EU Project Seeks More Help To Improve Effectiveness Of Flu Vaccines
Executive Summary
New research partners are being sought for a European initiative that hopes to increase the generation of data on the effectiveness of individual flu vaccines.
A European project attempting to assess the effectiveness of individual influenza vaccines has called for more research institutes and networks to join the initiative for the 2019/20 flu season in an effort to increase the amount of data and studies and to help improve the effectiveness of future vaccines.
DRIVE (Development of Robust and Innovative Vaccine Effectiveness) is a pan-European consortium involving both public sector and vaccine manufacturers that was launched in July 2017 by the Innovative Medicines Initiative, which itself is funded jointly by the EU and the European industry federation, EFPIA. The consortium collects data from independent effectiveness studies conducted by national or regional sites and analyses them jointly to ensure wide geographical coverage of results.
Its aim is to establish a sustainable platform for exploring new innovative approaches to measuring influenza vaccine effectiveness (IVE) and to build up a sufficiently large network of research bodies able to produce “high-quality, brand-specific effectiveness estimates for all influenza vaccines used in the EU each season.”
DRIVE stressed that the project was underpinned by a governance framework that allowed “transparent and efficient” collaboration between the public and private stakeholders. While decision-making is shared by the public and private partners, the IVE studies themselves are led by the public institutions without the involvement of the vaccine manufacturers and are overseen by an independent scientific committee. DRIVE said the results would “help all involved in vaccine development to improve the effectiveness of flu vaccines in the future.”
The data generated through DRIVE are expected to lead to enhanced monitoring of flu vaccine performance by public health institutes and allow manufacturers to fulfil EU regulatory requirements, specifically a new guideline from the European Medicines Agency.
This guideline, DRIVE says, “requires that observational IVE studies be conducted in the EU/EEA as part of the post-licensure commitments of the vaccine manufacturers. EMA expects the studies to be conducted in line with Good Epidemiological Practice (GEP) guidelines and with European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) guidelines.”
Need For New Approach
In its December 2018 report on an initial mapping exercise of existing and potential novel approaches, DRIVE said that measuring the effectiveness of flu vaccines relied on observational studies comparing the occurrence of influenza in vaccinated and unvaccinated populations.
However, it pointed out that many of the traditional observational study designs “are relatively costly to establish and maintain, yet remain susceptible to bias and may not provide reliable information on all the desired outcomes.” DRIVE aims to improve existing systems and explore novel and innovative approaches to measure IVE in order to promote robust IVE assessment and improve the utilization of existing data sources and new technologies.”
The report described novel diagnostic methods, participatory approaches, ways of capturing data on outcomes of special interest, novel study designs, non-traditional data sources, “relatively unexplored methods to control for confounding in IVE studies, and the use of ontologies for case identification.”
It said that ideas collected under the project would be prioritized, with some being chosen for more detailed examination, including a cost-assessment.
New Recruits Wanted
The project currently works with a dozen research sites across seven European countries and is now looking for more public bodies with existing IVE study data to become associate partners in the consortium and build up the DRIVE network. Sites that do not yet have study data can apply for funding and technical assistance to develop study capacity, it added. Those interested in taking part are invited to apply by April 15.
Professor Javier Díez-Domingo, DRIVE coordinator and director of the Vaccine Research Department at Spain’s biomedical research foundation Fisabio, said the project had started work on delivering 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.”
DRIVE said partners would 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.”
Benefits to the research partner would include generating robust, brand-specific IVE through a European network, implementing potentially innovative approaches for IVE estimation, participation in the scientific discussion and publications process, funding for data sharing and capacity building, and the ability to take part in the DRIVE annual forum and general assembly.
From the editors of Scrip Regulatory Affairs.