Looking at the history of viruses, we would be negligent to think that we can relax and stop worrying about viruses by overcoming the current pandemic
Novel viruses emerge regularly and, in some cases, make it into the human body and potentially causing harm to our health. HIV, Ebola, and SARS were and are just a few new viral threats in the last four decades.
Research on treating the diseases they cause or even finding a vaccine against them has been slow but recently more promising.
Traditionally, it took a few decades from identifying a virus to have an effective vaccine ready to be administered. As an example: Over three decades and $500 billion had to be spent to get close to curing HIV.
All of this dramatically changed with Covid-19.
While Covid-19 poses one of the most devastating public health challenges globally, scientists broke records by finding (multiple) effective vaccines against it within sometimes days and not decades. So while the coranavirus took countless lives, placed billions of people into lockdown, and the global economy in turmoil, there’s a silver lining given the pace of biotechnological innovations protecting us from this threat.
Health systems have several tools on hand to combat a viral threat: Using masks, disinfecting surfaces, social distancing, or applying existing drug treatments to new viruses. But when it comes to creating a general immunity among the population, there’s only one alternative to a large proportion of the population contracting the virus: mass vaccinations.
Thanks to massive advances in gene-editing technology and a deeper understanding of how to utilise messenger RNA to teach the human body to fight viruses, companies like Moderna and BioNTech developed their highly effective vaccines within days. This breakthrough came definitely at the right time and might have reduced the severity and shortened the duration of the pandemic by a significant factor.
Looking at the history of viruses, we would be negligent to think that we can relax and stop worrying about viruses by overcoming the current pandemic. On the contrary, we should utilise the lessons learned in the last year-and-a-half and tweak our regulatory approach to biotech innovations so that these vaccines can make it to patients even faster.
While it took Moderna merely 48 hours to come up with a vaccine, still, it took ten months of regulatory approvals, clinical trials, and other bureaucratic hurdles to overcome before their vaccine could get administered to regular patients. If we look at the lives lost, psychological isolation of people in lockdown, and the economic costs of each day, week, and month between discovering a vaccine and its authorisation, we should ensure to streamline this process as much as possible.
Most existing regulatory frameworks are built on the assumption that it takes at least a decade to develop a vaccine and hence not made for fast and computer simulation-supported development of mRNA vaccines.
A more agile framework would give AI tools and computer predictions a more prominent role to shorten clinical trials. It would also embrace global reciprocity: If one reputable authorisation body has greenlighted a vaccine, patients in other countries should automatically get access to it as well.
The UAE has recently shown that it approves some of the most innovative medical products as fast or even more quickly than the European Union or the United States.
Reciprocity in vaccine approval facilitates healthy competition among medicines agencies across the world in which pharmaceutical companies run trials and seek approval in those jurisdictions that embrace this agile approach.
Agencies that miss out on this will see fewer trials run in their countries and lose out on attractive biotech investments in their region. Smart regulation will not only create new and booming biotech clusters but also, and even more importantly, allow us to overcome the next pandemic within months and not years. Millions of lives could be saved and billions if not trillions of economic output secured.
Preparing for the next pandemic means developing and embracing a regulatory toolkit that gives as many vaccine developers and manufacturers the air to breathe they need to get these relatively inexpensive lifesavers to the people. The UAE should be at the forefront of this and embrace the most agile vaccine approval framework.
Publicado originalmente aquí.