risk benefit analysis
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Vaccines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 81
Author(s):  
Michal Stein ◽  
Liat Ashkenazi-Hoffnung ◽  
David Greenberg ◽  
Ilan Dalal ◽  
Gilat Livni ◽  
...  

As of October 2021, SARS-CoV-2 infections were reported among 512,613 children and adolescents in Israel (~33% of all COVID-19 cases). The 5–11-year age group accounted for about 43% (223,850) of affected children and adolescents. In light of the availability of the Pfizer-BioNTech BNT162b2 vaccine against COVID-19 for children aged 5–11 years, we aimed to write a position paper for pediatricians, policymakers and families regarding the clinical aspects of COVID-19 and the vaccination of children against COVID-19. The first objective of this review was to describe the diverse facets of the burden of COVID-19 in children, including the direct effects of hospitalization during the acute phase of the disease, multisystem inflammatory syndrome in children, long COVID and the indirect effects of social isolation and interruption in education. In addition, we aimed to provide an update regarding the efficacy and safety of childhood mRNA COVID-19 vaccination and to instill confidence in pediatricians regarding the benefits of vaccinating children against COVID-19. We reviewed up-to-date Israeli and international epidemiological data and literature regarding COVID-19 morbidity and its sequelae in children, vaccine efficacy in reducing COVID-19-related morbidity and SARS-CoV-2 transmission and vaccine safety data. We conducted a risk–benefit analysis regarding the vaccination of children and adolescents. We concluded that vaccines are safe and effective and are recommended for all children aged 5 to 11 years to protect them from COVID-19 and its complications and to reduce community transmissions. Based on these data, after weighing the benefits of vaccination versus the harm, the Israeli Ministry of Health decided to recommend vaccination for children aged 5–11 years.


2021 ◽  
Author(s):  
ABBA AMSAMI ELGUJJA

This paper reviewed the extent to which Bolam provided healthcare professionals with immunity from claims based on negligence in the past, and whether Bolitho was able to resolve that issue.During the early 1950s, when the NHS was in its golden era, the medical profession was still “unregulated and paternalistic” in approach. Consequently, the medical profession had enjoyed unreserved obedience from patients and was treated with great reverence by society. John Hector Bolam was a patient who sustained fractures because the defendants applied unmodified electro-convulsive therapy on him. So, his suit for negligence provided the much-needed opportunity for grounding the principles of medical negligence which was still in its early stage of development. The issue was unprecedented, and therefore the dictum of Lord President Clyde in the Scottish case of Hunter and Hanley became handy. The ruling gave doctors the latitude to set standards of care and justify their actions by simply having their peers support them. It placed the onus of proving “Wednesbury unreasonableness” on the patients in order to succeed in medical negligence litigation against a doctor. That was very difficult to prove. This attracted criticisms against Bolam that it provided excessive immunity to doctors and difficulties to the patients. Several cases had been decided in favor of the doctors and allied healthcare professionals.A similar opportunity arose in 1984 when the Bolitho rule was propounded which empowered the courts to intervene and determine if a body of medical opinion is indeed responsible, by subjecting their evidence to the logicality and risk/benefit analysis tests.Issues for consideration include, to what extent did Bolam provide immunity to healthcare professionals and, post-Bolitho, if the issues have now been resolved. To accomplish that, the author will examine the various court decisions pre-and post- Bolitho with a view to coming up with the answer(s) to the issues raised


2021 ◽  
pp. 014107682110525
Author(s):  
Deepti Gurdasani ◽  
Samir Bhatt ◽  
Anthony Costello ◽  
Spiros Denaxas ◽  
Seth Flaxman ◽  
...  

Objective To offer a quantitative risk–benefit analysis of two doses of SARS-CoV-2 vaccination among adolescents in England. Setting England. Design Following the risk–benefit analysis methodology carried out by the US Centers for Disease Control, we calculated historical rates of hospital admission, Intensive Care Unit admission and death for ascertained SARS-CoV-2 cases in children aged 12–17 in England. We then used these rates alongside a range of estimates for incidence of long COVID, vaccine efficacy and vaccine-induced myocarditis, to estimate hospital and Intensive Care Unit admissions, deaths and cases of long COVID over a period of 16 weeks under assumptions of high and low case incidence. Participants All 12–17 year olds with a record of confirmed SARS-CoV-2 infection in England between 1 July 2020 and 31 March 2021 using national linked electronic health records, accessed through the British Heart Foundation Data Science Centre. Main outcome measures Hospitalisations, Intensive Care Unit admissions, deaths and cases of long COVID averted by vaccinating all 12–17 year olds in England over a 16-week period under different estimates of future case incidence. Results At high future case incidence of 1000/100,000 population/week over 16 weeks, vaccination could avert 4430 hospital admissions and 36 deaths over 16 weeks. At the low incidence of 50/100,000/week, vaccination could avert 70 hospital admissions and two deaths over 16 weeks. The benefit of vaccination in terms of hospitalisations in adolescents outweighs risks unless case rates are sustainably very low (below 30/100,000 teenagers/week). Benefit of vaccination exists at any case rate for the outcomes of death and long COVID, since neither have been associated with vaccination to date. Conclusions Given the current (as at 15 September 2021) high case rates (680/100,000 population/week in 10–19 year olds) in England, our findings support vaccination of adolescents against SARS-CoV2.


Author(s):  
Eduardo Cesar Tondo ◽  
Claudia Titze Hessel Gonçalves

Abstract We have created a risk-benefit analysis (RBA) model to assist in food safety decision-making by analyzing Salmonella control in Brazilian chicken meat. First, we described the issues in a risk profile and used a 5 × 5 matrix to rank the risks associated with Salmonella. We then classified the magnitude of benefits and costs of control measures using another matrix. Finally, we verified the beneficial effects of recommended control measures using Quantitative Microbiological Risk Assessment (QMRA). The RBA classified Salmonella contamination as risk 6, indicating that control measures should be taken in the short and medium terms. It also recommended the adoption of biosecurity measures on farms to reduce the prevalence of Salmonella in birds, better control of carcass washings and chiller tank management, and information placement on packages and campaigns to raise the awareness of the population about the need to control Salmonella contamination before consumption. On the other hand, it did not recommend better controls at scalding and defeathering. QMRA confirmed the beneficial effects of the recommended control measures. For example, as Salmonella prevalence in poultry increased from 4.04% to 50%, the risk of infection per serving also increased from 0.0080 to 0.071. Although better controls in washings and chiller tank management did not affect the risk of infection, it reduced Salmonella counts on carcasses. We assume that the presence of Salmonella on carcasses was due to improper thermal processing or cross contamination, which increased the risk from 0.0080 to 0.015962. The RBA demonstrated the logic involved in the adoption of control measures, and this can be helpful in the risk management of food safety issues.


2021 ◽  
Author(s):  
Colleen L Lau ◽  
Helen J Mayfield ◽  
Jane E Sinclair ◽  
Sam J Brown ◽  
Michael Waller ◽  
...  

Thrombosis and Thromobocytopenia Syndrome (TTS) has been associated with the AstraZencea (AZ) COVID-19 vaccine. Australia has reported low TTS incidence of <3/100,000 after the first dose, with case fatality rate (CFR) of 5-6%. Risk-benefit analysis of vaccination has been challenging because of rapidly evolving data, changing levels of transmission, and age-specific variation in rates of TTS, COVID-19, and CFR. We aim to optimise risk-benefit analysis by developing a model that enables inputs to be updated rapidly as evidence evolves. A Bayesian network was used to integrate local and international data, government reports, published literature and expert opinion. The model estimates probabilities of outcomes under different scenarios of age, sex, low/medium/high transmission (0.05%/0.45%/5.76% of population infected over 6 months), SARS-CoV-2 variant, vaccine doses, and vaccine effectiveness. We used the model to compare estimated deaths from vaccine-associated TTS with i) COVID-19 deaths prevented under different scenarios, and ii) deaths from COVID-19 related atypical severe blood clots (cerebral venous sinus thrombosis & portal vein thrombosis). For a million people aged >70 years where 70% received first dose and 35% received two doses, our model estimated <1 death from TTS, 25 deaths prevented under low transmission, and >3000 deaths prevented under high transmission. Risks versus benefits varied significantly between age groups and transmission levels. Under high transmission, deaths prevented by AZ vaccine far exceed deaths from TTS (by 8 to >4500 times depending on age). Probability of dying from COVID-related atypical severe blood clots was 58-126 times higher (depending on age and sex) than dying from TTS. To our knowledge, this is the first example of the use of Bayesian networks for risk-benefit analysis for a COVID-19 vaccine. The model can be rapidly updated to incorporate new data, adapted for other countries, extended to other outcomes (e.g., severe disease), or used for other vaccines.


2021 ◽  
pp. 395-446
Author(s):  
Shelley Raine

This chapter begins with the principles of contraception (choice, access, measures of effectiveness) and a risk/benefit analysis and eligibility of different types. It explains emergency contraception. The chapter goes on to discuss different formulations, preparations, methods of use (or administration and insertion). This includes the combined oral contraceptive pill (COCOP), the transdermal patch, intra vaginal rings, progestogen-only pills, the subdermal implant, injectables, intra-uterine devices and systems, barrier methods for both male and female use, and spermicides. Finally it covers fertility awareness, and the sterilization of women and men.


2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Pawel Zagozdzon

Abstract Focus of Presentation During pandemic the social life has been transformed by new regimes of social distancing, face masks, and altered online education. The aim of this presentation is to review the recent philosophical concepts of biopolitics that bring an additional perspective to the COVID-19 pandemic. Findings The most important critical response was brought from the philosopher and cultural theorist Giorgio Agamben who in the book entitled “Where are we now? Epidemic as politics” evoked again, known from his previous writings, the figure of bare life. The epidemic restrictions have shown, that humanity no longer believes in anything but bare existence, to be preserved as such at any cost. There were no reliable risk-benefit analysis that took into account all other aspects of human condition except statistical data on positive test results or “asymptomatic illness”. The concepts of another Italian philosopher Roberto Esposito became more than relevant during pandemic. In his book entitled “Immmunitas: the Protection and Negation of Life” he assumes that the more we feel at risk of being infiltrated and infected by foreign elements, the more the life of the individual and society closes off within its protective boundaries, reminding us of the situations during lockdowns. Conclusions/Implications According to biopolitical interpretation of epidemic, the risk of infection can be considered as a “pretext” for ramping up political control on citizens. Key messages Epidemiologists should be aware what are the consequences of the decisions they recommended for governments when the social relations and the power structure are affected.


2021 ◽  
Author(s):  
Deepti Gurdasani

The UK JCVI committee recently announced that vaccines would not be offered to all 12-17 year olds, as the potential risks were not outweighed by the benefits. Here, we offer a quantitative risk-benefit analysis of vaccines among 12-17 year olds in England, showing that the benefits of vaccination greatly outweigh risks among12-17 year olds in England in the current context.


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