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Vaccines Against COVID-19
Published in Hanadi Talal Ahmedah, Muhammad Riaz, Sagheer Ahmed, Marius Alexandru Moga, The Covid-19 Pandemic, 2023
Majid Khan, Muhammad Faheem, Najmur Rahman, Rizwan Ahmad, M. Zia-Ul-Haq, Muhammad Ria
The vaccine trials must provide potentially crucial scientific information; the trials’ volunteers are at potential risk [63]. Every trial of the vaccine shall make sure the fair recruitment of the volunteers for the trials. There are several examples in history where some vulnerable groups of the population, such as mentally ill persons and prisoners, etc., were recruited for the trials, which is recognized as a violation of the proper selection procedure [64]. Volunteers’ choice for vaccine trials must be on a scientific basis with minimum risk [63]. A vaccine trial must present a balance of risks Vs benefit ratio, i.e., identify, and minimize the risk to the volunteers before vaccine trials.
The Long and Winding Road
Published in Norman Begg, The Remarkable Story of Vaccines, 2023
If a vaccine is successful in Phase 1, Phase 2 can begin. Here, the objective is different. The vaccine trials are not done in healthy adult volunteers, but in the people that you eventually want to benefit from the vaccine. This may be young children, teenagers, the elderly or people with specific medical conditions. In Phase 2, the goal is to show “proof of concept”; i.e. whether the vaccine is likely to be safe and effective in the population for whom it is eventually intended. Usually, the focus is on one “target” group – those that stand to benefit the most from the vaccine. I have worked on several types of meningitis vaccine over the years. The Phase 1 studies were done in adults, but the Phase 2 studies would have to be done in babies and teenagers, who would eventually be given the vaccine.
Cyberspace at Risk
Published in Kenneth Okereafor, Cybersecurity in the COVID-19 Pandemic, 2021
As the world's healthcare institutions and medical systems were being stretched to their limits while the pandemic raged in the most affected regions, the need for speedy access to medical data desperately grew owing to the rising cases of new infections [28]. Frontline medical workers needed credible data to plan for the use of limited facilities.Contact tracers needed accurate and timely statistics to support tracking.Isolation centres needed demographic data updated in real-time [29] to reflect the changing dynamics of the spread of the virus in order to plan for staffing, supplies, distribution of PPE, and other logistics.Hospitals needed health data to manage medications, disease mapping, and hospitalization.Pharmaceutical companies required data to plan market segmentation.Research institutes needed health statistical records to strategize on clinical analysis of vaccine trials.
Vaccine clinical trials in low- and middle-income countries: a brief review of standard, newer and proposed approaches
Published in Expert Review of Vaccines, 2022
Jacqueline Deen, John D Clemens
Adaptive vaccine trials refer to a whole family of designs that aim to shorten trial duration, minimize participant numbers and answer multiple-research questions by incorporating several endpoints in one study [11]. It has been proposed as a means to increase the efficiency of standard randomized controlled trials by allowing modifications in the sample size, intervention, primary endpoint, study population, plans for interim analyses and other parameters while the study is ongoing [40,41]. For example, an adaptive vaccine trial may assess multiple-candidate vaccines against a single control arm (placebo or active control vaccine) [42]. The adaptive vaccine trial design may also depart from the traditional separate phase 1 to 3 trials and instead include passage across the phases within a single protocol [43]. Adaptive vaccine trials, as a departure from the traditional trial paradigm, may require new mind-sets and training to implement in LMICs, but if successful, the design may use available technical expertise and research infrastructure more resourcefully. The adaptive approach has been taken up by the pharmaceutical industry in high-income countries (HIC) to reduce product development times and costs, has been endorsed by regulators, and could be implemented more widely in clinical research in LMICs [43].
Interplay of Anti-Viral Vaccines with Biologic Agents and Immunomodulators in Individuals with Autoimmune and Autoinflammatory Diseases
Published in Immunological Investigations, 2021
Barbara E. Ostrov, Daniel Amsterdam
Prevention of infection is true evidence of vaccine effectiveness. Clinical trials of new vaccines would, ideally, be comprised of large populations of previously uninfected individuals with test subjects compared to controls who are given sham injections. Recent SARS-CoV-2 vaccine trials followed this approach successfully since this is a new virus and a worldwide pandemic. Vaccine trials included 30,000 to 50,000 generally healthy adults of wide-ranging ages (16 to 85 years) (Walsh et al. 2020). Protection from infection (not just antibody levels) was proven within 4–5 months’ time with effectiveness, i.e., prevention of disease, in up to 95% of vaccine recipients (Walsh et al. 2020). This is an unprecedented situation; however, as most vaccine-preventable infections occur at much lower rates today and evidence of efficacy by proving prevention of infection in such a short time is not usually possible. Typically, retrospective analyses show suppressed influenza, hepatitis B virus (HBV), varicella zoster virus (VZV) and human papillomavirus (HPV) infection rates and/or complications many months to years after vaccination programs have been implemented.
To What Extent Are Calls for Greater Minority Representation in COVID Vaccine Research Ethically Justified?
Published in The American Journal of Bioethics, 2021
Angela Ballantyne, Agomoni Ganguli-Mitra
We can also consider research participation from the perspective of the individual participant. Individuals from minoritized communities are not likely to be especially vulnerable, or at higher risk of harm in comparison to their white counterparts, in the context of research—in part because anyone with poorly controlled comorbidities such as diabetes or hypertension has been excluded from trials (Levine 2020). Phase III trials allow access to a potentially effective vaccine that could benefit individual participants. There is significant overdemand for an effective vaccine, and it is expected that initial stages of vaccine distribution will prioritize essential or health care workers. Trial participation is associated with access to increased health monitoring, health care, and up to 2 years of follow-up (Levine 2020). In contexts where the access to health care is significantly unequal (such as the United States, where more than 40 million people lack health insurance), the personal benefits from participating in a Phase III vaccine trial might indeed outweigh the risks associated with research. Of course, the potential incentivization of research participation in exchange for health benefits in a context of severe health disparities is itself ethically problematic.