Periodic Reporting for period 5 - DRIVE (Development of Robust and Innovative Vaccine Effectiveness)
Periodo di rendicontazione: 2021-07-01 al 2022-06-30
Vaccines are the cornerstone of preventing influenza but their effectiveness can vary from year to year and across recipient groups. To complement clinical trial evidence of antiviral vaccines with real-world data, platforms for surveillance, virus circulation and vaccine safety and effectiveness are needed. Because of the complexity, this may best be done by combining efforts between public and private sectors, developing a multi-stakeholder approach.
The European Medicines Agency (EMA) has requested effectiveness evaluation for all individual influenza vaccine brands, a task that demands international cooperation between public health institutions and vaccine manufacturers. The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project established a platform for measuring brand-specific influenza vaccine effectiveness (IVE) in Europe upon a request for the European Medicines Agency (EMA). To this end, a multi-stakeholder public-private partnership (PPP) of 16 partners from seven European countries was set up, coming from public health institutes, universities, research institutes, small and medium enterprise, a patient association, a foundation, and vaccine companies. A transparent public-private collaborative framework with governance boundaries was the vehicle to bring the DRIVE initiative to its multiple achievements.
The European Medicines Agency (EMA) has requested effectiveness evaluation for all individual influenza vaccine brands, a task that demands international cooperation between public health institutions and vaccine manufacturers. The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project established a platform for measuring brand-specific influenza vaccine effectiveness (IVE) in Europe upon a request for the European Medicines Agency (EMA). To this end, a multi-stakeholder public-private partnership (PPP) of 16 partners from seven European countries was set up, coming from public health institutes, universities, research institutes, small and medium enterprise, a patient association, a foundation, and vaccine companies. A transparent public-private collaborative framework with governance boundaries was the vehicle to bring the DRIVE initiative to its multiple achievements.
To support the studies, DRIVE developed novel study protocols and statistical analysis plan. Other important accomplishments include a multi-stakeholder research agenda, guidelines for interpreting IVE results, report templates, Standard Operating Procedures, IT infrastructure for data collection & analysis, a data management plan, a report on the sources of vaccine brand data, a communications plan, and a website.
DRIVE’s main objective in its first pilot season (2017/2018) was to establish and test the feasibility of the new multi-country platform using a limited number of sites. In the following two seasons, an IT platform for data collection was developed, protocols and statistical analysis plan were improved and assessment of IVE results and site selection by the Independent Scientific Committee was fine-tuned to ensure transparency.
Test-negative design (TND) case-control studies were conducted in six countries in Europe during the 2018/19 season. While sample size from the pooled TND studies was still too low for precise (brand-specific) IVE estimates, the network has approximately doubled in size compared to the pilot season.
For the 2019/20 season, 4 primary care-based TND studies, 8 hospital-based TND studies and one register-based cohort study (Finland) were conducted. In 2019/20, DRIVE estimated IVE for 8 out of 11 vaccine brands available in the market in Europe and obtained the first precise brand-specific estimates from TND studies. Four precise estimates were obtained, two were for any vaccine, and two were brand-specific.
For the 2020/21 season, DRIVE faced its fourth influenza season with the uncertainties posed by the COVID-19 pandemic and the unforeseen changes in the influenza circulation patterns. In a season marked by the absence of influenza circulation in Europe, not enough lab-confirmed influenza cases were recruited in DRIVE dataset. Thus, no brand-specific or overall IVE estimates could be obtained for the TND studies, and only overall IVE estimates for the Finnish cohort study were produced. Nevertheless, DRIVE has conducted a descriptive analysis of the data collected by the DRIVE study sites during the 2020/21 season. DRIVE dataset has captured 7 out of these 9 marketed brands.
In its final 2021/22 influenza season, 13 sites from 8 different European countries, covering 21 hospitals and approximately 1125 GP for the TND studies and 1 nation-wide register-based cohort study in Finland participated in the DRIVE study. Low influenza circulation (in comparison to pre-pandemic flu seasons) was observed. Brand-specific IVE estimations were obtained for 8 out of the 12 influenza vaccines marketed in Europe in the season 2021/22. DRIVE was not able to reach the sample size required to produce precise brand-specific estimates due to the low influenza circulation in Europe.
DRIVE’s main objective in its first pilot season (2017/2018) was to establish and test the feasibility of the new multi-country platform using a limited number of sites. In the following two seasons, an IT platform for data collection was developed, protocols and statistical analysis plan were improved and assessment of IVE results and site selection by the Independent Scientific Committee was fine-tuned to ensure transparency.
Test-negative design (TND) case-control studies were conducted in six countries in Europe during the 2018/19 season. While sample size from the pooled TND studies was still too low for precise (brand-specific) IVE estimates, the network has approximately doubled in size compared to the pilot season.
For the 2019/20 season, 4 primary care-based TND studies, 8 hospital-based TND studies and one register-based cohort study (Finland) were conducted. In 2019/20, DRIVE estimated IVE for 8 out of 11 vaccine brands available in the market in Europe and obtained the first precise brand-specific estimates from TND studies. Four precise estimates were obtained, two were for any vaccine, and two were brand-specific.
For the 2020/21 season, DRIVE faced its fourth influenza season with the uncertainties posed by the COVID-19 pandemic and the unforeseen changes in the influenza circulation patterns. In a season marked by the absence of influenza circulation in Europe, not enough lab-confirmed influenza cases were recruited in DRIVE dataset. Thus, no brand-specific or overall IVE estimates could be obtained for the TND studies, and only overall IVE estimates for the Finnish cohort study were produced. Nevertheless, DRIVE has conducted a descriptive analysis of the data collected by the DRIVE study sites during the 2020/21 season. DRIVE dataset has captured 7 out of these 9 marketed brands.
In its final 2021/22 influenza season, 13 sites from 8 different European countries, covering 21 hospitals and approximately 1125 GP for the TND studies and 1 nation-wide register-based cohort study in Finland participated in the DRIVE study. Low influenza circulation (in comparison to pre-pandemic flu seasons) was observed. Brand-specific IVE estimations were obtained for 8 out of the 12 influenza vaccines marketed in Europe in the season 2021/22. DRIVE was not able to reach the sample size required to produce precise brand-specific estimates due to the low influenza circulation in Europe.
In DRIVE’s 5 seasons, data from more than 35 000 patients, approximately 60 variables and 13 influenza vaccines has been collected. DRIVE partners consider that this valuable database could be leveraged and further utilized for various reasons. Notably, a strong interest in Research and Development activities for new generation of influenza vaccines and a contribution to the worldwide efforts to enhance global surveillance network for respiratory viruses and associated diseases and monitor related vaccines performance. This is the reason why DRIVE developed an Open access to research data and secondary use framework, allowing the secondary use of the data generated since the 2018/19 season.
Finally, DRIVE went beyond the proof of concept and demonstrated the added value of joint public-private European platforms and their potential to be applied to other vaccines post-marketing evaluation, notably against COVID-19. As a spin-off, the DRIVE platform could rapidly be repurposed as a COVID-19 vaccine effectiveness platform under pandemic urgency; and COVIDRIVE (https://covidrive.eu/) was set up in 9 months. COVIDRIVE consortium is composed of 12 public and private partners and started its first CVE study in September 2021. As of July 2022, more than 3900 patients have been included in the study.
As a proof-of-concept, the DRIVE project concluded on:
- A multi-stakeholders public-private partnership of 16 partners from seven European countries
- a large study platform, including 13 sites covering 21 hospitals and more than 1,000 general practices in seven EU countries and one nationwide population-based cohort, in Finland
- a unique and representative brand-specific vaccine effectiveness platform capturing 67% of the influenza vaccines on the EU market
- A trusted public-private collaborative platform where IVE point estimates were consistent with those published by other initiatives and stakeholders
- A robust Real World Evidence (RWE) platform able to deliver some precise brand-specific IVE for informed decision-making
- an efficient RWE platform able to deliver IVE results two months after the end of the influenza season
- a cost-effective infrastructure spending an average of 800k€-1M€ per season for IVE studies
- a fruitful scientific collaboration having produced five peer-reviewed scientific publications and 21 scientific communications in journals and conferences
- a very active communication working group that has produced more than 80 website posts/press releases, 34 event participation/organisation, 26 newsletters, 6 promotional materials and hundreds of social media posts.
- a transparent and trusted public-private partnership where partners, as well as independent scientific members, experienced valuable scientific interactions, and no conflict of interest for vaccines evaluation
- a framework for data sharing practices and secondary analysis of the DRIVE dataset which already showed its interest
- a viable approach to repurpose a vaccine effectiveness platform under COVID-19 pandemic urgency (COVIDRIVE was set up in 9 months)
Finally, DRIVE went beyond the proof of concept and demonstrated the added value of joint public-private European platforms and their potential to be applied to other vaccines post-marketing evaluation, notably against COVID-19. As a spin-off, the DRIVE platform could rapidly be repurposed as a COVID-19 vaccine effectiveness platform under pandemic urgency; and COVIDRIVE (https://covidrive.eu/) was set up in 9 months. COVIDRIVE consortium is composed of 12 public and private partners and started its first CVE study in September 2021. As of July 2022, more than 3900 patients have been included in the study.
As a proof-of-concept, the DRIVE project concluded on:
- A multi-stakeholders public-private partnership of 16 partners from seven European countries
- a large study platform, including 13 sites covering 21 hospitals and more than 1,000 general practices in seven EU countries and one nationwide population-based cohort, in Finland
- a unique and representative brand-specific vaccine effectiveness platform capturing 67% of the influenza vaccines on the EU market
- A trusted public-private collaborative platform where IVE point estimates were consistent with those published by other initiatives and stakeholders
- A robust Real World Evidence (RWE) platform able to deliver some precise brand-specific IVE for informed decision-making
- an efficient RWE platform able to deliver IVE results two months after the end of the influenza season
- a cost-effective infrastructure spending an average of 800k€-1M€ per season for IVE studies
- a fruitful scientific collaboration having produced five peer-reviewed scientific publications and 21 scientific communications in journals and conferences
- a very active communication working group that has produced more than 80 website posts/press releases, 34 event participation/organisation, 26 newsletters, 6 promotional materials and hundreds of social media posts.
- a transparent and trusted public-private partnership where partners, as well as independent scientific members, experienced valuable scientific interactions, and no conflict of interest for vaccines evaluation
- a framework for data sharing practices and secondary analysis of the DRIVE dataset which already showed its interest
- a viable approach to repurpose a vaccine effectiveness platform under COVID-19 pandemic urgency (COVIDRIVE was set up in 9 months)