From program suspension to the pandemic: A qualitative examination of Australia’s vaccine pharmacovigilance system over 10 years

Phillips, Anastasia; Carlson, Steve A.; Danchin, Margie; Beard, Frank; Macartney, Kristine

doi:10.1016/j.vaccine.2021.07.059

Cited by 9 publications

(6 citation statements)

References 29 publications

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“…AusVaxSafety surveillance improves our understanding of the COVID-19 vaccine safety at the population level, including in people with underlying medical conditions. As an active surveillance system, AusVaxSafety complements spontaneous AEFI reporting to the TGA, 21…”

Section: Discussionmentioning

confidence: 99%

“…AusVaxSafety surveillance improves our understanding of the COVID‐19 vaccine safety at the population level, including in people with underlying medical conditions. As an active surveillance system, AusVaxSafety complements spontaneous AEFI reporting to the TGA, 21 and helps educate and counsel people about expected AEFI and their impact during the Australian COVID‐19 vaccination program. AusVaxSafety continues to monitor COVID‐19 vaccine safety in Australia, including that of booster and future doses as our vaccination program evolves.…”

Section: Discussionmentioning

confidence: 99%

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The short term safety ofCOVID‐19 vaccines in Australia:AusVaxSafetyactive surveillance, February – August 2021

Deng

Glover

Dymock³

et al. 2022

Medical Journal of Australia

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Objective To assess the short term safety of the COVID‐19 vaccines Comirnaty (Pfizer–BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia. Design Prospective observational cohort study; online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination. Setting, participants People aged 16 years or more who received COVID‐19 vaccines at sentinel vaccination hubs, general practices, or Aboriginal Community Controlled Health Organisation clinics, 22 February – 30 August 2021. Main outcome measures Primary outcome: proportion of respondents who reported any adverse event following immunisation (AEFI) 0–3 days after vaccination. Secondary outcomes: proportions of respondents who reported specific adverse events or medical review for AEFI within seven days of vaccination; impact on usual daily activities; recovery. Results 4 851 480 people received COVID‐19 vaccines at participating sentinel sites during the study period (25% of all COVID‐19 vaccine doses administered in Australia to 30 August 2021). 3 035 983 people responded to both surveys (response rate, 62.6%); 35.9% of respondents reported one or more AEFI 0–3 days after Comirnaty dose 1, 54.7% after Comirnaty dose 2, 52.8% after Vaxzevria dose 1, and 22.0% after Vaxzevria dose 2. Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms. After adjusting for demographic characteristics, vaccination site type, jurisdiction, and self‐reported medical conditions, the odds of reporting any AEFI were higher for women than men (range of adjusted odd ratios [aORs], by vaccine and dose, 1.53–1.84), for people with a history of anaphylaxis (aOR range, 1.28–1.45), and for people reporting certain underlying conditions, including obesity (aOR range, 1.15–1.75), immunodeficiency (aOR range, 1.04–2.24), or chronic inflammatory disease (aOR range, 1.05–1.75). 0.9% of respondents sought medical advice in the three days following vaccination, most frequently after Comirnaty dose 2 (1.4%) and Vaxzevria dose 1 (1.2%). Conclusion AusVaxSafety active surveillance affirms the short term safety profile of Comirnaty and Vaxzevria vaccines in a large population sample during the first six months of the Australian COVID‐19 vaccination program.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The short term safety ofCOVID‐19 vaccines in Australia:AusVaxSafetyactive surveillance, February – August 2021

Deng

Glover

Dymock³

et al. 2022

Medical Journal of Australia

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“…ADEM can be classified as an adverse event following immunization, defined as any untoward medical occurrence that follows immunization and does not necessarily have a causal relationship with the usage of the vaccine [7].…”

Section: Discussionmentioning

confidence: 99%

Acute disseminated encephalomyelitis post-SARS-COV-2 vaccination with Chadox1 nCov-19 (AZD1222) – A rare case report

Sivji¹,

MV²,

Pratap³

et al. 2024

Eastern J Med Sci

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Background: Acute disseminated encephalomyelitis (ADEM) is an inflammatory demyelinating disease of the CNS, characterized by fulminant multifocal neurologic injury and distinct neuropathologic findings. Case Report: We report a case of a forty-nine-year-old female who presented with progressive weakness of right side of the body of one-week duration. Clinical, laboratory and radiological features favored demyelination. There was temporal association with taking SARS COV 2 vaccination (ChAdOx1 n cov -19 (AZD1222)). She was treated with a course of steroids and made a good recovery. Conclusion: To our knowledge this is a rare case of ADEM noticed after ChAdOx1 nCoV-19 vaccine (AZD1222).

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“…The literature search was conducted by using the keywords “pharmacovigilance, adverse drug reactions, ADR, policy, regulation, qualitative study, policy analysis, coordination, and stakeholders” on search engines such as Google Scholar, ScienceDirect, HINARI, and PubMed. This literature review fed to develop the guide ( Ritchie and Lewis, 2003 ; DiCicco-Bloom and Crabtree, 2006 ; Guion and Mcdonald, 2006 ; Turner, 2010 ; Babar et al, 2012 ; Babar and Francis, 2014 ; Hussain et al, 2018 , Hussain et al, 2020b ; Phillips et al, 2021 ; Khan et al, 2022 ).…”

Section: Methodsmentioning

confidence: 99%

A Qualitative Study of Stakeholders’ Views on Pharmacovigilance System, Policy, and Coordination in Pakistan

et al. 2022

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Objectives:Due to the absence of necessary rules, poor coordination, and various challenges, the pharmacovigilance system of Pakistan is not optimally functional at all levels of the health system. The objective of the study was to assess the stakeholders’ perceptions of the current ADR reporting system and to identify the pharmacovigilance policy issues and problems of effective coordination.Methodology:Stakeholders from a broad range of disciplines, academia, regulatory authorities, the pharmaceutical industry, international health organizations, as well as pharmacovigilance experts, and healthcare professionals were included in the study. A total of 25 stakeholders throughout Pakistan were interviewed during exploratory semi-structured interviews. The interviews were recorded digitally, transcribed, coded, compared, and grouped according to their similarity of themes. Participants provided insights into gaps, limitations, and challenges of Pakistan’s current ADR reporting system, issues with proposed pharmacovigilance rules, and coordination difficulties.Results:The majority of the participants considered the ADR reporting system in Pakistan to be improving but in a nascent phase. The identified gaps, challenges, limitations of the system, and barriers to reporting were labeled as reasons for limited functioning. Almost all stakeholders were aware of the existence of draft pharmacovigilance rules; however, participants in the industry were familiar with the contents and context of draft pharmacovigilance rules. Bureaucratic red tape and lack of political will appeared to be the top reasons for delaying the approval of the pharmacovigilance rules. Wider consultation, advocacy, and awareness sessions of policymakers and HCPs were suggested for early approval of rules. Participants unanimously agreed that the approval of rules shall improve the quality of life and reduce the economic burden along with morbidity and mortality rates. The need for greater and collaborative coordination among the stakeholders in promoting medicines’ safety was highlighted. All participants suggested the use of media and celebrities to disseminate the safety information.Conclusion:Participants showed partial satisfaction with the way pharmacovigilance in Pakistan is moving forward. However, stakeholders believed that engagement of multi-stakeholders, approval of pharmacovigilance rules, and the establishment of pharmacovigilance centers in provinces, hospitals, and public health programs (PHPs) shall support in achieving the desired results.

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From program suspension to the pandemic: A qualitative examination of Australia’s vaccine pharmacovigilance system over 10 years

Cited by 9 publications

References 29 publications

The short term safety ofCOVID‐19 vaccines in Australia:AusVaxSafetyactive surveillance, February – August 2021

The short term safety ofCOVID‐19 vaccines in Australia:AusVaxSafetyactive surveillance, February – August 2021

Acute disseminated encephalomyelitis post-SARS-COV-2 vaccination with Chadox1 nCov-19 (AZD1222) – A rare case report

A Qualitative Study of Stakeholders’ Views on Pharmacovigilance System, Policy, and Coordination in Pakistan

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