• Project will improve understanding of natural infection, its protective effect ahead of vaccine trials, says NCDC
The Coalition for Epidemic Preparedness Innovations (CEPI) on Tuesday announced funding of up to US$375,000 to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the UK Health Safety Agency. (UKHSA) to support key laboratory development of tools to advance and standardize the evaluation of vaccines used to protect against monkeypox, including currently approved smallpox vaccines.
Monkeypox has been declared a public health emergency of international concern by the Director General of the World Health Organization (WHO), Dr Tedros Adhanom Ghebreyesus, following a second meeting of the Health Regulations Emergency Committee International (2005) (RSI). Over 16,000 cases have been reported worldwide to date, including changes in the epidemiology of monkeypox in previously endemic countries.
The tools that CEPI is supporting in development are: Assays, with UKHSA, to test for the presence of specific antibodies – indicative of an immune response to Monkeypox – following natural infection or vaccination; and A reference antibody standard, with the UK MHRA, to harmonize how different laboratories assess the strength and duration of immune responses generated by current and developing vaccines against Monkeypox.
The tools will be made freely available to the global scientific community, excluding administration costs, to provide a common standardized assessment between laboratories in different countries documenting Monkeypox vaccine performance. The data generated from their use will help inform current vaccine development and deployment strategies, while supporting the development and evaluation of Monkeypox diagnostics.
The Director General of the Nigerian Center for Disease Control (NCDC), Dr Ifedayo Adetifa, who recently attended the CEPI Joint Coordinating Group meeting to discuss the progress of Monkeypox vaccine research, welcomed the announcement and said, “The lack of validated antibody testing has been a barrier to assessing cumulative population exposure to Monkeypox virus in our setting. These tests will now also improve our understanding of natural infection and its protective effect ahead of vaccine trials. NCDC looks forward to building on existing collaborations with UKHSA and CEPI to fill this long-standing gap.
In addition to data collected from the use of a Monkeypox antibody standard and testing, further data still needs to be collected and analyzed by WHO and other global partners to better advise and inform the response. world. These include determining whether the virus has evolved to become more transmissible and the severity of symptoms and illness in those infected.
In its role as funder and facilitator of outbreak response, CEPI has worked with WHO and partners to explore and support additional research and development (R&D) activities needed to advance the development of the Monkeypox vaccine. and allow equitable access to them.
The announcement follows the release of a series of interim recommendations from the WHO Director-General, as well as discussions held last month at the CEPI Joint Coordinating Group meeting. Both identify the need for further research on the use of existing vaccines to equitably protect against monkeypox, with participants in the joint coordination group meeting raising and endorsing the need for a standard and trials of antibodies against monkeypox.
CEPI’s dedicated funding is part of the “Transform” pillar of CEPI’s $3.5 billion pandemic preparedness plan, which aims to invest and scale critical programs to further accelerate development and deployment of vaccines.
CEPI’s Chief Executive Officer (CEO), Dr Richard Hatchett, said: “The recent spread of Monkeypox in several non-endemic regions is a stark reminder of our interconnected world and the threat emerging infectious diseases pose to our health and society. . .
“Its global impact compels us to explore whether existing countermeasures, such as currently stockpiled smallpox vaccines, will be sufficient to combat the spread of human Monkeypox, and to ensure that tools to support the range of potential developers are available. CEPI’s core mission is to ensure equitable access to needed vaccines and it is essential to avoid the global equity issues that have hampered the response to COVID-19.
“When new outbreaks of emerging infectious diseases occur, CEPI seeks to take early action to advance science, while deciding whether additional vaccines will be needed. Our funding announced today will support laboratory research, led by the UK’s MHRA and UKHSA, to create essential tools that the WHO and others can use to assess current and future vaccines, and will increase our knowledge of the performance of vaccines against this worrying disease. Ensuring that antibody tests and standards are available for international use will amplify research efforts worldwide.
Vaccines against monkeypox are already licensed in some countries, including the United States and Canada, under the development and licensing of a vaccine against the closely related pathogen, smallpox, due to substantial and sustained previous investments in smallpox R&D. However, more data is needed to confirm the extent to which they provide sufficient protection in human populations currently facing current circulating strains of Monkeypox.
The development of tests allows laboratory scientists to determine whether or not a vaccine has generated an immune response, by detecting the presence of antibodies in serum samples from participants who have either received a vaccine under development (that is i.e. in a clinical trial) or an approved vaccine.
An antibody standard would then be used to compare whether this antibody response provides a sufficient level of protection against the current circulating Monkeypox strain.
To create the antibody standard, serum samples from individuals infected in the current Monkeypox outbreak and recovered from the disease will be collected and assessed by the UK MHRA.
Samples with the highest antibody levels will be pooled together to create the standard. Samples from vaccinated individuals can then be compared to the standard (acting as a comparator antibody) to allow researchers to better document and assess vaccine performance.
UKHSA’s Chief Scientific Adviser, Dr Isabel Oliver, said: “UKHSA’s cutting-edge scientific expertise in developing rapid tests and interventions for emerging diseases is proven, and with CEPI, we are particularly well placed to lead the development of a new Monkeypox test. .
“Accurate testing and robust surveillance are essential to help us monitor the impact of vaccines and inform public health policy, controlling the transmission of any virus.
“International cooperation is crucial to developing key tools that work to protect us all. We welcome continued cooperation with academic and pharmaceutical partners to accelerate progress towards safe and effective interventions to limit the impact of Monkeypox infection as quickly as possible.
MHRA Director of Science and Innovation, Dr Marc Bailey, added: “We are very pleased to be collaborating with CEPI to develop these key reagents to assess the immune response to infection and Monkeypox vaccination, a crucial step in maintaining consistent standards in vaccine development by many organizations around the world.
“This work builds on our successful partnership with CEPI and UKHSA to produce gold standard antibody standards for the standardization and harmonization of tests that diagnose infection and measure vaccine performance. This partnership has provided an important platform through which the international health system can respond quickly to emerging threats to global public health.