How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation

McGoldrick, Mic; Gastineau, Thierry; Wilkinson, Diane; Campa, Cristiana; Clercq, Norbert De; Mallia-Milanes, Andrea; Germay, Olivier; Krishnan, Jyothsna; Ooij, Mark van; Thien, Michael P.; Mlynarczyk, Peter J; Saltus, Edward; Wauters, Florence; Juvin, Philippe; Clénet, Didier; Basso, Ana; Dellepiane, Nora; Pagliusi, Sonia; Stávale, Monique Collaço de Moraes; Sivaramakrishnan, Venkatraman H; Desai, Samir

doi:10.1016/j.vaccine.2021.12.038

Cited by 10 publications

(10 citation statements)

References 10 publications

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“…These OMCL activities demonstrate reliance/ recognition, work sharing between the OMCLs, use of approaches based on science and a risk assessment, and an increased use of digital tools. These are key elements noted by vaccine industry to achieve accelerated supply of vaccines to the market 27,28 .…”

Section: Discussionmentioning

confidence: 99%

Independent control of COVID-19 vaccines by EU Official Control Authority Batch Release: challenges, strengths and successes

Milne¹,

Wagner

Cano

et al. 2023

npj Vaccines

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Vaccines have been a key tool in stemming the tide of the COVID-19 pandemic. The rapid development of effective vaccines against COVID-19, together with their regulatory approval and wide scale distribution has been achieved in an impressively short period thanks to the intense efforts of many. In parallel to vaccine development, the EU considered it important to prepare for the independent control of the COVID-19 vaccines, including testing, to help ensure that only vaccines that comply with the approved quality requirements reach the public and to help improve/increase public confidence in the vaccines. The existing EU Official Control Authority Batch Release (OCABR) system, co-ordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM), was able to effectively respond to the need, through rapid co-ordination, work-sharing, advance planning and early interaction with manufacturers, the Coalition for Epidemic Preparedness Innovation (CEPI) and regulatory authorities. The Official Medicines Control Laboratories (OMCLs) involved in the OCABR activity, using the strength of the established system in the OCABR network and adaptations to the crisis conditions, were ready to release the first COVID-19 vaccine batches, after protocol review and testing, at the time of the conditional marketing authorisation for each of the COVID-19 vaccines, with no delay for batches reaching the public. Thanks to the dedication of resources by the EU and national authorities as well as by the EDQM, this was done without impacting the release of the other vaccines and human blood and plasma derived medicinal products, essential for public health. Transparency and communication of practices were important factors to support reliance on the OCABR outcome in non-EU countries, with the goal to improve access to vaccines in Europe and beyond. An overview of the process, legal background, challenges and successes of OCABR for COVID-19 vaccines as well as a look at the international perspective and lessons learned is provided.

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Section: Discussionmentioning

confidence: 99%

Independent control of COVID-19 vaccines by EU Official Control Authority Batch Release: challenges, strengths and successes

Milne¹,

Wagner

Cano

et al. 2023

npj Vaccines

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Section: Introductionmentioning

confidence: 86%

“…These reflections and recommendations are intended to stimulate ongoing discussion among stakeholders (including industry, regulators, and patient groups) on measures that could facilitate public health responses in future pandemics, and that could also be valuable in non-pandemic situations. The recommendations and discussion points proposed within, augment and expand on the vaccine-specific recommendations proposed by McGoldrick et al (17,18) One of the most challenging issues faced by companies introducing innovative medicines for use in the COVID-19 pandemic was having to engage each authority and their respective governmental distribution organizations to negotiate regulatory criteria for authorization and distribution in each market. Companies found that differences in expectations between different regions could not be managed during parallel, simultaneous submissions due to resource constraints.…”

Section: Introductionmentioning

confidence: 99%

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines

Popkin

Goese

Wilkinson

et al. 2022

AAPS J

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This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate ‘post-approval’ changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.

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“…As per the plead from International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the WHO approved seven therapeutic formulations for COVID-19, and the same are produced in 150 manufacturing facilities around the globe [32] . The industry had brought vaccines within 12 months of the declaration of COVID-19 as a pandemic.…”

Section: Classification Of Covid-19 Therapeuticsmentioning

confidence: 99%

Anti-SARS-CoV-2 Biotherapeutics and Chemotherapeutics: An Insight into Product Specifications and Marketing Dynamics

Kotra¹,

Mallem²,

Kanuri³

et al. 2022

Prog Micobes Mol Biol

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Chemotherapeutics and biotherapeutics agents have been explored as a potential treatment for COVID-19. This study was aimed to elucidate latest update related to biotherapeutics and chemotherapeutics against COVID-19 and its variants as well as the product specifications and marketing dynamics of its pharmacotherapies. There are several chemotherapeutics that have been studied for the treatment of COVID-19, including Paxlovid (Nirmatrelvir & Ritonavir) fixed dose combination, nirmatrelvir and ritonavir fixed dose combination, Remdesivir (Vekulary/Covifor) fixed dose combination, chloroquine and hydroxychloroquine, molnupiravir, favipiravir, Infliximab (Remsima®) fixed dose combination tocilizumab (Actimera), casirivimab+imdevimab (Ronapreve) fixed dose combination, ivermectin, methylprednisole. These drugs have been repurposed for use in COVID-19 due to their antiviral properties and ability to reduce inflammation. The COVID-19 death cases have significantly reduced because of tested efficacy of advanced biotherapeutics and chemotherapeutics. As for marketing dynamics, the demand for chemotherapeutics for the treatment of COVID-19 has increased significantly since the outbreak of the pandemic. Hence, the prices of anti-viral and monoclonal antibodies in top COVID-19 affected countries is also presented here. Considering the molecular interactions, therapeutic activity, efficacy, and adverse effects, the USFDA and the WHO recommended the aforementioned drugs. The chances of approval seems favouring biotherapeutics as these have the best characteristics among the chemotherapeutics. Overall, this review contributes to the scientific understanding of the COVID-19. This can help to inform future research and development efforts and contribute to the overall advancement of knowledge in the field of medicine.

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How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation

Cited by 10 publications

References 10 publications

Independent control of COVID-19 vaccines by EU Official Control Authority Batch Release: challenges, strengths and successes

Independent control of COVID-19 vaccines by EU Official Control Authority Batch Release: challenges, strengths and successes

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines

Anti-SARS-CoV-2 Biotherapeutics and Chemotherapeutics: An Insight into Product Specifications and Marketing Dynamics

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