Moderna’s RSV Vaccine Could Have Further Implications for mRNA Technology

The recent approval of Moderna’s respiratory syncytial virus (RSV) vaccine mRNA-1345 (mRESVIA) could encourage the use of mRNA technology across different landscapes.¹ The FDA approved mRNA-1345 in May for the protection of adults aged 60 years and older against lower respiratory tract disease (LRTD) that is caused by RSV infection.² This is the second authorization for an mRNA vaccine, following another vaccine approved to treat COVID-19, according to study authors.¹

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"The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," Stéphane Bancel, CEO of Moderna, said in a news release. "mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators' time and reducing the risk of administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19."²

mRESVIA is the third FDA-approved vaccine for RSV, following Arexvy (GSK) and Abrysvo (Pfizer), which were launched in 2023.¹ However, mRESVIA is the first mRNA vaccine to protect against RSV, which is significant because mRNA vaccines can be rapidly designed and produced.¹

According to GlobalData Healthcare, mRNA vaccines are in late-stage development for a number of infectious diseases, including cytomegalovirus, influenza, mpox, shingles, Lyme disease, and COVID-19.¹

"The RSV market landscape has witnessed substantial change in recent years owing to the emergence of novel vaccines and monoclonal antibodies for prophylaxis, and the approval of mRESVIA now represents another important addition," said Anaelle Tannen, infectious disease analyst at GlobalData, in a news release. "The improved options for RSV prophylaxis will benefit physicians by providing more choice and tailoring vaccine administration for the individual."¹

The approval of mRESVIA was granted based on positive results from the global Phase 3 ConquerRSV trial that assessed the efficacy of mRNA-1345 among individuals with LRTD. The results displayed that the vaccine exhibited 83.7% efficacy against RSV LRTD among individuals who had at least 2 symptoms. Additionally, it displayed 82.4% efficacy against RSV LRTD among individuals with at least 3 symptoms, according to study authors. The researchers completed a median follow-up that extended 8.6 months and found that mRNA-1345 provided prolonged protection against infection.¹

The study authors noted that although there could be vaccine hesitancy due to safety and efficacy of the vaccine, limited adverse effects were reported.¹ The most reported adverse effects included injection site pain, fatigue, headache, myalgia, and arthralgia.²

The vaccine is expected to be available by the 2024/2025 season in the US, as the first single-dose prefilled syringe for RSV. Additionally, the vaccine is currently being investigated to aid other RSV populations, including pregnant woman and infants.¹

The study authors noted that further trials are currently investigating the use of mRNA vaccines to treat cytomegalovirus, influenza, mpox, shingles and Lyme disease, as well as COVID-19.¹

The findings suggest that the approval will aid the use of further mRNA technology across other regulations.¹

References

1. Moderna's mRESVIA FDA approval paves way for mRNA vaccines across multiple indications, says GlobalData. News release. GlobalData Healthcare. June 6, 2024. Accessed June 20, 2024. https://www.globaldata.com/media/pharma/modernas-mresvia-fda-approval-paves-way-mrna-vaccines-across-multiple-indications-says-globaldata/

2. Gallagher A. FDA Approves mRNA-1345 for Protection Against Lower Respiratory Tract Disease Caused by RSV. Pharmacy Times. News release. May 31, 2024. Accessed June 19, 2024. https://www.pharmacytimes.com/view/fda-approves-mrna-1345-for-protection-of-lower-respiratory-tract-disease-caused-by-rsv.