MF-59 adjuvanted QIV

Drug Overview

CSL’s MF-59 adjuvanted QIV is a subunit, surface antigen-containing seasonal QIV adjuvanted with
MF59. It contains antigens from two A strains and two B strains specified by the World Health
Organization seasonally for seasonal influenza vaccination. The vaccine is currently in Phase III
development in both the US and EU. Based on projected Phase III trial completion dates, Datamonitor
Healthcare forecasts the vaccine’s launch in infants aged six to 24 months in the 2018/19 season, and
for use in the elderly in the 2018/19 season in the US and in the 2019/20 season in the EU.

Analyst Outlook

Following its anticipated launch from 2018 in the US and the EU for pediatric populations, and from
2018 in the US and 2019 in the EU for elderly populations, CSL’s MF-59 adjuvanted QIV is expected to
rapidly facilitate the conversion of elderly populations to quadrivalent influenza vaccines (QIVs), and
will additionally expand the approved age range of QIVs to include infants aged 6–24 months in the
EU. Datamonitor Healthcare believes that CSL’s vaccine could see strong use in infants if it is able to
elicit superior immune responses compared to non-adjuvanted inactivated vaccines, and that it will
become the preferred vaccine for infants aged 6−24 months, where its main competitor FluMist
(intranasal live-attenuated vaccine; AstraZeneca/MedImmune) is not licensed for use. In the US,
Sanofi Pasteur’s Fluzone High-Dose trivalent influenza vaccine (TIV) poses a significant threat to CSL’s
product due to physician preference for high-dose vaccines for the elderly population. There is
evidence to suggest that high-dose vaccines are more protective for the 65 and over age group, whose
immune defenses have become weaker with age, because they contain significantly increased
amounts of antigen compared with the regular flu shot, and are subsequently associated with a
stronger immune response following vaccination (CDC, 2015). A head-to-head comparison of Fluzone
High-Dose TIV and MF-59 adjuvanted QIV could benefit CSL in demonstrating safety or efficacy
benefits to using an adjuvanted QIV over a high-dose TIV in the elderly. This would be useful to CSL if
the company hopes to capture Fluzone’s market share.