With few exceptions, most people usually take vaccinations – and their benefits - for granted. We simply assume that they are effective, and the dangerous and debilitating diseases they prevent pose no threat anymore. However, the COVID-19 pandemic changed all this. Suddenly, the race to develop a safe, effective vaccine was at the forefront of our minds; how long would it take, and more importantly, how would we know if it was effective?
These were understandable concerns, but fortunately – long before the pandemic - the EU had recognised the need for a reliable method of assessing vaccine effectiveness. Initially, this was oriented towards flu vaccines; each season there were different strains of the flu virus, and the vaccines used – which come from a range of producers – were adapted accordingly. However, their effectiveness varied from season-to-season and between recipient groups. Clearly, being able to know what worked, and under which circumstances, could lead to better outcomes from the vaccine campaigns. However, this data did not exist in sufficient quantities to provide such insights; the vaccine market was fragmented, and the data generated was often restricted to relatively small-scale studies undertaken by manufacturers independently. Also, they often had understandable concerns over sharing the data. To address this knowledge gap, the European Medicines Agency (EMA), in their 2017 revised guidelines, asked manufacturers to take responsibility for tracking the effectiveness of their products in real world settings.
To address this ambitious request, manufacturers worked to establish a joint platform for this in close coordination with EMA. This was a significant step; such an exercise had never been done before. The outcome was the Innovative Medicines Initiative (IMI) project DRIVE (Development of Robust and Innovative Vaccines Effectiveness) project, initiated in 2017. The project consortium – devised as a public-private partnership (PPP) – brought together a range of parties that included vaccine manufacturers, SMEs, academia and public health experts. The objective was to develop a network that was large enough to generate, collect and collate the robust, high-quality and brand-specific effectiveness data needed to assess all the flu vaccines used each season.
The PPP approach allowed the project to overcome the existing fragmentation, encouraging cooperation and delivering the insights needed. It was also designed in such a way that manufacturers would not analyse their own data; instead, to ensure transparency, this would be done by an independent third party.
So far, so good; indeed, in the near-five years since its inception, the work of the DRIVE project has proved invaluable, particularly to the EMA and public health bodies. The platform has been established, and has set a clear template and a ‘proof of concept’ for how to capture measures of vaccine effectiveness. It has also created an ongoing dialogue with the stakeholders involved as well as with the EMA and other bodies. This project has helped to establish a model for sustainable and transparent governance in PPPs.
Most of this was not on the public radar; however, when the coronavirus pandemic struck and efforts to develop effective vaccines were a priority, it became clear that DRIVE may offer previously unforeseen benefits in capturing important information on the COVID-19 vaccines. The robustness of the approach had already been established. Furthermore, the infrastructure required was similar, the potential challenges and bottlenecks to data collection had already been identified, and tactics to overcome them were tried and tested. This meant that DRIVE provided a clear template and a ‘proof of concept’ for capturing vaccine effectiveness in the fight against COVID-19. This led to the launch of COVIDRIVE, for monitoring the performance of the new vaccines in real-world settings. Given that the lockdown meant that there was virtually no flu circulating in 2020-21, it meant that the structures of DRIVE could work as a testbed for COVIDRIVE.
When we’re looking for solutions, a faster, better-informed and more targeted response is the one most likely to deliver the best outcomes.
Cedric Mahe, Sanofi Pasteur
One of the most significant contributions of COVIDRIVE is its capacity to provide rapid feedback on the different vaccine technologies. “Any pandemic response is, by definition, reactive; so clearly the quicker the reaction, the better. So when we’re looking for solutions, a faster, better-informed and more targeted response is the one most likely to deliver the best outcomes,” explains Dr Cedric Mahe, project leader of DRIVE, who works with one of the COVIDRIVE funders. “In simple terms, COVIDRIVE should show us what’s working well and where, allowing government and public health bodies to adapt their approach accordingly.”
In addition, because the data is analysed frequently, it can also highlight ‘breakthrough’ cases, where the vaccine has been less effective and thus where potentially new strains of the disease may be emerging.
Although DRIVE is nearing completion, Dr Mahe believes that the COVIDRIVE experience has provided fresh insights on how to make any future DRIVE-like approach more sustainable. Indeed, he points out that the EMA has already expressed a desire to see such a platform continue in some form; something he thinks is good news. “The ideal way to provide the best information for health authorities, regulators and citizens is to have all stakeholders working together on a common platform. It’s efficient, inclusive and maximises the use of available resources.”
DRIVE is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.