DRIVE Annual Forum 17th -18th September 2018, Rome

1. Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.
DRIVE Genesis
Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.
Cedric Mahe, Sanofi pasteur – DRIVE project leader
DRIVE Annual Forum
17th-18th September 2018, Rome

2. Background
• A draft EMA Guidance on influenza vaccines – “Non-
clinical and Clinical module”
(EMA/CHMP/VWP/457259/2014) was released for
consultation in August 2014 and finally published on
29/07/2016
• This guidance requests MAHs to generate product-
specific influenza vaccine effectiveness data,
recommending the use of laboratory-confirmed
influenza outcomes in any study design.
• MAH are encouraged to liaise with institutions and public
health authorities who have experience in influenza
effectiveness studies and who have implemented a
functioning infrastructure to conduct multicentre
studies.

3. • Any difference in vaccine effectiveness may NOT be
attributable to the vaccine type/brand
• No uniform administration of type of vaccines across
the various populations of the participating centers
• Differences in coverage between sites
• Large difference in strain circulation between EU
countries
• Difference in methods/designs (TND, cohort), settings
(community, hospital)
 Pooling is methodologically challenging
Challenge 1: methodological
considerations

4. • Only one platform available so far in EU to provide
community-based vaccine effectiveness results: I-Move
• After close to 10 years of capacity building and improvements,
I-Move still only has the capacity to estimate overall vaccine
effectiveness (versus brand-specific)
Challenge 2: Feasibility (size)
Need Assessment : EpiConcept’s assessment report for ECDC
• “Based on our simulations, to have crude product-specific influenza VE estimates the increases in
sample size should be 2.4 times greater to over 13 times greater.[…] this would mean the costs
for the multicentre study would be from 600,000 to 3,250,000 Euros per season with this increase”
• “the minimal costs of a hospital network to measure crude product-specific influenza VE for the
product with the higher VC would be 1,806,250 Euros per season (20% VE precision) and
2,900,000 Euros (15% VE precision). To measure influenza VE for the products with lower
VC, the costs will be higher”
• The cost would be in the range of 3-10 millions per year…. but the budget is not sufficient
to overcome capacity gaps

5. • Relatively low vaccination rates and a market
fragmented between many different manufacturers.
• Large share of the EU markets are subject to tenders
and it is very difficult to predict brands distribution
(yearly process, and late disclosure of tender
decisions)
• The share of the predictable vaccines (non-related to
tender) is very limited (below 15% for most vaccine
manufacturers in any country)
• Moreover, reliable brand documentation is not
available in most countries
Challenges 3: Feasibility (brand data)

6. • National public health authorities are the owners of the
vaccination program data. Hence, it is impossible for MAHs
to implement the regulatory requirements without
support/collaboration of national and supranational public
health authorities.
• Control by the MAHs over data integrity and quality is
expected as per GVP. However, MAHs do not have access to
public health programs and surveillance or immunisation data
• Most active surveillance system are from Western Europe
• Improvements will take time (e.g. availability of vaccine
brand data) and will need additional investments to reach a
convenient sample size
Challenge 4: Mechanism and capacity

7. • How to meet both Public Institutes and MAH
requirements and allow them to work together?
• How can brand-specific data be captured in those
countries that do not have vaccine registries in place?
• How to cope with the tender processes that may
impact vaccine coverage in populations and thus
impact statistical power of brand-specific VE
studies?
• What about capacity to run brand-specific VE studies
to get sufficient EU wide representation?
Key unanswered questions

8. www.drive-eu.org
Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.
Thank you
for your attention!