The Approval of Moderna’s Vaccine for Respiratory Syncytial Virus

Recently, the Food and Drug Administration approved Moderna’s vaccine for respiratory syncytial virus (RSV) for adults ages 60 and above. This approval marks a significant milestone for Moderna, especially considering the company’s need for an additional revenue source due to declining demand for its Covid jab.

The Approval Process

Moderna’s vaccine for RSV was approved based on a late-stage trial involving older adults who are more susceptible to severe cases of the virus. RSV is known to cause between 6,000 and 10,000 deaths among seniors annually, with 60,000 to 160,000 hospitalizations resulting from the virus. Moderna’s vaccine, to be marketed under the brand name mRESVIA, is the first messenger RNA vaccine to receive approval for a disease other than Covid. Notably, the vaccine is available in a pre-filled syringe, making administration easier for medical professionals.

Moderna’s entry into the RSV vaccine market puts it in direct competition with established players like GSK and Pfizer, both of whom launched their own RSV vaccines last fall. While Pfizer’s vaccine has faced challenges in catching up to GSK’s offering, both companies have seen significant sales from their respective vaccines. Moderna’s full-year 2024 sales guidance, which includes revenue from its RSV vaccine, is estimated to reach approximately $4 billion.

Expanding Possibilities with mRNA Technology

The approval of Moderna’s RSV vaccine showcases the versatility of the company’s messenger RNA platform beyond addressing Covid. Moderna has a robust pipeline of over 40 products in development, with a focus on treating various diseases such as RSV, cancer, and norovirus. The company is also working on innovative combination shots like those targeting Covid and the flu, as well as standalone flu vaccines and personalized cancer treatments in collaboration with Merck.

Investor Expectations and Future Outlook

Investors are optimistic about the long-term potential of Moderna’s mRNA product pipeline, as evidenced by a significant increase in the company’s share price this year. Despite setbacks in 2023, Moderna aims to return to sales growth by 2025 and achieve breakeven by 2026 through the launch of new products. The company’s commitment to driving innovation and addressing global public health challenges remains unwavering.

Notably, Moderna’s RSV vaccine demonstrated an efficacy rate of 83.7% in preventing at least two symptoms of the virus after three months in a phase three trial. However, efficacy declined to 63% at 8.6 months, raising concerns among investors about the durability of protection compared to GSK and Pfizer’s vaccines. Moderna has emphasized that direct comparisons are challenging due to differences in study populations, locations, and case definitions. Importantly, no significant safety concerns were identified during the trial, reassuring both regulators and the public.

The approval of Moderna’s vaccine for respiratory syncytial virus heralds a new chapter in the company’s journey to revolutionize healthcare through mRNA technology. With a robust pipeline of innovative products and a commitment to addressing global health threats, Moderna is well-positioned to make a lasting impact on public health.