key: cord-0906906-xz16v6cb authors: Kumar, Arun; Bernasconi, Valentina; Manak, Mark; de Almeida Aranha, Ana Paula; Kristiansen, Paul A title: The CEPI centralised laboratory network: supporting COVID-19 vaccine development date: 2021-06-03 journal: Lancet DOI: 10.1016/s0140-6736(21)00982-x sha: 3361ed5610273f2a657dafa43c07b9750ddc5c4a doc_id: 906906 cord_uid: xz16v6cb nan Six qualified assays were included to evaluate humoral and cellular immune responses after vaccination. The humoral response analysis includes the evaluation of binding and neutralising antibodies. The prefusion spike protein and receptor-binding domain ELISA were used to quantify anti-SARS-CoV-2 IgG antibodies in sera to the most common targets used in vaccine formulations. The nucleocapsid ELISA can be used to measure responses to immunisation with both whole virus vaccines and SARS-CoV-2 infection. The wild-type virus neutralisation assay (VNA) and the pseudovirus neutralising assay (PNA) measure virus-specific neutralising antibodies in serum samples. 5 VNA targets the original SARS-CoV-2 Victoria/1/2020 (subsequently renamed BetaCoV/ Australia/VIC01/2020) strain and requires biosafety level 3 facilities, whereas PNA allows determina tion of neutralisation activity in a standard biosafety level 2 laboratory. The ELISAs and the neutralisation assays are standardised to the WHO International Standard for anti-SARS-CoV-2 immunoglobulin developed by the National Institute for Biological Standards and Control, 6 which will allow harmonisation of data produced in laboratories around the globe. Cellmediated immunity is measured by the enzyme-linked immunospot (ELISpot) assay, which detects production of interferon-γ and interleukin-5 to SARS-CoV-2 spike protein peptides. CEPI is currently focusing on expanding to analysis of samples against the most relevant variants of concern. The mentioned assays were developed and qualified by Public Health England (VNA) and Nexelis (ELISA, PNA, and ELISpot); validation is in progress. All assays are in the process of technology transfer to the other participating laboratories using common standardised operating procedures, the same key reagents, and standardised controls and acceptance criteria to ensure that all laboratories are generating concordant results. be subject to evidence-based evaluation of its benefits (and possible harms). This is a challenge because it means evaluating what specific contributions of patients sway decisions, and how. Different regulators are at different stages in developing strategies and methods of patient engagement, which are more advanced in some areas (eg, anticancer medicines) than in others. 8 Embedding patients' chosen methods of engagement into the regulatory process for philosophical and political reasons without assessing their effect (and, importantly, whether it could be done better) would leave their patient engagement unvalued. Regulators publishing their experiences in well described reports will help establish best possible practice for the good of both patients and society in general. It will also guide other regulators globally and will enhance the reputations of regulators with regard to thoughtful engagement with patients and the public. BC is a non-executive director of the Medicines and Healthcare Products Regulatory Agency and its Patient Safety and Engagement Committee. AS declares no competing interests. The views expressed are those of the authors and not necessarily those of the agencies listed here. Data on diabetesspecific distress are needed to improve the quality of diabetes care We commend the Lancet Commission on diabetes 1 but the section on comorbidities and mental health is limited to psychiatric comorbidities. Mental wellbeing is not simply the absence of mental disorders. 2 Diabetes-specific distress is the negative emotional impact of living with and managing diabetes, a sign of coping difficulties. Diabetes-specific distress is very common, affecting around a third of people with diabetes. 3 We suggest that ignoring diabetesspecific distress contributes to the suboptimal outcomes highlighted by the Commission. One metaanalysis shows that interventions to reduce diabetes-specific distress also reduce the concentration of glycated haemoglobin, 4 and are therefore important for preventing complications. Despite 25 years of research into diabetes-specific distress, 3 this central issue is unmentioned in the Commission report. Given that diabetes-specific distress is "anchored in the day-to-day experience of living with diabetes", 3 it can be assessed and addressed within the diabetes care team, and this approach is what people with diabetes want. 5 Integrating the management of diabetes-specific distress into a basic care plan is practical and inexpensive, 6 with no need for advanced equipment or diagnostic tools. Nor, in most cases, is there need for referral to mental health professionals. Thus, data on diabetesspecific distress are accessible, actionable, and can facilitate better diabetes outcomes globally. There is international agreement on a standard set of person-centred outcomes for diabetes, which include, alongside depressive symptoms (Patient Health Questionnaire-9), The CEPI centralised laboratory network is a global resource, committed to provide testing support to all COVID-19 vaccine developers to facilitate standardised measurement of immune responses to vaccines. A global footprint reduces sample shipment challenges. We have so far received sample analysis requests from 60 vaccine developers and, with the endorsement from regulators, we encourage all others to use this harmonised approach. 7 Evolution of the COVID-19 vaccine development landscape CEPI establishes global network of laboratories to centralise assessment of COVID-19 vaccine candidates Two more laboratories join CEPI's centralised network to standardise assessment of COVID-19 vaccines CEPI expands global footprint of its COVID-19 vaccine lab network, and opens testing against Variants of Concern Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays WHO International Standard for anti-SARS-CoV-2 immunoglobulin Enabling preparedness innovations-enabling sciences outcome-experience-measures/ the-world-health-organisationfive-well-being-index-who-5/ For more on the PsychoSocial Aspects of Diabetes Study Group see We declare no competing interests. AK and VB contributed equally. CEPI is funding the centralised laboratory network initiative.