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  1. TI=Vaccines for emerging pathogens: prospects for licensure
  2. TI=An approximation based approach for periodic estimation of effective reproduction number: a tool for decision making in the context of coronavirus disease 2019 COVID 19 outbreak

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  1. Article ; Online: Vaccines for emerging pathogens: prospects for licensure.

    Williamson, E D / Westlake, G E

    Clinical and experimental immunology

    2019  Volume 198, Issue 2, Page(s) 170–183

    Abstract: Globally, there are a number of emerging pathogens. For most, there are no licensed vaccines ... and increasing list of emerging pathogens and the investment required to bring vaccines into clinical ... However, vaccines for pathogens which cause severe, but occasional, disease outbreaks in endemic pockets have ...

    Abstract Globally, there are a number of emerging pathogens. For most, there are no licensed vaccines available for human use, although there is ongoing research and development. However, given the extensive and increasing list of emerging pathogens and the investment required to bring vaccines into clinical use, the task is huge. Overlaid on this task is the risk of anti-microbial resistance (AMR) acquisition by micro-organisms which can endow a relatively harmless organism with pathogenic potential. Furthermore, climate change also introduces a challenge by causing some of the insect vectors and environmental conditions prevalent in tropical regions to begin to spread out from these traditional areas, thus increasing the risk of migration of zoonotic disease. Vaccination provides a defence against these emerging pathogens. However, vaccines for pathogens which cause severe, but occasional, disease outbreaks in endemic pockets have suffered from a lack of commercial incentive for development to a clinical standard, encompassing Phase III clinical trials for efficacy. An alternative is to develop such vaccines to request US Emergency Use Authorization (EUA), or equivalent status in the United States, Canada and the European Union, making use of a considerable number of regulatory mechanisms that are available prior to licensing. This review covers the status of vaccine development for some of the emerging pathogens, the hurdles that need to be overcome to achieve EUA or an equivalent regional or national status and how these considerations may impact vaccine development for the future, such that a more comprehensive stockpile of promising vaccines can be achieved.
    MeSH term(s) Animals ; Communicable Diseases, Emerging/immunology ; Communicable Diseases, Emerging/prevention & control ; Drug Resistance, Microbial ; Humans ; Tropical Climate ; Vaccination ; Vaccines/immunology ; Vaccines/therapeutic use ; Zoonoses/immunology ; Zoonoses/prevention & control
    Chemical Substances Vaccines
    Keywords covid19
    Language English
    Publishing date 2019-04-11
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 218531-3
    ISSN 1365-2249 ; 0009-9104 ; 0964-2536
    ISSN (online) 1365-2249
    ISSN 0009-9104 ; 0964-2536
    DOI 10.1111/cei.13284
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Vaccines for emerging pathogens: from research to the clinic. Part two.

    Williamson, E D

    Clinical and experimental immunology

    2019  Volume 198, Issue 2, Page(s) 141–142

    Abstract: ... research and development for emerging pathogens. Part One addressed our progress in developing vaccines for emerging and re ... formulation and of the use of effective delivery vehicles, as well as the prospects for licensure for current ... emerging viruses and considered current work on effective vaccines for bacterial pathogens. In this edition ...

    Abstract For this two-part Clinical & Experimental Immunology Review Series, Guest Editor E. Diane Williamson invited experts in their fields to contribute articles on the status of vaccine research and development for emerging pathogens. Part One addressed our progress in developing vaccines for emerging and re-emerging viruses and considered current work on effective vaccines for bacterial pathogens. In this edition of the journal, we are pleased to present Part Two, in which our authors emphasise the importance of vaccine formulation and of the use of effective delivery vehicles, as well as the prospects for licensure for current candidate vaccines.
    MeSH term(s) Communicable Diseases, Emerging/immunology ; Communicable Diseases, Emerging/prevention & control ; Humans ; Vaccination ; Vaccines/immunology ; Vaccines/therapeutic use
    Chemical Substances Vaccines
    Language English
    Publishing date 2019-10-17
    Publishing country England
    Document type Editorial
    ZDB-ID 218531-3
    ISSN 1365-2249 ; 0009-9104 ; 0964-2536
    ISSN (online) 1365-2249
    ISSN 0009-9104 ; 0964-2536
    DOI 10.1111/cei.13378
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Prospects for a safe COVID-19 vaccine.

    Haynes, Barton F / Corey, Lawrence / Fernandes, Prabhavathi / Gilbert, Peter B / Hotez, Peter J / Rao, Srinivas / Santos, Michael R / Schuitemaker, Hanneke / Watson, Michael / Arvin, Ann

    Science translational medicine

    2020  Volume 12, Issue 568

    Abstract: ... essential, but rigorous studies are required to determine the safety of candidate vaccines. Here, on behalf ... of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group, we evaluate research ... on the potential risk of immune enhancement of disease by vaccines and viral infections, including ...

    Abstract Rapid development of an efficacious vaccine against the viral pathogen severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the cause of the coronavirus disease 2019 (COVID-19) pandemic, is essential, but rigorous studies are required to determine the safety of candidate vaccines. Here, on behalf of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group, we evaluate research on the potential risk of immune enhancement of disease by vaccines and viral infections, including coronavirus infections, together with emerging data about COVID-19 disease. Vaccine-associated enhanced disease has been rarely encountered with existing vaccines or viral infections. Although animal models of SARS-CoV-2 infection may elucidate mechanisms of immune protection, we need observations of enhanced disease in people receiving candidate COVID-19 vaccines to understand the risk of immune enhancement of disease. Neither principles of immunity nor preclinical studies provide a basis for prioritizing among the COVID-19 vaccine candidates with respect to safety at this time. Rigorous clinical trial design and postlicensure surveillance should provide a reliable strategy to identify adverse events, including the potential for enhanced severity of COVID-19 disease, after vaccination.
    MeSH term(s) Animals ; COVID-19 ; COVID-19 Vaccines ; Clinical Trials as Topic ; Coronavirus Infections/immunology ; Coronavirus Infections/prevention & control ; Disease Models, Animal ; Drug Development ; Humans ; Pandemics ; Pneumonia, Viral/immunology ; Vaccination ; Viral Vaccines/adverse effects ; Viral Vaccines/immunology
    Chemical Substances COVID-19 Vaccines ; Viral Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-10-19
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2518854-9
    ISSN 1946-6242 ; 1946-6234
    ISSN (online) 1946-6242
    ISSN 1946-6234
    DOI 10.1126/scitranslmed.abe0948
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Prospects for a safe COVID-19 vaccine

    Haynes, Barton F. / Corey, Lawrence / Fernandes, Prabhavathi / Gilbert, Peter B. / Hotez, Peter J. / Rao, Srinivas / Santos, Michael R. / Schuitemaker, Hanneke / Watson, Michael / Arvin, Ann

    Science Translational Medicine

    2020  , Page(s) eabe0948

    Abstract: ... by vaccines and viral infections, including coronavirus infections, together with emerging data about COVID-19 ... Rigorous clinical trial design and post-licensure surveillance should provide a reliable strategy ... the safety of candidate vaccines. Here, on behalf of the Accelerating COVID-19 Therapeutic Interventions and ...

    Abstract Rapid development of an efficacious vaccine against the viral pathogen SARS-CoV-2, the cause of the coronavirus disease-2019 (COVID-19) pandemic, is essential, but rigorous studies are required to determine the safety of candidate vaccines. Here, on behalf of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group, we evaluate research on the potential risk of immune enhancement of disease by vaccines and viral infections, including coronavirus infections, together with emerging data about COVID-19 disease. Vaccine-associated enhanced disease has been rarely encountered with existing vaccines or viral infections. Although animal models of SARS-CoV-2 infection may elucidate mechanisms of immune protection, we need observations of enhanced disease in people receiving candidate COVID-19 vaccines to understand the risk of immune enhancement of disease. Neither principles of immunity nor preclinical studies provide a basis for prioritizing among the COVID-19 vaccine candidates with respect to safety at this time. Rigorous clinical trial design and post-licensure surveillance should provide a reliable strategy to identify adverse events, including the potential for enhanced severity of COVID-19 disease, following vaccination.
    Keywords General Medicine ; covid19
    Language English
    Publisher American Association for the Advancement of Science (AAAS)
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2518854-9
    ISSN 1946-6242 ; 1946-6234
    ISSN (online) 1946-6242
    ISSN 1946-6234
    DOI 10.1126/scitranslmed.abe0948
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article: Prospects for a safe COVID-19 vaccine

    Haynes, Barton F / Corey, Lawrence / Fernandes, Prabhavathi / Gilbert, Peter B / Hotez, Peter J / Rao, Srinivas / Santos, Michael R / Schuitemaker, Hanneke / Watson, Michael / Arvin, Ann

    Sci. transl. med

    Abstract: ... essential, but rigorous studies are required to determine the safety of candidate vaccines. Here, on behalf ... of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group, we evaluate research ... on the potential risk of immune enhancement of disease by vaccines and viral infections, including ...

    Abstract Rapid development of an efficacious vaccine against the viral pathogen severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the cause of the coronavirus disease 2019 (COVID-19) pandemic, is essential, but rigorous studies are required to determine the safety of candidate vaccines. Here, on behalf of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group, we evaluate research on the potential risk of immune enhancement of disease by vaccines and viral infections, including coronavirus infections, together with emerging data about COVID-19 disease. Vaccine-associated enhanced disease has been rarely encountered with existing vaccines or viral infections. Although animal models of SARS-CoV-2 infection may elucidate mechanisms of immune protection, we need observations of enhanced disease in people receiving candidate COVID-19 vaccines to understand the risk of immune enhancement of disease. Neither principles of immunity nor preclinical studies provide a basis for prioritizing among the COVID-19 vaccine candidates with respect to safety at this time. Rigorous clinical trial design and postlicensure surveillance should provide a reliable strategy to identify adverse events, including the potential for enhanced severity of COVID-19 disease, after vaccination.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #880947
    Database COVID19

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