Pharma News: U.S. FDA Approves Moderna's mRNA RSV Vaccine for Seniors, mRESVIA
Nikhil Prasad Fact checked by:Thailand Medical News Team Jun 03, 2024 5 months, 2 weeks, 4 days, 17 hours, 8 minutes ago
Pharma News: Despite all the controversies regarding the COVID-19 vaccines and the new mRNA technology, Moderna has received the U.S. FDA approval for its latest vaccine, mRESVIA, designed to protect older adults from respiratory syncytial virus (RSV). The pharma giant claims that this approval marks a critical milestone for the biotech company, showcasing its mRNA technology's versatility and potential in addressing various infectious diseases.
U.S. FDA Approves Moderna's mRNA RSV Vaccine for Seniors, mRESVIA
A New Chapter for Moderna
With the COVID-19 pandemic receding, Moderna faced a notable decline in revenue. However, the recent U.S. FDA approval of mRESVIA signals a promising new chapter for the company.
https://www.fda.gov/media/179015/download?attachment
mRESVIA, targeting adults aged 60 and above, aims to prevent lower respiratory tract disease caused by RSV. Moderna told
Pharma News outlets that it plans to launch the vaccine in time for the 2024-2025 RSV season, which typically starts in late fall in the U.S.
The mRNA Edge
mRESVIA is not just another RSV vaccine; it is the first RSV vaccine based on mRNA technology to receive FDA approval. This innovation follows Moderna's success with its COVID-19 vaccine, Spikevax, approved in 2022. While GSK’s Arexvy holds the title of the first FDA-approved RSV vaccine, Moderna's mRESVIA distinguishes itself by leveraging the company’s advanced mRNA platform.
Clinical Success and Market Competition
Moderna’s mRESVIA demonstrated impressive efficacy in a large Phase 3 trial conducted across 22 countries. The vaccine showed an 83.7% efficacy rate against RSV-associated lower respiratory tract disease after a median follow-up of 3.7 months.
https://www.nejm.org/doi/full/10.1056/NEJMoa2307079?query=featured_home
This high efficacy positions Moderna well in a competitive market, where it will face off against GSK’s Arexvy and Pfizer’s Abrysvo.
Both GSK and Pfizer’s RSV vaccines have generated significant revenue, with Arexvy bringing in £1.2 billion ($1.5 billion) and Abrysvo earning approximately $1.03 billion. Unlike its competitors, mRESVIA is the only RSV vaccine available in a pre-filled syringe, enhancing ease of administration and reducing the risk of errors.
Robust Clinical Data
The FDA’s approval was based on the Phase 3 ConquerRSV trial, a randomized, double-blind, placebo-controlled study involving around 37,000 adults aged 60 and above. The trial focused on two primary efficacy endpoints: RSV-LRTD with either two or more symptoms or three or more symptoms. The interim analysis revealed significant res
ults, with 83.7% efficacy against RSV-LRTD with two or more symptoms and 82.4% efficacy with three or more symptoms.
A subsequent analysis with a longer median follow-up of 8.6 months confirmed the vaccine’s durable efficacy. The data presented at the RSVVW'24 conference showed a sustained vaccine efficacy of 63.3% against RSV-LRTD with two or more symptoms and 74.6% efficacy against RSV-LRTD with two symptoms, including shortness of breath.
Safety and Tolerability
Safety was a critical component of the ConquerRSV trial. The mRESVIA vaccine was well tolerated, with no major safety concerns reported. Most adverse reactions were mild or moderate, including injection site pain, fatigue, headache, myalgia, and arthralgia. The overall rate of severe adverse reactions was low, with 4.0% in the mRESVIA group compared to 2.8% in the placebo group.
Scientific Innovation
mRESVIA consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein, crucial for RSV infection. This glycoprotein exists in two states, prefusion and postfusion, with the prefusion form being a significant target for neutralizing antibodies. Moderna’s use of lipid nanoparticles (LNPs) in mRESVIA is the same technology employed in its COVID-19 vaccines, highlighting the platform's adaptability.
Looking Ahead
Moderna is poised to manufacture and distribute mRESVIA for the 2024-2025 RSV season, marking an important step in its mission to combat infectious diseases globally. The company’s expanding pipeline includes mRNA candidates for influenza, HIV, Lyme disease, Zika, and a cancer vaccine in partnership with Merck & Co., underscoring its commitment to addressing a broad spectrum of health threats.
The FDA approval of mRESVIA not only diversifies Moderna’s product portfolio but also reinforces the potential of mRNA technology in modern medicine. As the company continues to innovate, its contributions to public health are expected to grow, providing new tools to fight diseases and improve health outcomes worldwide.
Conclusion
Moderna’s FDA approval for mRESVIA signifies a major achievement in its post-pandemic trajectory. The new RSV vaccine, backed by strong clinical data and innovative mRNA technology, positions Moderna as a formidable player in the vaccine market. As the company prepares for the upcoming RSV season, the world watches with anticipation, hopeful for continued breakthroughs in the fight against infectious diseases.
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https://www.thailandmedical.news/news/breaking-moderna-s-chief-admits-that-current-vaccines-might-be-ineffective-against-omicron-and-foresees-a-worrying-pandemic-state
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