Assessing vaccines against other epidemic, pandemic threats

The Coalition for Epidemic Preparedness Innovations (CEPI), yesterday, announced plans to expand its COVID-19 vaccine-testing network to also assess the development of vaccines against other epidemic and pandemic diseases.

CEPI, in a statement, said this network is the largest global group using the same methods and materials, like reagents— substances used to carry out a scientific test—to standardise the evaluation of infectious disease vaccines currently undergoing preclinical and clinical trials.

This expanded network is set to also now assess candidate vaccines being developed against CEPI’s priority diseases – Chikungunya, Lassa fever, Middle East Respiratory Syndrome (MERS), Nipah, Rift Valley fever, and Disease X.

CEPI is currently supporting the development of multiple vaccines against these high-risk pathogens, identified on the World Health Organisation (WHO) Research and Development (R&D) Blueprint as having epidemic potential or as a major public health risk, as part of its $3.5 billion plan to minimise or even eradicate future deadly disease threats.

Providing the tools to harmonise the assessment of epidemic and pandemic vaccines will allow researchers and regulators to evaluate the most promising vaccine candidates quickly and accurately – a key part of the process needed to support CEPI’s ambitious goal to reduce the vaccine development timeline to 100 days.

The extension of scope requires additional laboratories to join the centralised group, with CEPI, yesterday, opening a Call for Proposals to identify laboratories worldwide able to assess these vaccines undergoing clinical testing. CEPI is particularly eager to receive applications from laboratories capable of performing such testing in South America, Africa, and Oceania – regions where the centralised network does not currently have laboratories.

Director of Vaccine R&D at CEPI, Dr. Melanie Saville, said: “We have already seen multiple deadly disease outbreaks affecting populations over the twenty-first century – and we know that the next pandemic is not a case of ‘if’ but ‘when’.

“So, while we continue to tackle COVID-19, we must also make sure that vaccine developers working on other emerging infectious diseases with epidemic or pandemic potential have the same level of scientific research and resource available to them to best prepare for future outbreaks.

“This means building on what we’ve learned and created during this current crisis and extending our centralised labs network to also test against other known threats – and a potential future ‘Disease X’. Through this expansion, we can provide the resources to uniformly assess multiple vaccines under evaluation which could, in turn, speed up the development of future vaccine candidates.”

During the typical vaccine evaluation process, the immune response of each vaccine candidate under development is assessed using different tools and measurements at individual testing sites, allowing for variability in results. For example, there may be potential variation in the way in which different type of immune biomarkers, like antibodies and T-cells, are measured. Technical differences in how and where vaccine clinical trial samples are collected, transported, and stored can also occur, impacting the quality and usefulness of the data produced and making comparisons between measurements difficult.

By following the same protocols and using the same biological reagents, laboratories within CEPI’s centralised network can instead ensure uniformity in the assessment of different vaccine candidates.

CEPI’s centralised laboratory network first opened to all COVID-19 vaccine developers—both CEPI- funded and non-CEPI-funded—free of charge, in October 2020, for the analysis of COVID-19 vaccine clinical trial samples, up to Phase III studies.

Laboratories already part of this group are located in Bangladesh, Canada, China, India, Italy, Mexico, the Netherlands, UK, and USA. To date, over 30 COVID-19 vaccine developers have now used the service, with more than 15,000 clinical trial samples submitted for testing.

Data obtained from the tests performed by laboratories currently in the network are being used to inform COVID-19 vaccine developers as to whether their candidate could advance to later-stage clinical trials and could also guide regulatory decisions. Results are also being used to guide investments made around the CEPI COVID-19 vaccine portfolio by providing quick and accurate evaluation of its candidate vaccines. The same principles will apply to the expanded network testing clinical trial samples against other emerging infectious diseases.

Since July 2021, some laboratories within the current network have started assessing and harmonising incoming data on the performance of multiple COVID-19 vaccines against identified variants of concern – Alpha, Beta, Gamma, and Delta.

CEPI has, to date, provided up to US $17.5 million in funding to support the running of the current network. Additional funding will be made available to support the expansion of the network.

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19, CEPI’s work focused on developing vaccines against the Ebola Virus Disease, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus. It has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale, and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19, as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation of these vaccines worldwide through COVAX.

CEPI’s five-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a broadly protective vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens.