IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?

Vandeputte, Joris; Saville, Mélanie; Cavaleri, Marco; Friede, Martin; Hacker, Adam; Mueller, Stefan O.; Rizzi, Ruben; Smith, Dean; Thirstrup, Steffen; Wagner, Ralf; Baay, Marc; Neels, Pieter

doi:10.1016/j.biologicals.2021.04.005

Cited by 8 publications

(6 citation statements)

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“…Prior knowledge is of paramount importance to rapidly develop new vaccines as it provides a platform-based framework beyond product-specific information [ 11 , 41 ]. In a pandemic scenario, the use of consolidated platforms for the rapid execution of developability assessments, formulation studies, and process development is essential.…”

Section: Key Enablers Of Acceleration and Pandemic Preparednessmentioning

confidence: 99%

CMC Strategies and Advanced Technologies for Vaccine Development to Boost Acceleration and Pandemic Preparedness

Castellanos,

Gressard,

et al. 2023

Vaccines

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This review reports on an overview of key enablers of acceleration/pandemic and preparedness, covering CMC strategies as well as technical innovations in vaccine development. Considerations are shared on implementation hurdles and opportunities to drive sustained acceleration for vaccine development and considers learnings from the COVID pandemic and direct experience in addressing unmet medical needs. These reflections focus on (i) the importance of a cross-disciplinary framework of technical expectations ranging from target antigen identification to launch and life-cycle management; (ii) the use of prior platform knowledge across similar or products/vaccine types; (iii) the implementation of innovation and digital tools for fast development and innovative control strategies.

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Section: Key Enablers Of Acceleration and Pandemic Preparednessmentioning

confidence: 99%

CMC Strategies and Advanced Technologies for Vaccine Development to Boost Acceleration and Pandemic Preparedness

Castellanos,

Gressard,

et al. 2023

Vaccines

View full text Add to dashboard Cite

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“…As this involved swift, on-demand design and manufacturing of vaccines tailored to each individual patient, the proficiency of mRNA technology for a platform approach in regulatory terms had already been pursued [ 57 ]. This prior experience enabled early discussions with regulators on the use of platform technology approaches to develop vaccines and led to adoption of these principles during COVID-19, allowing the extrapolation of safety information across different vaccine candidates and implementation of a platform-based non-clinical toxicology program in support of first-in-human trials [ 58 ].…”

Section: Vaccine Developmentmentioning

confidence: 99%

“…Platform technology approaches with known safety and efficacy profiles that allow for reactive vaccine design should continue to be used to expedite access to vaccines. A vaccine Platform Technology Master File (PTMF) could be utilized in future, which would act as a stand-alone part of the dossier and remain unchanged regardless of the sequence change to the platform [ 58 ].…”

Section: Expert Opinionmentioning

confidence: 99%

Clinical development and approval of COVID-19 vaccines

Kalinke

Barouch

Rizzi

et al. 2022

Expert Review of Vaccines

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Introduction The coronavirus 19 (COVID-19) pandemic triggered a simultaneous global demand for preventative vaccines, which quickly became a high priority among governments as well as academia and the pharmaceutical industry. Within less than a year after COVID-19 was declared a pandemic, vaccines had received emergency approvals and vaccination campaigns were initiated. Areas covered We discuss the several factors that led to the unprecedented, accelerated development and approval of COVID-19 vaccines, which includes optimization of processes by regulatory authorities, redesign of sequential development processes, learnings from previous pandemics, and prior development of novel vaccine platforms. Expert Opinion Despite unanticipated and complex challenges presented by real-time vaccine development in the context of the evolving COVID-19 pandemic and subsequent ever-changing landscape of public health measures and recommendations, important milestones were reached within extraordinarily short periods and, following roll-out to billions worldwide, the approved vaccines have proven to be well tolerated and effective. Whilst this is an exceptional feat and an example of what can be achieved with collaboration and innovation, there are lessons that can still be learned, including the need for further harmonization between regulatory authorities, modes to react to the pandemic’s ever-evolving challenges, and ensuring equitable vaccine access among low-income countries.

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“…viral vectors, mRNA and self-amplifying mRNA, structural vaccinology); platform technology takes the same basic components of a vaccine to use as a backbone, yet is adaptable for use against different pathogens by inserting new genetic or protein sequences. 46 Recurring use of a platform not only allows rapid development of new vaccines but will increase confidence in the overall safety profile of vaccines. Such technologies have been used to develop the various influenza vaccines and have facilitated the rapid development of an unprecedented number of COVID-19 vaccines in a significantly condensed timeframe, thereby averting prolonged morbidity and mortality.…”

Section: Disease Outbreaksmentioning

confidence: 99%

Unveiling the contributions of immunization for progressing towards Universal Health Coverage

Ota

Moraes

Vojtek

et al. 2022

Human Vaccines & Immunotherapeutics

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The aim of the United Nations’ Sustainable Development Goal (SDG)3 is to ensure healthy lives and promote well-being for all, at all ages; including reducing maternal and child mortality, combating communicable and non-communicable diseases, and achieving Universal Health Coverage (UHC). UHC aims to provide everyone with equal access to quality essential and comprehensive healthcare services including preventions, interventions, and treatments, without exposing them to financial hardship. Making progress toward UHC requires significant investment in technical and financial resources and countries are pursuing the implementation of cost-saving measures within health systems to help them achieve UHC. Whilst many countries are far from attaining UHC, all countries, particularly low- and middle-income countries, can take steps toward achieving UHC. This paper discusses key data showing how immunization is a fundamental, cost-effective tool for reducing morbidity and mortality associated with infectious disease in all populations, creating more productive communities, reducing treatment costs, and consequently, facilitating social and economic advancement. Immunization is key to advancing toward UHC by relieving the burden that diseases place on the healthcare services, freeing essential resources to use elsewhere within the healthcare system. Immunization is an essential, readily available strategy that countries can deploy to achieve UHC and the SDG3 agenda.

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IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?

Cited by 8 publications

References 0 publications

CMC Strategies and Advanced Technologies for Vaccine Development to Boost Acceleration and Pandemic Preparedness

CMC Strategies and Advanced Technologies for Vaccine Development to Boost Acceleration and Pandemic Preparedness

Clinical development and approval of COVID-19 vaccines

Unveiling the contributions of immunization for progressing towards Universal Health Coverage

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