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  1. Article ; Online: Safety and reactogenicity of second booster doses for mRNA vaccines.

    Wilder-Smith, Annelies / Kochhar, Sonali

    The Lancet. Respiratory medicine

    2022  Volume 11, Issue 2, Page(s) 112–113

    MeSH term(s) Humans ; Haemophilus Vaccines ; Immunization, Secondary/adverse effects ; mRNA Vaccines/adverse effects ; Pneumococcal Vaccines
    Chemical Substances Haemophilus Vaccines ; mRNA Vaccines ; Pneumococcal Vaccines
    Language English
    Publishing date 2022-11-18
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 2686754-0
    ISSN 2213-2619 ; 2213-2600
    ISSN (online) 2213-2619
    ISSN 2213-2600
    DOI 10.1016/S2213-2600(22)00451-9
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  2. Article ; Online: Harmonized case definitions for endpoints in vaccine efficacy trials are needed.

    Heininger, Ulrich / Buttery, Jim / Kochhar, Sonali

    Vaccine

    2022  Volume 41, Issue 27, Page(s) 3947

    MeSH term(s) Endpoint Determination ; Vaccine Efficacy ; Clinical Trials as Topic ; Humans
    Language English
    Publishing date 2022-12-07
    Publishing country Netherlands
    Document type Letter
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2022.11.070
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  3. Article ; Online: Expecting the unexpected with COVID-19 vaccines.

    Bar-Zeev, Naor / Kochhar, Sonali

    The Lancet. Infectious diseases

    2020  Volume 21, Issue 2, Page(s) 150–151

    MeSH term(s) Adolescent ; Adult ; COVID-19 ; COVID-19 Vaccines ; Double-Blind Method ; Humans ; Middle Aged ; SARS-CoV-2 ; Young Adult
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2020-11-17
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(20)30870-7
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  4. Article ; Online: Author Correction: Placebo use and unblinding in COVID-19 vaccine trials: recommendations of a WHO Expert Working Group.

    Singh, Jerome Amir / Kochhar, Sonali / Wolff, Jonathan

    Nature medicine

    2021  Volume 27, Issue 5, Page(s) 925

    Language English
    Publishing date 2021-05-04
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-021-01360-3
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  5. Article ; Online: Ethics of Conducting Clinical Research in an Outbreak Setting.

    Edwards, Kathryn M / Kochhar, Sonali

    Annual review of virology

    2020  Volume 7, Issue 1, Page(s) 475–494

    Abstract: The conduct of clinical trials during the West Africa Ebola outbreak in 2014 highlighted many ethical challenges. How these challenges were addressed, what clinical studies were conducted during that outbreak, and the lessons learned for dealing with ... ...

    Abstract The conduct of clinical trials during the West Africa Ebola outbreak in 2014 highlighted many ethical challenges. How these challenges were addressed, what clinical studies were conducted during that outbreak, and the lessons learned for dealing with future outbreaks were the subject of a National Academy of Medicine committee report titled
    MeSH term(s) Adult ; Africa, Western/epidemiology ; Antiviral Agents/therapeutic use ; Biomedical Research/ethics ; Biomedical Research/organization & administration ; Child ; Clinical Trials as Topic/ethics ; Clinical Trials as Topic/organization & administration ; Disease Outbreaks ; Ebola Vaccines/administration & dosage ; Ebolavirus/pathogenicity ; Female ; Hemorrhagic Fever, Ebola/epidemiology ; Hemorrhagic Fever, Ebola/immunology ; Hemorrhagic Fever, Ebola/mortality ; Hemorrhagic Fever, Ebola/prevention & control ; Humans ; International Cooperation ; Male ; Patient Selection/ethics ; Pregnancy ; Survival Analysis
    Chemical Substances Antiviral Agents ; Ebola Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-03-25
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2764224-0
    ISSN 2327-0578 ; 2327-056X
    ISSN (online) 2327-0578
    ISSN 2327-056X
    DOI 10.1146/annurev-virology-013120-013123
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  6. Article ; Online: Placebo use and unblinding in COVID-19 vaccine trials: recommendations of a WHO Expert Working Group.

    Singh, Jerome Amir / Kochhar, Sonali / Wolff, Jonathan

    Nature medicine

    2021  Volume 27, Issue 4, Page(s) 569–570

    MeSH term(s) COVID-19/prevention & control ; COVID-19 Vaccines/immunology ; Clinical Trials as Topic ; Humans ; Placebo Effect ; SARS-CoV-2/immunology ; World Health Organization
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2021-03-16
    Publishing country United States
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-021-01299-5
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  7. Article ; Online: Planning for COVID-19 vaccines safety surveillance.

    Kochhar, Sonali / Salmon, Daniel A

    Vaccine

    2020  Volume 38, Issue 40, Page(s) 6194–6198

    Abstract: COVID-19 vaccines are the most important tool to stem the pandemic. They are being developed with unprecedented global collaboration and accelerated timelines to achieve WHO Emergency Use Listing, while using regulatory pathways through national ... ...

    Abstract COVID-19 vaccines are the most important tool to stem the pandemic. They are being developed with unprecedented global collaboration and accelerated timelines to achieve WHO Emergency Use Listing, while using regulatory pathways through national regulatory authorities. Alongside preparations to ensure equitable access to the vaccines among people globally, preparations must be made within countries for COVID-19 vaccines safety surveillance on an urgent basis. Safety surveillance must be capable of investigating adverse events of special interest (AESI) and adverse events following immunization to determine a change in the benefit-risk profile of the vaccine, and to be able to anticipate coincidental events that might be attributed to the vaccine. Active surveillance systems should calculate the incidence of background rates of AESI prior to vaccine roll out. These background rates vary tremendously across regions, populations and case ascertainment methods. Active surveillance systems must be established or strengthened now, (including in LMIC), to calculate the background rates. Utilizing standardized case definitions and global standards for AESI will help in harmonization. Vaccine safety communication plans should be developed. Expanding the global vaccine safety system to meet the needs of COVID-19 and other emergency and routine use vaccines is a priority currently.
    MeSH term(s) Adverse Drug Reaction Reporting Systems ; Betacoronavirus/immunology ; COVID-19 ; COVID-19 Vaccines ; Coronavirus Infections/immunology ; Coronavirus Infections/prevention & control ; Humans ; Pandemics/prevention & control ; Pneumonia, Viral/immunology ; Pneumonia, Viral/prevention & control ; Product Surveillance, Postmarketing ; SARS-CoV-2 ; Vaccination ; Viral Vaccines/adverse effects ; Viral Vaccines/immunology
    Chemical Substances COVID-19 Vaccines ; Viral Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-07-10
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2020.07.013
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  8. Article ; Online: Communicating vaccine safety during the development and introduction of vaccines.

    Kochhar, Sonali

    Current drug safety

    2015  Volume 10, Issue 1, Page(s) 55–59

    Abstract: Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy ... ...

    Abstract Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.
    MeSH term(s) Adverse Drug Reaction Reporting Systems ; Cooperative Behavior ; Drug Approval/methods ; Drug Discovery/methods ; Health Communication/methods ; Humans ; Immunization Programs ; Immunization Schedule ; Interdisciplinary Communication ; Patient Acceptance of Health Care ; Patient Safety ; Policy Making ; Protective Factors ; Risk Assessment ; Risk Factors ; Trust ; Vaccination/adverse effects ; Vaccines/adverse effects ; Vaccines/therapeutic use
    Chemical Substances Vaccines
    Language English
    Publishing date 2015-02-06
    Publishing country United Arab Emirates
    Document type Journal Article
    ZDB-ID 2250840-5
    ISSN 2212-3911 ; 1574-8863
    ISSN (online) 2212-3911
    ISSN 1574-8863
    DOI 10.2174/157488631001150407110435
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Benefit-risk assessment of vaccines.

    Kochhar, Sonali / Izurieta, Hector S / Chandler, Rebecca E / Hacker, Adam / Chen, Robert T / Levitan, Bennett

    Vaccine

    2023  Volume 42, Issue 4, Page(s) 969–971

    Abstract: Benefit-risk assessment (BRA) is critical for decision-making throughout the vaccine life cycle. It requires scientific assessment of evidence to make an informed judgment on whether the vaccine has a favourable benefit-risk profile i.e. the benefits of ... ...

    Abstract Benefit-risk assessment (BRA) is critical for decision-making throughout the vaccine life cycle. It requires scientific assessment of evidence to make an informed judgment on whether the vaccine has a favourable benefit-risk profile i.e. the benefits of the vaccine outweigh its risks for use in its intended indication. The assessment must also consider data gaps and uncertainties, using sensitivity analyses to show the impact of these uncertainties in the assessment. The BRA field has advanced considerably over the past years, including the use of structured BRA frameworks, quantitative BRA models and use of the patient experience data. Analytical tools and procedures to standardize BRA implementation have become increasingly important. A Benefit-Risk Assessment Module has been prepared to enable the planning, assessment, and communication of relevant BRA information via a structured B-R framework. The module can help facilitate the conduct and communication of defensible BRAs by vaccine developers, funders, regulators and policy makers in high, middle or low-income countries, both for regulatory submissions and in public health responses to infectious diseases, including for epidemics.
    MeSH term(s) Humans ; Risk Assessment/methods ; Vaccines ; Communication ; Uncertainty
    Chemical Substances Vaccines
    Language English
    Publishing date 2023-08-08
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2023.07.041
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  10. Article: Planning for COVID-19 vaccines safety surveillance

    Kochhar, Sonali / Salmon, Daniel A

    Vaccine. 2020 Sept. 11, v. 38, no. 40

    2020  

    Abstract: COVID-19 vaccines are the most important tool to stem the pandemic. They are being developed with unprecedented global collaboration and accelerated timelines to achieve WHO Emergency Use Listing, while using regulatory pathways through national ... ...

    Abstract COVID-19 vaccines are the most important tool to stem the pandemic. They are being developed with unprecedented global collaboration and accelerated timelines to achieve WHO Emergency Use Listing, while using regulatory pathways through national regulatory authorities. Alongside preparations to ensure equitable access to the vaccines among people globally, preparations must be made within countries for COVID-19 vaccines safety surveillance on an urgent basis. Safety surveillance must be capable of investigating adverse events of special interest (AESI) and adverse events following immunization to determine a change in the benefit-risk profile of the vaccine, and to be able to anticipate coincidental events that might be attributed to the vaccine.Active surveillance systems should calculate the incidence of background rates of AESI prior to vaccine roll out. These background rates vary tremendously across regions, populations and case ascertainment methods. Active surveillance systems must be established or strengthened now, (including in LMIC), to calculate the background rates. Utilizing standardized case definitions and global standards for AESI will help in harmonization. Vaccine safety communication plans should be developed. Expanding the global vaccine safety system to meet the needs of COVID-19 and other emergency and routine use vaccines is a priority currently.
    Keywords COVID-19 infection ; immunization ; monitoring ; pandemic ; people ; vaccines
    Language English
    Dates of publication 2020-0911
    Size p. 6194-6198.
    Publishing place Elsevier Ltd
    Document type Article
    Note NAL-AP-2-clean
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2020.07.013
    Database NAL-Catalogue (AGRICOLA)

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