Views from the bar: A swift covid19 vaccine

KANISA GEORGE

It is safe to say that when we started this year, no one anticipated that a virus, sneakily spreading its way throughout Wuhan, would wreak havoc by the first quarter, claiming lives, jobs, and our access to basic human interaction. Societies have been fighting tooth and nail to stop the spread of the virus, and now after months of waiting, there is finally light at the end of the tunnel.

Vaccines are arguably vital to humanity's development. The quality control of vaccines has also evolved.

In the 21st century, healthcare is a shared responsibility, involving equitable access to essential care and collective defence against transnational health threats. As such, the World Health Organisation's (WHO) role in drug regulation is pivotal. The WHO ensures norms and standards through its expert committees. It supports regulatory capacity building leading to the implementation of drug regulation on an international level and ensures the quality, safety and efficacy of limited essential medicines and facilitates the exchange of regulatory information.

At the beginning of the second quarter of 2020, the world's leading pharmaceutical companies announced that the search for a drug that would return the world to a state of normalcy was on. Many shrugged in disbelief, for a trial of this magnitude required financing, expertise and time, a luxury that was no longer available. Experts were adamant that a drug would soon be developed. Many questioned how these companies were going to get this newly developed drug from lab to health care facilities in the predicted timeline.

The Tufts Center for the Study of Drug Development in the US estimates that the comprehensive research, development, and approval process to get a new drug from the laboratory to pharmacy can take 12 to 15 years at an average cost of about US$2.6 billion. While it might appear excessive, this timeline is used to satisfy a host of legal, administrative and scientific requirements that most science-led organisations in charge of overseeing the drug approval process have in place. Drug regulation and approval have scientific and administrative facets at its core, but these are both underscored by legal requirements.

Regulations are crucial in the world of pharmaceuticals, and they are drafted to deal with concerns related to efficacy and drug safety. Because the use of any drug carries with it some degree of risk, regulations must be drafted to ensure the risk-to-benefit ratio of the drug is favourable. According to one researcher, the role of pharmaceuticals has become prominent on international agencies' agendas as health indicators have been increasingly linked to a country's successful development.

With the covid19 vaccine being developed in record time, concerns were raised as to whether regulatory guidelines and law have been strictly followed. A BBC article titled, "Ten years' vaccine work achieved in about ten months, yet no corners cut in designing, testing, and manufacturing," examines the concerns surrounding the speedy development of the covid19 vaccine.

According to the article, the incredible feat was a result of good fortune as well as scientific brilliance. The article notes that the biggest misconception is that work only started on the vaccine when the pandemic began. The origins of this vaccine can be traced to initial research on the Ebola outbreak and SARS, leading to a few steps in the trial being completed years before.

Quality control is an essential regulatory aspect of research and development, for researchers cannot start giving an experimental vaccine to people until they are sure it has been made to a high enough standard. Lead scientist, Dr Mark Toshner, describes the process as tedious paper filing, which entails writing grant applications, having them rejected, writing them again and then getting approval to do the trial. Then, there is the task of negotiating with manufacturers and trying to recruit enough people to take part, which can take years to get from one phase to the next. This he adds, is a long process, mainly due to bureaucracy.

Clinical trials are a complicated and time-consuming enigma, with regulations and processes at its centre. But with the world's health system on the verge of collapse, it causes one to consider how much of these regulations are complied with and which one are thrown out the door?