The National Institute for Biological Standards and Control (NIBSC) will play a key role in evaluating vaccines that have been developed for COVID-19
Oct 20, Medicines and Healthcare products Regulatory Agency: We are delighted to announce that the National Institute for Biological Standards and Control (NIBSC) will play a key role in evaluating vaccines that have been developed for COVID-19.
The institute is one of seven partner laboratories that have been selected by CEPI (the Coalition for Epidemic Preparedness Innovations) to form a centralised laboratory to standardise the measurement of immune responses generated by multiple COVID-19 vaccine candidates. Samples from volunteers participating in phase I and phase II clinical trials will be tested in our labs as well as samples from preclinical studies.
Our scientists will be evaluating antibody responses and T-cell responses alongside other partner laboratories that are all using the same methods and biological reference materials. This will ensure that data are obtained in a consistent way so that the results for different vaccine candidates can be directly compared.
Additionally, as the world’s leading producer of biological reference materials, the NIBSC has received funding from CEPI to develop an International Standard for COVID-19 antibody. This will consist of a sample of the antibody with a defined amount of biological activity. It will act as the ‘gold standard’ that can be used by regulators and vaccine manufacturers all over the world to calibrate their own tests.
This work will be crucial - both for enabling the most promising vaccine candidates to be identified quickly and accurately and for determining the key procedures that are required to assure vaccine quality.
Dr Nicola Rose, Head of Virology at the NIBSC, said:
Standardisation of assays in vaccine development and more centralised measurement of vaccine responses is key for the robustness of the data obtained. The NIBSC is well placed to deliver this for the benefit of public health in the fight against the pandemic.
Dr Mark Page, Principal Scientist leading this work at the NIBSC adds:
This is an important initiative providing a service to vaccine developers globally and permits accurate evaluation of candidate vaccines for this pandemic.
Dr Melanie Saville, Director of Vaccine R&D at CEPI, further adds:
We are delighted that NIBSC will be joining CEPI’s centralised lab network for the standardised assessment of COVID-19 vaccine candidates. With our global group of testing laboratories now in place, samples from COVID-19 vaccine clinical trials can be shipped to one of seven sites around the world for uniform evaluation, allowing us to evaluate candidates in high quality assays and identify which vaccine candidates may be performing well, in terms of immune response, in clinical trials.
Health and Care Secretary Matt Hancock said:
The UK is leading the way in developing a safe and effective vaccine for COVID-19 which will be absolutely crucial to saving lives and starting our return to normality.
We have one of the best medical regulators in the world and I’m delighted the NIBSC will play a crucial role in developing international standards to help ensure all vaccines are of the highest quality, safety and effectiveness.