Upon the initial licensure the life of a medicine or vaccines starts. An essential part of this is a continuous update through variation to the original license, known as post approval changes (PAC). These changes are done to enhance robustness and efficiency of the manufacturing process, improve QC techniques, upgrade to state-of-the art facilities and continuously update to meet regulatory and safety information. However, throughout the world there is a wide range of guidance governing PACs. A comparison of these regulations/guidelines, requirements, and procedures for management of PACs from some key countries across the world was performed. Our results show the lack of alignment between them and in addition also demonstrates the lack of predictability of timelines for review and approval in many countries. The latter, especially, has a considerable impact on the supply chain flexibility and by consequence may limit access for patients to that most up to date medicines and vaccines. The WHO guidelines, which are comprehensive and could represent a consensual model for alignment. Unfortunately, these WHO guidelines are still underused. Reliance on the review and approval by the health authority in country of origin, other Stringent Regulatory Authorities (soon to be WHO listed Authorities or WHO-PQ could be another way forward. These and other options or opportunities to improve the management of changes during the product lifecycle will be outlined. Ultimately, industry and regulators owe it to patients to provide and facilitate access to the most up to date versions of medicines and vaccines.
Ulrike Kreysa is responsible for the Healthcare sector at the GS1 Global Office in Brussels and works with her local colleagues in 116 countries across the world to develop and implement GS1 standards in the healthcare industry. Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, group purchasing organizations, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations. GS1 Healthcare has the mission to lead the Healthcare sector to the successful development and implementation of global standards. Worldwide patient safety and supply chain efficiencies will be enhanced globally through standards for AIDC (Automatic Identification and Data Capture), global data synchronisation and traceability. Ulrike works regularly with decision makers from leading companies and regulatory bodies to drive harmonisation of standards in the implementation across the world. She has facilitated the WHO Vaccines barcode subgroup, which developed worldwide guidance for the automatic identification with barcodes for vaccines to enable traceability and an improved supply chain. Ulrike was also one of the facilitators of the APEC work group on Track and Trace systems. This was one of the work streams which were essential to the APEC Roadmap to promote Global Medical Product Quality and Supply Chain Security (“APEC Roadmap for Supply Chain Security”).
Principal Research Leader, Professor Michael F. Good AO heads the Laboratory of Vaccines for the Developing World, Institute for Glycomics, Griffith University on the Gold Coast, Queensland. He is the past Chairman of the National Health and Medical Research Council, Director of the Queensland Institute of Medical Research and President of the Association of Australian Medical Research Institutes (AAMRI). Professor Good’s interests are in the field of immunity and immunopathogenesis to malaria and group A streptococcus/ rheumatic fever, with particular relevance to the development of vaccines. In 2008 Professor Good was awarded an Order of Australia for his services to medical research and in 2009 he received the Eureka Prize for Leadership. In 2010, Professor Good was a recipient of the Queensland Greats Awards. Professor Good was elected Fellow of the Australian Academy of Health and Medical Sciences (FAHMS) in 2015.
Dr. Ramiro Gilardino brings 12+ years of experience in health economics, outcomes research, and global health policy in pharmaceutical, medical devices companies, and not-for-profit organizations both at the regional and global reach. His research interests include medical devices comparative effectiveness, health technology assessment for medical devices, pricing, stakeholder involvement and non-traditional outcomes like PRO and ClinRO. He is particularly interested in health systems sustainability within the Latin America region. He has edited a publication related to establishing health technology assessment in Latin America as well as written chapters for publications and published more than 30 articles in both indexed and non-indexed peer-reviewed journals. He continues teaching Health Economics Evaluations and Health Technology Assessment as a part-time Professor at the Universidad ISALUD in Argentina.
The ongoing COVID-19 pandemic is the result of a zoonotic transmission event, similar to previous coronavirus epidemics. Antiviral therapeutics are urgently needed to combat SARS-CoV-2 in the current pandemic and will be the first line of defense for future coronavirus epidemics during the typical lag time of vaccine development. The SARS-CoV-2 coronavirus is reliant on host cell proteins to successfully complete the viral replication cycle and our previously published SARS-CoV-2 interactome highlighted 332 host proteins that are likely to play a role in the viral life cycle, representing potential host targets for therapeutic intervention. Thus far we have screened over 800 potential antiviral drugs using an evidence-based approach, targeted to both the host and viral proteins, against SARS-CoV-2 in cell culture. In this manner we have identified over 40 compounds which inhibit SARS-CoV-2 with a sub-micromolar IC90 in vitro, with our top host-targeted antiviral drug, plitidepsin, having a sub-nanomolar IC90. Furthermore, we have identified multiple FDA-approved HCV protease inhibitors that have antiviral activity against SARS-CoV-2 and synergize with the current standard of care, remdesivir. Finally, we have tested our most potent clinically-approved host-targeted antiviral in animal models of SARS-CoV-2 infection with highly promising results that have led to ongoing COVID-19 clinical trials. Taken together, our results offer multiple clinically-approved drugs with significant potential to impact patient health in the ongoing COVID-19 pandemic and offer many insights into SARS-CoV-2 biology that can be used for the specific design of future antivirals for the treatment of coronavirus infection. Our ultimate goal is to produce a host-targeted antiviral treatment or a cocktail of synergistic viral-targeted drugs with potent efficacy that can prevent the rise of drug-resistant SARS-CoV-2 variants.
Bridget Msolomba Malewezi is a medical doctor, public health practitioner, activist & health columnist.
She is currently the Vice President of the Malawi Chapter of Women in Global Health (WGH) as well as Acting Chair of the task force for the establishment of the Women Doctors Association of Malawi (WDAM). She is one of the founding members and currently an executive member and chairperson of Public Relations and COVID Public Awareness for the Society of Medical Doctors Malawi (SMD).
She has worked in various capacities including Country Director for Seed Global Health Malawi focusing on health systems strengthening and human resources for health (HRH).
To be updated soon.
Laura Doornekamp works in the Erasmus Medical Center, Rotterdam, the Netherlands. After obtaining her PhD, she continues her research comprising the prevention of virus infections in risk groups, including education strategies and vaccinology.
Vaccine hesitancy of mothers is a significant public health concern especially after the Dengvaxia controversy in the Philippines. This cross-sectional study assessed the demographic profile, vaccination factors, and influences of Filipino mothers (n = 384) in the National Capital Region (NCR). Descriptive and inferential statistics were used to analyze the obtained data, and significant factors in vaccine hesitancy of mothers (μ = 42.12 y/o) were revealed. Factors in the demographic profile such as educational attainment (p = 0.035) and monthly income (p = 0.034) have affected their perception of vaccination. High vaccine hesitancy (20.1%) of the participants is relatively increased in the Philippines despite their relatively high level of knowledge and a positive attitude regarding vaccination. Most of the participants trust the government and pharmaceutical companies for their vaccines (p = 0.037; p = 0.002). Majority followed the recommended vaccination schedule of their child (p = 0.001) and half suppose that there are more ways for disease prevention other than vaccination (p = 0.015). Vaccine cost (p = 0.012) and accessibility (p = 0.005) also influenced the decisions of the participants. The participants show a positive perception towards vaccination despite high vaccine hesitancy prevalence. However, there remains a need for the government and health professionals to prioritize parental education not only to correct false information on vaccination but also to gain the public’s trust while improving the public health system against its fight with vaccine hesitancy.
Currently, as a postdoctoral fellow at the Department for BioMedical Research (joint collaboration with Alveolix AG and the Organoid CORE), Mirjam Kiener is optimizing advanced 3D in vitro models (organoids and lung-on-chip) for studying SARS-CoV-2 infection in the lung. She has become responsible to equip and coordinate the work in the newly built BSL3 laboratory on the insel campus. In order to develop a validated workflow for pre-clinical anti-viral drug screening she is currently optimizing the SARS-CoV-2 infection protocol in alveolar cells under nearly physiological conditions in the lung-on-chip (stretch, air-liquid interface, co-culture) and hAEpC organoids.
Background: The novel coronavirus (SARS-CoV-2) that emerged in December 2019, resulting in COVID-19, continues to affect the population, putting more pressure on healthcare systems and global socioeconomic balances. The World Health Organization declared COVID-19 a global pandemic, referring to approximately 179 million confirmed cases and 3.87 million confirmed deaths as of June 2021. Easy in vitro viral systems are required to study viral entry and sera neutralisation of the different emerging strains of SARS-CoV-2.
Methods: The aim was to generate an HIV-1 pseudotyped virus particle (PVP) system that expresses spike protein (CoV-S2wt) and compare infectivity profiles in two different cells, 293T and 293T-ACE2. We also monitored infection in macrophages (MQ), Dendritic Cells (DCs) and Vero cells. Furthermore, we tested SARS-CoV-S2wt PVP treated with COVID-19 patient's sera to investigate neutralisation capacity.
Results: We generated HIV-1 PVP expressing SARS-CoV-2S2 protein, which infected 293T-ACE2 cells but less efficiently 293T cells, showing the development of a virus mimicking SARS-CoV-2. This virus was successfully neutralised with patient sera generated from acute infected COVID-19 patients. The same viruses were tested for infectivity of MQ, DCs and Vero cells and where it was shown to be infectious, but to far lower levels as on 293T-ACE2 cells. These results indicate that primary cells of the immune system can be infected with SARS-CoV-2 to low levels.
Conclusions: We have demonstrated the successful generation of an HIV-1 PVP expressing SARS-CoV-2Swt protein, which infects cells expressing the ACE2 receptor and can be inhibited with sera from COVID-19 survivors. Utilising these viruses, we demonstrate that MQ, DCs and Vero cells can be infected to low levels.
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