Leaky Vaccines: A Wicked Problem in Accelerated Vaccine Development

Janice Graham; Koen Peeters Grietens

doi:10.18357/anthropologica66120242649

Auteurs-es

Janice Graham https://orcid.org/0000-0002-6326-8122
Koen Peeters Grietens Institute of Tropical Medicine and Nagasaki University

DOI :

https://doi.org/10.18357/anthropologica66120242649

Résumé

Si aucun vaccin ne peut offrir une protection totale, un haut niveau de réglementation en matière de sécurité, d’efficacité et de qualité est fondamental pour la confiance du public et l’adoption des vaccins en tant qu’outils essentiels de la santé publique mondiale. Cet article traite d’une préoccupation croissante au sujet des vaccins sous-optimaux « imparfaits » qui menacent les interventions d’urgence en cas de pandémie, ainsi que les programmes de santé publique habituel. Des normes réglementaires souples permettent aujourd’hui d’approuver plus rapidement des vaccins et des produits thérapeutiques dont l’efficacité n’est peut-être pas optimale. Des normes réglementaires flexibles permettent aujourd›hui d›approuver plus rapidement des vaccins et des produits thérapeutiques dont l›efficacité pourrait être sous-optimale. Les compromis entre les avantages et les inconvénients qui jouent un rôle considérable dans l’évaluation réglementaire, et à tous les stades du développement et de l’administration des vaccins, méritent d’être mieux connus du public, d’être plus transparents et de faire l’objet d’une plus grande responsabilisation. En nous basant sur le cas du premier vaccin antipaludique homologué, le RTS,S Mosquirix™, et à la lumière de l’approbation rapide des vaccins contre la COVID-19, nous examinons les implications socio-techniques des vaccins imparfaits dans les logiques vaccinales mondiales et suggérons des possibilités de renforcement de la légitimité pour informer la prochaine génération de la politique réglementaire en matière de technologie.

Téléchargements

Les données relatives au téléchargement ne sont pas encore disponibles.

Références

Agarwal, Ritu, Michelle Dugas, and Jui Ramaprasad. 2021. “Socioeconomic Privilege and Political Ideology are Associated with Racial Disparity in COVID-19 Vaccination.” Proceedings of the National Academy of Sciences 118 (33) e2107873118. https://doi.org/10.1073/pnas.2107873118. DOI: https://doi.org/10.1073/pnas.2107873118

Albrecht, Don. 2022. “Vaccination, Politics and COVID-19 Impacts.” BMC Public Health 14 22(1): 96. https://doi.org/10.1186/s12889-021-12432-x. DOI: https://doi.org/10.1186/s12889-021-12432-x

Alghounaim, Mohammad, Zainab Alsaffar, Abdulla Alfraij, Saadoun Bin-Hasan, and Entesar Hussain. 2022. “Whole-Cell and Acellular Pertussis Vaccine: Reflections on Efficacy.” Medical Principles and Practice 31 (4): 313–321. https://doi.org/10.1159/000525468. DOI: https://doi.org/10.1159/000525468

Ashepet, Mercy G., Liesbet Jacobs, Michiel Van Oudheusden, and Tina Huyse. 2021. “Wicked Solution for Wicked Problems: Citizen Science for Vector-Borne Disease Control in Africa.” Trends in Parasitology 37(2): 93-96. https://doi.org/10.1016/j.pt.2020.10.004. DOI: https://doi.org/10.1016/j.pt.2020.10.004

Azuma, Kentaro. 2015. “Regulatory Landscape of Regenerative Medicine in Japan.” Current Stem Cell Reports 1: 118–128. https://doi.org/10.1007/s40778-015-0012-6. DOI: https://doi.org/10.1007/s40778-015-0012-6

Bardosh K., A. de Figueiredo, R. Gur-Arie, E. Jamrozik, J. Doidge, T. Lemmens, S. Keshavjee, J.E. Graham, and S. Baral. 2022. “The Unintended Consequences of COVID-19 Vaccine Policy: Why Mandates, Passports, and Restrictions May Cause More Harm than Good.” BMJ Global Health. https://gh.bmj.com/content/bmjgh/7/5/e008684.full.pdf. DOI: https://doi.org/10.1136/bmjgh-2022-008684

Björkman, Anders, Christine Stabell Benn, Pater Aaby, Allan Schapira. 2023. “RTS,S/ AS01 Malaria Vaccine -Proven Safe and Effective?” Lancet Infectious Disease 23 (8) e318-e322. https://doi.org/10.1016/S1473-3099(23)00126-3. DOI: https://doi.org/10.1016/S1473-3099(23)00126-3

Bothwell, L.E., J.A. Greene, S.H. Podolsky, and D.S. Jones. 2016. “Assessing the Gold Standard—Lessons from the History of RCTs.” New England Journal of Medicine 374(22): 2175–2181. https://www.nejm.org/doi/10.1056/NEJMms1604593. (Accessed 29 August 2024). DOI: https://doi.org/10.1056/NEJMms1604593

Brende, B., J. Farrar, D. Gashumba, C. Moedas, T. Mundel, Y. Shiozaki, H. Vardhan, J. Wanka, and J.A. Røttingen. 2017. “CEPI—A New Global R and D Organisation for Epidemic Preparedness and Response.” Lancet 389(10066): 233–235. https://doi.org/10.1016/S0140-6736(17)30131-9 DOI: https://doi.org/10.1016/S0140-6736(17)30131-9

Broutin, Hélène, O. Thiongane, L. Agier, I. Van-Engelgem, J.-P. Jemmy Ghomsi, A. Ouattara, M. Doutchi, H.B. Manassara, A.T. Dia, and J. E. Graham. 2018. “Fighting Meningitis in Africa: A Call for a Multi-Sectorial Action.” Journal of Tropical Medicine and Health. JTMH-129. https://www.gavinpublishers.com/article/view/fighting-meningitis-in-africa-a-call-for-a-multi-sectorial-action.

Butler, D. 2017. “Billion-Dollar Project aims to prep Vaccines before Epidemics Hit.” Nature. 26 January; 541(7638): 444–445. https://doi.org/10.1038/nature.2017.21329. DOI: https://doi.org/10.1038/nature.2017.21329

Centers for Disease Control and Prevention (CDC). 2021. Vaccines. https://web.archive.org/web/20200831141506/https://www.cdc.gov/malaria/malaria_worldwide/reduction/vaccine.html. (Accessed 29 August 2024).

——. 2023. “Rotavirus Vaccine (RotaShield®) and Intussusception.” https://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-rotashield-historical.htm. (accessed 3 June 2023).

——. 2024. Malaria Vaccines. https://www.cdc.gov/malaria/php/public-health-strategy/malaria-vaccines.html (Accessed 29 August 2024).

Chandramohan, Daniel, Issaka Zonga, Issaka Sagara, Matthew Cairms, et al. 2021. “Seasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention.” The New England Journal of Medicine 25 August. 385:1005–1017. https://doi.org/10.1056/NEJMoa2026330. DOI: https://doi.org/10.1056/NEJMoa2026330

Clark, Andrew, Jacqueline Tate, Umesh Parashar, Mark Jit, M. Hasso-Agopsowicz, N. Henschke, B. Lopman B, K.Van Zandvoort, C. Pecenka, P. Fine, and C. Sanderson. 2019. “Mortality Reduction Benefits and Intussusception Risks of Rotavirus Vaccination in 135 Low-Income and Middle-Income Countries: A Modelling Analysis of Current and Alternative Schedules.” Lancet Global Health. November 7(11): e1541-e1552. https://doi.org/10.1016/S2214-109X(19)30412-7. DOI: https://doi.org/10.1016/S2214-109X(19)30412-7

Coleho, C. H., J.Y.A. Doritchamou, I. Zaidi, and P.E. Duffy. 2017. “Advances in Malaria Vaccine Development: Report from the 2017 Malaria Vaccine Symposium.” NPJ Vaccines 2 (34) https://doi.org/10.1038/s41541-017-0035-3. DOI: https://doi.org/10.1038/s41541-017-0035-3

Dabira, E. D., H.M. Soumare, H.B. Conteh, F. Ceesay, M.O. Ndiath, J. Bradley, N. Mohammed, B. Kandeh, M. R. Smit, H. Slater, K. Peeters Grietens, H. Broekhuizen, T. Bousema, C. Drakeley, S.W. Lindsay, J. Achan and U. D’Alessandro. 2022. “Mass Drug Administration of Ivermectin and Dihydroartemisinin-Piperaquine against Malaria in Settings with High Coverage of Standard Control Interventions: A Cluster-Randomised Controlled Trial in The Gambia.” Lancet Infectious Diseases, 22(4): 519–528. https://doi.org/10.1016/S1473-3099(21)00557-0. DOI: https://doi.org/10.1016/S1473-3099(21)00557-0

Datoo, MS., H.M. Natama, A. Somé, O. Traoré, T. Rouamba, D. Bellamy, et al. 2021. “Efficacy of a Low-Dose Candidate Malaria Vaccine, R21 in Adjuvant Matrix-M, with Seasonal Administration to Children in Burkina Faso: A Randomized Controlled Trial.” The Lancet 397 (10287):1809–1818. https://doi.org/10.1016/S0140-6736(21)00943-0. DOI: https://doi.org/10.1016/S0140-6736(21)00943-0

Datoo, M.S., H.M. Natama, A. Somé, D. Bellamy, O. Traoré, T. Rouamba, et al. 2022. “Efficacy and Immunogenicity of R21/Matrix-M Vaccine Against Clinical Malaria after 2 Years’ Follow-up in Children in Burkina Faso: a Phase 1/2b Randomized Controlled Trial.” The Lancet Infectious Diseases 22(12):1728–1736. https://doi.org/10.1016/S1473-3099(22)00442-X. DOI: https://doi.org/10.1016/S1473-3099(22)00442-X

Dinga, J.N., S.D. Gamua, S.M. Ghogomu, V.P.K. Titanji. 2018. “Preclinical Efficacy and Immunogenicity Assessment to show that a Chimeric Plasmodium Falciparum UB05-09 Antigen could be a Malaria Vaccine Candidate.” Parasite Immunology 40(3): e12514. https://doi.org/10.1111/pim.12514. DOI: https://doi.org/10.1111/pim.12514

Doshi, Peter. 2020. “Will COVID-19 Vaccines Save Lives? Current Trials aren’t designed to tell us.” British Medical Journal 371: m4037. https://doi.org/10.1136/bmj.m4037. DOI: https://doi.org/10.1136/bmj.m4037

Douglas, Mary. 1970. Natural Symbols: Explorations in Cosmology. New York: Pantheon Books.

Douglas, Mary and Aaron Wildavsky. 1982. Risk and Culture: An Essay on the Selection of Technical and Environmental Dangers. Berkeley: University of California Press. DOI: https://doi.org/10.1525/9780520907393

Edmonds, Sterling, Andrea MacGregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, and Matthew Herder. 2020. “Transparency too little, too late? Why and how Health Canada should make Clinical Data and Regulatory Decision-Making Open to Scrutiny in the Face of COVID-19.” Journal of Law and the Biosciences 7 (1) January-June 2020, lsaa083, https://doi.org/10.1093/jlb/lsaa083.

El Zarrad, M. Khair, Aaron Y. Lee, Rose Purcell, and Scott J. Steele. 2022. “Advancing an Agile Regulatory Ecosystem to Respond to the Rapid Development of Innovative Technologies.” Clinical and Translational Science 15(6): 1332–1339. https://doi.org/10.1111/cts.13267. DOI: https://doi.org/10.1111/cts.13267

European Medicines Agency (EMA) 2015. “First Malaria Vaccine Receives Positive Scientific Opinion from EMA.” https://www.ema.europa.eu/en/news/first-malaria-vaccine-receives-positive-scientific-opinion-ema. (accessed 3 June 2023).

Fehr, A., C. Nieto-Sanchez, J. Muela, F. Jaiteh, O. Ceesay, E. Maneh, and K. Peeters Grietens. 2021. “From Informed Consent to Adherence: Factors Influencing Involvement in Mass Drug Administration with Ivermectin for in The Gambia.” Malaria Journal 20(1), [198]. https://doi.org/10.1186/s12936-021-03732-z. DOI: https://doi.org/10.1186/s12936-021-03732-z

Fraiman, J. J., M. Erviti, S. Jones, P. Greenland, P. Whelan, R.M. Kaplan, P. Doshi. 2022. “Serious Adverse Events of Special Interest Following mRNA COVID-19 Vaccination in Randomized Trials in Adults.” Vaccine 40 (40):5798–5805. https://doi.org/10.1016/j.vaccine.2022.08.036. DOI: https://doi.org/10.1016/j.vaccine.2022.08.036

Franco-Paredes, Carlos. 2022. “Transmissibility of SARS-CoV-2 Among Fully Vaccinated Individuals.” Lancet Infectious Diseases 22(1):16. https://doi.org/10.1016/S1473-3099(21)00768-4. DOI: https://doi.org/10.1016/S1473-3099(21)00768-4

Gavi. 2023. “Five Things you Need to Know About the New R21 Malaria Vaccine.” https://www.gavi.org/vaccineswork/five-things-you-need-know-about-new-r21-malaria-vaccine (accessed 3 June 2023).

Goddard-Borger, Ethan D. and Justin A. Boddey. 2018. “Implications of Plasmodium Glycosylation on Vaccine Efficacy and Design.” Future Microbiology 13 (6): 609–612. https://doi.org/10.2217/fmb-2017-0284. DOI: https://doi.org/10.2217/fmb-2017-0284

Good, Byron. 1993. Medicine, Rationality and Experience. Cambridge: Cambridge University Press.

Good, Michael F. and Louis H. Miller. 2018. “Interpreting Challenge Data from Early Phase Malaria Blood Stage Vaccine Trials.” Expert Review of Vaccines 17 (3):189–196. https://doi.org/10.1080/14760584.2018.1435278. DOI: https://doi.org/10.1080/14760584.2018.1435278

Goodman, Jesse L, John D. Grabenstein, and M. Miles Braunn. 2020. “Answering Key Questions About COVID-19 Vaccines.” Journal of the American Medical Association 324 (20): 2027–2028. https://doi.org/10.1001/jama.2020.20590. DOI: https://doi.org/10.1001/jama.2020.20590

Graham, J.E. 2016. “Ambiguous Capture: Collaborative Capitalism and the Meningitis Vaccine Project.” Medical Anthropology: Cross-Cultural Studies in Health and Illness 35 (5): 419–432. https://doi.org/10.1080/01459740.2016.1167055. DOI: https://doi.org/10.1080/01459740.2016.1167055

Graham, J.E. 2019. “Ebola vaccine innovation: a Case Study of Pseudoscapes in Global Health.” Critical Public Health 29 (4):401–412. https://doi.org/10.1080/09581596.2019.1597966. DOI: https://doi.org/10.1080/09581596.2019.1597966

Graham J.E., A. Borda-Rodrigeuz, F. Huzair, and E. Zinck. 2012. “Capacity for a Global Vaccine Safety System: The Perspective of National Regulatory Authorities.” Vaccine, 30(33): 4953–4959. https://doi.org/10.1016/j.vaccine.2012.05.045. DOI: https://doi.org/10.1016/j.vaccine.2012.05.045

Greenwood, Brian. 2021. Vaccine Decision Marks Historic Moment in Malaria Control. https://www.lshtm.ac.uk/newsevents/news/2021/vaccine-decision-marks-historic-moment-malaria-control (accessed 3 June 2023).

Gryseels, C., S. Uk, V. Sluydts, L. Durnez, P. Phoeuk, S. Suon, S. Set, S. Heng, S. Siv, R. Gerrets, S. Tho, M. Coosemans, and K. Peeters. 2015. “Factors Influencing the Use of Topical Repellents: Implications for the Effectiveness of Malaria Elimination Strategies.” Scientific Reports 5 (16847). https://doi.org/10.1038/srep16847. DOI: https://doi.org/10.1038/srep16847

Gryseels, C., S. Uk, A. Erhart, R. Gerrets, V. Sluydts, L. Durnez, J. Muela Ribera, S. Hausmann Muela, D. Menard, S. Heng, T. Sochantha, U. D’Alessandro, M. Coosemans, and K. Peeters Grietens. 2013. “Injections, cocktails and diviners: therapeutic flexibility in the context of malaria elimination and drug resistance in northeast Cambodia.” PLOS ONE, 8 (11): e80343. https://doi.org/10.1371/journal.pone.0080343. DOI: https://doi.org/10.1371/journal.pone.0080343

Gryseels, C., M. Bannister-Tyrrell, S. Uk, S. Set, S. Sokha, R. Gerrets, and Peeters Grietens, K. 2019. “A Critical Enquiry into Variability of Insecticidal Net Use in Cambodia: Implications for Assessing Appropriateness of Malaria Elimination Interventions.” American Journal of Tropical Medicine and Hygiene. 100 (6): 1424–1432. https://doi.org/10.4269/ajtmh.18-0730. DOI: https://doi.org/10.4269/ajtmh.18-0730

GSK. 2016. “Our Commitment to Fighting Malaria.” https://www.gsk.com/media/2534/malaria-factsheet-23-feb-2016.pdf (accessed 3 June 2023).

——. 2023a. “Our 30-year Quest for a Malaria Vaccine.” https://www.gsk.com/media/2212/malaria-timeline-full.pdf (accessed 3 June 2023).

——. 2023b. “Behind the science of GSK.” https://www.gsk.com/en-gb/behind-the-science/access-to-healthcare/why-are-we-fighting-malaria-in-the-lab-and-on-the-ground/ (accessed 3 June 2023).

Halloran ME, M. Haber, and I.M. Longini. 1992. “Interpretation and estimation of vaccine efficacy under heterogeneity.” American Journal of Epidemiology 136 (3): 328–343. https://doi.org/10.1093/oxfordjournals.aje.a116498. DOI: https://doi.org/10.1093/oxfordjournals.aje.a116498

Haber, M., L. Watelet, and M.E. Halloran. 1995. “On individual and population effectiveness of vaccination.” International Journal of Epidemiology 24 (6) :1249–1260. https://doi.org/10.1093/ije/24.6.1249. DOI: https://doi.org/10.1093/ije/24.6.1249

Haraway, Donna J. 1996. Modest_Witness@Second_Millennium.FemaleMan©_Meets_OncoMouse™. Feminism and Technoscience. New York and London: Routledge.

Head, B. 2008. “Wicked Problems in Public Policy.” Public Policy 3(2):110–118. Health Justice Initiative. 2023. https://healthjusticeinitiative.org.za/. (accessed 3 June 2023).

Iglesias-López, Carolina, Antonia Agustí, Mercè Obach, and Antonio Vallano. 2019. “Regulatory framework for advanced therapy medicinal products in Europe and United States.” Frontiers in Pharmacology 10: 921. https://doi.org/10.3389/fphar.2019.00921 DOI: https://doi.org/10.3389/fphar.2019.00921

Infectious Prevention and Control Canada (IPAC). 2023. Coronavirus (COVID-19) SARS- CoV-2. https://ipac-canada.org/coronavirus-resources#:~:text=On%20May%204%2C%202023%2C%20the,of%20international%20concern%20(PHEIC). (Accessed 12 June 2023).

Jaiteh, F., Y. Masunaga, J. Okebe, U. D’Alessandro, J. Balen, C. Gryseels, J. Muela Ribera, and K. Peeters Grietens. 2019. “Community Perspectives on Treating Asymptomatic Infections for Malaria Elimination in The Gambia.” Malaria Journal 18 (39). https://doi.org/10.1186/s12936-019-2672-7. DOI: https://doi.org/10.1186/s12936-019-2672-7

Jaiteh, Fatou, J. M. Ribera, Y. Masunaga, J. Okebe, U. D’Alessandro, J. Balen, and K. Peeters Grietens. 2021a. “Complexities in Defining the Unit of Intervention for Reactive Community-Based Malaria Treatment in the Gambia.” Frontiers in Public Health, 9 [601152]. https://doi.org/10.3389/fpubh.2021.601152 DOI: https://doi.org/10.3389/fpubh.2021.601152

Jaiteh, F., J. Okebe, Y. Masunaga, U. D’Alessandro, J. Achan, C. Gryseels, and K. Peeters Grietens. 2021b. “Understanding Adherence to Reactive Treatment of Asymptomatic Malaria Infections in The Gambia.” Scientific Reports, 11(1), [1746]. https://doi.org/10.1038/s41598-021-81468-1. DOI: https://doi.org/10.1038/s41598-021-81468-1

Janssen M.A., and W. J. M. Martens. 1997. “Modeling Malaria as a Complex Adaptive System.” Artificial Life 3(3): 213–236. https://doi.org/10.1162/artl.1997.3.3.213. DOI: https://doi.org/10.1162/artl.1997.3.3.213

Ioannidis, John P.A., Sally Cripps and Martin A. Tanner. 2022. “Forecasting for COVID- 19 has Failed.” International Journal of Forecasting 28(2): 423–438. https://doi.org/10.1016/j.ijforecast.2020.08.004. DOI: https://doi.org/10.1016/j.ijforecast.2020.08.004

Klein S. L., F. Shann, W. J. Moss, C. S. Benn, and P. Aaby. 2016. “RTS,S Malaria Vaccine and Increased Mortality in Girls.” mBio 7(2): e00514– e00516. https://doi.org/10.1128/mBio.00514-16. DOI: https://doi.org/10.1128/mBio.00514-16

Kupperschmidt, Kai. 2015. “Risk of ‘Leaky’ Vaccines Debated.” Science 349 (6247): 461–462. https://doi.org/10.1126/science.349.6247.461. DOI: https://doi.org/10.1126/science.349.6247.461

Lakoff, Andrew. 2007. “Are we Prepared for the Next Disaster?” Contexts 6(3): 10–12. https://doi.org/10.1525/ctx.2007.6.3.10. DOI: https://doi.org/10.1525/ctx.2007.6.3.10

Latour, Bruno. 1993. We Have Never Been Modern. Cambridge: Cambridge University Press.

Lauerman, John. 1988. “One Colombian’s Quest for a Malaria Vaccine.” The Scientist. https://www.the-scientist.com/news/one-colombians-quest-for-a-malaria-vaccine-62354 (accessed 3 June 2023).

Laurens, Matthew B. 2021. “Novel Malaria Vaccines.” Human Vaccines and Immunotherapeutics 17 (11): 4549–4552. https://doi.org/10.1080/21645515.2021.1947762. DOI: https://doi.org/10.1080/21645515.2021.1947762

Lock, Margaret, et Vinh-Kim Nguyen. 2011. An Anthropology of Biomedicine. 2 ed. Oxford: Wiley Blackwell.

Lundh, A., J. Lexchin, B. Mintzes, J.B. Schroll, and L. Bero. 2017. “Industry Sponsorship and Research Outcome.” Cochrane Database Systematic Review, 2 (2): MR000033. https://doi.org/10.1002/14651858.mr000033.pub3. DOI: https://doi.org/10.1002/14651858.MR000033.pub3

Malaria Vaccination Initiative. 2022. “PATH welcomes US$% million grant to expand malaria vaccine access in Ghana, Kenya, and Malawi.” PATH, 19 April. https://www.path.org/media-center/path-welcomes-us-5-million-grant-expand-malaria-vaccine-access-ghana-kenya-and-malawi/#:~:text=Seattle%2C%20April%2019%2C%202022%E2%80%94,Ghana%2C%20Kenya%2C%20and%20Malawi (accessed 3 June 2023).

Patarroyo, Manuel., R. Amador, R., P. Clavijo, Alberto Moreno, Fanny Guzman, Pedro Romero, Ricardo Tascon, Antonio Franco, Luis A. Murillo, Gabriel Ponton & Gustavo Trujillo. 1988. “A Synthetic Vaccine Protects Humans Against Challenge with Asexual Blood Stages of Plasmodium falciparum malaria.” Nature 332: 158–161. https://doi.org/10.1038/332158a0.

Märzhauser, Helene. 2018. “Risks of Dengue Vaccination.” Science, 2 July. http://www.dw.com/en/dengue-risks-and-side-effects-of-the-worlds-first-vaccine/a-42488407 (Accessed 3 June 2023).

Masunaga, Y., J. Muela Ribera, T. T. Nguyen., K. Tesfazghi, and K. Peeters Grietens. 2021. “In Search of the Last Malaria Cases: Ethnographic Methods for Community and private-sector Engagement in Malaria Elimination in Vietnam, Laos, and Cambodia.” Malaria Journal 20 (1): [370]. https://doi.org/10.1186/s12936-021-03903-y. DOI: https://doi.org/10.1186/s12936-021-03903-y

Masunaga, Y., F. Jaiteh, E. Manneh, J. Balen, J. Okebe, U. D’Alessandro, C. Nieto- Sanchez, D. H. de Vries, R. Gerrets, K. Peeters Grietens, and J. Muela Ribera. 2021. “The Community Lab of Ideas for Health: Community-Based Transdisciplinary Solutions in a Malaria Elimination Trial in The Gambia.” Frontiers in Public Health 9: [637714]. https://doi.org/10.3389/fpubh.2021.637714. DOI: https://doi.org/10.3389/fpubh.2021.637714

Morgan S., A. Hollis, C. McCabe, M. Herder, and M. Paulden. 2023. “Canada’s Misguided Changes to Drug Regulation Could Fast-Track Unproven Medications and Divert Funds From Other Health Needs.” The Conversation, 26 June. https://theconversation.com/canadas-misguided-changes-to-drug-regulation-could-fast-track-unproven-medications-and-divert-funds-from-other-health-needs-207463 (accessed 30 June 2023).

Moris, Philippe, Erik Jongert, and Robbert G. van der Most. 2018. “Characterization of T-cell Immune Responses in Clinical Trials of the Candidate RTS,S Malaria Vaccine.” Human Vaccines and Immunotherapies 14 (1): 17–27. https://doi.org/10.1080/21645515.2017.1381809. DOI: https://doi.org/10.1080/21645515.2017.1381809

Muela Ribera, J., S. Hausmann-Muela, C. Gryseels, and K. Peeters Grietens. 2016. “Re-imagining Adherence to Treatment from the ‘Other Side’: Local Interpretations of Adverse Anti-Malarial Drug Reactions in the Peruvian Amazon.” Malaria Journal, 15(136). https://api.semanticscholar.org/CorpusID:14703669. (Accessed 30 June 2023). DOI: https://doi.org/10.1186/s12936-016-1193-x

Muurlink, Olav T., and Andrew W Taylor-Robinson. 2020. “The ‘Lifecycle’ of Human Beings: A Call to Explore Vector-Borne Diseases from an Ecosystem Perspective.” Infectious Diseases of Poverty 9(1): 37. https://doi.org/10.1186/s40249-020-00653-y. DOI: https://doi.org/10.1186/s40249-020-00653-y

Nguyen, T. T., C. Gryseels, D. T. Tran, T. Smekens, R. Gerrets, X. X. Nguyen, and K. Peeters Grietens. 2021. “Understanding Malaria Persistence: A Mixed-Methods Study on the Effectiveness of Malaria Elimination Strategies in South-Central Vietnam.” Frontiers in Public Health, 9, [742378]. https://doi.org/10.3389/fpubh.2021.742378. DOI: https://doi.org/10.3389/fpubh.2021.742378

Nielsen CM., J. Vekemans, M. Lievens, K.E. Kester, J.A. Regules, and C.F. Ockenhousee. 2018. “RTS,S Malaria Vaccine Efficacy and Immunogenicity During Plasmodium Falciparum Challenge is Associated with HLA Genotype.” Vaccine 36(12):1637–1642. https://doi.org/10.1016/j.vaccine.2018.01.069. DOI: https://doi.org/10.1016/j.vaccine.2018.01.069

Nlinwe, Nfor Omarine, Kwadwo Asamoah Kusi, Bright Adu, and Martha Sedegah. 2018. “T-cell Responses Against Malaria: Effect of Parasite Antigen Diversity and Relevance for Vaccine Development.” Vaccine 36(17): 2237–2242. https://doi.org/10.1016/j.vaccine.2018.03.023. DOI: https://doi.org/10.1016/j.vaccine.2018.03.023

Olotu A., V Urbano, A. Hamad, M. Eka, M. Chemba, E. Nyakarungu, Jose Raso, Esther Eburi, Dolores O. Mandumbi, Dianna Hergott, Carl D. Maas, Mitoha O. Ayekaba, Diosdado N. Milang, Matilde R. Rivas, Tobias Schindler, Oscar M. Embon, Adam J. Ruben, Elizabeth Saverino, Yonas Abebe, Natasha KC, Eric R. James, Tooba Murshedkar, Anita Manoj, Sumana Chakravarty, Minglin Li, Matthew Adams, Christopher Schwabe, J. Luis Segura, Claudia Daubenberger, Marcel Tanner, Thomas L. Richie, Peter F. Billingsley, B. Kim Lee Sim, Salim Abdulla, and Stephen L. Hoffman. 2018. “Advancing Global Health through Development and Clinical Trials Partnerships: A Randomized, Placebo-Controlled, Double-Blind Assessment of Safety, Tolerability, and Immunogenicity of PfSPZ Vaccine for Malaria in Healthy Equatoguinean Men.” American Journal of Tropical Medicine and Hygiene 98 (1): 308–318. https://doi.org/10.4269/ajtmh.17-0449. DOI: https://doi.org/10.4269/ajtmh.17-0449

O’Ryan, Miguel. 2017. “Rotavirus Vaccines: A Story of Success with Challenges Ahead.” F1000 Research 18(6): 1517. https://doi.org/10.12688/f1000research.11912.1. DOI: https://doi.org/10.12688/f1000research.11912.1

Osterholm, M. T., N. S. Kelley, J. M. Manske, K. S. Ballering, T. R. Leighton, and K. A. Moore. 2012. The Compelling Need for Game-Changing Influenza Vaccines: An Analysis of the Influenza Vaccine Enterprise and Recommendations for the Future. Center for Infectious Diseases Research and Policy (CIDRAP) Report. Minneapolis, MN: University of Minnesota. http://www.cidrap.umn.edu/sites/default/files/public/downloads/ccivi_report.pdf. (Accessed 30 June 2023).

Otto S.P., T. Day, J. Arino, C. Colijn, J. Dushoff, M. Li, S. Mechai, G.V. Domselaar, J. Wu, D.J.D. Earn, and N.H. Ogden. 2021. “The Origins and Potential Future of SARS- CoV-2 Variants of Concern in the Evolving COVID-19.” Current Biology 31 (14): PR918–929. https://doi.org/10.1016/j.cub.2021.06.049. DOI: https://doi.org/10.1016/j.cub.2021.06.049

Patarroyo, M., R. Amador, P. Clavijo, A. Moreno, F. Guzzman, P. Romero, R. Tascon., Antonio Franco, Luis A. Murillo, Gabriel Ponton and Gustavo Trujillo. 1988. “A Synthetic Vaccine Protects Humans Against Challenge with Asexual Blood Stages of Plasmodium falciparum malaria.” Nature 332: 158–161. https://doi.org/10.1038/332158a0. DOI: https://doi.org/10.1038/332158a0

Peeters Grietens, K., X. Nguyen Xuan, J. Muela Ribera, T. Ngo Duc, W. Van Bortel, N. Truong Ba, K.P. Van, H. Le Xuan, U. D’Alessandro, and A. Erhart. 2012. “Social Determinants of Long-Lasting Insecticidal Hammock-Use Among the Ra-Glai Ethnic Minority in Vietnam: Implications for Forest Malaria Control.” PLOS ONE 7(1): e29991. https://doi.org/10.1371/journal.pone.0029991. DOI: https://doi.org/10.1371/journal.pone.0029991

Peeters Grietens, K., J. Muela Ribera,, V. Soto, A. Tenorio, S. Hoibak, A.R. Aguirre, E. Toomer, H. L. K. Rodriguez., A. Llanos Cuentas, U. D’Alessandro, D. Gamboa, and A. Erhart. 2013. “Traditional Nets Interfere with the Uptake of Long-Lasting Insecticidal Nets in the Peruvian Amazon: The Relevance of Net Preference for Achieving High Coverage and use.” PLOS ONE 8(1): e50294. https://doi.org/10.1371/journal.pone.0050294. DOI: https://doi.org/10.1371/journal.pone.0050294

Peeters Grietens, K., C. Gryseels, S. Dierickx, M. Bannister-Tyrrell, S. Trienekens, S. Uk., P. Phoeuk, S. Suon, S. Set, R. Gerrets, S. Hoibak, J. Muela Ribera S. Hausmann-Muela, S. Tho, L. Durnez, V. Sluydts, U. D’Alessandro, M. Coosemans, and A. Erhart. 2015. “Characterizing Types of Human Mobility to Inform Differential and Targeted Malaria Elimination Strategies in Northeast Cambodia.” Scientific Reports 5: 16837. https://doi.org/10.1038/srep16837. DOI: https://doi.org/10.1038/srep16837

Peeters Grietens, K., C. Gryseels, and G. Verschraegen 2019. “Misdirection in the Margins of the Methods of the Malaria Elimination Paradigm.” Critical Public Health. https://doi.org/10.1080/09581596.2019.1597965. DOI: https://doi.org/10.1080/09581596.2019.1597965

Peng, Yilang. 2022. “Politics of COVID-19 Vaccine Mandates: Left/right-wing Authoritarianism, Social Dominance Orientation, and Libertarianism.” Personality and Individual Differences 194: 111661. https://doi.org/10.1016/j.paid.2022.111661. DOI: https://doi.org/10.1016/j.paid.2022.111661

Proper, Olivia, Nick Ruktanonchai and Maia Martcheva. 2014. “Optimal Vaccination and Bednet Maintenance for the Control of Malaria in a Region with Naturally Acquired Immunity.” Journal of Theoretical Biology 353(21): 142–156. https://doi.org/10.1016/j.jtbi.2014.03.013. DOI: https://doi.org/10.1016/j.jtbi.2014.03.013

Prugger, C., A. Spelsberg, U. Keil, J. Erviti, and P. Doshi. 2021. “Evaluating COVID-19 Vaccine Efficacy and Safety in the Post-Authorisation Phase.” British Medical Journal 375. https://doi.org/10.1136/bmj-2021-067570. DOI: https://doi.org/10.1136/bmj-2021-067570

Read, A.F., S.J. Baigent, C. Powers, L.B. Kgosana, L. Blackwell, L.P. Smith, David A. Kennedy, Stephen W. Walkden-Brown, and Venugopal K. Nair. 2015. “Imperfect Vaccination Can Enhance the Transmission of Highly Virulent Pathogens.” PLOS Biology 13(7): e1002198. https://doi.org/10.1371/journal.pbio.1002198 DOI: https://doi.org/10.1371/journal.pbio.1002198

Ross, A. 2017. “Vaccination Alone will not halt the Next Global Pandemic.” BMJ Opinion. http://blogs.bmj.com/bmj/2017/06/09/allen-ross-vaccination-alone-will-not-halt-the-next-global-pandemic/ (accessed 30 June 2023). DOI: https://doi.org/10.1136/bmj.j2864

Røttingen J.A, D. Gouglas, M. Feinberg, S. Plotkin, K.V. Raghavan, A. Witty, R. Draghia- Akli, P. Stoffels, and P. Piot. 2017. “New Vaccines Against Epidemic Infectious Diseases.” New England Journal of Medicine 376 (7): 610–613. https://doi.org/10.1056/NEJMp1613577. DOI: https://doi.org/10.1056/NEJMp1613577

RTS,S Clinical Trials Partnership. 2012. “First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants.” New England Journal of Medicine 365(20): 1863– 1875. https://doi.org/10.1056/NEJMoa1102287. DOI: https://doi.org/10.1056/NEJMoa1102287

——. 2014. “Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine during 18 Months after Vaccination: A Phase 3 Randomized, Controlled Trial in Children and Young Infants at 11 African Sites.” PLOS Medicine 29 July. https://doi.org/10.1371/journal.pmed.1001685. DOI: https://doi.org/10.1371/journal.pmed.1001685

——. 2015. “Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine With or Without a Booster Dose in Infants and Children in Africa: Final Results of a Phase 3, Individually Randomized Clinical Trial. The Lancet 386 (9988): 31–45. https://doi.org/10.1016/S0140-6736(15)60721-8. DOI: https://doi.org/10.1016/S0140-6736(15)60721-8

Ryan, Molly, Tamara Giles-Vernick, and Janice E. Graham. 2019. “Technologies of Trust in Epidemic Response: Openness, Reflexivity and Accountability During the 2014- 2016 Ebola Outbreak in West Africa.” BMJ Global Health 2019(4): e001272 https://gh.bmj.com/content/4/1/e001272. DOI: https://doi.org/10.1136/bmjgh-2018-001272

Schwartz K. L., J. C. Kwong, S. L. Deeks, M.A.Campitelli, F.B. Jamieson, A. Marchand- Austin, T.A. Stukel, L. Rosella, N. Daneman, S. Bolotin, S.J. Drews, H. Rilkoff, and N. S. Crowcroft. 2016. “Effectiveness of Pertussis Vaccination and Duration of Immunity.” Canadian Medical Association Journal 188(16): E399–E406. https://doi.org/10.1503/cmaj.160193. DOI: https://doi.org/10.1503/cmaj.160193

Serum Institute of India PVT, Ltd. 2023. “R21/Matrix-M™ Malaria Vaccine Developed by University of Oxford Receives Regulatory Clearance for Use in Ghana.” https://www.seruminstitute.com/press_release_sii_130423.php (accessed 3 June 2023).

Stengers, Isabelle. 2005. “The Cosmopolitical Proposal.” In Making Things Public: Atmospheres of Democracy, Bruno Latour, ed. 994–1003. Cambridge, MA: MIT Press.

University of Oxford. 2023. “R21/Matrix-M™ Malaria Vaccine Developed by University of Oxford Received Regulatory Clearance for use in Ghana.” https://www.ox.ac.uk/news/2023-04-13-r21matrix-m-malaria-vaccine-developed-university-oxford-receives-regulatory (accessed 3 June 2023).

Vural, I. E., Matthew Herder and Janice E. Graham. 2021. “From Sandbox to Pandemic: Agile Reform of Canadian Drug Regulation.” Health Policy 125 (9): 1115–1120. https://doi.org/10.1016/j.healthpol.2021.04.018. DOI: https://doi.org/10.1016/j.healthpol.2021.04.018

Wexler, Mark K. 2009. “Exploring the Moral Dimension of Wicked Problems.” International Journal of Sociology and Social Policy 2919(10): 531–542. https://doi.org/10.1108/01443330910986306. DOI: https://doi.org/10.1108/01443330910986306

World Health Organization. 2005. “International Health Regulations.” World Health Organization, 1 January. https://www.who.int/publications/i/item/9789241580410. (accessed 3 June 2023).

——. 2013. “Malaria Vaccine Technology Roadmap.” World Health Organization, 5 November. https://www.who.int/publications/m/item/malaria-vaccine-technology-roadmap. (accessed 3 June 2023).

——. 2016. “WHO Welcomes Global Health Funding for Malaria Vaccine.” World Health Organization, 17 November. http://www.who.int/en/news-room/detail/17-11-2016-who-welcomes-global-health-funding-for-malaria-vaccine (accessed 3 June 2023).

——. 2020. Malaria: “The Malaria Vaccine Implementation Program (MVIP).” World Health Organization, 2 March. https://www.who.int/news-room/questions-and-answers/item/malaria-vaccine-implementation-programme (accessed 3 June 2023).

——. 2021. “Vaccine Efficacy, Effectiveness and Protection.” World Health Organization, 14 July. https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection (accessed 3 June 2023).

——. 2023a. “The Access to COVID-19 Tools (ACT) Accelerator.” World Health Organization. https://www.who.int/initiatives/act-accelerator. (accessed 3 June 20230.

——. 2023b. “Malaria.’ World Health Organization, 4 December. https://www.who.int/news-room/fact-sheets/detail/malaria. (accessed 3 June 2023).

Zeng, Wu, Y.-A. Halasa-Rappel, N. Baurin, L. Coudeville, and D. Shepard. 2018. “Cost- Effectiveness of Dengue Vaccination in Ten Endemic Countries.” Vaccine 3(3): 413–420. https://doi.org/10.1016/j.vaccine.2017.11.064. DOI: https://doi.org/10.1016/j.vaccine.2017.11.064

Zimmer, Carl and Keith Collins. 2021. “What do vaccine efficacy numbers actually mean?” New York Times, 3 March. https://www.nytimes.com/interactive/2021/03/03/science/vaccine-efficacy-coronavirus.html (accessed 3 June 2023).