Moderna just got FDA approval for its RSV vaccine — only its second product on the market

Moderna Receives FDA Approval for RSV Vaccine

The Food and Drug Administration (FDA) has recently given its approval for Moderna’s mRNA-based respiratory syncytial virus (RSV) vaccine, making it only the second product from the pharmaceutical company to hit the market. This groundbreaking approval for the vaccine, named mRESVIA, is specifically for individuals aged 60 and older. Moderna, well-known for its COVID-19 vaccine, is now set to launch its second product, marking a significant milestone for the company.

Moderna CEO Stéphane Bancel expressed enthusiasm about the FDA approval, stating that “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform.” This milestone is particularly noteworthy as it represents the FDA’s first approval for an mRNA vaccine designed to protect against a disease other than COVID-19.

A pivotal phase 3 trial of mRESVIA included approximately 37,000 adults aged 60 years or older and demonstrated an impressive efficacy rate of nearly 84% in protecting against RSV lower respiratory tract disease. Given that RSV contributes to a significant number of hospitalizations and fatalities among older adults in the U.S., with an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually according to the Centers for Disease Control and Prevention, the approval of this vaccine represents a crucial advancement in healthcare.

In addition to its COVID-19 vaccine and now the RSV vaccine, Moderna is aiming to expand its respiratory franchise, with projections indicating a potential revenue of $4 billion this year. The company is also in the process of developing a combination vaccine for COVID-19 and influenza, showcasing its commitment to innovation and addressing public health needs. With over 40 products in development, including a vaccine for norovirus, Moderna continues to be a key player in the pharmaceutical industry.

Despite experiencing a decline in revenue in the first quarter of 2024, Moderna remains optimistic about the future of its product pipeline. The company’s stock saw a slight decrease following the FDA approval news but has shown a 28% increase since the beginning of the year, reflecting investor confidence in Moderna’s capabilities and potential for growth.