Prof. Ivana Knezevic
World Health Organization
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Academic Career Length
29Years (1998-Present)
(Calculated once Scilit publication data is synced: current year − year of first publication + 1)
Representative Publications
View All Publications1 October 2018 in The Lancet Infectious Diseases
Journal Article
NMNatalie I Mazur
Natalie I Mazur
DHDeborah Higgins
Deborah Higgins
MNMarta Nunes
Marta NunesJMJosé A Melero
José A Melero
ALAnnefleur C Langedijk
Annefleur C Langedijk
LBLouis J Bont
Louis J Bont +25
The global burden of disease caused by respiratory syncytial virus (RSV) is increasingly recognised, not only in infants, but also in older adults (aged ≥65 years). Advances in knowledge of the structural biology of the RSV surface fusion glycoprotein have revolutionised RSV vaccine development by providing a new target for preventive interventions. The RSV vaccine landscape has rapidly expanded to include 19 vaccine candidates and monoclonal antibodies (mAbs) in clinical trials, reflecting the urgency of reducing this global health problem and hence the prioritisation of RSV vaccine development. The candidates include mAbs and vaccines using four approaches: (1) particle-based, (2) live-attenuated or chimeric, (3) subunit, (4) vector-based. Late-phase RSV vaccine trial failures highlight gaps in knowledge regarding immunological protection and provide lessons for future development. In this Review, we highlight promising new approaches for RSV vaccine design and provide a comprehensive overview of RSV vaccine candidates and mAbs in clinical development to prevent one of the most common and severe infectious diseases in young children and older adults worldwide.
1 April 2021 in The Lancet
Journal Article
PKPaul A Kristiansen
Paul A Kristiansen
MPMark Page
Mark Page
VBValentina Bernasconi
Valentina Bernasconi
GMGiada Mattiuzzo
Giada Mattiuzzo
PDPeter Dull
Peter Dull
Ivana Knezevic +2
1 September 2015 in Biologicals
Journal Article
MWMeenu Wadhwa
Meenu WadhwaIvana KnezevicHKHye-Na Kang
Hye-Na Kang
RTRobin Thorpe
Robin Thorpe
Biotherapeutic products (BTPs) are the fastest growing medicines in the pharmaceutical market. Despite their clinical success, the immunogenicity of BTPs continues to be a major concern. Assessment of immunogenicity as well as appropriate interpretation of immunogenicity data is therefore, of critical importance for defining safety profile of these products for the purpose of their licensure and use. In the past decade, much progress has been made towards how immunogenicity should be studied. This article reflects the content of the brief presentation on principles of methods used for immunogenicity assessment and their merits and limitations given at the first World Health Organization (WHO) implementation workshop on rDNA derived biotherapeutic products held in the Republic of Korea in May 2014 to support the case studies on immunogenicity presented and discussed during the workshop. The purpose of this article is to provide an overview of the methods used for assessing immunogenicity of biotherapeutic products (BTPs) and the most important considerations in interpreting results in the context of regulatory overview of these products.
1 March 2022 in The Lancet Microbe
Journal Article
Ivana KnezevicGMGiada Mattiuzzo
Giada Mattiuzzo
MPMark Page
Mark Page
PMPhilip Minor
Philip Minor
EGElwyn Griffiths
Elwyn Griffiths
VMVasee Moorthy
Vasee Moorthy
+1
The first WHO International Standard and International Reference Panel for anti-SARS-CoV-2 immunoglobulin were established by the WHO Expert Committee on Biological Standardization in December, 2020. The WHO International Antibody Standards are intended to serve as global reference reagents, against which national reference preparations or secondary standards can be calibrated. Calibration will facilitate comparison of results of assays (eg, of the neutralising antibody response to candidate COVID-19 vaccines) conducted in different countries. Use of these standards is expected to contribute to better understanding of the immune response, and particularly of the correlates of protection. This Personal View provides some technical details of the WHO Antibody Standards for SARS-CoV-2, focusing specifically on the use of these standards for the evaluation of the immune response to COVID-19 vaccines, rather than other applications (eg, diagnostic or therapeutic). The explanation with regard to why rapid adoption of the standards is crucial is also included, as well as how funders, journals, regulators, and ethics committees could drive adoption in the interest of public health.
12 February 2015 in Regenerative Medicine
Journal Article
PAPw Andrews
Pw Andrews
DBD Baker
D Baker
NBN Benvinisty
N Benvinisty
BMB Miranda
B MirandaKBK Bruce
K Bruce
QZQ Zhou
Q Zhou
+59
Journal Article
Ivana KnezevicMLMargaret Liu
Margaret Liu
Keith PedenTZTiequn Zhou
Tiequn ZhouHKHye‐Na Kang
Hye‐Na KangThe global research and development of mRNA vaccines have been prodigious over the past decade, and the work in this field has been stimulated by the urgent need for rapid development of vaccines in response to an emergent disease such as the current COVID-19 pandemic. Nevertheless, there remain gaps in our understanding of the mechanism of action of mRNA vaccines, as well as their long-term performance in areas such as safety and efficacy. This paper reviews the technologies and processes used for developing mRNA prophylactic vaccines, the current status of vaccine development, and discusses the immune responses induced by mRNA vaccines. It also discusses important issues with regard to the evaluation of mRNA vaccines from regulatory perspectives. Setting global norms and standards for biologicals including vaccines to assure their quality, safety and efficacy has been a WHO mandate and a core function for more than 70 years. New initiatives are ongoing at WHO to arrive at a broad consensus to formulate international guidance on the manufacture and quality control, as well as nonclinical and clinical evaluation of mRNA vaccines, which is deemed necessary to facilitate international convergence of manufacturing and regulatory practices and provide support to National Regulatory Authorities in WHO member states.
About Me
Position: Scientist, Technical Standards and Specifications Unit; Group Lead, Norms and Standards for Biologicals; Health Product Policy and Standards Department (HPS); Access to Medicines and Health Products Division (MHP); World Health Organization (WHO), Switzerland.
Dr Knezevic is Specialist in Medical Microbiology and Parasitology. She received her MD from the University of Novi Sad, MSc in Medicine (Microbiology) and PhD in Medicine (Virology) from the University of Belgrade, Republic of Serbia. Dr Ivana Knezevic has 28 years of professional experience in standardization, scientific and regulatory overview of biologicals.
Dr Knezevic joined WHO Biological Standardization Programme in September 2000. Since 2006, she has been leading the team for standardization of vaccines and biological therapeutics in WHO Headquarters. Main aspects of the work include development and establishment of WHO International Standards as well as the assistance to regulators, manufacturers, academia and other users of these standards. Dr Knezevic initiated numerous scientific projects of importance for global public health with colleagues from WHO Collaborating Centers and other Institutions in the world.
Dr Knezevic is the author of publications that made broad audience aware of WHO initiatives in the area of vaccines, biotherapeutics and cell & gene therapy products. She is also contributing to the peer-review scientific journals with the international reputation.