Has COVID-19 changed the future of pharmaceutical regulation?
Keywords:COVID-19, SARS-CoV-2, AAV Vaccine, MHRA Conditional Approval, Advanced Therapy Medicinal Products, regenerative medicine, regulation, mRNA Vaccine, emergency use authorization
COVID-19, or SARS-CoV-2, has undoubtedly changed the world as we know it, affecting daily life, health, and economics to an unprecedented degree. Due to the widespread and devastating impact of this previously unknown virus, there has been a massive effort from the pharmaceutical industry to rapidly develop a vaccine to protect the population. As a consequence of the increasingly evolving threat of COVID-19, developers and regulators have had to respond accordingly, learning about the virus while attempting to develop and regulate treatments concurrently. As if this task was not complex enough, developers and regulators have had to face this challenge while simultaneously tackling arguably the largest widescale media attention and pressure that has ever been felt by the industry, with mainstream media, politicians, and the general public all having a vested interest in the development of the vaccines and an opinion on how they should be developed, distributed, and monitored. It is therefore a true testament to developers and regulators alike that many vaccines have already been authorized for use (or are about to be) in so many countries and territories across the world, in record time. However, this success brings many questions as to why other medicines have not been regulated at such speed before and whether the SARS-CoV-2 vaccines have received ‘special treatment’, with many posing the question: ‘are these vaccines actually safe?’. One thing that is clear, at least to the industry, is that the incredible flexibility, pragmatism, and creativity of developers and regulators in their approach to authorizing the vaccines has, unequivocally, been a main contributor to the rapid availability of these novel vaccines. This article aims to examine whether COVID-19 (SARS-CoV-2) has changed the future of regulation through identifying and discussing the notable regulatory milestones achieved over the course of the COVID-19 pandemic (to date), and critically analyzing the regulation of those successful vaccine candidates that have been authorized at the time of writing, while posing the ultimate question; has COVID-19 revolutionized the future of regulation of medicine development and authorization or are we simply responding to an unprecedented global pandemic?
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Copyright (c) 2021 Harriet Edwards
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