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CEPI Expands Global Footprint of Its COVID- 19 Vaccine Lab Network

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The Coalition for Epidemic Preparedness Innovations, or CEPI, will expand its centralised laboratory network—a global initiative to harmonise the assessment of COVID-19 vaccine candidates undergoing testing—to also evaluate clinical trial samples against priority Variants of Concern. From July, all COVID-19 vaccine developers will be invited to test performance of their vaccines, including those already being rolled out around the world, against B.1.1.7, first identified in the UK, P.1, first identified in Brazil, B.1.351, first identified in South Africa, as well as early circulating SARS-CoV-2 strains.

To support this extended vaccine testing, CEPI has also signed an agreement to collaborate with two laboratories that are part of the Universidad Nacional Autónoma de México (UNAM) in Mexico City, the Unidad de Investigación Preclínica (UNIPREC), and the Laboratorio de Análisis de Moléculas y Medicamentos Biotecnológicos (LAMMB), becoming the ninth and tenth sample testing laboratories to join the global network. An additional US$1.5 million is being provided by CEPI to support the variant testing, taking the total funding for the vaccine assessment work to $17.5 million. The ongoing effort is part of CEPI’s $3.5 billion plan, announced in March 2021, to mitigate the immediate threat of COVID- 19 and its variants, while also looking to the long-term, advancing countermeasures and networks to dramatically reduce or even eliminate future pandemics and epidemics.

“As the devastating COVID-19 virus has continued to rapidly spread around the world, we have come to observe significant mutations in its genetic make-up which have impacted levels of viral transmissibility, the risk of re-infection, and vaccine immunity,” said Dr. Melanie Saville, Director of Vaccine R&D at CEPI.

“We need to make sure that the candidates currently undergoing COVID-19 vaccine clinical testing are not only protective against earlier SARS-CoV-2 strains, but also emerging variants. CEPI’s expanded centralised laboratory network is set to play a crucial role in providing extended data on vaccine performance against these new strains to inform both the development of candidate vaccines currently in clinical trials, as well as the vaccines already being rolled out around the world. At the same time, the network will keep to its initial goal offering uniform assessment across multiple vaccine candidates.”

Providing uniform assessment of COVID-19 vaccine candidates

Launched in October, 2020, CEPI’s centralised laboratory network opened worldwide to COVID-19 vaccine developers, free of charge1, to minimise variation in results documenting the performance of COVID-19 vaccine candidates undergoing preclinical and clinical trials (up to Phase II).

In typical vaccine evaluation, the immunogenicity of vaccine candidates is assessed through individual laboratories measuring biomarkers of immune response, like antibodies and T-cell responses, in the clinical trial samples provided. However, with the potential widespread variation in the range of correlates of immunity being measured by laboratories, technical differences in how and where samples were collected, transported, and stored, and a wide range of COVID-19 vaccine approaches being deployed (e.g., recombinant viral vectors, live attenuated vaccines, recombinant proteins, and nucleic acids), comparative assessment of COVID-19 vaccines in clinical trials can be complex and challenging.

Through centralising the analysis to a group of selected laboratories worldwide2—now also including Universidad Nacional Autónoma de México (UNAM) in Mexico—samples obtained from trials of COVID-19 vaccine candidates are instead tested by the same group of laboratories using the same methods and key reagents (i.e., substances used to carry out a laboratory test), therefore removing much of the inter-laboratory variability and allowing for head-to-head comparisons of multiple vaccine candidates.

To date, over 20 COVID-19 vaccine developers have now used the service, with 6,000 clinical trial samples submitted for testing.

Dr. William Lee, Vice-President for Scientific Research at UNAM, expressed UNAM’s enthusiasm and commitment in joining CEPI and contributing to the Coalition. “As the first laboratory of the network in Latin America, it is particularly relevant regionally, and will allow the development of capabilities that are crucial to face the COVID-19 pandemic in particular, and to have greater preparedness and resilience when facing epidemics in the future in general.”

Staying one step ahead of SARS-CoV-2 variants

In the following months, CEPI will expand its testing service and use an optimised vaccine test (known as an ‘assay’) to measure immunogenicity against B.1.1.7, P.1., and B.1.351 variants. Some of the network laboratories with high levels of biosecurity, will also receive new virus stocks and updated protocols to guide them on the implementation of such tests.

The aim of the expanded testing programme is to harmonise incoming data on the performance of multiple vaccines against emerging SARS-CoV-2 variants. It will also inform vaccine developers as to whether their candidate is protective against multiple variants and could advance to later-stage clinical trials. Data provided by the network could also be used to guide regulatory decisions.

If additional Variants of Concern emerge or existing variants are prioritised for observation, CEPI’s centralised laboratory network may also work with its partners to further update the vaccine assays being used by the laboratories to ensure COVID-19 vaccine candidates can be tested against other identified strains.