Therapy Areas: Cardiovascular
Moderna Announces First Participant Dosed in Phase 1/2 Study of Its Quadrivalent Seasonal Flu mRNA Vaccine
9 July 2021 - - The first participants have been dosed in the Phase 1/2 study of mRNA-1010, US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) quadrivalent seasonal influenza mRNA vaccine candidate, the company said.

This Phase 1/2 randomized, stratified, observer-blind, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010, Moderna's seasonal influenza vaccine candidate in healthy adults 18 years and older in the US.

The company intends to enroll approximately 180 participants in the study. mRNA-1010 is Moderna's first seasonal influenza vaccine candidate to enter the clinic and targets lineages recommended by the World Health Organization for the prevention of influenza, including seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria.

Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems.

The WHO estimates approximately 3-5m severe cases of flu each year globally1, and 290,000-650,000 flu-related respiratory deaths.

Approximately 8% of the US population experiences symptoms from flu each year.

In the US, the estimated average economic burden of flu is approximately USD 11bn per year.

Current flu vaccines are only approximately 40-60% effective and their formulation is decided 6-9 months before the vaccines are intended to be used.

Egg-based vaccine production, the process used for the majority of currently licensed influenza vaccines, also has the potential to cause unintended antigenic change to the vaccine virus.

Moderna plans to explore potential combination vaccines against flu, SARS-CoV-2, respiratory syncytial virus and human metapneumovirus.

The company's overarching seasonal influenza program will aim to evaluate multiple candidates exploring different antigen combinations against seasonal influenza viruses in the clinic.

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA, to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing.

Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Today, 24 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic.

Moderna has been named a top biopharmaceutical employer by Science for the past six years.
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