Biotechnology company Moderna has announced promising results from a large Phase 3 trial testing an mRNA vaccine for respiratory syncytial virus (RSV) in older adults. The data show the vaccine is nearly 84% effective in preventing moderate disease, and the company plans to apply for U.S. Food and Drug Administration (FDA) approval this year.
RSV infection can develop into fatal respiratory disease in very young to very old people. For more than half a century, researchers have been trying to develop an effective vaccine, and 2023 looks set to be the breakthrough year when not just one, but perhaps three different vaccines will finally be approved. am.
Last year, pharmaceutical companies GSK and Pfizer released preliminary Phase 3 data for their RSV vaccine candidates. Both focus on disease in adults over the age of 60, and successful results indicate that the vaccine is 60% to 80% effective in preventing lower respiratory tract symptoms.
Both GSK and Pfizer’s RSV vaccines use more traditional protein-based technology. Specific viral protein fragments are manipulated and propagated in the laboratory before being prepared and administered directly to individuals. Meanwhile, Moderna’s RSV vaccine utilizes recent mRNA technology that was first widely used in his 2020 COVID-19 vaccine.
Moderna’s RSV vaccine is the second mRNA vaccine to show positive Phase 3 data after the company accelerated clinical studies following the success of its 2020 COVID vaccine.
“This study demonstrated a vaccine efficacy of 83.7% for RSV-associated lower respiratory tract disease defined by 2 or more symptoms and an 82.4% vaccine efficacy for RSV-associated lower respiratory tract disease defined by 3 With the vaccine efficacy, we met the pre-defined statistical criteria for efficacy.There are more symptoms,” Moderna CEO Stefan Bansel reported in a recent blog post. bottom.
In the next 12 months, all three RSV vaccines will reach clinical use, vying for a portion of the multi-billion dollar market. Comparing results from different Phase 3 clinical trials is less useful, but preliminary publications suggest that GSK and Moderna report relatively similar efficacy data, while Pfizer’s candidates are few. It has been suggested that the
It is unclear what this means for practical efficacy. His RSV vaccine from Pfizer and his GSK has already undergone FDA evaluation, with a decision expected by May. Moderna plans to submit applications for the RSV vaccine over the next few months, so it won’t be too late.
Going forward, the first approval for the elderly is just the first step in RSV vaccine development, with pediatric and maternal trials currently underway with all three pharmaceutical companies. Moderna is also investigating a range of new mRNA vaccine formulations, using antigens from SARS-CoV-2, influenza, and human metapneumovirus (hMPV) to combine RSV vaccines into a single shot.
Source: Moderna
