Moderna Receives FDA Nod for Single-Dose RSV mRNA Vaccine

FDA approval | Image Credit: MargJohnsonVA - stock.adobe.com

Moderna received its second FDA approval for a respiratory syncytial virus (RSV) vaccine for mRNA-1345 (mRESVIA), to prevent lower respiratory tract disease (LRTD) caused by RSV infection.¹

Phase 3 trial results from ConquerRSV,² a global study involving nearly 37,000 adults over 60 across 22 countries for an average of 3.7 months, paved the way for this approval.³ Following the study results, participants demonstrated efficacy of 83.7% against RSV-associated LRTD with at least two symptoms and 82.4% against LRTD with at least three symptoms.

Additionally, a long-term analysis was completed, extending over an average of 8.6 months conducted on the mRNA-1345 vaccine and displayed protection against RSV LRTD.

The vaccine consists of an mRNA sequence that encompasses a stabilized prefusion F glycoprotein.¹ The F glycoprotein is necessary to help the virus enter the host cells. Additionally, the prefusion conformation of the F glycoprotein is an important target of potent neutralizing antibodies and his highly conserved across RSV-A and RSV-B subtypes. The mRNA-1345 vaccine utilizes the same lipid nanoparticles as the Moderna COVID-19 vaccine.

RSV is a highly contagious, seasonal respiratory virus that can lead to LRTD and pneumonia. While the phase 3 trial focused on older aged adults, RSV causes burden among infant ages as well. Overall, there are an average of 60,000 to 160,000 older adults that end up hospitalized from RSV and around 6,000 to 10,000 ultimately die from the infection.

mRESVIA joins 2 other RSV vaccines that are available. The first RSV vaccine to receive approval was Arexy in May 2023.⁴ Pfizer's Abrysvo is approved in both adults age 60 years and older⁵ and in pregnant individuals between 32- and 36-weeks’ gestational age to prevent LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.⁶

“[mRNA-1345] 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," Stéphane Bancel, chief executive officer of Moderna, said in a statement about the recent approval.¹ "This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

This is an advancement in the treatment for patients with RSV and accessibility of medication since the vaccine is administered as a single-dose in a pre-filled syringe.

The only adverse events reported from mRNA-1345 were injection site pain, fatigue, headache, myalgia, and arthralgia.

To keep up with RSV season, Moderna expects the vaccine to be available among the US population for the start of the 2024/2025 respiratory virus season.

References:

1. Moderna receives US FDA approval for RSV vaccine mRESVIA(R). News release. Moderna; May 31, 2024. Accessed May 31, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx

2. Wilson E, Goswami J, Baqui AH, et al; ConquerRSV study group. Efficacy and safety of an mRNA-based RSV PreF vaccine in older adults. N Engl J Med. 2023;389(24):2233-2244. doi:10.1056/NEJMoa2307079

3. Meara K. Moderna’s mRNA RSV vaccine shows positive results in phase 3 trial. Drug Topics^®. January 3, 2024. Accessed May 31, 2024. https://www.drugtopics.com/view/moderna-s-mrna-rsv-vaccine-shows-positive-results-in-phase-3-trial

4. Bonavitacola J. First respiratory syncytial virus vaccine approved by FDA. AJMC^®. May 3, 2023. Accessed May 31, 2024. https://www.ajmc.com/view/first-respiratory-syncytial-virus-vaccine-approved-by-fda

5. AJMC Staff. What we’re reading: FDA approves RSV vaccine; Medicare to cover Alzheimer drugs; more states extend postpartum coverage. AJMC^®. June 1, 2023. Accessed May 31, 2024. https://www.ajmc.com/view/what-we-re-reading-fda-approves-rsv-vaccine-medicare-to-cover-alzheimer-drugs-more-states-extend-postpartum-coverage

6. Joszt L. FDA approves RSV vaccine for pregnant individuals to prevent virus in infants. AJMC^®. August 21, 2023. Accessed May 31, 2024. https://www.ajmc.com/view/fda-approves-rsv-vaccine-for-pregnant-individuals-to-prevent-virus-in-infants