Moderna Expands Reach with FDA-Approved RSV Vaccine

Since the COVID-19 pandemic has started to abate, Moderna has experienced a significant decline in revenue. However, a new approval from the U.S. Food and Drug Administration (FDA) highlights the company's continued innovation in the biomedical field. Moderna's latest product, mRESVIA, has received FDA approval to protect individuals aged 60 and older from lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection. The company aims to launch this vaccine in time for the 2024-2025 RSV season, which usually begins in late fall in the United States.

This latest approval is Moderna's second from the FDA, following the 2022 approval of its COVID-19 vaccine, Spikevax. Both vaccines are based on Moderna's messenger RNA (mRNA) technology platform. Although mRESVIA is not the first RSV vaccine to get FDA approval—an honor that went to GSK's Arexvy—it is the first mRNA-based vaccine for RSV.

In a large-scale phase 3 clinical trial conducted across 22 countries, Moderna's mRESVIA showed an efficacy rate of 83.7% against RSV-associated lower respiratory tract disease after a median follow-up of 3.7 months. This high efficacy rate positions Moderna's vaccine as a strong competitor in the RSV market alongside GSK and Pfizer.

The approval of mRESVIA sets the stage for competition against GSK’s Arexvy and Pfizer’s Abrysvo, both of which have already secured FDA approvals for protecting older adults. Notably, Pfizer’s vaccine also has approval for use as a maternal vaccination to protect newborns from RSV. To date, GSK's Arexvy has generated approximately 1.2 billion pounds (about $1.5 billion), while Pfizer's Abrysvo has garnered around $1.03 billion.

In addition to its work on COVID-19 and RSV, Moderna is developing mRNA-based vaccines for several other diseases, including influenza, HIV, Lyme disease, and Zika. One of the company's most discussed projects in recent months is its collaboration with Merck & Co. on a cancer vaccine, which has attracted considerable attention as they advance their development plans.

Overall, Moderna's latest FDA approval demonstrates the company's ability to diversify its portfolio and maintain a competitive edge in the pharmaceutical market. As the RSV season approaches, it will be interesting to see how mRESVIA performs against its competitors and what impact it will have on Moderna's financial recovery.