The US Food and Drug Administration (FDA) has approved Moderna‘s respiratory syncytial virus (RSV) vaccine for adults aged 60 and older. Moderna’s vaccine, branded as mRESVIA is the first mRNA RSV vaccine approved and it is the company’s second product to receive FDA approval after its COVID-19 vaccine.

FDA Approves Moderna’s mRNA RSV Vaccine for Older Adults

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The approval adds to the existing arsenal of RSV vaccines including those developed by GSK and Pfizer. mRESVIA is the only RSV vaccine available in a pre-filled syringe which simplifies administration and reduces the risk of administrative errors.

RSV is a common virus that generally causes mild symptoms but can be severe for certain populations, especially older adults, young children, and individuals with underlying health conditions.

Annually, RSV leads to 60,000 to 160,000 hospitalizations among older adults in the US and results in 6,000 to 10,000 deaths, according to the CDC.

The FDA’s approval was based on clinical trial data from a study involving 37,000 adults across 22 countries.

The trial demonstrated that mRESVIA had an 83.7% efficacy in preventing lower respiratory tract disease four months after vaccination.

A longer-term analysis showed continued protection nearly nine months post-vaccination although efficacy declined to 63% at 8.6 months.

Moderna addressed that no serious safety concerns were identified with common side effects including pain at the injection site, headache, and fatigue.

The approval of mRESVIA is crucial for Moderna as it seeks new revenue sources amidst declining demand for its COVID-19 vaccine, its only other commercially available product.

Stéphane Bancel, CEO of Moderna highlighted that the approval demonstrates the strength and versatility of their mRNA platform which is being used to develop vaccines for various diseases including cancer and norovirus.

The Centers for Disease Control and Prevention (CDC) will hold a meeting on June 26 to discuss whether to recommend the mRESVIA vaccine for older adults. If recommended the vaccine could become available for the 2024-2025 RSV season which typically starts in the fall and peaks in winter.

Moderna’s mRESVIA will compete with RSV vaccines from GSK and Pfizer both of which launched their vaccines in the US last fall.

While Pfizer’s RSV vaccine has trailed behind GSK’s in sales both have generated hundreds of millions in revenue.

Moderna’s 2024 sales guidance includes revenue projections from mRESVIA contributing to a total expected revenue of around $4 billion.

The company’s long-term financial health is by a robust pipeline of over 40 products in development including a combination shot for COVID-19 and flu, and a personalized cancer vaccine.

Moderna’s stock has seen volatility, falling nearly 45% in 2023 but rebounding by over 40% this year.

mRESVIA is Moderna’s second mRNA vaccine to receive FDA approval following its highly successful COVID-19 vaccine, Spikevax. This approval is the first instance of an mRNA vaccine being approved for a disease other than COVID-19.

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mRESVIA is the only RSV vaccine available in single-dose pre-filled syringes. The pre-filled syringe format is designed to maximize ease of administration, save vaccinators’ time and reduce the risk of administrative errors.

RSV is a highly contagious seasonal virus leading to lower respiratory tract infections and pneumonia particularly severe in infants and older adults.

Annually in the U.S., approximately 60,000-160,000 older adults are hospitalized and 6,000-10,000 die due to RSV infection.

The FDA’s approval of mRESVIA is based on positive data from the Phase 3 clinical trial, ConquerRSV. The trial involved approximately 37,000 adults aged 60 years or older across 22 countries.

Primary analysis with 3.7 months of median follow-up demonstrated a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%).

A follow-up analysis during FDA review included cases confirmed after the primary analysis cut-off date, showing consistent results with a vaccine efficacy of 78.7% (CI 62.9%, 87.8%).

Longer-term analysis indicated continued protection over 8.6 months median follow-up. No serious safety concerns were identified.

The most commonly reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna expects mRESVIA to be available for eligible populations in the U.S. by the 2024/2025 respiratory virus season. The company has filed for approval of mRNA-1345 with regulators in multiple markets worldwide.

mRESVIA consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein, crucial for RSV infection by aiding virus entry into host cells.

The prefusion conformation of the F protein is a target for potent neutralizing antibodies conserved across both RSV-A and RSV-B subtypes. The vaccine utilizes the same lipid nanoparticles (LNPs) as Moderna’s COVID-19 vaccines.

Stéphane Bancel, CEO of Moderna said, “The FDA approval of mRESVIA builds on the strength and versatility of our mRNA platform. This approval is a testament to our commitment to addressing global public health threats related to infectious diseases.”

Moderna’s vaccine portfolio includes 28 vaccines targeting respiratory, latent, and other pathogens.

The Company has Successfully Advanced Four Respiratory Disease Programs to Positive Phase 3 Data:

  1. mRNA-1273 (COVID-19 Vaccine, Spikevax®): In November 2020, Moderna announced positive Phase 3 data and requested Emergency Use Authorization from the FDA. Spikevax is now approved in markets worldwide.
  2. mRNA-1345 (RSV Vaccine): Announced positive Phase 3 results in January 2023 and now approved in the U.S. Regulatory reviews are pending in multiple countries.
  3. mRNA-1010 (Flu Vaccine): Announced positive Phase 3 data in September 2023, with ongoing discussions with regulators and plans to file in 2024.
  4. mRNA-1283 (Next-Generation COVID-19 Vaccine): Announced positive Phase 3 data in March 2024. Critical component of Moderna’s combination vaccine against flu and COVID-19, mRNA-1083.

Moderna is also advancing vaccine candidates against viruses causing latent infections. Positive clinical trial data from vaccines targeting Epstein-Barr virus, Varicella-Zoster virus, and norovirus.

These Programs are Progressing towards Phase 3 Development:

  • 70% success rate in Phase 1 trials across 20 candidates, compared to the industry average of 35%.
  • 78% success rate in Phase 2 trials across nine candidates, nearly three times the industry average of 27%.
  • 80% success rate in Phase 3 trials across five candidates, versus the industry average of 69%.

Moderna’s strategy is focused on developing a robust portfolio of mRNA vaccines to target respiratory diseases like COVID-19, RSV, and flu.

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