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Wednesday, December 25th, 2024

CEPI adds two labs to centralized effort to standardize COVID-19 vaccine assessment

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The National Institute for Biological Standards and Control (NIBSC) in the United Kingdom and Q2 Solutions in the United States became the latest labs to join the Coalition for Epidemic Preparedness Innovations’ (CEPI) centralized laboratory network for COVID-19 vaccines this week.

“We are delighted to bring the NIBSC and Q2 Solutions on board our centralised laboratories network to get a more accurate picture of which vaccine candidates have the best safety and immunogenicity profiles,” Valentina Bernasconi, Preclinical and Immunology Scientist in CEPI’s Vaccine R&D Team and Project Leader of the Centralised Laboratory Network, said. “Through harmonising assessment, we can speed up the selection of promising COVID-19 vaccine candidates to later help developers and regulators in the licensure decision-making process.”

The open network aims to gather, empower, and standardize the evaluation of COVID-19 vaccine candidate immune responses currently undergoing preclinical up to phase two clinical testing. By doing so, CEPI hopes to consolidate the evaluation process and reduce variation in results that dozens of labs utilizing different tests and techniques could otherwise yield.

NIBSC, in particular, will work with CEPI to create an international antibody standard against COVID-19 developed from a pool of infected and recovered patient samples. The standard will be tapped for comparing test results measuring immune responses among those either naturally infected or who have received a COVID-19 vaccine candidate. Once developed, the standard will be endorsed by the World Health Organization’s Expert Committee on Biological Standardization.

With the addition of NIBSC and Q2, the CEPI lab network now contains seven testing laboratories worldwide. Each applied to a call for proposals that accepts all COVID-19 vaccine developers, be they CEPI-support or not. Among other criteria, selection into the network is based on their quality system, capacity to perform required tests, and the ability to work internationally with other labs. CEPI hopes to make it easier and cheaper for vaccine developers in various regions to ship clinical trial samples to their nearest laboratory by adding more labs.