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SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues.
Biologicals. 2020 Sep; 67:69-74.B

Abstract

This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Authors+Show Affiliations

P95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: marc.baay@p-95.com.International Alliance for Biological Standardization - IABS, Geneva, Switzerland. Electronic address: Pieter.neels@vaccine-advice.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32829985

Citation

Baay, Marc, and Pieter Neels. "SARS-CoV-2 Controlled Human Infection Models: Ethics, Challenge Agent Production and Regulatory Issues." Biologicals : Journal of the International Association of Biological Standardization, vol. 67, 2020, pp. 69-74.
Baay M, Neels P. SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues. Biologicals. 2020;67:69-74.
Baay, M., & Neels, P. (2020). SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues. Biologicals : Journal of the International Association of Biological Standardization, 67, 69-74. https://doi.org/10.1016/j.biologicals.2020.08.006
Baay M, Neels P. SARS-CoV-2 Controlled Human Infection Models: Ethics, Challenge Agent Production and Regulatory Issues. Biologicals. 2020;67:69-74. PubMed PMID: 32829985.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues. AU - Baay,Marc, AU - Neels,Pieter, Y1 - 2020/08/15/ PY - 2020/08/11/received PY - 2020/08/12/accepted PY - 2020/8/25/pubmed PY - 2020/10/21/medline PY - 2020/8/25/entrez KW - CMC KW - Controlled human infection models KW - Ethics KW - SARS-CoV-2 SP - 69 EP - 74 JF - Biologicals : journal of the International Association of Biological Standardization JO - Biologicals VL - 67 N2 - This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SN - 1095-8320 UR - https://www.unboundmedicine.com/medline/citation/32829985/SARS_CoV_2_controlled_human_infection_models:_Ethics_challenge_agent_production_and_regulatory_issues_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1045-1056(20)30096-8 DB - PRIME DP - Unbound Medicine ER -