Rapid deployment of vaccines is the key lesson being taken from the Covid-19 pandemic. It should not be the only one.
Now Covid-19 has been displaced from media headlines by war and natural disasters, most people are happy to forget about viruses. Virologists, however, are worried by rapidly-spreading bird flu and the countless other viruses with the potential to infect and spread among mammals—potentially including humans.
Partly due to ecological deterioration and climate change, the risk of such zoonotic disease outbreaks is indeed growing. The need to prepare for a possible future pandemic is widely accepted, although no one can predict its onset. Nor is it clear which kind of virus might be involved. The experience with SARS-CoV-2 over the past two to three years should however be drawn upon.
Crucial to control of the Covid-19 pandemic was the development, testing and production of vaccines in record time: it was a mere 326 days from release of the virus’ genetic sequence to authorisation of the first vaccines. This lesson, already being drawn, plays into widespread faith in technological solutions to social and environmental problems.
For the Oslo-based Coalition for Epidemic Preparedness Innovations, speed of vaccine development is indeed key. At the end of 2022, CEPI issued a report detailing how future pandemic-beating vaccines could be produced in just 100 days.
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Other lessons which can and should be drawn from the Covid-19 experience cannot however count on similar support. In 2020, before a vaccine became available, the constant refrain was ‘when there’s a vaccine life will return to normal’. The socially and politically complex questions which would still have to be tackled, though foreseeable, were ignored.
These included inequitable access to vaccines, liability in the event of vaccine-related injury, and vaccine refusal and hesitancy. Policy-makers began to address these issues only later, when vaccination campaigns were well under way in much of the world.
Now there is a risk that epidemic preparedness is again being dominated by a single-minded focus on technological solutions. This despite evidence that in Europe public confidence in vaccines and vaccination is actually falling: people are less convinced now than before that vaccines are safe and effective. Unwillingness to accept a Covid-19 vaccine was often due to fear of side-effects. Where is reassurance to come from?
Post-marketing detection, analysis and prevention of adverse effects of a vaccine or a drug is known as pharmacovigilance. Pharmacovigilance observes the way medicines work in real-life settings and their risk-benefit balance. The pharmacovigilance of vaccines thus monitors adverse events and safety issues that emerge after the vaccine has been approved. This can lead to modification of the group for whom the vaccine is recommended and potentially its withdrawal from the market.
Eudravigilance was established in 2001 as a system for managing and analysing information on suspected adverse drug reactions (ADRs) across the European Economic Area. Pharmacovigilance systems played an important role during the Covid-19 pandemic.
Until recently, national pharmacovigilance centres collected reports on ADRs only from healthcare professionals and pharmaceutical companies. In 2003, Denmark and the Netherlands became the first countries to allow patients and consumers to report suspected ADRs directly. Italy (2004), the United Kingdom (2005) and Sweden (2008) followed suit.
Research shows that that ADRs can be identified and described sooner by consumers and patients themselves. Their reports can provide key insights regarding drug-related problems. Since 2012, EU-wide legislation has required that patients be able to report suspected ADRs to competent authorities.
A recent review of Dutch experience of public participation in pharmacovigilance was very positive. A review in the UK showed growing numbers of ADRs identified by patients. Yet enabling patients to report does not mean that they will do so. The literature shows that many are not aware they can report or where they should do so.
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The number of reports submitted directly by patients and consumers to Eudravigilance rose more than five-fold (+443 per cent) between 2020 and 2021. Reports related to Covid-19 vaccines accounted for 87 per cent of these. Nevertheless, in much of the world direct patient reporting remains an unfamiliar practice.
Pharmacovigilance agencies have introduced new reporting tools, including mobile applications. While these have led to more reports, this is still not enough. Building mutual trust requires more, and patient engagement should go beyond providing personal data.
Pharmacovigilance is not acknowledged as the key component of epidemic preparedness it ought to be. Pharmacovigilance centres must engage with civil society—and not only as a source of data. Information has to flow both ways, and in this patient and health-advocacy organisations could play an important role. What information regarding possible adverse events would the public like to see collected? Do people trust that their reports are taken seriously? What kind of feedback or reporting to the community would be best?
Responses to the Covid-19 pandemic have shown the value of a well-functioning pharmacovigilance system.Yet this is still far from being a democratic, transparent and accessible space where civil society can negotiate rights and duties. Most studies of pharmacovigilance in practice focus on ways of enhancing statistical confidence in causal relationships between a vaccine and any associated symptoms.
But public confidence is not the same as statistical confidence. Enhancing pharmacovigilance systems, and supporting civil society’s participation in them, should be an important part of epidemic preparedness. What will be the value of having a vaccine in less than 100 days if many citizens do not trust it?