The Coalition for Epidemic Preparedness Innovations (CEPI) has announced a central global network of laboratories to assess and compare immunological responses generated by the Covid-19 vaccine candidates.

And to establish this global vaccine-assessment network, CEPI has announced partnerships with five clinical sample testing laboratories that included India’s Translational Health Sciences and Technological Institute (THSTI).

The other labs initially selected include, Nexelis (Canada) and Public Health England (PHE, UK), VisMederi Srl (Italy), Viroclinics-DDL (The Netherlands) and icddr,b (Attn: it is in lower case) (formerly International Centre for Diarrhoeal Disease Research, Bangladesh), a note from CEPI said.

The network will use the same testing reagents originating in the labs of Nexelis and PHE and follow common protocols to measure the immunogenicity of multiple Covid-19 vaccine candidates (both CEPI-funded and non-CEPI funded developers).

This approach will ensure uniformity in assessment and informed identification of the most promising vaccine candidates. CEPI is actively negotiating with additional laboratories to participate in this network, it added.

Over 320 vaccine candidates against Covid-19 in development

Outlining the advantages of centralising immunological response assessment, CEPI said, “the immunogenicity of potential candidate vaccines is assessed through individual laboratory analyses, aiming to determine whether biomarkers of immune response—such as antibodies and T-cell responses—are produced after clinical trial volunteers receive a dose(s) of a vaccine candidate. However, with over 320 vaccine candidates against Covid-19 currently in development, there are likely to be numerous differences in data collection and evaluation methods.”

Further, CEPI pointed out that, “Technical differences in how and where samples are collected, transported and stored can also occur, impacting the quality and usefulness of the data produced and making comparisons between measurements in individual laboratories difficult.” In addition, with the wide range of Covid-19 vaccine approaches and technologies currently being deployed (eg, recombinant viral vectors, live attenuated vaccines, recombinant proteins and nucleic acids), standard evaluation of the true potential of these vaccine formulations becomes very complex, it added.

Through centralising the analysis of samples obtained from trials of Covid-19 vaccine candidates, the new clinical-sample-testing network will minimise variation in results obtained, which could otherwise arise due to such technical differences when carrying out independent analysis. “The samples from participating vaccine developers will instead be tested in the same group of laboratories using the same methods, therefore, removing much of the inter-laboratory variability and allowing for head-to-head comparisons of immune responses induced by multiple vaccine candidates,” CEPI explained.

By opening the sample testing network to other Covid-19 vaccine programmes, CEPI also aims to ensure that all eligible developers—regardless of their size—can benefit from this analysis. “Encouraging data is now emerging on multiple Covid-19 vaccine candidates, however, there is no way to draw direct comparisons, as different labs may use different measurements to infer immune response,” said Dr Richard Hatchett, CEPI Chief Executive Officer.

Representing the Indian partner to the laboratory network, Dr Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC), said, “The bioassay laboratory at THSTI, an autonomous institute of DBT, is being supported by the Ind-CEPI mission of the Indian government, to provide validated assays for vaccine development at par with global standards.”The lab was well-positioned to run comparability studies with other laboratories both nationally and internationally and will form an important part of the global network of centralised laboratories being supported by CEPI, she added.