Clinical trials of COVID 19 vaccines and vaccination campaign: ethical issues

2021 ◽  
Author(s):  
VE Goncharova
Keyword(s):  
Clinical Trials ◽  
Preventive Measures ◽  
Ethical Issues ◽  
Vaccine Development ◽  
Vaccination Campaign ◽  
Public Confidence ◽  
Basic Principles ◽  
Literary Sources ◽  
The World ◽  
Decisive Action

For many centuries, infectious diseases have posed a serious threat: epidemics and pandemics claim lives and multiply the burden on health systems and countries' economies. Humanity managed to defeat a number of infections only thanks to specific preventive measures, i.e., vaccination. In 2020, society faced the new COVID-19 virus that has swept the whole world. The situation required swift and decisive action, including in what concerned vaccine development. It has also raised a number of ethical issues. The article analyzes ethical issues related to clinical trials and vaccination against COVID-19 by studying the regulations, literary sources and bioethical incidents. The key problems identified are: human participation in clinical trials during a pandemic, availability and, simultaneously, voluntariness of vaccination, public confidence in the SARS-Cov-2 vaccines approved for clinical practice. The study showed that the basic principles of clinical trials, voluntariness and awareness, are violated. It was revealed that despite all the efforts of public organizations and WHO initiatives in the world, there is a pronounced imbalance in the availability of the developed vaccines, while the vaccination voluntariness principle is violated by application of various mechanisms to put pressure on people, and public confidence in the developed vaccines can be called insufficient. In general, the problem of vaccination against COVID-19 remains relevant and requires comprehensive discussion.

scholarly journals Influence of the Covid-19 pandemic on trends in development of professional ethics

2021 ◽  
Vol 11 (3) ◽  
pp. 87-97
Author(s):  
V.V. Samsonova ◽  
Keyword(s):  
Professional Ethics ◽  
Ethical Issues ◽  
Human Life ◽  
Business Environment ◽  
Low Carbon ◽  
Moral Norms ◽  
Basic Principles ◽  
Low Carbon Economy ◽  
Professional Activities ◽  
The World

The COVID-19 pandemic has created unprecedented challenges for businesses and organizations in the public and private sectors around the world. It has forever changed the business environment and pushed companies to a turning point in technology change. The catastrophic consequences of the pandemic for human health, its psychological endurance, emotional resilience and moral consciousness are striking. The results of the study show that in the near future it is necessary to prepare for overcoming the consequences of the pandemic not only in terms of medical and practical aspects, but also in terms of ethical issues. The article considers the challenges and consequences of the COVID-19 pandemic for the world economy, professional moral norms. Six megatrends that transform the world after the end of the pandemic, identified by the United Nations, including the advent of the big data economy: hyper-connected society; the wellbeing economy; low-carbon economy; the circular economy; the bio growth economy; the experience economy. It is noted that the likely emergence of new approaches to professional activities may create new threats or affect the level of previously identified threats to the basic principles of professional ethics and lead to certain ethical dilemmas in the performance of professional duties. These examples of the application of the basic principles of professional ethics in modern conditions will help to formulate the necessary ethical values for each person and better guide professionals in solving complex problems that currently arise in decision-making and create an ethical infrastructure that will improve the culture of business management at the operational and strategic levels. This will increase the efficiency of managing the economic development of the country. The emphasis is on the ethical responsibility of professionals in any field in the post-pandemic period. The results of the study suggest that the risk of discrediting ethics increases against the background of a pandemic. The article outlines the main directions of overcoming these challenges, trends in the development of professional ethical systems. There is a growing need for ethical regulation of professional behavior and actions in vital areas of human life.

scholarly journals How to continue COVID-19 vaccine clinical trials? The ethics of vaccine research in a time of pandemic

2021 ◽  
pp. 147775092110524
Author(s):  
Silvia Ceruti ◽  
Marco Cosentino ◽  
Mario Picozzi
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
Vaccination Campaign ◽  
Scientific Information ◽  
Well Being ◽  
Resource Scarcity ◽  
European Medicines Agency ◽  
Human Beings ◽  
Controlled Clinical Trials ◽  
The Us

Between December 2020 and March 2021, the US Food and Drug Administration and the European Medicines Agency issued Emergency Use Authorizations and Conditional Marketing Authorizations for the distribution of the first COVID-19 vaccines. Although these vaccines were thoroughly assessed before their approval, regulators required companies to continue ongoing placebo-controlled clinical trials in order to gather further reliable scientific information on their safety and efficacy, as well as to start new studies to evaluate additional candidates. The aim of this paper is to present and discuss the ethical issues raised by the tension between the need to continue these types of clinical trials and the obligations related to the protection of the rights and well-being of research participants. Specifically, we question whether—how, and to what extent—fundamental principles governing research involving human beings can be applied to the current pandemic situation. We argue that continuing ongoing placebo-controlled clinical trials can be considered ethically justifiable only if all participants are adequately informed of any developments that may affect their willingness to remain enrolled, including the current situation of resource scarcity and the prioritization criteria established for vaccination. However, we also argue that currently approved vaccines, which are considered safe and effective enough to be administered to millions of people as part of the vaccination campaign, necessarily represent the “best proven intervention” currently available and, therefore, should be used as comparators in future studies instead of placebo.

scholarly journals Immunoprophylaxis of infectious diseases in premature infants

2018 ◽  
Vol 15 (5) ◽  
pp. 376-389 ◽  
Author(s):  
Alexander A. Baranov ◽  
Leyla S. Namazova-Baranova ◽  
Irina A. Belyaeva ◽  
Irina V. Davydova ◽  
Nikolay N. Volodin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Infectious Diseases ◽  
Premature Infants ◽  
Russian Federation ◽  
Vaccination Schedule ◽  
Professional Association ◽  
Basic Principles ◽  
Key Points ◽  
The World ◽  
The Russian Federation

Premature infants are especially in need of timely and effective specific immunoprophylaxis due to their vulnerability to infectious diseases. The article describes the basic principles for vaccination of premature infants used in healthcare by the leading countries of the world. Based on the results of clinical trials, the peculiarities of the vaccination schedule for certain infections have been determined, the specific features of the course of the post-vaccinal period have been described. The operating procedures for active immunoprophylaxis of various types of infections have been explained in detail depending on the pathology and the therapy being performed. The article uses the key points of the recommended practices for prevention of the main controlled types of infections developed by the professional association of pediatricians ‘Union of Pediatricians of Russia’ and approved by the Ministry of Healthcare of the Russian Federation.

Ethical Aspects of Placebo in Migraine Research

Cephalalgia ◽  
2003 ◽  
Vol 23 (7) ◽  
pp. 491-495 ◽  
Author(s):  
M Linde ◽  
A May ◽  
V Limmroth ◽  
C Dahlöf ◽  
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
International Headache Society ◽  
Evaluation Process ◽  
Ethics Committees ◽  
Professional Associations ◽  
Controlled Clinical Trials ◽  
Study Protocols ◽  
The World ◽  
Golden Standard

Randomized placebo-controlled clinical trials have been the ‘golden standard’ during the last decades in the development of new drug therapies. This scientifically valid approach has recently been questioned in the fifth revised version of the Declaration of Helsinki, which states that the use of placebo-controlled clinical trials is only acceptable when no proven treatment exists for the studied disease. The World Medical Association further claims that no national ethical, legal or regulatory requirements should be allowed to reduce or eliminate any of the statements in the declaration. In spite of this, the document is not generally accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations. In the evaluation process for a drug to be approved in many countries today, clinical investigators at the hospitals and researchers at the pharmaceutical companies are obliged to use study protocols that would be rejected if the new declaration were to be fully adopted. Adherence to the clinical trial guidelines of the International Headache Society could also mean violation of the new Helsinki declaration of ethics. Some ethics committees have already adopted the new declaration, which has caused concern among clinical investigators, who find this document to be vastly out of the line with common practice. At the moment, the situation is unclear and debated with increasing polarity concerning the scientific and ethical issues regarding the use of placebo in clinical trials.

scholarly journals Vaccination during a pandemic - a public health challenge

2020 ◽  
Vol 32 (4) ◽  
pp. 617-619
Author(s):  
Faruqueuddin Ahmed
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Adverse Events ◽  
Vaccine Development ◽  
Route Of Administration ◽  
Health Challenge ◽  
The World ◽  
Public Health Challenge ◽  
Pass Through

Since the emergence of COVID 19 virus, scientists all over the world are working at breakneck speed to develop a vaccine. Development of a vaccine is not a competitive race to the finish as it must pass through a stringent process of evaluation. The process includes vaccines’ immunogenicity, duration of immunity, efficacy of protection, interaction with other antigens, dosage, route of administration, packaging, and thermostability and expected adverse events and safety. Efficacy of a new vaccine is measured in clinical trials under ideal conditions, whereas its effectiveness is measured in the field under actual program conditions. (1) In normal circumstances, vaccine development is a prolonged process, averaging over 10 years from start to finish (2). To meet the urgent, need a COVID 19 vaccine may be available in a much shorter-term frame, at the earliest in 18 months.

Statin wars: have we been misled about the evidence? A narrative review

2018 ◽  
Vol 52 (14) ◽  
pp. 905-909 ◽  
Author(s):  
Maryanne Demasi
Keyword(s):  
Clinical Trials ◽  
Heart Disease ◽  
Low Risk ◽  
Healthy People ◽  
Public Confidence ◽  
Efficacy And Safety ◽  
Cholesterol Lowering ◽  
Raw Data ◽  
The World ◽  
Total Sales

Statins are the most widely prescribed, cholesterol-lowering drugs in the world. Despite the expiration of their patents, revenue for statins is expected to rise, with total sales on track to reach an estimated US$1 trillion by 2020. A bitter dispute has erupted among doctors over suggestions that statins should be prescribed to millions of healthy people at low risk of heart disease. There are concerns that the benefits have been exaggerated and the risks have been underplayed. Also, the raw data on the efficacy and safety of statins are being kept secret and have not been subjected to scrutiny by other scientists. This lack of transparency has led to an erosion of public confidence. Doctors and patients are being misled about the true benefits and harms of statins, and it is now a matter of urgency that the raw data from the clinical trials are released.

scholarly journals Vaccine Development against COVID-19: Study from Pre-Clinical Phases to Clinical Trials and Global Use

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 836
Author(s):  
Sagheer Ahmed ◽  
Saeed Khan ◽  
Imran Imran ◽  
Fadwa Al Mughairbi ◽  
Fahad Sultan Sheikh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Clinical Investigation ◽  
World Health ◽  
Phase 3 ◽  
Global Demand ◽  
The World ◽  
Advanced Stages ◽  
The Moment ◽  
Health Organization

As per the World Health Organization (WHO), more than 288 vaccines against COVID-19 are being developed, with an estimated 184 being presently investigated in the pre-clinical phases, while 104 of these vaccine candidates are at various stages of clinical trials. Twelve of these are in the advanced stages of clinical investigation, and promising results in the phase 3 trials have already paved the way for their regulatory approval and subsequent dissemination for global use. Preliminary and interim results of some of these candidate vaccines are being analyzed for public dissemination. Some of these vaccines have already been rolled out to immunize not only the highest risk individuals but also the general population in several countries. Once their safety and efficacy are established, the next limiting step would be their mass manufacturing by the pharmaceutical companies to fulfill the global demand. The challenge of manufacturing billions of doses of high-quality vaccines is under-appreciated at the moment. A massive vaccination drive would be needed to protect people of all ages. The timely and coordinated execution of the vaccination effort would require unprecedented coordination at the national and international levels for generating funds to purchase the required doses of vaccines, fair distribution of doses and managing the mechanics of delivering vaccines throughout the world.

Elucidating the drug repurposing spectra of COVID-19 with its analogues SARS and MERS

2021 ◽  
Vol 21 ◽  
Author(s):  
Jayanti Mishra ◽  
Chakrawarti Prasun ◽  
P.K. Sahoo ◽  
Maya S Nair
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Virus Disease ◽  
Cathepsin L ◽  
Drug Repurposing ◽  
Disease Treatment ◽  
Acceptable Alternative ◽  
Drug Molecules ◽  
The World ◽  
Novel Drug

: COVID-19 disease, caused by the SARS CoV-2 virus, has been announced as Pandemic by the WHO. To date it has affected almost every part of the world, more than 39.8 million people were infected and up to 1.11 million have lost their lives. Currently, there has been no success to develop measures to cure the disease. Additionally, the vaccine development may take several months, and many novel drug molecules attempted have been fallen short of achieving success yet. Hence, an effective alternative solution is a need for these darkest hours. Repurposing of drugs has already proved efficacy in diseases, like, and it significantly provides the most acceptable alternative. There are hundreds of drug molecules approved for clinical trials by the FDA. SARS COV 2 virus has shown resemblance with enzyme targets such as 3CLpro/Mpro, RdRp, Cathepsin L, and TMPRSS2 with SARS CoV and MERS CoV that gives an option to use drugs that have shown efficacy in these viruses for COVID-19 (Corona Virus Disease) treatment. This review focuses on why repurposing could provide a better alternative in COVID-19 treatment and the similarity in the structural and progression of infection of these viruses gives a direction and validation to evaluate the drugs approved for SARS and MERS against COVID-19. It has been indicated that multiple therapeutic options that demonstrate efficacy against SARS CoV 2 are available to mitigate the potential emergence of COVID-19 infection.

scholarly journals Clinical trials in the time of a pandemic

2020 ◽  
Vol 17 (5) ◽  
pp. 467-471 ◽  
Author(s):  
Susan S Ellenberg
Keyword(s):  
Clinical Trials ◽  
World Health Organization ◽  
Vaccine Development ◽  
World Health ◽  
Severity Of Disease ◽  
The Past ◽  
The World ◽  
Global Spread ◽  
Severity Of The Disease ◽  
Health Organization

The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health emergency. By February 2020, cases had been identified in multiple countries, clinical trials of treatments with some biological plausibility had begun in China, and the initial steps of vaccine development were underway. In mid-March, by which time countries around the world were experiencing rapidly increasing numbers of cases and deaths, the World Health Organization categorized the outbreak as a pandemic. This new coronavirus was designated SARS-COV-2 in recognition of its similarity to the coronavirus responsible for the severe acute respiratory syndrome outbreak in 2002–2003. The race is on to develop treatments that can mitigate the severe consequences of infection and vaccines that can prevent infection and/or diminish the severity of disease in those who do get infected. Many challenges face these development efforts. Some are similar to those faced in the past; others are new. The urgency of finding ways to treat, and ultimately prevent, the consequences of this new and potentially deadly infection has led to unprecedented focus on clinical trials.

scholarly journals Efforts at COVID-19 Vaccine Development: Challenges and Successes

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 739 ◽  
Author(s):  
Azizul Haque ◽  
Anudeep B. Pant
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Vaccine Development ◽  
Public Health Emergency ◽  
Safety And Efficacy ◽  
Vast Array ◽  
Advantages And Disadvantages ◽  
Rapid Spread ◽  
The World ◽  
The U.S

The rapid spread of SARS-CoV-2, the new coronavirus (CoV), throughout the globe poses a daunting public health emergency. Different preventive efforts have been undertaken in response to this global health predicament; amongst them, vaccine development is at the forefront. Several sophisticated designs have been applied to create a vaccine against SARS-CoV-2, and 44 candidates have already entered clinical trials. At present, it is unclear which ones will meet the objectives of efficiency and safety, though several vaccines are gearing up to obtain emergency approval in the U.S. and Europe. This manuscript discusses the advantages and disadvantages of various vaccine platforms and evaluates the safety and efficacy of vaccines in advance stages. Once a vaccine is developed, the next challenge will be acquisition, deployment, and uptake. The present manuscript describes these challenges in detail and proposes solutions to the vast array of translational challenges. It is evident from the epidemiology of SARS-CoV-2 that the virus will remain a threat to everybody as long as the virus is still circulating in a few. We need affordable vaccines that are produced in sufficient quantity for use in every corner of the world.

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