mRESVIA RSV Vaccine Is a Key Area to Watch for Community Pharmacy in 2025

Author(s):

Kennedy Ferruggia, Assistant Editor

Key Takeaways

mRNA-1345 is an FDA-approved RSV vaccine for adults 60+, showing high efficacy in preventing RSV-LRTD with manageable adverse events.
The CDC recommends mRNA-1345 for adults 75+ and those 60-74 at increased RSV risk, with ongoing trials for younger high-risk groups.
mRNA-1345 faces market competition from RSVPreF3 and RSVpreF, with challenges in storage and shelf-life despite not requiring preparation by healthcare providers.
The vaccine could reduce RSV-related morbidity, mortality, and hospital burden, but delayed ACIP recommendations for 50-59 age group may impact sales.

mRNA-1345 (mRESVIA; Moderna) has the potential to significantly transform the RSV disease state in 2025, according to data analysts.

Experts from Clarivate released a series of drugs that could significantly transform their indicated disease states in 2025, including mRNA-1345 (mRESVIA; Moderna), a single dose, 0.5-mL respiratory syncytial virus (RSV) vaccine for the protection of adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by RSV infection. The vaccine consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein and uses the same lipid nanoparticles as the Moderna COVID-19 vaccine.^1-4

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mRNA-1345 was granted FDA Breakthrough Therapy Designation in February 2023, followed by the FDA approval in May 2024 for adults 60 years and older to protect against LRTD.^3,4

The FDA approval of mRNA-1345 was based on results from the phase 2/3 randomized, observer-blind, placebo-controlled ConquerRSV trial that was divided into Part A and Part B and included over 37,000 adults aged 60 years and older. Part A assessed the safety and tolerability of the vaccine with a single dose compared with a placebo 14 days post-infection through 12 months, whereas Part B evaluated the safety, tolerability, and immunogenicity of a booster dose at 24 months after the initial dose. The results demonstrated that mRNA-1345 was effective in preventing RSV-LRTD with 2 or more symptoms at an 83.7% rate in the primary analysis, with 82.4% efficacy for RSV-LRTD with 3 or more symptoms.^1,4

Additionally, in a supplementary analysis of data from a median 8.6-month follow-up, sustained vaccine efficacy of mRNA-1345 for RSV-LRTD was 63.3% for 2 symptoms; 74.6% for 2 or more symptoms, including shortness of breath; and 63% for 3 or more symptoms. There were no serious safety concerns with infection site pain, fatigue, headache, myalgia, and arthralgia as the most reported adverse events.^1,4

Following the approval of mRNA-1345, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the use of the vaccine in all adults 75 and older and in adults aged 60 to 74 at an increased risk of severe RSV disease.^1,2

Clinical trials are ongoing to evaluate the effects of the vaccine in other age groups, including a phase 3 study focused on high-risk individuals aged 18 to 60 years of age in Part A and individuals younger than 18 years who received a solid organ transplant in Part B. A single intramuscular injection will be administered in Part A and 2 intramuscular infections on day 1 and 57 will be administrated in Part B, with an expected completion date of July 2026.¹

mRNA-1345 joins RSVPreF3 (Arexvy; GSK) and RSVpreF (Abrysvo; Pfizer) as the current 2025 RSV vaccine to watch, as the other 2 vaccines were identified as drugs to watch in the 2024 report. RSVPreF3 is approved to treat at-risk individuals 50 to 59 years of age in the US, Canada, European Union, and Japan as well as high-risk individuals aged 18 to 59 years.¹

However, mRNA-1345 could impact the market differently for RSV prevention as RSVPreF3 and RSVpreF fared inversely from each other. Most 2023 sales of the RSVPreF3 vaccine were in the US, and it currently is the leading RSV vaccine in market share due to its contracts with retail pharmacies. However, in 2024, sales for RSVPreF3 slowed but could increase with the 2024-2025 RSV season. Revenue for the RSVpreF vaccine was primary from older adults and sales decreased in the beginning of 2024.¹

According to the 2025 drugs to watch report, mRNA-1345 could fill gaps in treatment by reducing morbidity and mortality and reduce hospital burden caused by RSV infection among older adults and individuals with underlying health conditions. This can be achieved with all 3 RSV vaccines, demonstrating a hurdle mRNA-1345 may need to overcome to reach blockbuster status.¹

Although mRNA-1345 does not require preparation by health care providers, putting it above its competitors, the vaccine has a shorter shelf-life and requires extremely cold temperatures to remain viable. Additionally, all RSV sales could be impacted following the delayed recommendation for vaccination among adults aged 50 to 59 years by ACIP.¹

REFERENCES

1. Clarivate. Drugs to Watch in 2025. 2025. Accessed January 15, 2025. https://clarivate.com/drugs-to-watch/.

2. Halpern L. Key Drugs to Watch for Community Pharmacy in 2025. Pharmacy Times. News release. January 15, 2025. Accessed January 15, 2025. https://www.pharmacytimes.com/view/key-drugs-to-watch-for-community-pharmacy-in-2025.

3. Antrim A. FDA Grants Breakthrough Therapy Designation to Moderna for Investigational RSV Vaccine. Pharmacy Times. News release. February 2, 2023. Accessed January 15, 2025.https://www.pharmacytimes.com/view/fda-grants-breakthrough-therapy-designation-to-moderna-for-investigational-rsv-vaccine.

4. Gallagher A. FDA Approves mRNA-1345 for Protection Against Lower Respiratory Tract Disease Caused by RSV. Pharmacy Times. News release. May 31, 2024. Accessed January 15, 2025. https://www.pharmacytimes.com/view/fda-approves-mrna-1345-for-protection-of-lower-respiratory-tract-disease-caused-by-rsv.