The race is on for vaccines and treatments for COVID-19. All around the planet researchers in universities, institutions and companies are rushing to find the magic bullet to defeat the SARS-CoV-2 (COVID-19) virus. The collaboration and information sharing amongst scientists all around the world couldn't be better in the time of COVID. According to the online publication Clinical Trials Arena, there are currently two drugs that have varying levels of approval for use to treat the infection: Chloroquine approved for emergency use by US FDA and Favilavir, the first approved coronavirus drug in China. In addition, there are at least 25 vaccines and dozens of therapeutics currently at various stages of trials around the world. There are many sites keeping track of vaccine and therapeutics development, some more comprehensive than others. I've found this site, this site and this site be helpful. Sooner or later we'll have a vaccine, and sooner than that, we should have therapeutics.

But while science is forging ahead in this crisis, what are governments doing? A preliminary survey of the literature shows that understandably, governments like the US, the UK and EU among others are revisiting certain aspects of their regulatory approval processes to allow for more rapid access to some of the promising research. But as we know this crisis is not just a crisis of the west, it is a global crisis. There is a need for global harmonization of systems to allow for safe and rapid access to therapies.

So how are global harmonization forums* addressing this issue? A look at some of the most well known harmonization forums shows that out of sheer necessity the regulatory authorities of the world have already begun to take steps to streamline approval processes to meet the COVID-19 challenge. 

In a recent virtual meeting of international regulators and the World Health Organization (WHO) co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (US FDA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). During this meeting the groups agreed to principles for the type and extent of preclinical and preliminary clinical data needed to inform the clinical development program for COVID-19 vaccines. The group cautioned that these requirements must be weighed against the overall risk-benefit assessment of the unmet medical need for such a vaccine. In general the group agreed that where there is adequate knowledge around the immune response elicited by specific vaccines, those vaccines could be used in humans without having to complete animal studies. There was also agreement amongst the regulators that there is a need to develop an information sharing mechanism with respect to various animal model and clinical trial data amongst regulators. You can view the full report here.

The report is simply a recommendation and has no binding authority, but it does give regulatory authorities some cover for speeding up approvals. While one could potentially extrapolate these recommendations to COVID therapeutics (as opposed to preventatives), there is no specific statement in this regard. Moreover, the issues surrounding therapeutics can vary, more specifically in the pre-clinical setting. Given that therapeutics can address the current immediate crisis, perhaps the ICMRA might consider new recommendations for therapeutics as well in the coming weeks.

What has the leading global health organization- the World Health Organization (WHO)- been doing on this front?

Well, on March 31 the WHO came out with a medical product alert warning to healthcare professionals and health authorities as a caution against a growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19. They also created a clinical registry platform (which, by the way is not accessible from outside of the WHO due to increased traffic) and a "Solidarity" site for the identification of drugs that can be used for the treatment of COVID-19 at a rapid pace and with limited paperwork. But the International Cooperation on Harmonization site of the WHO has had no activity since the beginning of the COVID crisis. Neither has the WHO's International Conference of Drug Regulatory Authorities... Given the magnitude of the COVID crisis, shouldn't these regulatory arms of the WHO be more active?? Additional information about COVID-19 and WHO’s recommendations can be found here.

What the COVID crisis has made crystal clear is that certain regulations are redundant and/or unnecessary, and information sharing is critical. It has also shown what regulatory authorities can actually achieve when the right impetus exists. The efforts I've mentioned above are good initial steps but they don’t fully address the immediate need for treatments and cures to deal with the burgeoning issue, or any other medical crisis for that matter.  There is a need for regulatory guidance on sharing/leveraging existing data and information in the assessment of treatments and vaccines as well. This would, of course, presume accuracy and complete transparency of information and data from all quarters. 

As the old saying goes, "every cloud has a silver lining". Perhaps the silver lining of this unfortunate global storm may make regulatory authorities more willing to share accurate data, and speed up global regulatory harmonization... even after we've weathered the COVID crisis. We have our fingers crossed.

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*International forums are generally comprised of regulatory authorities of the world and other entities such as health authorities, industry and academia, with the mission to streamline the approval of drugs.