Author: Karolina Kujawa
Publisher: Datamonitor Healthcare
MVA-BN RSV is a vaccine based on a recombinant MVA vector which expresses the RSV F and G glycoproteins, as well as the internal N and M2 proteins. The vaccine has been designed with the intention of stimulating neutralizing antibody responses to the F and G proteins, as well as strong T-cell responses to the conserved internal N and M2 proteins. MVA-BN RSV is currently in Phase II development for the prevention of serious lower respiratory tract disease caused by RSV, and Bavarian Nordic intends to investigate its use in both the pediatric and elderly patient segments.
MVA-BN RSV (Bavarian Nordic) is a respiratory syncytial virus (RSV) vaccine based on a recombinant modified vaccinia virus Ankara (MVA) vector which expresses the surface RSV fusion (F) and attachment (G) glycoproteins, as well as the conserved internal nucleocapsid (N) and matrix (M2) proteins. Following the unexpected failures of Novavax’s and AstraZeneca’s F protein-based
vaccines to demonstrate efficacy in the elderly population, Datamonitor Healthcare believes that MVA-BN RSV’s inclusion of multiple viral proteins positions it well to avoid similarly disappointing results. Indeed, Phase I data have shown that the vaccine elicits both serum immunoglobulin G (IgG) and broad T-cell responses, potentially providing a protective advantage over the former subunit approaches, which are less likely to stimulate strong cellular immunity. The utilization of an MVA vector, which Phase I data suggest is not neutralized by pre-existing antibodies, further increases the commercial potential of the vaccine because it could be used in all three high-risk target populations: infants aged under six months, infants aged 6−24 months, and the elderly. However, Bavarian Nordic will face competition from Johnson & Johnson’s replication-deficient adenovirus vector vaccine (Ad26.RSV.preF) and Novavax’s nanoparticle vaccine (RSV F), which are anticipated to launch for the elderly one year ahead of Bavarian Nordic’s vaccine in the 2021/22 season, as well as Pfizer’s vaccine (RSV preF), which is expected to launch in the 2023/24 season.
4 Drug Overview
5 Product Profiles
5 MVA-BN RSV : Respiratory syncytial virus (RSV) vaccines
LIST OF FIGURES
11 Figure 1: MVA-BN RSV for RSV prophylaxis – SWOT analysis
15 Figure 2: Potential sales for RSV vaccines in the elderly across the US and five major EU markets, by country, 2016/17–2025/26
LIST OF TABLES
6 Table 1: MVA-BN RSV drug profile
7 Table 2: MVA-BN RSV completed Phase I and Phase II clinical trials in RSV vaccination
16 Table 3: Potential sales for RSV vaccines in the elderly across the US and five major EU markets, by country ($m), 2016/17–2025/26
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