New investment in monkeypox vaccine assessment tools

By Rachel Arthur

- Last updated on GMT


Related tags Monkeypox smallpox vaccine Smallpox assays Mhra Uk CEPI

The Coalition for Epidemic Preparedness Innovations (CEPI) will provide funding of up to $375,000 to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Health Security Agency (UKHSA) to support the development of laboratory tools to assess monkeypox vaccines.

Such tools will standardize the assessment of monkeypox vaccines: helping advance development as well as informing public health agencies of the best deployment strategies.

The funding will go towards developing assays to test for the presence of specific antibodies — indicative of an immune response to monkeypox — following either natural infection or vaccination.

It will also help create a reference antibody standard to harmonize how different laboratories assess the strength and duration of immune responses generated vaccines.

The tools – which can be used for new candidates as well as existing smallpox vaccines – will be made freely available (excluding admin fees) to the global scientific community to provide a common standardized assessment in laboratories across different countries. Data generated from their use will help to inform current vaccine development and deployment strategies.

Monkeypox has been declared a Public Health Emergency of International Concern by the World Health Organization. Over 16,000 cases have been reported worldwide to date, including changes in epidemiology in previously endemic countries.

Testing and comparing Monkeypox immune responses

Vaccines against monkeypox are already licensed in some countries; alongside those with licensure for the closely related smallpox pathogen.

Estimates from the 1980s suggest 85% efficacy of smallpox vaccines against monkeypox, but CEPI notes that more data needs to be gathered from the current circulating strains of monkeypox to assess their effectiveness today.

“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 (ie, in a clinical trial) or an approved vaccine,” ​notes the organization.

“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.”

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

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