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  1. Article: Case reports as early safety signals: learning from the COVID-19 vaccination campaign.

    Goldman, Michel / Chandler, Rebecca E

    Frontiers in medicine

    2024  Volume 10, Page(s) 1348376

    Language English
    Publishing date 2024-01-09
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2023.1348376
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  2. Article ; Online: The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities.

    Chandler, Rebecca E

    Drug safety

    2022  Volume 45, Issue 6, Page(s) 597–599

    MeSH term(s) Adverse Drug Reaction Reporting Systems ; Humans ; Pharmacovigilance ; Public Opinion ; Vaccines/adverse effects
    Chemical Substances Vaccines
    Language English
    Publishing date 2022-05-09
    Publishing country New Zealand
    Document type Editorial
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-022-01179-y
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  3. Article ; Online: Case reports as early safety signals

    Michel Goldman / Rebecca E. Chandler

    Frontiers in Medicine, Vol

    learning from the COVID-19 vaccination campaign

    2024  Volume 10

    Keywords safety ; vaccine ; adjuvant ; COVID-19 ; case report ; pharmacovigilance ; Medicine (General) ; R5-920
    Language English
    Publishing date 2024-01-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Optimizing safety surveillance for COVID-19 vaccines.

    Chandler, Rebecca E

    Nature reviews. Immunology

    2020  Volume 20, Issue 8, Page(s) 451–452

    MeSH term(s) Betacoronavirus/immunology ; COVID-19 ; COVID-19 Vaccines ; Coronavirus Infections/immunology ; Coronavirus Infections/prevention & control ; Humans ; Immunologic Surveillance/immunology ; Pandemics ; Pneumonia, Viral/immunology ; SARS-CoV-2 ; Safety ; Viral Vaccines/adverse effects ; Viral Vaccines/immunology
    Chemical Substances COVID-19 Vaccines ; Viral Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-06-18
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2062776-2
    ISSN 1474-1741 ; 1474-1733
    ISSN (online) 1474-1741
    ISSN 1474-1733
    DOI 10.1038/s41577-020-0372-8
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  5. Article ; Online: Nintedanib and ischemic colitis: Signal assessment with the integrated use of two types of real-world evidence, spontaneous reports of suspected adverse drug reactions, and observational data from large health-care databases.

    Chandler, Rebecca E

    Pharmacoepidemiology and drug safety

    2020  Volume 29, Issue 8, Page(s) 951–957

    Abstract: Purpose: Statistical screening of Vigibase, the global database of individual case safety reports, highlighted an association between the MedDRA Preferred Term (PT) "colitis" and nintedanib. Nintedanib is a protein kinase inhibitor authorized in ... ...

    Abstract Purpose: Statistical screening of Vigibase, the global database of individual case safety reports, highlighted an association between the MedDRA Preferred Term (PT) "colitis" and nintedanib. Nintedanib is a protein kinase inhibitor authorized in accelerated regulatory procedures for the treatment of idiopathic pulmonary fibrosis (IPF). The aim of this report is to describe the integration of two types of real-world evidence, spontaneous reports of adverse drug reactions (ADR), and observational health data (OHD) in the assessment of a post-authorization safety signal of ischemic colitis.
    Methods: Assessment of the statistical signal of "nintedanib - colitis" was undertaken using data from VigiBase, OHD from the Observational Heath Data Sciences and Informatics (OHDSI) collaborative, published literature, and openly available regulatory documents. Evidence synthesis was performed to support Bradford Hill criteria in causality assessment.
    Results: Evidence for strength of association, specificity, consistency, and analogy was found upon review of the case series. OHD was used to calculate incidence rates of colitis in new users of nintedanib across multiple populations, supportive of consistency, and further evidence for strength of association. Literature review identified support for biological plausibility and analogy. Signal assessment was supplemented with characterization of real-world users and exploration of potential risk factors using OHD.
    Conclusions: An integrated approach using two forms of real-world data, spontaneous reports of ADRs and data from observational databases allowed a comprehensive and efficient signal assessment of nintedanib and colitis. Further exploration of the complementary use of real-time OHD in signal assessment could inform more efficient approaches to current signal management practices.
    MeSH term(s) Aged ; Asia/epidemiology ; Colitis, Ischemic/chemically induced ; Colitis, Ischemic/epidemiology ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Europe/epidemiology ; Female ; Humans ; Indoles/adverse effects ; Male ; Middle Aged ; Observational Studies as Topic ; Pharmacovigilance ; Protein Kinase Inhibitors/adverse effects ; United States/epidemiology
    Chemical Substances Indoles ; Protein Kinase Inhibitors ; nintedanib (G6HRD2P839)
    Language English
    Publishing date 2020-05-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 1099748-9
    ISSN 1099-1557 ; 1053-8569
    ISSN (online) 1099-1557
    ISSN 1053-8569
    DOI 10.1002/pds.5022
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  6. Article ; Online: Modernising vaccine surveillance systems to improve detection of rare or poorly defined adverse events.

    Chandler, Rebecca E

    BMJ (Clinical research ed.)

    2019  Volume 365, Page(s) l2268

    MeSH term(s) Adverse Drug Reaction Reporting Systems/organization & administration ; Adverse Drug Reaction Reporting Systems/standards ; Communication Barriers ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/prevention & control ; Humans ; Papillomavirus Vaccines/adverse effects ; Papillomavirus Vaccines/pharmacology ; Pharmacovigilance ; Public Opinion ; Quality Improvement ; Risk Management/methods ; Risk Management/organization & administration ; Risk Management/standards ; Vaccines/adverse effects ; Vaccines/pharmacology
    Chemical Substances Papillomavirus Vaccines ; Vaccines
    Language English
    Publishing date 2019-05-31
    Publishing country England
    Document type Journal Article
    ZDB-ID 1362901-3
    ISSN 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    ISSN (online) 1756-1833
    ISSN 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    DOI 10.1136/bmj.l2268
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  8. Article ; Online: Optimizing safety surveillance for COVID-19 vaccines

    Chandler, Rebecca E.

    Nature Reviews Immunology

    2020  Volume 20, Issue 8, Page(s) 451–452

    Keywords Immunology ; covid19
    Language English
    Publisher Springer Science and Business Media LLC
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2062776-2
    ISSN 1474-1741 ; 1474-1733
    ISSN (online) 1474-1741
    ISSN 1474-1733
    DOI 10.1038/s41577-020-0372-8
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Harm caused by vaccines might vary between individuals.

    Chandler, Rebecca E

    BMJ (Clinical research ed.)

    2017  Volume 358, Page(s) j3631

    Language English
    Publishing date 2017--03
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 1362901-3
    ISSN 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    ISSN (online) 1756-1833
    ISSN 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    DOI 10.1136/bmj.j3631
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  10. Article ; Online: Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally.

    ShamaeiZadeh, Parisa A / Jaimes, Carmen Villamizar / Knoll, Maria Deloria / Espié, Emmanuelle / Chandler, Rebecca E

    Vaccine: X

    2024  Volume 18, Page(s) 100485

    Abstract: Background: Evidence of COVID-19 vaccine safety relied upon the global vaccine monitoring infrastructure due to shortened clinical development timelines and emergency use licensure. Differences in AVSS capacity between high-income countries (HICs) ... ...

    Abstract Background: Evidence of COVID-19 vaccine safety relied upon the global vaccine monitoring infrastructure due to shortened clinical development timelines and emergency use licensure. Differences in AVSS capacity between high-income countries (HICs) versus low- and middle-income countries (LMICs) were known prior to the pandemic.
    Objective: To assess the global landscape of COVID-19 vaccine AVSS activities to identify gaps in safety evidence generation across vaccine products and populations with a focus on LMICs.
    Methods: A cross-sectional survey was conducted in January 2022 on AVSS activities evaluating adverse events following immunization (AEFI). Data collected included country, targeted population, COVID-19 vaccine product(s), design of surveillance/monitoring activities or study, and AEFIs to be monitored.To supplement these findings, we conducted a literature review of COVID-19 vaccine safety activities published in PubMed through January 2023. Observational activities assessing AEFI, specifically adverse events of special interest (AESI), following routine use of COVID-19 vaccines in medical practice were included; systematic reviews, benefit/risk assessments, clinical trials, and case reports/series were excluded.
    Results: The survey, completed by 34 respondents and compiled with reviews of 7 publicly available Risk Management Plans from five vaccine manufacturers, identified 79 monitoring activities in HICs, 24 in LMICs, and 9 in multiple regions. Most activities in LMICs were planned cohort event monitoring (CEM) studies (n = 18); two multi-national hospital-based sentinel surveillance studies for AESI were ongoing. Activities in LMICs evaluated multiple COVID-19 vaccine products simultaneously and were sponsored by health authorities. The literature review identified 1245 unique citations, of which 379 met inclusion criteria. The majority evaluated vaccines primarily used in high-income countries: Pfizer BioNTech (Comirnaty; n = 303), Moderna (mRNA-1273; n = 164), AstraZeneca (AZD1222; n = 126), and Janssen (Ad26.COV2.S); n = 62); 14 citations assessed vaccines used exclusively in LMICs: Sinovac (CoronaVac), Beijing CNBG (BBIBP-Corv), Bharat (Covaxin), SII (Covashield), and Gamaleya (Gam-Covid-Vac) vaccines.
    Conclusions: Robust safety evidence for input into benefit/risk assessments is likely unavailable for most COVID-19 vaccines used primarily in LMICs due to emphasis on cohort event monitoring methods. Goals for equitable vaccine access should be coupled with investment and support for building infrastructure and capacity for safety evidence generation to inform policy and regulatory decisions at local levels.
    Language English
    Publishing date 2024-04-10
    Publishing country England
    Document type Journal Article
    ISSN 2590-1362
    ISSN (online) 2590-1362
    DOI 10.1016/j.jvacx.2024.100485
    Database MEDical Literature Analysis and Retrieval System OnLINE

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