Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data

Vasileiou, Eleftheria; Shi, Ting; Kerr, Steven; Robertson, Chris; Joy, Mark; Tsang, Ruby S M; McGagh, Dylan; Williams, John; Vlymen, Jeremy van; Bradley, Declan; O’Reilly, Dermot; Murphy, Siobhán; Chuter, Antony; Beggs, Jillian; Ford, David; Orton, Chris; Akbari, Ashley; Bedston, Stuart; Davies, Gareth; Griffiths, Lucy J; Griffiths, Rowena; Lowthian, Emily; Lyons, Jane; Lyons, Ronan A.; North, Laura; Perry, Malorie; Torabi, Fatemeh; Pickett, James; McMenamin, Jim; McCowan, Colin; Agrawal, Utkarsh; Wood, Rachael; Stock, Sarah; Moore, Emily; Henery, Paul; Simpson, Colin R; Sheikh, Aziz

doi:10.1136/bmjopen-2021-050062

Cited by 11 publications

(10 citation statements)

References 40 publications

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“…The EAVE II surveillance platform drew on near real-time nationwide health care data for 5.4 million individuals (∼99%) in Scotland 1–4 . It includes information on clinical and demographic characteristics of each individual, their vaccination status and type of vaccine used and information on positive SARS-COV-2 infection and subsequent hospitalization or death.…”

Section: Methodsmentioning

confidence: 99%

“…To investigate the real-world effectiveness of SARS-CoV-2 vaccination, we used the EAVE II surveillance platform which draws on near real-time nationwide health care data for 5.4 million individuals (~99%) in Scotland, UK [22][23][24][25] . We interrogated data on 3,522,331 individuals aged 18 and over who received a second dose (of the primary vaccination schedule) or a third booster dose of vaccine and were followed up until hospitalization, death or the end of the study.…”

Section: Hospitalization and Death Due To Covid-19 In Vaccinated Peoplementioning

confidence: 99%

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Accelerated waning of the humoral response to SARS-CoV-2 vaccines in obesity

Klaauw

Horner

Pereyra-Gerber

et al. 2022

Preprint

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Obesity is associated with an increased risk of severe Covid-19. However, the effectiveness of SARS-CoV-2 vaccines in people with obesity is unknown. Here we studied the relationship between body mass index (BMI), hospitalization and mortality due to Covid-19 amongst 3.5 million people in Scotland. Vaccinated people with severe obesity (BMI>40 kg/m2) were significantly more likely to experience hospitalization or death from Covid-19. Excess risk increased with time since vaccination. To investigate the underlying mechanisms, we conducted a prospective longitudinal study of the immune response in a clinical cohort of vaccinated people with severe obesity. Compared with normal weight controls, six months after their second vaccine dose, significantly more people with severe obesity had unquantifiable titres of neutralizing antibody against authentic SARS-CoV-2 virus, reduced frequencies of antigen-experienced SARS-CoV-2 Spike-binding B cells, and a dissociation between anti-Spike antibody levels and neutralizing capacity. Neutralizing capacity was restored by a third dose of vaccine, but again declined more rapidly in people with severe obesity. We demonstrate that waning of SARS-CoV-2 vaccine-induced humoral immunity is accelerated in people with severe obesity and associated with increased hospitalization and mortality from breakthrough infections. Given the prevalence of obesity, our findings have significant implications for global public health.

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Section: Methodsmentioning

confidence: 99%

Section: Hospitalization and Death Due To Covid-19 In Vaccinated Peoplementioning

confidence: 99%

Accelerated waning of the humoral response to SARS-CoV-2 vaccines in obesity

Klaauw

Horner

Pereyra-Gerber

et al. 2022

Preprint

Self Cite

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“…So far, this is one of the few studies to actively investigate VAEs in the primary care setting (data from an Australian large-scale system are already available [ 17 ], while those from Europe have not yet been published [ 18 , 19 ]). Our findings reflect the possible daily experience of primary care physicians vaccinating their patients against COVID-19.…”

Section: Discussionmentioning

confidence: 99%

COVID-19 vaccine short-term adverse events in the real-life family practice in Krakow, Poland

Oleszczyk

Marciniak

Nessler

et al. 2022

European Journal of General Practice

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Background In manufacturers’ trials, vaccination against COVID-19 proved to be safe and effective. The officially reported frequency of vaccine adverse events (VAEs) in Poland is lower than that declared by the manufacturers. The anti-vaccination activists questioned the trustworthiness of official data. Objectives The aim was to explore the real-life prevalence of VAEs in general practice settings and the factors that may influence it. Methods In this pragmatic, mixed prospective and retrospective study, patients vaccinated against COVID-19 between May and October 2021 in three GP practices in Krakow, Poland, were enrolled. Their demographic (age, sex, level of education) and clinical data (weight and height, smoking status, history of allergies, COVID-19 and chronic diseases) were collected. Then, they were interviewed about VAEs they experienced. Results Out of 1530 patients invited to participate, 1051 (69%) agreed and were eligible for analyses. Only 8.8% did not report any VAE. Pain at the injection site was the most frequently reported reaction (800, 76.2%). The most prevalent systemic ones were excessive fatigue/lethargy (527, 50.6%), sleep/circadian rhythm disturbances (433, 41.6%) and headache (399, 38.3%). Fifty required medical assistance − 39 experienced presyncope (3.7%) and 11 loss of consciousness (1.1%). Only two others were hospitalised. Females, younger adults, those with higher education and with a history of COVID-19 reported systemic VAEs more frequently, while those who were older and obese were less likely to report local reactions. Conclusion Although more than 90% of patients vaccinated against COVID-19 in general practice settings may experience VAEs, in short-term observation, the vast majority are localised and mild.

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“…Canadian data was from Ontario, as health services are run by province. Although England (56 million) is approximately 85% of the UK (65 million population), the devolved nations, Scotland, Wales, and Northern Ireland have their own health systems; though they did collaborate and conduct pooled analyses [16].…”

Section: Country Reportsmentioning

confidence: 99%

Integrated Management Systems (IMS) to Support and Sustain Quality One Health Services: International Lessons from the COVID-19 Pandemic by the IMIA Primary Care Working Group

et al. 2023

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Objectives: One Health considers human, animal and environment health as a continuum. The COVID-19 pandemic started with the leap of a virus from animals to humans. Integrated management systems (IMS) should provide a coherent management framework, to meet reporting requirements and support care delivery. We report IMS deployment during, and retention post the COVID-19 pandemic, and exemplar One Health use cases. Methods: Six volunteer members of the International Medical Association’s (IMIA) Primary Care Working Group provided data about any IMS and One Health use to support the COVID-19 pandemic initiatives. We explored how IMS were: (1) Integrated with organisational strategy; (2) Utilised standardised processes, and (3) Met reporting requirements, including public health. Selected contributors provided Unified Modelling Language (UML) use case diagram for a One Health exemplar. Results: There was weak evidence of synergy between IMS and health system strategy to the COVID-19 pandemic. However, there were rapid pragmatic responses to COVID-19, not citing IMS. All health systems implemented IMS to link COVID test results, vaccine uptake and outcomes, particularly mortality and to provide patients access to test results and vaccination certification. Neither proportion of gross domestic product alone, nor vaccine uptake determined outcome. One Health exemplars demonstrated that animal, human and environmental specialists could collaborate. Conclusions: IMS use improved the pandemic response. However, IMS use was pragmatic rather than utilising an international standard, with some of their benefits lost post-pandemic. Health systems should incorporate IMS that enables One Health approaches as part of their post COVID-19 pandemic preparedness.

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Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data

Cited by 11 publications

References 40 publications

Accelerated waning of the humoral response to SARS-CoV-2 vaccines in obesity

Accelerated waning of the humoral response to SARS-CoV-2 vaccines in obesity

COVID-19 vaccine short-term adverse events in the real-life family practice in Krakow, Poland

Integrated Management Systems (IMS) to Support and Sustain Quality One Health Services: International Lessons from the COVID-19 Pandemic by the IMIA Primary Care Working Group

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