Human respiratory syncytial virus (RSV) is a common respiratory virus which is now recognized as an important pathogen in adults, especially the elderly and vulnerable. A 2020 study estimated that in adults, about 1.5m episodes of RSV acute respiratory infection (RSV-ARI) occurred in industrialized countries in 2015 (n=41) (Shi T et al., 2020). On a global level, the same study estimated 336,000 hospital admissions and 14,000 in-hospital deaths, although the true burden is thought to be much higher. In the USA 60-160,000 hospitalizations are estimated for persons >65 yrs with around 6-10,000 deaths (CDC, RSV-NET cited figures), again with wide variance in estimates. Cardiovascular, chronic lung and diabetes are common underlying conditions in persons (>18 yrs) hospitalized with RSV infection with in-hospital mortality at ~12% (Shi T et al., 2022). There is no specific treatment for RSV infection and for those adults who require hospitalization, supportive therapy is still the mainstay of care.
The RSV older adult, elderly vaccine development field is one of the most active in the industry with several pivotal Phase 3 studies now ongoing. Major companies such as Pfizer, PF-06928316, GSK Biologicals, GSK3844766A, Janssen NV, Ad26.RSV.preF (VAC18193), ModernaTX, mRNA-1345, Sanofi Pasteur, CL-0059, CL-0137 are involved with also the mid-tier player, Bavarian Nordic, MVA-BN-RSV. 3 of the RSV vaccine candidates have recently met pre-specified primary efficacy endpoints against lower respiratory tract disease (RSV-LRTD), 2 of which have already undergone regulatory submissions with key agencies. Companies are pursuing a range of RSV-preF vaccine approaches, including traditional recombinant proteins (+/- adjuvant), vector-based to newer mRNA technologies. mRNA vaccines could facilitate future combination pan-respiratory vaccine concepts, already at early stages in seasonal influenza and COVID-19 segments (mRNA-1073, 1230, 1045). Regarding potential recommendation and adoption of new adult RSV vaccines, the US ACIP committee met in October 2022 to discuss the Pfizer and GSK Phase 3 datasets and is expected to make a policy decision in June 2023, post-FDA PDUFA dates in May 2023 for those manufacturers who have already filed regulatory submissions. Many key questions remain regarding vaccine durability and more data regarding outcomes e.g., hospitalization.
This MarketVIEW product is a comprehensive Executive Presentation (~300 slides, .pdf) and interactive MS-Excel forecast model(s) which investigate the scenario-based commercial potential of RSV older adult elderly vaccines profiles to 2037. 52 countries are included (public/private sector) where the impact of different country-specific pricing analogues, at-risk stratifications, and cohort target ranges can be explored. The new 2023 model can accommodate both yearly and 2-yearly schedules and the potential impact of combination products.
This report also contains a thorough review of disease background/epidemiology/cost-effectiveness studies along with vaccinology/R&D competitive landscape with an emphasis on future product differentiators, product longevity & company-specific revenues/share per USA, EU, Developed ROW and Emerging markets. It is ideally suited to organisations wishing to access an up-to-date advanced global quantification of the RSV older adult, elderly vaccines future market.
VacZine Analytics is a strategic research agency based in the United Kingdom since 2007. We aim to provide disease and commercial analysis for the vaccine industry and help build the case for developing new vaccines and biologics.
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