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Open AccessAvailability and use of Standards in vaccine development
Reference materials are critical in assay development for calibrating and assessing their suitability. The devasting nature of the COVID-19 pandemic and subsequent proliferation of vaccine platforms and techno...
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Open AccessRegulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience
The World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in ...
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Open AccessA cautionary perspective regarding the isolation and serial propagation of SARS-CoV-2 in Vero cells
An array of SARS-CoV-2 virus variants have been isolated, propagated and used in in vitro assays, in vivo animal studies and human clinical trials. Observations of working stocks of SARS-CoV-2 suggest that seq...
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Animal models for COVID-19
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the aetiological agent of coronavirus disease 2019 (COVID-19), an emerging respiratory infection caused by the introduction of a novel coronaviru...
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Article
Open AccessWHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019
Consultations have been held to promote the revision of the WHO guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines adopted by the Expert Committee on Biological Standardizati...
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Open AccessHarmonization of Zika neutralization assays by using the WHO International Standard for anti-Zika virus antibody
During outbreaks of emerging viruses, such as the Zika outbreak in 2015–2016, speed and accuracy in detection of infection are critical factors to control the spread of the disease; often serological and diagn...
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Protocol
Assuring the Quality and Safety of Vaccines
Ensuring the consistent safety and efficacy of a vaccine has long been recognized as an essential element in a successful disease-control program. Indeed, the development of appropriate laboratory methods to c...
