Moderna's RSV Approval Sparks Three-Way Battle with Pfizer, GSK

After a minor regulatory delay, Moderna has secured FDA approval for its RSV vaccine, mRESVIA (mRNA-1345), designed for adults aged 60 and older. This achievement marks a significant milestone for Moderna, demonstrating the versatility of its mRNA technology beyond COVID-19. The approval, granted on Friday, not only endorses the efficacy of mRNA vaccines but also offers a financial boost to Moderna, which has seen declining sales of its COVID-19 vaccine, Spikevax. Analysts predict that mRESVIA will generate approximately $340 million in revenue this year and over $800 million by 2025.

The mRESVIA vaccine comprises a single mRNA sequence that encodes a stabilized prefusion F glycoprotein and utilizes the same lipid nanoparticle delivery system as Spikevax. The FDA's decision was based on results from the Phase III ConquerRSV trial, which involved around 37,000 adults aged 60 and older, who received either a single dose of mRESVIA or a placebo. After a median follow-up period of 3.7 months, the vaccine demonstrated an efficacy rate of 83.7% against RSV-related lower respiratory tract disease.

Earlier this month, the US regulator delayed its decision on the vaccine by approximately three weeks due to "administrative constraints." However, this postponement does not appear to have significantly impacted the rollout timeline, with Moderna confident that mRESVIA will be available in the US for the 2024-2025 respiratory virus season. Crucially, the approval was finalized before the CDC's Advisory Committee on Immunization Practices meeting scheduled for June 26-27. A positive recommendation from this committee is critical for mRESVIA to compete with existing RSV vaccines, namely GSK’s Arexvy and Pfizer’s Abrysvo, in the upcoming winter season.

Arexvy and Abrysvo received approval last year for use in older adults, with Pfizer’s vaccine also being approved for maternal immunization to protect infants up to six months old. Despite Pfizer's broader label, GSK’s vaccine has seen a more rapid market launch. The timely approval of mRESVIA positions it as a potential contender in the RSV vaccine market, provided it receives the necessary endorsement from the CDC committee.

Moderna’s success with mRESVIA underscores the adaptability of mRNA technology beyond its initial application for COVID-19 vaccines. This diversification is crucial for Moderna’s financial health, especially as the demand for Spikevax declines. The Phase III ConquerRSV study's robust findings, showing a high efficacy rate, were pivotal in securing FDA approval and could help build public and professional confidence in the broader use of mRNA vaccines.

Looking ahead, Moderna aims to establish mRESVIA as a significant player in the RSV vaccine landscape. The company’s ability to navigate regulatory challenges and achieve timely product rollout will be critical in its efforts to gain market share against established competitors like GSK and Pfizer. With anticipated revenues climbing in the coming years, mRESVIA's success could be a testament to the potential of mRNA technology in combating a range of infectious diseases beyond COVID-19.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!