18 Nov 2020
18 November 2020, Oslo, Norway – To rapidly monitor the emergence of new COVID-19 viral strains and evaluate their impact on vaccine candidates in development, CEPI, the Coalition for Epidemic Preparedness Innovations, has today announced the launch of a first-of-its-kind collaboration with the GISAID Initiative, Public Health England (PHE) and the National Institute for Biological Standards and Control (NIBSC) to further strengthen real-time global tracking and testing of SARS-CoV-2 sequences– the virus behind COVID-19. The announcement follows recent attention to a mutant strain of the virus detected in mink and human populations in Denmark.
Chief Executive Officer, CEPI
As part of the new cross-cutting taskforce, CEPI will strengthen the work of GISAID, a global science initiative and the primary source of virological data of SARS-CoV-2 virus. GISAID is an essential component of COVID-19 R&D that enables real-time progress in the understanding of the geographical spread, circulation, and evolution of the SARS-CoV-2 virus and the new COVID-19 disease it causes.
Since the first SARS-CoV-2 viral genomes were shared via GISAID on 10 January 2020, over 200,000 SARS-CoV-2 viral sequences have since been made available with unprecedented speed on its publicly accessible platform. CEPI’s support will bolster GISAID’s global operations to meet growing user demands and technical enhancements to facilitate not only data submission, but also the enablement of solutions to strengthen reporting by public health laboratories.
GISAID will produce for CEPI regular reports on genomic diversity which will be openly shared by CEPI, to support analyses on the diversity of the spike protein sequence—a key target for COVID-19 vaccine development. Tracking viral mutations and diversity is important to ensure current COVID-19 vaccine candidates can be tested against circulating strains of the virus.
If a newly emerging SARS-CoV-2 strain with a potentially significant sequence mutation is reported by GISAID, CEPI will inform its two laboratory partners, Public Health England (PHE) and the National Institute for Biological Standards and Control (NIBSC), both based in the UK. The laboratories will be asked to conduct tests, known as neutralisation assays, on laboratory-grown stocks of the new viral strain to determine whether, compared to current SARS-CoV-2 strains, antibodies are still able to effectively respond to (‘neutralise’) the new strain.
The neutralisation tests will be performed using the NIBSC’s antibody standard. Developed with CEPI-support, the NIBSC antibody standard is a pool of samples from patients who have been infected and recovered from SARS-CoV-2 infection, and is currently in use by R&D partners worldwide. Both laboratories will conduct the tests to confirm the reliability of results.
Should the tests detect changes in the ability for antibodies to neutralise the new SARS-CoV-2 viral strain, preclinical testing will then be performed to evaluate whether there are any changes in pathogenesis (disease progression) and virulence (severity of infection) associated with the new strain. Findings will be immediately communicated to the global research community via the World Health Organization (WHO) and CEPI networks. As a result, the rapid sharing of key data should help guide vaccine developers to determine if their vaccine candidates are protective against current circulating strains of SARS-CoV-2.
WHO Chief Scientist
Scientific Leader, Public Health England
Chief Science and Innovation Officer, Medicines and Healthcare products Regulatory Agency
This new collaboration extends CEPI’s existing partnerships with PHE and the NIBSC, which are also part of CEPI’s centralised laboratory network to standardise the assessment of COVID-19 vaccine candidates undergoing clinical testing.
A total of US $1.3 million in funding will be provided by CEPI to GISAID to enhance their global operations. Up to an additional US $1.3 million funding will also be provided to PHE and the NIBSC to carry out the neutralisation tests to provide information on the effectiveness of vaccine candidates in development against newly circulating SARS-CoV-2 strains.
About CEPI’s partnership with GISAID
CEPI has entered into an implementing partnering agreement with the GISAID initiative. GISAID is a global science initiative and the primary source of virological data of the emerging coronavirus, making it an essential component of COVID-19 R&D. The success of GISAID’s unique sharing mechanism for the rapid release of data incentivises data generators to rapidly share their viral genomes and related clinical and epidemiological data, such as geography, species, and timeframe, to advance scientific collaboration.
CEPI’s funding will bolster GISAID’s global operations to meet growing user community demands and technical enhancements to facilitate not only data submission but the enablement of solutions to strengthen reporting by public health laboratories. The CEPI-GISAID partnership will also support grassroots capacity building on the African continent to close gaps strengthen local research capacity, to monitor the spread and the evolution of the coronavirus.
GISAID will produce for CEPI regular reports on genomic diversity which will be openly shared by CEPI to support analyses on the diversity of the spike protein sequence—a key target for COVID-19 vaccine development—and inform the active management of CEPI’s COVID-19 vaccine portfolio and ensure all can benefit from the detection of any new coronavirus strains. Since the beginning of the outbreak, GISAID also provides WHO and public health authorities real-time analyses updates of the viral genome.
In addition, the partnering agreement will also support GISAID staff and advisors working on a new data sharing application which is already undergoing development and will include enhanced functionalities, such as virus strain trend reporting and evaluation of new mutations to allow for the evolution of pathogens closely. GISAID’s new application will be pathogen agnostic and adaptable to pathogens for example those addressed by the WHO R&D Blueprint.
About CEPI’s partnership with Public Health England and the National Institute for Biological Standards and Control (NIBSC)
Once newly emerging SARS-CoV-2 strains are identified for further investigation, PHE will coordinate laboratory work conducted in parallel at PHE and NIBSC. The parallel testing will ensure inter-laboratory results reliability and use of robust methods. The virus will be propagated (grown) at the laboratories using best practice and will be sequenced to ensure stability and quality. This viral stock will be available for sharing to advance global R&D. The virus will then be tested to compare the extent to which an antibody standard can neutralise the new variant compared with earlier SARS-CoV-2 strains. This will give early information on a possible impact on vaccine development. Findings (e.g. any changes in neutralisation, virulence, or pathology) will be immediately communicated to the global community via WHO and COVAX working groups, and CEPI networks.
The NIBSC antibody standard has been submitted for review by the WHO Expert Committee on Biological Standardization (ECBS), in early December, as a candidate for the WHO International Standard for anti-SARS-CoV-2 Antibody.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated nine partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.
Before the emergence of COVID-19, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).
An additional US $800m is needed to support CEPI’s COVID-19 programmes. For investor enquiries, please email [email protected]. See more on www.cepi.net. Follow us on Twitter and LinkedIn for the latest updates.
About CEPI’s COVID-19 vaccine programmes
Built on the principles of speed, scale and equitable access, CEPI is supporting the research and development of a diverse portfolio of vaccine candidates based on a range of vaccine approaches. Of the nine vaccine candidates currently in the CEPI portfolio – the world’s largest – eight have entered clinical trials.
Alongside Gavi and the World Health Organization (WHO), CEPI also co-leads the vaccines pillar of the ACT Accelerator, COVAX, which is working to accelerate research and development for promising vaccine candidates, manufacture doses at scale, and ensure rapid global access. CEPI has raised US $1.3bn in support of COVID-19 vaccine R&D, but urgently needs US $800m in additional funds to achieve its aim of developing three safe and effective vaccines which will be made globally available through COVAX.
About GISAID Initiative
GISAID was originally launched in 2008 as the global initiative on sharing all influenza data, because access to the latest genetic data for highly pathogenic H5N1 influenza zoonotic infections was often restricted. GISAID involves public-private-partnerships with governments around the world including Brazil, Germany, Singapore and United States. GISAID is also an essential asset for the WHO Global Influenza Surveillance and Response System (GISRS) and for post-regulatory quality control of manufacturer seed viruses relative to candidate vaccine viruses.
GISAID is a key player in global health security and crucial for pandemic preparedness of the global community, as evident in the early response to the 2009 influenza pandemic and to emerging threat of H7N9 bird flu in China 2013. Health Ministers of the G20 nations recognized the importance of GISAID in 2017.
About Public Health England (PHE)
PHE exists to protect and improve the nation’s health and wellbeing and reduce health inequalities. It does this through world-leading science, research, knowledge and intelligence, advocacy, partnerships and the delivery of specialist public health services. PHE is an operationally autonomous executive agency of the Department of Health. It provides government, local government, the NHS, Parliament, industry and the public with evidence-based professional, scientific and delivery expertise and support. For more information on PHE visit www.gov.uk/phe or follow on Twitter @PHE_uk.
About the National Institute for Biological Standards and Control (NIBSC)
The National Institute for Biological Standards and Control (NIBSC) is a centre of the Medicines and Healthcare products Regulatory Agency. The institute plays a major national and international role in assuring the quality of biological medicines. The NIBSC is the leading producer and distributor of WHO International Standards and biological reference materials, supplying over 90% of International Standards used worldwide. The NIBSC also acts as the UK’s Official Medicines Control Laboratory and conducts independent batch release testing of biological medicines.
In addition to its standardisation and control activities, the NIBSC hosts several expert research and resource centres. The institute is a WHO Collaborating Centre for Reference and Research on Poliomyelitis and a WHO Essential Regulatory Laboratory for Influenza. The NIBSC is also home to the UK Stem Cell Bank and the Centre for AIDS Reagents.
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