CEPI, UK MHRA, UK Health Security Agency advance laboratory tools, vaccines for Monkeypox

•Project will enhance 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 United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Health Security Agency (UKHSA) to support the development of key laboratory tools to advance and standardise assessment of vaccines used to protect against Monkeypox, including the currently approved Smallpox vaccines.

Monkeypox has been declared a Public Health Emergency of International Concern by the World Health Organisation (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, following a second meeting of the International Health Regulations (2005) (IHR) Emergency Committee. Over 16,000 cases have been reported worldwide to date, including changes in Monkeypox epidemiology in previously endemic countries.

The tools CEPI is supporting the development of are: Assays, with the UKHSA, to test for the presence of specific antibodies—indicative of an immune response to Monkeypox—following either natural infection or vaccination; and A reference antibody standard, with the UK MHRA, to harmonise how different laboratories assess the strength and duration of immune responses generated by current vaccines and those in development against Monkeypox.

The tools will be made freely available—excluding admin fees—to the global scientific community to provide a common standardised assessment between laboratories in different countries documenting vaccine performance against Monkeypox. Data generated from their use will help to inform current vaccine development and deployment strategies, while also supporting the development and evaluation of Monkeypox diagnostics.

Director-General, Nigeria Centre for Disease Control (NCDC), Dr. Ifedayo Adetifa, who recently attended CEPI’s Joint Coordination Group meeting to discuss advancing Monkeypox vaccine research, welcomed the announcement, said: “The absence of validated antibody assays has been a significant impediment to assessing the population cumulative exposure to Monkeypox virus in our setting. These assays will now also enhance our understanding of natural infection and its protective effect ahead of vaccine trials. The NCDC looks forward to building on existing collaborations with the UKHSA and CEPI to address this long-standing gap.”

In addition to the data collected from the use of a Monkeypox antibody standard and assays, further data still needs to be collected and analysed by WHO and other global partners to best advise and inform the global response. This includes looking at whether the virus has evolved to become more transmissible and the severity of symptoms and illness in those infected.

In its role as an outbreak response funder and facilitator, CEPI has been working with WHO and partners to explore and support additional Research and Development (R&D) activities needed to advance Monkeypox vaccine development and enable equitable access to them.

The announcement follows the publication of a set of Temporary Recommendations from the WHO Director-General, as well as discussions held last month at CEPI’s Joint Coordination Group Meeting. Both identify the need for additional research into the use of existing vaccines to equitably protect against Monkeypox, with Joint Coordination Group meeting attendees raising and endorsing the need for a Monkeypox antibody standard and assays.

The dedicated CEPI funding forms part of the ‘Transform’ pillar of CEPI’s $3.5bn pandemic preparedness plan, which seeks to invest and scale critical enabling programmes to further accelerate vaccine development and deployment.

Chief Executive Officer (CEO) of CEPI, Dr. Richard Hatchett, said: “The recent spread of Monkeypox to multiple non-endemic regions serves as a stark reminder of our interconnected world and the threat that emerging infectious diseases pose to our health and society.

“Its global impact requires us to explore whether existing countermeasures, like currently stockpiled Smallpox vaccines, will be sufficient to address the further spread of human Monkeypox, and to ensure that tools to support the array of potential developers are available. Core to CEPI’s mission is to ensure equitable access to needed vaccines and it is critical to avoid global equity issues that beleaguered the COVID-19 response.

“When new emerging infectious disease outbreaks occur, CEPI seeks to take early actions to move the scientific field forward, while deciding whether additional vaccines will prove necessary. Our funding announced today will support lab research, conducted by the UK MHRA and UKHSA, to create critical tools that WHO and others can use to assess current and future vaccines, and will increase our knowledge on vaccine performance against this worrisome disease. Ensuring assays and antibody standards are available for international use will amplify research efforts worldwide.”

Vaccines against Monkeypox are already licensed in some countries including example, the US and Canada by virtue of the development and licensure of a vaccine against the closely related pathogen, Smallpox, due to substantial and sustained prior investment in Smallpox R&D. However, more data are needed to confirm the extent to which they provide sufficient protection in the human populations now encountering the current circulating strains of Monkeypox.

The development of assays allows laboratory scientists to determine whether or not a vaccine has generated an immune response, through detecting for the presence of antibodies in the serum samples of participants who have either received a vaccine undergoing development (that is, in a clinical trial) or an approved vaccine.

An antibody standard would then be used to compare whether that antibody response provides a sufficient level of protection against the current circulating Monkeypox strain.

To create the antibody standard, serum samples from individuals infected during the current Monkeypox outbreak and recovered from disease will be collected and assessed by UK MHRA.

Samples with the highest antibody levels will be pooled together to create the standard. Samples from vaccinated individuals can then be compared against the standard (acting as a comparator antibody) to allow researchers to better document and assess vaccine performance.

Chief Scientific Advisor at UKHSA, Dr. Isabel Oliver, said: “UKHSA’s world-leading scientific expertise in rapid assay development and interventions for emerging diseases are tried and tested, and with CEPI we are uniquely positioned to drive the development of a new Monkeypox assay.

“Accurate testing and strong surveillance is vital to help us monitor the impact of vaccines and inform public health policy, controlling the transmission of any virus.

“International co-operation is crucial in developing key tools that work to protect all of us. We welcome the continued cooperation with academic and pharmaceutical partners to accelerate progress towards safe and effective interventions to limit the impact of the Monkeypox infection as rapidly as possible.”

MHRA’s Chief Science and Innovation Officer, Dr. Marc Bailey, added: “We are very pleased to collaborate with CEPI to develop these key reagents to assess immune response to Monkeypox infection and vaccination, a crucial step in maintaining consistent standards in vaccine development by many organisations across the world.

“This work builds on our successful partnership with CEPI and UKHSA to produce reference antibody standards for the standardisation and harmonisation of assays that diagnose infection and measure vaccine performance. This partnership has provided an important platform through which the international health system can respond rapidly to new threats to global public health.”