VLP QIV
Publisher: Datamonitor Healthcare
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Analyst Outlook
Novavax’s virus-like particle (VLP) quadrivalent influenza vaccine (QIV), currently in Phase II
development, has the potential for significant market success if it is able to demonstrate superior
safety or efficacy data in Phase III studies. In animal studies, VLPs have proven to have superior
immunogenicity to other vaccines, and to be cross-reactive to and protective against diverse subtypes
of influenza virus when compared to inactivated influenza virus vaccination (Lee et al., 2014).
However, it is unclear whether these benefits observed in animal models will translate to superior
protection in Phase II proof-of-concept studies in humans.
Drug Overview
Novavax’s VLP QIV is a seasonal influenza vaccine that is formulated from VLPs made using a
baculovirus expression system in insect cells. The vaccine includes three structural virus proteins:
hemagglutinin, neuraminidase, and matrix 1 (Novavax, 2016). The VLP QIV is currently in Phase II
development in the US. Based on competitive Phase II trial data, Phase III studies are expected to be
initiated in 2016. Datamonitor Healthcare forecasts that VLP QIV will be approved for use in the adult
population in the 2020/21 season in the US and in the 2021/22 season in the EU.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 VLP QIV : Seasonal influenza vaccines
LIST OF FIGURES
9 Figure 1: VLP QIV as a seasonal influenza vaccine – SWOT analysis
LIST OF TABLES
4 Table 1: VLP QIV drug profile
7 Table 2: VLP QIV Phase II data as a seasonal influenza vaccine
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MF-59 adjuvanted QIV 
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