Moderna’s mRNA-1345 vaccine for respiratory syncytial virus (RSV) in older adults has been approved for Priority Review by the TGA.
Moderna announced on 28 July that its vaccine candidate for adults aged 60 years and over had successfully passed the validation process and proceeded to TGA evaluation under the Priority Review pathway.
The application to the TGA was based on positive data from a prespecified interim analysis of the pivotal Phase 3 ConquerRSV study involving approximately 37,000 adults 60 years or older in 22 countries, including Australia.
Moderna said that mRNA-1345 met both its primary efficacy endpoints during the trial, demonstrating vaccine efficacy (VE) of 83.7% against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% against RSV-LRTD defined by three or more symptoms.
The vaccine was well tolerated with a favourable safety profile and most solicited adverse reactions were mild or moderate, with the most commonly reported including injection site pain, fatigue, headache, myalgia and arthralgia.
Moderna’s General Manager of Australia and New Zealand, Mr Michael Azrak, said that this critical milestone moved Moderna one step closer to potentially offering a preventative option that could alleviate the burden of RSV, the primary etiologic pathogen of bronchitis and pneumonia, on older adults and the Australian health system.
“As a next step, the evaluation process by the TGA will involve a comprehensive and rigorous assessment of the safety, efficacy, and quality data in the submission, which will then be reviewed by the TGA’s expert Advisory Committee on Vaccines (ACV) early next year,” he said.
The FDA has already granted mRNA-1345 ‘breakthrough therapy designation’ for the prevention of RSV-LRTD in adults aged 60 years or older and the vaccine was first approved for fast tracking by the Authority in August 2021.
Moderna’s CEO, Mr Stéphane Bancel, explained that the company’s existing expertise in working with mRNA, developed throughout the pandemic, had helped facilitate the process.
“Our mRNA platform allowed us to move from initial clinical testing to our first international Phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just two years, enabling us to tackle this pervasive public health burden with speed and clinical rigor,” he said.
The vaccine uses the same lipid nanoparticles (LNPs) as in the Moderna COVID vaccines and consists of a single mRNA sequence encoded for a stabilized pre-fusion F glycoprotein, a protein sequence found on the surface of host cells which provides the virus with an entry point for infection.
F glycoprotein exists in two states, pre-fusion, and post-fusion, with the pre-fusion conformation a significant target of potent neutralizing antibodies and similar across both RSV-A and RSV-B subtypes.
“The vaccine mRNA-1345 represents the second product coming from our mRNA platform to seek global approval, and with recent positive data in rare disease and cancer, we expect more in the future – further demonstrating the tremendous potential of mRNA to combat disease.
“The ConquerRSV study is ongoing, and additional efficacy analyses are planned as cases accrue, including for severe RSV and in addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in paediatric populations.”
Moderna’s respiratory disease vaccine pipeline also includes Phase 3 trials for influenza and a next-generation COVID candidate, as well as four additional influenza vaccines with expanded antigens, vaccines against other respiratory pathogens, and five combination vaccine programs.