Throughout the history of vaccinology and drug safety, there have been innumerable adaptations and breakthroughs within the medication and vaccination development processes. However, since the very first inoculations of smallpox and measles, one clinical research and development staple has remained an integral component of ensuring drug efficacy and public health: Time.

While the average vaccine takes 10-15 years to develop according to CDC, the COVID-19 vaccine was rolled out only 9 months after clinical research and development began, giving pharmacovigilance professionals an extremely limited time period to adapt to the stringent demands of monitoring safety data for the vaccine. The highly pressured release of this vaccine combined with the pharmacovigilance industry being forced to rapidly adapt to safety monitoring requirements led to 3 key issues:

● Delayed identification of adverse events and adverse events of special interests
● Delayed reporting of serious adverse reactions
● Difficulty to share safety data between health authorities such as the FDA, EMA, MHRA, TGA and others

Delayed Identification of Adverse Events and Adverse Events of Special Interest

The first key issue caused by the speed of which vaccine rollout occurred was the discovery that in most countries where the COVID-19 vaccine had been given, it had been administered in what is known as a ‘prioritization scheme’. While these plans were meant to prioritize the health of certain at-risk groups, such as pregnant women, the elderly or the chronically ill, they failed to consider a critical component of clinical research: These same at-risk groups are often barred from participating in most clinical trials for safety reasons, so the amount of clinical research available on vaccine safety for at-risk populations is severely lacking.

What’s more, adverse events of special interest were to be defined using historical data from previous vaccination campaigns, also excluding members of at-risk populations and leavingpharmacovigilance professionals little choice but to identify safety flaws in real-time due to the overall lack of existing data.

Delayed Reporting of Serious Adverse Reactions

The first reports of suspected adverse reactions caused by the COVID-19 vaccine were sent shortly after the first round of administrations. As a mass amount AE reports began to spill in and override the current reporting methods, the WHO digitized the ‘WHO Adverse Events Following Immunization (AEFI) Form’ on a global data collection and analyzation software, introduced as VigiFlow. While VigiFlow was the first real solution to the AE reporting crisis, new issues emerged as more reports were made available.

Due to the amount of people that had the capability of filing reports such as consumers, healthcare professionals and additional health organizations, VigiFlow quickly became riddled with report duplicates, sending pharmacovigilance professionals back to square one. The next solution to efficiently report AEs was VigiMatch, a software that accurately identified and disposed of drug report duplicates. Unfortunately, the software was not as accurate in discovering vaccine report duplicates and once again sent drug safety professionals back to the drawing board.

Difficulty to Share Safety Data Among Health Authorities

Finally, the clinical research department of the Uppsala Monitoring Centre (UMC) produced a decision support tool capable of assessing the signals of large case series’. After the abilities to effectively identify and report adverse reactions caused by the COVID-19 vaccine were created, yet another issue arose in terms of safety data sharing among world health authorities; each country had their own unique medical coding system.

After struggling to identify AE trends due to multiple medical codes detailing the same clinical instance, clinical professionals were pushed to create yet another algorithm to organize the effects caused by the COVID-19 vaccine.

In November of 2021, a clustering algorithm was applied to the vaccine AE reports. While the program did have some drawbacks, such as failing to examine content or only focusing on single terms at times, it was ultimately successful in identifying safety signals and practices rather than single adverse vaccine reactions. Altogether, the innumerable rapid adaptations that were made from the digitization of forms to the creation of multiple clustering algorithms did show the incredible ability of pharmacovigilance professionals to innovate creative solutions in times of crisis. However, the need to do so could have been avoided if the COVID-19 vaccination was researched and developed using similar methods and timelines as most other drugs and vaccines.

The allocation of time and resources, not to mention the thousands of people who were forced to endure adverse reactions, suffered due to the lack of time and research given to the COVID-19 vaccine.

Uppsala Reports –