RSV F vaccine is an intramuscular recombinant nanoparticle vaccine comprising a highly purified post-fusion form of the RSV F protein that can be administered with or without an alum adjuvant. In July 2012, Novavax entered into a collaboration with PATH, a nonprofit organization, which will provide funding to advance the development of the vaccine in low-income countries .
Novavax’s Phase III respiratory syncytial virus (RSV) vaccine is a highly purified nanoparticle vaccine comprising a recombinant postfusion form of the RSV fusion (F) protein. The vaccine’s commercial potential has been reduced following its unexpected failure to meet its primary or secondary efficacy endpoints in the pivotal Resolve study in the elderly population. Novavax is now investigating the safety and immunogenicity of adjuvanted and unadjuvanted formulations of the vaccine in single- or two-dose schedules (ClinicalTrials.gov identifier: NCT03026348), and topline results show that the two-dose regimens improved the vaccine’s immunogenicity in older adults (Novavax, 2017b). This setback in development means the RSV F vaccine for the elderly will not have a first-to-market advantage, and Novavax will need to compete for market share in this lucrative patient population with alternative approaches which may be capable of stimulating superior immune responses. Irrespective of RSV F’s fortunes in the elderly sector, it remains the most advanced vaccine for maternal immunization, which bypasses the need to demonstrate immunogenicity in very young neonates (rival live-attenuated vaccines [LAVs] have struggled to achieve this), while potentially providing protection to an age group at very high risk of RSV disease. While this strategy is likely to provide only short-term protection to newborns and has very limited commercial potential, the vaccine could be subsequently administered to infants at six months post-partum; that is, once maternal antibody titers have waned and immunogenicity is easier to demonstrate. However, Novavax will face fierce competition in the pediatric sector from several rival LAV and viral vector vaccine approaches that may elicit superior cellular and mucosal antibody responses.
4 Drug Overview
5 Product Profiles
5 RSV F vaccine : Respiratory syncytial virus (RSV) vaccines
LIST OF FIGURES
12 Figure 1: RSV F vaccine for RSV prophylaxis – SWOT analysis
17 Figure 2: Potential sales for RSV vaccines across the US and five major EU markets, by risk group, 2016/17–2025/26
LIST OF TABLES
6 Table 1: RSV F vaccine profile
8 Table 2: RSV F vaccine Phase III Resolve data for RSV vaccination
9 Table 3: RSV F vaccine ongoing clinical trial in RSV vaccination
10 Table 4: RSV F vaccine key Phase II data in RSV vaccination
18 Table 5: Potential sales for RSV vaccines across the US and five major EU markets, by risk group ($m), 2016/17–2025/26
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