Coronavirus disease (COVID-19)
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, SARS-CoV-2. Coronaviruses are a large family of viruses which may cause illness in animals or humans. In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), and the most recent coronavirus disease COVID-19. WHO Director-General declared that the outbreak constitutes a Public Health Emergency of International Concern (PHEIC) on 30 January 2020 and a Pandemic on 11 March 2020.
Learn more about coronavirus disease (COVID-2019)
COVID-19 vaccines
To fast respond the COVID-19 pandemic, a broad range of candidate COVID-19 vaccines are being investigated using various technologies and platforms including: viral-vectored, protein subunit, nucleic acid (DNA, RNA), live attenuated and inactivated vaccines with some entered clinical trials. For up-to-date information of the landscape of candidate COVID-19 vaccines, please consult WHO Blueprint website.
COVID-19 vaccine standardization
Written standards
WHO secretariat has reviewed and published a list of existing WHO guidance documents adopted by the WHO Expert Committee on Biological Standardization (ECBS) and published in the Technical Report Series that are relevant to the development, production and evaluation of COVID-19 vaccines. The listing explains how current WHO written standards may provide useful guidance and information for the development, production and evaluation of candidate COVID-19 vaccines. The list is not exhaustive but focuses on evaluation of quality, safety and efficacy of vaccines. Some WHO guidelines may also be applicable for other COVID-19 interventions such as biological therapeutic products (e.g. antibodies). Details regarding the applicability of existing WHO documents for various types of vaccines such as Ebola, RSV, etc. are provided to assist national regulatory authorities and manufacturers of vaccines and other biologicals. In particular, ECBS has adopted the revised WHO Guidelines for assuring the quality, safety, and efficacy of plasmid DNA vaccines at its 71st meeting during 24-28 August 2020, which will be useful for development and evaluation of COVID-19 vaccines based on DNA technology.
Relevant WHO documents for SARS-CoV-2 vaccines and other biologicals
Measurement standards
Accurate tests are key to ensuring generating accurate data for studying COVID-19 disease and interventions. Currently a variety of molecular and serological assays are in use in worldwide settings for detection of SARS-CoV-2 infection and for measurement of antibody response to SARS-CoV-2 infection and to COVID-19 vaccines. In support of the global response to COVID-19, WHO has highlighted the importance of the availability of International Standards and/or reference reagents for anti-SARS-CoV-2 antibody and for SARS-CoV-2 RNA. The availability of International Standards will facilitate development, validation and assessment of the assays and allow for comparability of results from different assays, thus eventually facilitate and harmonize evaluation of diagnostics, vaccines, therapeutics and other products.
The WHO collaborating center for biological standardization, National Institute for Biological Standards and Control (NIBSC), UK, is leading the projects listed below with the support of other WHO Collaborating Centers and worldwide laboratories.
- Development of the 1st WHO International Standard and Reference Panel for anti-SARS-CoV-2 antibody
Vaccines and treatments for COVID-19 are rapidly being developed and reliable assays are needed for their evaluation. The availability of an International Standard for antibodies to SARS-CoV-2 would facilitate the standardization of SARS-CoV-2 serological methods and allow for comparison and harmonization of datasets across laboratories. This will help determine the antibody levels that are needed for efficacious vaccines and therapeutics, and improve our understanding of virus epidemiology. An international collaborative study has been completed in 2020 to evaluate a pool of convalescent plasma from COVID-19 recovered patients as a candidate international standard, and to assess whether the candidate material is able to harmonize the results from serological assays detecting anti-SARS-CoV-2 antibodies. Also, as part of the study, a candidate International Reference Panel for anti-SARS-CoV-2 antibody was characterized with the aim to facilitate the development and evaluation of serological assays. The collaborative study report is available here. This project has been supported by the Coalition for Epidemic Preparedness Innovations (CEPI).
At the 73rd meeting of the WHO ECBS held on 9 and 10 December 2020, the First WHO International Standard of anti-SARS-CoV-2 immunoglobulin was established by the Committee, with assigned unitage of 250 IU/ampoule (neutralizing antibody activity); the First WHO International Reference Panel of anti-SARS-CoV-2 immunoglobulin was established with no assigned units.
- Development of the 1st WHO International Standard for SARS-CoV-2 RNA
The intended use of the International Standard is for the calibration and control of nucleic acid amplification techniques (NAT), which are considered the gold standard method for accurate diagnosis of infection. An international collaborative study to evaluate the ability of candidate materials to harmonize the potencies of a panel of SARS-CoV-2 RNA samples between different laboratories has been completed. The collaborative study report is available here.
At the 73rd meeting of the WHO ECBS held on 9 and 10 December 2020, the First WHO International Standard of SARS-CoV-2 RNA for NAT-based assays was established by the Committee, with assigned unitage of 7.40 log10 IU/ampoule.
The above standards can be ordered from WHO custodian laboratory at the National Institute for Biological Standards and Control in UK, through this Link, with products details below:
- First WHO International Standard for anti-SARS-CoV-2 immunoglobulin (human), NIBSC code: 20/136.
- First WHO International Reference Panel for anti-SARS-CoV-2 immunoglobulin, NIBSC code: 20/268.
- First WHO International Standard for SARS-CoV-2 RNA, NIBSC code: 20/146.
More Coronavirus (COVID-19)-related research reagents are available from the NIBSC.
The 73rd ECBS meeting also endorsed a proposal to develop a standard for SARS-CoV-2 antigens to support the development, assessment and comparability of antigen-based rapid diagnostic tests.
More information about ECBS meetings including Executive Summary and reports from collaborative studies are available at: https://www.who.int/groups/expert-committee-on-biological-standardization.