Moderna’s RSV Vaccine for Older Adults Approved by FDA: A Win for the Biotech Company

Moderna, the biotech company known for its mRNA technology, has received approval from the FDA for its vaccine targeting respiratory syncytial virus (RSV) in adults aged 60 and above. This marks Moderna’s second product to enter the U.S. market, providing a much-needed revenue source as demand for its Covid jab wanes.

The approval is significant as RSV poses a serious threat to older adults, causing thousands of deaths and hospitalizations each year. By addressing this unmet medical need, Moderna’s vaccine, marketed as mRESVIA, has the potential to make a significant impact on public health.

What sets Moderna’s shot apart is that it is the first mRNA vaccine to be approved for a disease other than Covid. Additionally, it is the only RSV vaccine available in a pre-filled syringe, making administration easier for healthcare providers.

While the FDA approval is a major milestone, Moderna still awaits a positive recommendation from an advisory panel to the CDC in June. If approved, Moderna’s vaccine would compete against existing RSV shots from GSK and Pfizer, which have already generated hundreds of millions in sales. Moderna executives expressed confidence that their shot would receive a similar recommendation.

Moderna’s mRNA platform has proven its versatility beyond Covid. The company is leveraging this technology to develop treatments for various diseases, including cancer and norovirus. With more than 40 products in development and several in late-stage trials, Moderna is poised for further growth and innovation.

Investors have recognized the long-term potential of Moderna’s mRNA product pipeline, resulting in a 60% increase in the company’s shares this year. This optimism is fueled by the expectation of sales growth starting in 2025 and achieving profitability by 2026 with the launch of new products.

It’s worth noting that the FDA’s decision on Moderna’s RSV vaccine was delayed due to administrative constraints. However, phase three trial data demonstrated its effectiveness in preventing RSV symptoms. While efficacy declined slightly over time, Moderna emphasized that comparing its vaccine to others would require head-to-head trials.

In terms of safety, the trial revealed no significant concerns, with most side effects being mild to moderate. These included injection site pain, fatigue, headache, muscle pain, and joint pain.

The approval of Moderna’s RSV vaccine showcases the company’s commitment to addressing global health threats and highlights the potential of mRNA technology in healthcare. With ongoing development in various therapeutic areas, Moderna is well-positioned to make a lasting impact on public health and generate continued success in the future.