A call has been issued for public health and research institutes and networks to join new efforts to increase the understanding of brand-specific influenza vaccine effectiveness in Europe. The call is open to any European organisation and closes on 30th of March 2020.

IMPORTANT UPDATES: Due to the COVID-19 outbreak, the call for tenders’ deadline is postponed to 28th of May 2020. Advised by the European Medicines Agency (EMA) and the Innovative Medicines Initiative (IMI), DRIVE will adapt its European brand specific IVE platform to address the COVID-19 situation. Therefore, the annual study tender has been updated to encompass data collection on SARS-COV2 infection which will be essential to interpret its impact on the IVE assessment. EMA and IMI representatives also agreed on the recommendation proposal for a more focused investment prioritizing to populations with higher coverage and disease burden with the aim to improve the feasibility of estimating brand specific IVE. This implies targeting the adult and older adult populations and in the  hospital settings in order to obtain more reliable IVE data. Accordingly, the annual DRIVE call for tenders has been updated and only studies focused on adult/older adult populations in hospital settings will be included in the selection process. DRIVE is adapting its protocols to the influence of COVID-19 in the next season (2020/2021), as COVID-19 is expected to substantially impact the IVE studies. Therefore, it will be valuable for interested sites to share some COVID-19 related data with DRIVE as a new condition.

This is the third season when organisations interested in studying brand-specific influenza vaccine effectiveness are given the possibility to join the growing DRIVE (Development of Robust and Innovative Vaccine Effectiveness) study platform as Research Collaborators. This time, the annual call for tenders commences for the 2020/21 influenza season.

The DRIVE Research Collaborators will be compensated for sharing data from existing studies as well as contributing to innovative approaches to developing estimates on brand-specific influenza vaccine effectiveness for all brands used in Europe each season.

Sites without established vaccine effectiveness studies are also eligible to apply for funds and technical assistance to develop new study capacity.

The current DRIVE network consists of 15 research sites from nine European countries. Nine new sites joined the network last year as the result of the second call.

The DRIVE project is a pan-European consortium which involves both the public sector and vaccine manufacturers in brand-specific evaluation of influenza vaccine effectiveness – a new regulatory requirement from the European Medicines Agency (EMA).

DRIVE has already delivered a first pilot (2017/2018) and second season (2018/2019) brand-specific influenza vaccine effectiveness results.

The study platform is underpinned by a governance framework that allows transparent and efficient collaboration between public and private stakeholders and includes firewalling measures recommended by public stakeholders. This includes an independent scientific committee that has been established to ensure the integrity of DRIVE studies.

Link to an introductory video on DRIVE project governance:  https://www.youtube.com/watch?v=E-PNh_z04d4

Influenza is a deadly disease that causes up to 50 million of cases of illness and up to 70,000 deaths in Europe every year, according to the European Centre for Disease Prevention and Control [1]. DRIVE study outputs will help fill knowledge gaps, meet new regulatory requirements, and improve communication about influenza vaccination.

“We welcome DRIVE as a timely initiative bringing both public and private partners together to make the best use of influenza vaccine effectiveness data. Working together according to the highest scientific standards and in a transparent manner is in the interest of modern public health”, says Dr. Hanna Nohynek, Chief physician and Deputy Head of Infectious Diseases Control and Vaccines, the National Institute for Health and Welfare (THL), Finland.

“DRIVE has started work to deliver high-quality brand-specific information on influenza vaccines to regulators, policy-makers, clinicians and the public. We are now seeking more research partners to help us achieve the scale of data needed for robust studies and to develop new ways to assess influenza vaccine effectiveness”, said Professor Javier Díez-Domingo, Director of the Vaccine Research Department, FISABIO- Public Health in Spain and DRIVE Coordinator.

DRIVE is a public-private partnership funded by the Innovative Medicines Initiative. The members include public health institutes, universities, small and medium-sized enterprises, industry and a patient organisation. The role and contribution of each member, including the vaccine manufacturers, is clearly defined and traceable to ensure scientific integrity.

Acknowledgement: This 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.

Disclaimer: This press release reflects only the author’s views and neither IMI nor the European Commission is liable for any use that may be made of the information contained therein.

[1] ECDC: Factsheet about seasonal influenza. https://www.ecdc.europa.eu/en/seasonal-influenza/facts/factsheet

More information

Submit your application now at https://www.drive-eu.org/index.php/2020/02/03/tenders-20202021/

Frequently asked questions: https://www.drive-eu.org/index.php/faq/

The pilot year’s results, 2017/18 season: https://www.drive-eu.org/index.php/results/results-2017-18-season/

2018/2019 season results: https://www.drive-eu.org/index.php/results/results-2018-19-season/

Interview requests for:

Professor Javier Díez-Domingo, Director of the Vaccine Research Department, FISABIO- Public Health in Spain and DRIVE Coordinator and

Dr. Hanna Nohynek, Chief physician and Deputy Head of Infectious Diseases Control and Vaccines, the National Institute for Health and Welfare, Finland.

Via

Antonio Carmona

Vaccine Research Department, FISABIO

Phone: +(34) 961 926325

E-mail: carmona_antser@gva.es