Moderna joins Pfizer and GSK in RSV regulatory sprint as TGA evaluation phase begins

Biotech News: In a new development in the field of respiratory disease prevention, biotech company Moderna has filed a local regulatory submission for its mRNA-1345 vaccine. This vaccine aims to combat RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older.

“We are proud to announce the regulatory submissions for the use of our RSV vaccine candidate, mRNA-1345, in Australia, European Union, Switzerland and the U.S. RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions,” stated Stephane Bancel, CEO of Moderna.

In Australia, the Therapeutic Goods Administration (TGA) submission for mRNA-1345 vaccine will undergo evaluation under the Priority Pathway after the Priority Determination application was approved in April 2023. GSK’s Arexvy and Pfizer’s Abrysvo, both RSV vaccines for adults, are also undergoing TGA evaluation currently.

Bancel further emphasised the achievements of Moderna’s mRNA platform, highlighting the rapid progress made from initial clinical testing to the initiation of regulatory submissions for mRNA-1345 in just two years. He expressed confidence in the potential of mRNA technology, with mRNA-1345 representing the second product from their mRNA platform seeking global approval. He also mentioned recent positive data in rare diseases and cancer and expressed optimism about future breakthroughs in combating various diseases using mRNA technology.

The race to tackle respiratory diseases extends beyond RSV-LRTD in older adults. Sanofi and AstraZeneca have jointly developed Beyfortus (nirsevimab), a single-dose passive immunisation designed to prevent RSV lower respiratory tract disease in infants under 12 months of age. This condition is a leading cause of childhood hospitalisations. The vaccine is currently undergoing review by the TGA with the aim of securing approval to protect infants during their first winter season.

Moderna’s regulatory applications for mRNA-1345 are supported by positive data from the pivotal ConquerRSV study. This randomised study involved approximately 37,000 adults aged 60 years or older across 22 countries. The trial successfully met both primary efficacy endpoints, demonstrating vaccine efficacy (VE) of 83.7% against RSV-LRTD defined by two or more symptoms and 82.4% against RSV-LRTD defined by three or more symptoms. The ongoing ConquerRSV study will continue to assess efficacy, including severe RSV cases. Additionally, Moderna is conducting a fully enrolled Phase 1 trial of mRNA-1345 in paediatric populations.

Moderna’s commitment to combating respiratory diseases is evident in its robust vaccine pipeline. The pipeline includes Phase 3 trials for influenza and a next-generation COVID-19 candidate. In addition to these, Moderna is also developing four additional influenza vaccines with expanded antigens, vaccines targeting other respiratory pathogens, and five combination vaccine programs.

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