@article{af3a67a253a14be19c417e52107433e0,
title = "Global public health security and justice for vaccines and therapeutics in the COVID-19 pandemic",
abstract = "A Lancet Commission for COVID-19 task force is shaping recommendations to achieve vaccine and therapeutics access, justice, and equity. This includes ensuring safety and effectiveness harmonized through robust systems of global pharmacovigilance and surveillance. Global production requires expanding support for development, manufacture, testing, and distribution of vaccines and therapeutics to low- and middle-income countries (LMICs). Global intellectual property rules must not stand in the way of research, production, technology transfer, or equitable access to essential health tools, and in context of pandemics to achieve increased manufacturing without discouraging innovation. Global governance around product quality requires channelling widely distributed vaccines through WHO prequalification (PQ)/emergency use listing (EUL) mechanisms and greater use of national regulatory authorities. A World Health Assembly (WHA) resolution would facilitate improvements and consistency in quality control and assurances. Global health systems require implementing steps to strengthen national systems for controlling COVID-19 and for influenza vaccinations for adults including pregnant and lactating women. A collaborative research network should strive to establish open access databases for bioinformatic analyses, together with programs directed at human capacity utilization and strengthening. Combating anti-science recognizes the urgency for countermeasures to address a global-wide disinformation movement dominating the internet and infiltrating parliaments and local governments.",
keywords = "COVID-19, Health equity, Vaccine distribution, global governance, public health justice, public health security, therapeutics, vaccine access, vaccine development, vaccine technologies",
author = "Hotez, {Peter J.} and Carolina Batista and Amor, {Yanis Ben} and Onder Ergonul and Figueroa, {J. Peter} and Sarah Gilbert and Mayda Gursel and Mazen Hassanain and Gagandeep Kang and Kaslow, {David C.} and Kim, {Jerome H.} and Bhavna Lall and Heidi Larson and Denise Naniche and Timothy Sheahan and Shmuel Shoham and Annelies Wilder-Smith and Sow, {Samba O.} and Nathalie Strub-Wourgaft and Prashant Yadav and Bottazzi, {Maria Elena}",
note = "Funding Information: The pandemic has generated impetus to accelerate the establishment of multiple new publicly owned manufacturing facilities worldwide and many manufacturing technology providers have generated solutions to allow easier installation and operation of vaccine and mAb production facilities [48–53] . The Canadian government is investing $126 million to build a new Good Manufacturing Practices (GMP) compliant Biologics Manufacturing Centre (BMC), in Montr{\'e}al, which will support the manufacturing of COVID-19 vaccine candidates, accelerate the scale-up production, and prepare the country for future pandemics [54] . In the UK, the government will invest up to £93 million to build a new Vaccines Manufacturing and Innovation Centre (VMIC), which will be capable of producing large quantities of COVID-19 vaccines to serve the entire UK population [55] . In the US [56] , public funding from Biomedical Advanced Research and Development Authority (BARDA) entered into technology investment agreement with Cytiva [57] and awarded US $628 million to Emergent BioSolutions and US $265 million to Texas A&M University (subcontracts the work to Fujifilm Diosynth Biotechnologies) to increase production capacity [58] . Saudi Arabia is establishing the Saudi Vaccine and Biomanufacturing center (SVBC), which will be located in the King Abdullah University of Science and Technology (KAUST) Research and Technology Park, sponsored by King Abdulaziz City of Science and Technology, and operated by SaudiVax [59] . ImmunityBio is working to build capacity in South Africa in collaboration with the DCVMN member, BioVac [60] . Along these lines, the Africa CDC is launching the Partnerships for African Vaccine Manufacturing (PAVM), an initiative that could also serve as a model for other regions in the world including Latin America and Southeast Asia. Finally, the addition of filling and finish facilities for both vaccines and mAbs worldwide can also unlock a bottleneck in manufacturing that will be faced when producing the huge volumes of promised biologics and vaccines to combat COVID-19 [61] . Funding Information: MEB and PJH are developers of a COVID-19 vaccine construct, which was licensed by Baylor College of Medicine to Biological E Ltd., a commercial vaccine manufacturer for scale up, production, testing and licensure. MG participates in one of eight SARS-CoV-2 vaccine development projects supported by The Scientific and Technological Research Council of Turkey (T{\"U}BİTAK) since March 2020. SG is cofounder of Vaccitech and has a patent on ChAdOx1 nCoV-19 licensed to AstraZeneca. MH is Founder and Managing Director of SaudiVax. JPF, GK and DCK are members of the WHO SAGE Working Group on COVID-19 vaccines. GK is independent director appointed by the Wellcome Trust, MSD Wellcome Trust Hilleman Laboratories Private Limited and Vice Chair of the Board, Coalition of Epidemic Preparedness Innovations (CEPI). DCK reports grants from Bill and Melinda Gates Foundation (BMGF) and grants from CEPI, JHK reports personal fees from SK biosciences. HL reports grants and honoraria from GlaxoSmithKline for training talks and from Merck as a member of the Merck Vaccine Confidence Advisory Board, grants from J&J outside the submitted work. AWS serves as Consultant to WHO. The views presented here reflect her views and not necessarily those of WHO. TS reports grants from National Institute of Allergy and Infectious Disease and Fast Grants and research contracts from GlaxoSmithKline, and ViiV Healthcare. SS reports grants from Ansun BioPharma, Astellas Pharma, Cidara Therapeutics, F2G, Merck, T2 Biosystems, Shire Pharmaceuticals, Shionogi, and Gilead Sciences, outside the submitted work; and personal fees from Amplyx Pharmaceuticals, Acidophil, Janssen Pharmaceuticals, Reviral, Intermountain Healthcare, Karyopharm Therapeutics, Immunome, Celltrion, and Adagio outside the submitted work. Publisher Copyright: {\textcopyright} 2021 The Authors",
year = "2021",
month = sep,
doi = "10.1016/j.eclinm.2021.101053",
language = "English (US)",
volume = "39",
journal = "EClinicalMedicine",
issn = "2589-5370",
publisher = "Lancet Publishing Group",
}