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Making COVID-19 mRNA vaccines accessible: challenges resolved
被引:8
|作者:
Niazi, Sarfaraz K.
[1
]
机构:
[1] Univ Illinois, Pharm, Deerfield, IL 60015 USA
关键词:
COVID-19;
vaccines;
mRNA vaccine;
LNP;
SARS-CoV2;
WTO;
TRIPS;
LDCs;
developing countries;
FDA;
EMA;
D O I:
10.1080/14760584.2022.2089121
中图分类号:
R392 [医学免疫学];
Q939.91 [免疫学];
学科分类号:
100102 ;
摘要:
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.
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页码:1163 / 1176
页数:14
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