phase 1/2 randomized and observer-blinded test of Moderna’s new quadrivalent seasonal flu vaccine were dosed last week, officially beginning a trial much desired by global health experts.

The World Health Organization (WHO) has a list of targets for preventing influenza, which includes influenza A H1N1, H3N2, and influenza B Yamagata and Victoria — all targets of Moderna’s new shot. The vaccine candidate (mRNA-1010) is mRNA-based, the first of its kind for seasonal flu testing. While developing a respiratory vaccine for adults and elderly populations is a solid end goal, Moderna also hopes to eventually develop the vaccine into a combination of seasonal flu, COVID-19 variant booster, and RSV.

For this stage of testing, approximately 180 healthy adults will be enrolled from the United States. The safety, reactogenicity, and immunogenicity of mRNA-1010 will be investigated through patient reactions.

“We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines,” Moderna CEO Stéphane Bancel said. “Respiratory combination vaccines are an important pillar of our overall mRNA vaccine strategy. We believe that 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. Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses.”

Seasonal flu epidemics are an annual occurrence. Although their severity varies, the WHO roughly estimates somewhere between 290,000 and 650,000 people die of flu-related respiratory complications each year. In the U.S. alone, around 8 percent of the total population suffers from flu symptoms annually. Despite the disease’s regular occurrence, and the regularity of flu vaccines, they tend to be only between 40-60 percent effective, and their formulation determined months in advance.

While mRNA-1010 represents the first of its kind from Moderna, the company intends to evaluate multiple candidates, with different antigen combinations, for their efficacy against seasonal flu viruses.