Introduction to DRIVE - Cedric Mahe
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This document summarizes the challenges of conducting brand-specific influenza vaccine effectiveness studies in Europe. It notes that methodological issues like differences in vaccine administration, circulation of strains between countries, and study designs and settings make pooling data challenging. Existing surveillance systems like I-Move only estimate overall effectiveness, not brand-specific. The costs of expanding systems to allow brand-specific estimates would be very high, around 3-10 million euros per year. Additional challenges include low and varying vaccination rates, vaccine tenders that impact brand distribution, and lack of reliable brand-level data in most countries. Public health authorities control the data but manufacturers need oversight due to regulatory requirements. Improvements will take time and investment.
![• 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](https://image.slidesharecdn.com/introductiondrivecedricmahe-181019094940/85/Introduction-to-DRIVE-Cedric-Mahe-4-320.jpg)
Introduction to DRIVE - Cedric Mahe
- 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!