Introduction: The rapid spread of SARS-CoV2 infection allowed testing of mRNA vaccines that translate the target antigen, unlike introducing antigens in traditional vaccines. It proved safer and more effective and, as a chemical vaccine, much easier to develop and manufacture.
Areas covered: The science and technology behind the mRNA vaccines are pertinent to establishing low-cost manufacturing of reverse-engineered mRNA vaccines, as suggested by the WHO. A stepwise approach to establishing a compliant manufacturing facility, testing, supply chain, regulatory submissions, and intellectual property handling is presented.
Expert opinion: mRNA technology is more straightforward, and the cost of establishing a manufacturing facility is affordable, even in developing countries. The technology and supplies are widely available; however, based on experience, several misconceptions and misunderstandings about mRNA vaccines need to be removed, such as the regulatory and intellectual property issues that are resolved in this paper.
【저자키워드】 COVID-19, SARS-CoV2, Vaccines, mRNA vaccine, FDA, LNP, developing countries, EMA, TRIPS, LDCs, WTO,