Covid-19 vaccine testing
Why early reaction and sustained focus are vital in combatting the global pandemic
DURING my education and training in the field of engineering, I was constantly reminded of the value of systems: a set of components working together as parts of a mechanism or an interconnecting network; a complex whole.
In subsequent years, I realised time and time again how system principles can be applied equally successfully in management. In any organisation, systems ensure unified and stable operation. And in times of crisis, they prevent hysteria, uncertainty, and unnecessary waste of time.
At the University of the Free State (UFS), we quickly learned the value of acting proactively when it comes to the Covid-19 pandemic, as well as getting sustainable systems in place that operated in unity.
Amid all the uncertainty and change, we found that it was vital not to re-act in a knee-jerk manner and steered away from implementing random measures that did not consider the entire institution, its history (how it grew and developed up to this point in time), and its future (the altered, post-Covid-19 landscape).
Early reaction and a sustained focus on the period after the pandemic, characterised our response action. A UFS Covid-19 Task Team was already formed at the end of February last year, as news of the first infections trickled in from Wuhan, China.
When the first South African Covid-19 infection was reported on March 5 last year, a special executive group moved into action. It had several focus areas: teaching and learning, staff, operations, re-integration of staff and students on campus, finance, risk and legal, Covid-19 science, and future thinking. We immediately began the migration to remote teaching and learning, which involved the training of staff, getting the material online, briefing students, procuring laptops, and zero rating the learning portals.
A successful system never operates in isolation, but is affected by, and has an influence on the systems around it.
As we are entering the vaccine phase of the pandemic, it is more vital than ever to maintain a “system” approach. Now is not the time for short cuts, untested remedies, and vague claims of efficiency. Now is the time for systematic implementation of tried and tested processes, developed over time and underscored by good science.
At UFS we are privileged to play a role on two important fronts:
The South African National Control Laboratory for Biological Products (NCLBP) located on our Bloemfontein Campus, is performing the all-important task of vaccine-lot release. As the sole provider of this service in the country and one of only 12 World Health Organisation (WHO)-contracted laboratories worldwide for vaccine quality-control testing, it forms part of a carefully crafted regulatory system, which has been established, fine-tuned, and tested over many years to serve the interests of the global community.
Vaccines are biological medicines and some of the most complex pharmaceuticals available today. It is vital that their regulation be governed by scientific and not commercial or political principles. It is a role that should under no circumstances simply be given to the “lowest bidder” or the one who promises “speedy delivery”.
The NCLBP did not get to play this regulatory role overnight. It was already established in 1997 after an extremely stringent audit by the National Regulatory Authority (NRA) and subsequent recommendations by the WHO.
This means that all its operations – from the way documents are compiled and stored, to the maintenance of equipment and infrastructure, as well as staff competency – are performed according to strict international guidelines and are closely monitored.
It forms part of an involved system with checks and balances in place to ensure that no mistakes are made.
Similarly, FARMOVS – a wholly owned clinical research company of the UFS, with several medical and scientific experts at the university – has submitted a clinical trial protocol for approval to the South African Health Products Regulatory Authority (SAHPRA) to determine the efficacy of Ivermectin for Covid-19.
FARMOVS was systematically prepared and shaped for this role, having been involved in countless pharmaceutical trials, proving its own efficacy over a protracted period.
Not only is it the only onsite ISO (International Organisation for Standardisation) and GLP- (Good Laboratory Practice) certified bioanalytical laboratory on the African continent – it has proven itself to adhere to the most rigorous international requirements over the past 47 years.
The co-incidental meteoric rise in the popularity of social media has fuelled the fire of unverified and unscientific claims that are so often just lapped up by information consumers in the public sphere. Unfortunately, since we have entered the vaccine phase, this has become rife.
Here, the role of universities as education and research facilities is becoming more important.
Not only do we need to provide and communicate the “good science” that everyone craves. But instead of advising from the side-lines, we should also be playing a vital practical role, actively applying our knowledge, resources, and expertise within the broader society we serve, as has been aptly demonstrated in our important role of vaccine regulating.