26-27 - COVID-19: Event horizon

During those early months of the pandemic, pharmacovigilance (PV) was thrust into the spotlight in a way that many of the industry’s workforce had never felt before.

The public was more aware of health regulators and terms such as ‘adverse events’ became part of general society’s vocabulary. The demand for information was high and everyone in PV had to find ways of keeping up while ensuring the testing and subsequent data was robust.

Three years on from the start of the COVID-19 pandemic, the life sciences, medical and pharmaceutical sectors are still feeling the effects, but we have learnt valuable lessons that make the industry a better place.

PV is the assessment, monitoring and prevention of adverse events from pharmaceutical products. Under the leadership of Professor Saad Shakir, the Drug Safety Research Unit was heavily involved with monitoring the safety of new and repurposed anti-COVID-19 drugs and vaccines from the start of the pandemic.

We conducted systematic benefit-risk assessments of the repurposed drugs proposed to treat COVID-19, including remdesivir and lopinavir-ritonavir and as one by one COVID-19 vaccines were approved for use in the UK and across Europe, we were involved in a number of studies, which between them examined the safety of all the UK vaccines.

These included a Post-Authorisation Safety Study (PASS) on the AstraZeneca COVID-19 vaccine, which we designed using active surveillance methodology and set up in record time soon after the vaccine was approved in the UK.

The process of developing, testing and marketing a new medicinal product was previously somewhat rigid, taking ten to 15 years, but the pandemic forced us to pivot and adapt at pace. The pressure to find and test new anti-COVID-19 medicines and vaccines as well as repurposing existing drugs as quickly as possible meant we needed new and streamlined processes.

The prioritisation of COVID-19 treatments meant medicines regulators and pharmaceutical companies could set up clinical trials to run in parallel rather than sequentially and as a result lengthy process of testing and bringing to market was rapidly reduced to 18 months to two years.

New initiatives were put in place to monitor the safety of the new drugs and vaccines, mostly paperless, using online and app reporting. For example, Public Health England’s Post-Implementation Vaccine Surveillance monitored the coverage, safety and effectiveness of the COVID vaccines in England and continues to publish monthly reports.

In addition, hundreds of thousands of patients registered for the pan-European COVID Vaccine Monitor study in which any potential post-vaccination side effects were reported via an app. We were proud to have set up and led the UK arm of this study.

New technologies such as AI also came to the fore and became crucial in the effective monitoring of medication safety and public health when the pandemic arose. AI was used to streamline administrative processes and gather accurate data particularly on vaccine-specific adverse drug reaction (ADR) reports.

AI also helped the Medicines and Healthcare products Regulatory Agency (MHRA) to update and expand the capacity of the Yellow Card system, to which the public and healthcare professionals can report suspected medication side effects. This enabled the MHRA to handle large amounts of data and rapidly identify any potential safety issues with the COVID-19 vaccines.

The biggest challenge during the early months of the pandemic was the lack of real-world data relating to new COVID treatments. This information is important to highlight issues that may be encountered by patients outside the artificial conditions of clinical trials, such as the experience of patients with comorbidities or drug interactions in patients taking concomitant medicines.

But the only data that was readily available in such a short amount of time was data from clinical trials. As usage of the COVID treatments and vaccines increased rapidly, the DSRU team and other PV specialists could access real-world data directly from patients, prescribers, spontaneous reporting data and databases such as the CPRD general practice database.

Like many industries many staff in medicines development and safety continue to work remotely at least some of the time. This has resulted in reduced costs (travel, heating and lighting in the office) and increased productivity, but at the expense of face-to-face interactions, which are often spontaneous and can produce remarkable collaborations.

The impact of this loss is difficult to quantify and we may never know what the lasting effect of this is. The rapid development of new anti-COVID drugs and vaccines during the pandemic, however, has shown what is possible.

There is now an expectation, within medicines development and drug safety, that streamlined processes will continue, especially steps requiring regulatory, ethics and NHS approval. This will hopefully lead to faster access to medicines.

Public awareness of drug safety increased greatly during the pandemic. The term ‘pharmacovigilance’ was mentioned in some of the daily briefings from Downing Street, while regulatory body leaders like Dame June Raine, Chief Executive of the MHRA, appeared on television to explain how the safety of vaccines had been diligently checked, despite their rapid development and approval.

Public perception of where their medications come from also duly increased and the demand for information rose. A more informed society is a good thing but at the same time debates by anti-vaccination groups and increased media reporting about rare, but important, adverse events, may have led some people to delay and/or abandon plans to have vaccines.

Nevertheless, the public is now far more literate and interested in the field of pharmacovigilance, and future drugs will likely face closer scrutiny. An increased public awareness of the existence of PV will go a long way in reassuring the public that medicines and vaccines are monitored for side effects, especially with drugs and vaccines that have launched in the NHS, because it is the first time that they have been used in real-world conditions and new side effects may emerge that had not been seen previously in clinical trials.

Pharmacovigilance has learned a lot from the pandemic and is in a better place for the future. We have proven that we can adapt, work flexibly and at speed to be a faster and more efficient drug development industry. This means new medicines and vaccines reach patients faster, saving patient lives and increasing quality of life.

The time is right to build on these developments, ensuring we ignite this momentum without returning to the slow lane.

Event horizon

Adapting to change

Challenge like no other

The final analysis