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  1. Artikel: The Platform Technology Approach to mRNA Product Development and Regulation.

    Skerritt, John H / Tucek-Szabo, Carolyn / Sutton, Brett / Nolan, Terry

    Vaccines

    2024  Band 12, Heft 5

    Abstract: mRNA-lipid nanoparticle (LNP) medicinal products can be considered a platform technology because the development process is similar for different diseases and conditions, with similar noncoding mRNA sequences and lipid nanoparticles and essentially ... ...

    Abstract mRNA-lipid nanoparticle (LNP) medicinal products can be considered a platform technology because the development process is similar for different diseases and conditions, with similar noncoding mRNA sequences and lipid nanoparticles and essentially unchanged manufacturing and analytical methods often utilised for different products. It is critical not to lose the momentum built using the platform approach during the development, regulatory approval and rollout of vaccines for SARS-CoV-2 and its variants. This review proposes a set of modifications to existing regulatory requirements for mRNA products, based on a platform perspective for quality, manufacturing, preclinical, and clinical data. For the first time, we address development and potential regulatory requirements when the mRNA sequences and LNP composition vary in different products as well. In addition, we propose considerations for self-amplifying mRNA, individualised oncology mRNA products, and mRNA therapeutics. Providing a predictable development pathway for academic and commercial groups so that they can know in detail what product characterisation and data are required to develop a dossier for regulatory submission has many potential benefits. These include: reduced development and regulatory costs; faster consumer/patient access and more agile development of products in the face of pandemics; and for rare diseases where alternatives may not exist or to increase survival and the quality of life in cancer patients. Therefore, achieving consensus around platform approaches is both urgent and important. This approach with mRNA can be a template for similar platform frameworks for other therapeutics and vaccines to enable more efficient development and regulatory review.
    Sprache Englisch
    Erscheinungsdatum 2024-05-11
    Erscheinungsland Switzerland
    Dokumenttyp Journal Article ; Review
    ZDB-ID 2703319-3
    ISSN 2076-393X
    ISSN 2076-393X
    DOI 10.3390/vaccines12050528
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: On entering Australia's third year with COVID-19.

    Duckett, Stephen J / Sutton, Brett

    The Medical journal of Australia

    2021  Band 215, Heft 11, Seite(n) 509–510

    Mesh-Begriff(e) Australia/epidemiology ; COVID-19/epidemiology ; COVID-19/therapy ; COVID-19 Vaccines/administration & dosage ; Delivery of Health Care/organization & administration ; Delivery of Health Care/trends ; Humans ; Public Health ; Public Policy ; Vaccination/legislation & jurisprudence ; Vaccination/trends
    Chemische Substanzen COVID-19 Vaccines
    Sprache Englisch
    Erscheinungsdatum 2021-10-27
    Erscheinungsland Australia
    Dokumenttyp Editorial
    ZDB-ID 186082-3
    ISSN 1326-5377 ; 0025-729X
    ISSN (online) 1326-5377
    ISSN 0025-729X
    DOI 10.5694/mja2.51328
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: An era of untreatable gonorrhoea?

    Sutton, Brett / Ivan, Mihaela

    The Medical journal of Australia

    2018  Band 209, Heft 4, Seite(n) 188

    Mesh-Begriff(e) Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Australia ; Azithromycin/pharmacology ; Azithromycin/therapeutic use ; Ceftriaxone/pharmacology ; Ceftriaxone/therapeutic use ; Drug Resistance, Bacterial ; Gonorrhea/drug therapy ; Gonorrhea/microbiology ; Humans ; Neisseria gonorrhoeae/drug effects ; Neisseria gonorrhoeae/pathogenicity
    Chemische Substanzen Anti-Bacterial Agents ; Ceftriaxone (75J73V1629) ; Azithromycin (83905-01-5)
    Sprache Englisch
    Erscheinungsdatum 2018-08-13
    Erscheinungsland Australia
    Dokumenttyp Journal Article
    ZDB-ID 186082-3
    ISSN 1326-5377 ; 0025-729X
    ISSN (online) 1326-5377
    ISSN 0025-729X
    DOI 10.5694/mja18.00564
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Acting on climate change and health in Victoria.

    Sutton, Brett / Mulvenna, Vanora / Voronoff, Daniel / Humphrys, Tiernan

    The Medical journal of Australia

    2020  Band 212, Heft 8, Seite(n) 345–346.e1

    Mesh-Begriff(e) Climate Change ; Health Policy ; Humans ; Policy Making ; Public Health ; Victoria
    Sprache Englisch
    Erscheinungsdatum 2020-03-13
    Erscheinungsland Australia
    Dokumenttyp Journal Article
    ZDB-ID 186082-3
    ISSN 1326-5377 ; 0025-729X
    ISSN (online) 1326-5377
    ISSN 0025-729X
    DOI 10.5694/mja2.50527
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel ; Online: Quarantine preparedness - the missing factor in COVID-19 behaviour change? Qualitative insights from Australia.

    Davis, Angela / Munari, Stephanie / Doyle, Joseph / Sutton, Brett / Cheng, Allen / Hellard, Margaret / Gibbs, Lisa

    BMC public health

    2022  Band 22, Heft 1, Seite(n) 1806

    Abstract: Background: A key feature of the global public health response to contain and slow the spread of COVID-19 has been community-based quarantine and self-isolation. As part of The Optimise Study, this research sought to understand the factors that ... ...

    Abstract Background: A key feature of the global public health response to contain and slow the spread of COVID-19 has been community-based quarantine and self-isolation. As part of The Optimise Study, this research sought to understand the factors that influence people's ability to undertake home-based quarantine and isolation to contain the spread of COVID-19.
    Methods: Semi-structured qualitative phone interviews (n = 25) were conducted by telephone with people who participated in community-based quarantine in Australia before 31 March 2020. The Capability Opportunity Motivation Behaviour model was used to conduct a thematic analysis.
    Results: Participants required clear, accessible and trusted information to guide them in home-based quarantine and isolation. A sense of social responsibility and belief in the efficacy of the restrictions to reduce viral transmission aided their motivation. Access to essential needs, supportive living environments, and emotional support were required to adhere to restrictions, but few were prepared.
    Conclusions: Findings demonstrate that in addition to having the capability and motivation to adhere to restrictions, it is vital that people are also encouraged to prepare for the challenge to ensure access to physical, social and emotional support. Findings also illustrate the importance of engaging communities in planning and preparedness for quarantine and self-isolation public health responses.
    Mesh-Begriff(e) Australia ; COVID-19/prevention & control ; Humans ; Motivation ; Public Health ; Quarantine/psychology
    Sprache Englisch
    Erscheinungsdatum 2022-09-23
    Erscheinungsland England
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041338-5
    ISSN 1471-2458 ; 1471-2458
    ISSN (online) 1471-2458
    ISSN 1471-2458
    DOI 10.1186/s12889-022-14185-7
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel ; Online: COVID-19 epidemic modelling for policy decision support in Victoria, Australia 2020-2021.

    Scott, Nick / Abeysuriya, Romesh G / Delport, Dominic / Sacks-Davis, Rachel / Nolan, Jonathan / West, Daniel / Sutton, Brett / Wallace, Euan M / Hellard, Margaret

    BMC public health

    2023  Band 23, Heft 1, Seite(n) 988

    Abstract: Background: Policy responses to COVID-19 in Victoria, Australia over 2020-2021 have been supported by evidence generated through mathematical modelling. This study describes the design, key findings, and process for policy translation of a series of ... ...

    Abstract Background: Policy responses to COVID-19 in Victoria, Australia over 2020-2021 have been supported by evidence generated through mathematical modelling. This study describes the design, key findings, and process for policy translation of a series of modelling studies conducted for the Victorian Department of Health COVID-19 response team during this period.
    Methods: An agent-based model, Covasim, was used to simulate the impact of policy interventions on COVID-19 outbreaks and epidemic waves. The model was continually adapted to enable scenario analysis of settings or policies being considered at the time (e.g. elimination of community transmission versus disease control). Model scenarios were co-designed with government, to fill evidence gaps prior to key decisions.
    Results: Understanding outbreak risk following incursions was critical to eliminating community COVID-19 transmission. Analyses showed risk depended on whether the first detected case was the index case, a primary contact of the index case, or a 'mystery case'. There were benefits of early lockdown on first case detection and gradual easing of restrictions to minimise resurgence risk from undetected cases. As vaccination coverage increased and the focus shifted to controlling rather than eliminating community transmission, understanding health system demand was critical. Analyses showed that vaccines alone could not protect health systems and need to be complemented with other public health measures.
    Conclusions: Model evidence offered the greatest value when decisions needed to be made pre-emptively, or for questions that could not be answered with empiric data and data analysis alone. Co-designing scenarios with policy-makers ensured relevance and increased policy translation.
    Mesh-Begriff(e) Humans ; COVID-19/epidemiology ; Victoria/epidemiology ; SARS-CoV-2 ; Communicable Disease Control ; Policy
    Sprache Englisch
    Erscheinungsdatum 2023-05-27
    Erscheinungsland England
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041338-5
    ISSN 1471-2458 ; 1471-2458
    ISSN (online) 1471-2458
    ISSN 1471-2458
    DOI 10.1186/s12889-023-15936-w
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  7. Artikel ; Online: Achieving COVID-19 vaccination equity in South Eastern Metropolitan Victoria, Australia: a population-based study.

    Wong, Evelyn / Sutton, Brett / McLaughlin, Tom / McGrath, Catherine / Baptista, Mohana / Stripp, Andrew / Stuart, Rhonda L

    The Lancet regional health. Western Pacific

    2023  Band 39, Seite(n) 100900

    Abstract: Background: We describe COVID-19 first and second vaccine uptake across Local Government Areas (LGAs) in Victoria using southeast metropolitan Melbourne catchment as a case study. We explore key policy and implementation strategies that contributed to ... ...

    Abstract Background: We describe COVID-19 first and second vaccine uptake across Local Government Areas (LGAs) in Victoria using southeast metropolitan Melbourne catchment as a case study. We explore key policy and implementation strategies that contributed to equitable uptake.
    Methods: Population level data within the South East Public Health Unit (SEPHU) was used to compare trends in COVID-19 vaccination first and second dose uptake for each of the 11 LGAs in year 2021. Changes in vaccination uptake over the year were reviewed against social and public health measures used during the COVID-19 pandemic in Victoria and strategies in the SEPHU vaccination program.
    Findings: By September 2021, 57% of the eligible population in the least disadvantaged LGA, Bayside, had received their second dose vaccination compared to 32% in the most disadvantaged LGA, Greater Dandenong. By end of 2021, the gap had narrowed with 95% in Bayside and 92% in Greater Dandenong having received their second dose. The increase in vaccination uptake for both LGAs was bimodal. Government policies on vaccine eligibility and the opening of mass vaccination sites preceded the first peak in vaccination uptake. Strong community engagement, addressing misinformation, providing culturally appropriate vaccination services and mass outbreaks preceded the second peak in vaccination uptake.
    Interpretation: Vaccine equity across culturally and economically diverse populations can be achieved through a combination of robust, targeted community engagement, mass deployment of appropriate workforce, vaccination services tailored to cultural needs and sensitivities and accessibility to mass vaccination sites on a backdrop of state-wide policies that incentivise vaccination.
    Funding: None.
    Sprache Englisch
    Erscheinungsdatum 2023-09-15
    Erscheinungsland England
    Dokumenttyp Journal Article
    ISSN 2666-6065
    ISSN (online) 2666-6065
    DOI 10.1016/j.lanwpc.2023.100900
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  8. Artikel ; Online: The Tortoise and the Hare: Guinea Worm, Polio and the Race to Eradication.

    Sutton, Brett / Canyon, Deon

    PLoS currents

    2015  Band 7

    Abstract: Introduction: The eradication of a human infectious disease is a major challenge and, if achieved, represents a enormous achievement. This article explores the long and difficult journey towards eradication for polio and guinea worm.: Methods: The ... ...

    Abstract Introduction: The eradication of a human infectious disease is a major challenge and, if achieved, represents a enormous achievement. This article explores the long and difficult journey towards eradication for polio and guinea worm.
    Methods: The authors reviewed the programmatic approaches taken in the eradication strategies for these two diseases and the unique socio-political contexts in which these strategies are couched. The epidemiology of the last 15 years is compared and contrasted. The specific challenges for both programs are outlined and some key elements for success are highlighted.
    Discussion: The success of these eradication programs is contingent upon many factors. Nothing is assured, and progress remains fragile and vulnerable to setbacks. Security must be ensured in guinea worm transmission areas in Africa and polio transmission areas in Pakistan and Afghanistan. Technical solutions alone cannot guarantee eradication. National leadership and continued international focus and support are necessary, today more than ever. The legacy of success would be extraordinary. It would reverberate to future generations in the same way that the eradication of smallpox does for this generation.
    Sprache Englisch
    Erscheinungsdatum 2015-08-31
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 2583641-9
    ISSN 2157-3999 ; 2157-3999
    ISSN (online) 2157-3999
    ISSN 2157-3999
    DOI 10.1371/currents.outbreaks.16e2349da74ec9bdfe26cc6598bee881
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  9. Artikel ; Online: Measles immunisation status of healthcare workers in smaller Victorian hospitals: can we do better?

    Bennett, Noleen / Sutton, Brett / Strachan, Janet / Hoskins, Alex / Malloy, Michael J / Worth, Leon J

    Australian and New Zealand journal of public health

    2020  Band 44, Heft 5, Seite(n) 346–348

    Abstract: Objective: To determine the proportion of healthcare workers (HCWs) in smaller Victorian public healthcare facilities with documented evidence of measles immunity.: Methods: A cross-sectional survey, developed by the Victorian Healthcare Associated ... ...

    Abstract Objective: To determine the proportion of healthcare workers (HCWs) in smaller Victorian public healthcare facilities with documented evidence of measles immunity.
    Methods: A cross-sectional survey, developed by the Victorian Healthcare Associated Surveillance System Coordinating Centre, was completed by all eligible facilities. HCWs were reported as having evidence or no evidence of measles immunity. Those without evidence of immunity were sub-classified as incomplete, declined or unknown status.
    Results: Seventy-five facilities reported measles immunity status of 17,522 employed HCWs. Of these, 11,751 (67.1%) had documented evidence of immunity. The proportion with evidence of immunity was lowest (45.6%) in facilities with ≤50 HCWs. The majority of HCWs without evidence of immunity (88.2%) had 'unknown' status. Declination or incomplete status comprised very low overall proportions (0.3% and 3.6%, respectively).
    Conclusions: Reported evidence of HCW measles immunity was moderate in surveyed facilities, with a large proportion having unknown status. HCW immunisation programs in some facilities require refinement to appropriately support public health responses to measles cases and prevention of occupational acquisition of measles. Implications for public health: Non-immune HCWs are at increased risk for acquiring and transmitting measles. Timely access to accurate HCW immunisation records is required to ensure that public health responses are effective.
    Mesh-Begriff(e) Adult ; Australia ; Female ; Guideline Adherence ; Health Personnel/psychology ; Health Personnel/statistics & numerical data ; Health Surveys ; Hospitals/statistics & numerical data ; Humans ; Immunization/statistics & numerical data ; Immunization Programs ; Male ; Measles/prevention & control ; Measles Vaccine/administration & dosage ; Middle Aged ; Occupational Diseases/epidemiology ; Occupational Health
    Chemische Substanzen Measles Vaccine
    Sprache Englisch
    Erscheinungsdatum 2020-07-22
    Erscheinungsland Australia
    Dokumenttyp Journal Article
    ZDB-ID 1323548-5
    ISSN 1753-6405 ; 1326-0200
    ISSN (online) 1753-6405
    ISSN 1326-0200
    DOI 10.1111/1753-6405.12989
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  10. Artikel ; Online: Effectiveness of community-based oral antiviral treatments against severe COVID-19 outcomes in people 70 years and over in Victoria, Australia, 2022: an observational study.

    Van Heer, Christina / Majumdar, Suman S / Parta, Indra / Martinie, Marcellin / Dawson, Rebecca / West, Daniel / Hewett, Laura / Lister, David / Sutton, Brett / O'Brien, Daniel P / Cowie, Benjamin C

    The Lancet regional health. Western Pacific

    2023  Band 41, Seite(n) 100917

    Abstract: Background: Oral Antiviral (OAV) COVID-19 treatments are widely used, but evidence for their effectiveness against the Omicron variant in higher risk, vaccinated individuals is limited.: Methods: Retrospective study of two vaccinated cohorts of COVID- ...

    Abstract Background: Oral Antiviral (OAV) COVID-19 treatments are widely used, but evidence for their effectiveness against the Omicron variant in higher risk, vaccinated individuals is limited.
    Methods: Retrospective study of two vaccinated cohorts of COVID-19 cases aged ≥70 years diagnosed during a BA.4/5 Omicron wave in Victoria, Australia. Cases received either nirmatrelvir-ritonavir or molnupiravir as their only treatment. Data linkage and logistic regression modelling was used to evaluate the association between treatment and death and hospitalisation and compared with no treatment.
    Findings: Of 38,933 individuals in the mortality study population, 13.5% (n = 5250) received nirmatrelvir-ritonavir, 51.3% (n = 19,962) received molnupiravir and 35.2% (n = 13,721) were untreated. Treatment was associated with a 57% (OR = 0.43, 95% CI 0.36-0.51) reduction in the odds of death, 73% (OR = 0.27, 95% CI 0.17-0.40) for nirmatrelvir-ritonavir and 55% (OR = 0.45, 95% CI 0.38-0.54) for molnupiravir. Treatment was associated with a 31% (OR = 0.69, 95% CI 0.55-0.86) reduction in the odds of hospitalisation, 40% (OR = 0.60, 95% CI 0.43-0.83) for nirmatrelvir-ritonavir and 29% (OR = 0.71, 95% CI 0.58-0.87) for molnupiravir. Cases treated within 1 day of diagnosis had a 61% reduction in the odds of death (OR = 0.39, 95% CI 0.33-0.46) compared with 33% reduction for a delay of 4 or more days (OR = 0.67, 95% CI 0.44-0.97).
    Interpretation: Treatment with both nirmatrelvir-ritonavir or molnupiravir was associated with a reduction in death and hospitalisation in vaccinated ≥70 years individuals during the Omicron era. Timely, equitable treatment with OAVs is an important tool in the fight against COVID-19.
    Funding: There was no funding for this study.
    Sprache Englisch
    Erscheinungsdatum 2023-10-03
    Erscheinungsland England
    Dokumenttyp Journal Article
    ISSN 2666-6065
    ISSN (online) 2666-6065
    DOI 10.1016/j.lanwpc.2023.100917
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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