The Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership to develop vaccines against emerging infectious diseases, has partnered with the Faridabad-based Translational Health Sciences and Research Institute (THSTI) as one of the five laboratories that will create a global network for reliably assessing all vaccines against the coronavirus disease (Covid-19).
“THSTI Faridabad recognised under the global network of laboratories established by CEPIvaccines to centralise assessment. The laboratory supported under DBTIndia and IndCEPI. Very important to assess multiple vaccines,” said department of biotechnology secretary Dr Renu Swarup in a tweet. The department has encouraged Indian Covid-19 vaccine developers to partner with THSTI.
The other four laboratories include Nexelis (Canada) and Public Health England (UK), VisMederi Srl (Italy), Viroclinics-DDL (Netherlands), and the International Centre for Diarrhoeal Disease research (Bangladesh).
The network will use the same reagents – from the labs of Nexelis and PHE – and follow common protocols to measure the immune response generated by multiple vaccine candidates, including the ones that are not being funded by CEPI. According to the organisation, the network will ensure uniformity in assessment across candidate helping in identifying the most promising one.
Currently, there are over 320 vaccine candidates in development across the world, with about 30 just from India. Two vaccines developed by India biotech companies and government institutes have already entered phase II human trials.
For vaccine development, pre-clinical trials are done in animals to see whether a candidate is safe and able to protect against the disease. In humans, a small phase I trial is done to assess the safety of the vaccine candidate, a phase II trial is done to see whether it produces an immune response, and a large phase III study assess whether it protects against the infection in field trial.
Usually, the tests to see whether an immune response is produced – measured through antibody levels or T-cell response – after a person is vaccinated is done by individual laboratories selected by the vaccine makers. However, this is likely to produce varied data collection and evaluation methods for all the vaccine candidates, making it difficult to compare them.
“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,” according to the CEPI website.
The vaccine manufacturers can use the network without per sample charges up to the limit of funding available to the programme. For eligibility, certain commitments would be needed from vaccine manufacturers such as timely publication of sample testing results and sharing the immunogenicity data for future regulatory decisions.