Impact of COVID-19 pandemic on pharmacovigilance

Record vaccine development

Only a year after the start of the pandemic caused by SARS-CoV-2 had been announced, COVID-19 vaccines were already available to us. Currently, there are several vaccines involved in clinical trials, which are now being conducted faster and more efficiently than ever before. Considering that “normal” vaccine development takes 10 – 15 years, this represents a remarkable success.

Development has been accelerated by many factors, in particular the decision that clinical development and regulatory phases should take place simultaneously, rather than sequentially, at stages where this is possible.

Role of the media in informing the public

Due to growing public interest, the steps of vaccine development were being reported on a daily basis by the media. The development of new vaccines has been closely monitored as part of informing the general public, increasing awareness of clinical trials more than ever before.

Many candidates were willing to participate in clinical trials with the aim of helping stop the pandemic as soon as possible, while at the same time agile work strategies, prioritisation and cooperation were being formed within the industry.

Pharmacovigilance challenges in the COVID-19 pandemic

The record speed of vaccine development has also brought new challenges: post-authorisation safety monitoring and communication on vaccine safety. Therefore, presence of robust pharmacovigilance and active monitoring systems is vital for the rapid, effective and safe use of new vaccines in various populations.

Pharmacovigilance experts collect, analyse and share information on adverse reactions from the start of a clinical trial. By studying available scientific literature, they interpret it analytically and prepare documents required for obtaining a marketing authorisation. They also monitor the safety of already authorised products, with monitoring being continued even after product withdrawal from the market.

Safety monitoring is aimed at safe use of medicinal products and the detection of changes in the benefit-risk balance of product use for the purpose of patient protection.

Commonly the definition of Eastern Europe is expanded to include the following countries: Albania, Bosnia and Herzegovina, Croatia, North Macedonia, Montenegro, Serbia, and Slovenia.

The impact of universal healthcare on clinical trials

Due to globalization, over half of all clinical trials have been performed outside the USA since 2019.

Poland, Russia, Bulgaria, Czech Republic, Romania, and Ukraine are among the top 20 clinical trial participant countries worldwide in the period between 2015 and 2019 by share of participants.

So, what makes these countries stand out?

All countries in this part of Europe have one thing in common: universal healthcare, a government system providing mandatory public insurance to all people.

The state owns sizeable tertiary-care teaching hospitals and specialist institutes. Countries own health centers and the majority of general and specialist hospitals. Physicians increasingly provide primary care under contract with the insurance fund.

Vaccine benefit-risk assessments ensure that all available vaccines lead to better protection and health of the overall population. The task of pharmacovigilance experts is to closely monitor information that would indicate changes in this balance, and to inform all relevant regulatory bodies in a timely manner of such changes.

The role of pharmacovigilance experts came to the fore at challenging times such as in 2020, when accelerated vaccine development and safety monitoring had to be supported by adequate pharmacovigilance system tools to protect patients.

Pharmacovigilance in Marti Farm during the COVID-19 pandemic

It has been more than a year since our pharmacovigilance team began monitoring pandemic-induced developments. Thanks to our business continuity and disaster recovery plan (so-called BCP) we have successfully overcome all challenges related to the pandemic, while practical problems such as teleworking have been easily covered by our pharmacovigilance database Sympto and its modules that facilitate communication and timely exchange of information.

Despite challenges, we have adapted to these changes and closely monitor how practices and regulations are evolving. As a reflection of the practice of digitalising numerous aspects of life, we have also noticed more online ADR reports and the habituation of conducting remote audits and inspections.

With a steadily increasing vaccination rate, we are starting to turn to the future and wonder where pharmacovigilance and clinical trials will venture after this pandemic ends. We are hoping to emerge from this crisis with more efficient and resilient processes, which will prepare us for any further (unexpected) challenges.

Tanja Manzin, MPharm / Senior Pharmacovigilance Associate