It’s been the biggest healthcare crisis of our lifetimes. COVID-19 has changed the world we live in, impacting all six of our continents with over 90 million confirmed cases of the virus.
Healthcare services have worked admirably during this time and now there is light at the end of the tunnel. In December 2020, the Pfizer- BioNTech vaccine gained authorisation for use in record time. This was shortly followed by the Moderna and Oxford-AstraZeneca COVID-19 vaccines.
We are now undergoing the biggest vaccination program in history, aiming to finally bring this global pandemic to an end.
It traditionally takes 10-15 years to bring a new vaccine to market, but the COVID-19 vaccines have been developed in under 12 months.
This is thanks to the collaboration between regulators and pharmaceuticals to get them to market, with fast-tracked approval processes and emergency use schemes in place.
Emergency Use Authorization requires a reasonable belief that the product may be effective, and that the known and potential benefits outweigh the potential risks. Compared to the typical approval standard, this permits significantly more uncertainty and unknowns about the benefit-risk balance of a product.
There’s no doubt that making these vaccines available quickly was necessary considering the scale of the global pandemic. However, this uncertainty and the speed at which the mass vaccination is expected to be carried out poses a test for pharmacovigilance.
Monitoring and researching ‘post authorisation’ must be accurate and efficient in recording rare and long latency side effects, so that the vaccination process can be as safe as possible.
The COVID-19 vaccination program launch is big news and will gain an unprecedented level of media coverage over the coming months.
While pharma companies should see a steady increase in the volume of adverse event reports because of the scale of the program, the media attention is likely to mean a significant spike in these figures. Shortened development timelines, regulators allowing shots to be used under emergency authorisations and the speed of the mass vaccination program; will also contribute to this spike.
To prepare for these adverse event reports, companies and regulators need to step up efforts to gather as much quality information as they can to quickly identify any safety concerns.
Risk management will be crucial. While the principles for this remain the same – to collect data, analyse it in real time and act on it quickly – the consequences of delay and lack of transparency will be amplified for the pandemic. Any delays in signal management and communication to patients and healthcare professionals (HCPs) could result in other patients being exposed to those same risks, which will be harmful to public health and create liability for the manufacturer.
There’s a huge spotlight on pharmacovigilance right now and I don’t see that going away after the pandemic. COVID-19 has increased awareness about drug safety and I expect the public to be increasingly curious about the space as a result.
That means the companies should be investing in their pharmacovigilance departments. Not only to meet the COVID-19 demand, but also to keep up with the ever-growing emergence of new drugs on the market. After all, what’s more important than safety and efficacy?
COVID-19 has also shown the pharmaceutical industry that its stronger when working together. I expect this to trigger increased collaboration between companies, using their combined pharmacovigilance data on side effects or adverse reactions to ensure patient safety.
While there’s non-profit organisations, like the UMC, which are already collecting data across the globe and they are doing a fantastic job promoting GvP and global patient safety, I believe the industry can and will be doing more in the future. Once companies begin to truly collaborate and combine their data in this way, then pharmacovigilance can truly harness the powers of cloud-based software, AI, machine learning and deep learning.
This will help advance its current adverse event processes, which are still largely based around HCPs, call centres and email processes that are not scalable, are error-prone and may fail to link the details of the vaccine to the subject.
There’s still a long way for the pharmacovigilance space to go and a lot of work to be done during the mass COVID-19 vaccination program. However, I expect the industry to rise to the challenge in the same admirable fashion that the rest of global healthcare has.
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I've collaborated with multiple experts at major small molecule CDMOs to talk about the impact that biologics has has on their industry. This article featured in the industry leading publication, Speciality Chemicals Magazine.