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4.
AAPS PharmSciTech ; 22(5): 172, 2021 Jun 07.
Article in English | MEDLINE | ID: covidwho-1261286

ABSTRACT

Vaccination development and production was an essential question for the prevention and global control of COVID-19. The strong support from governing authorities such as Operation Warp Speed and robust funding has led to the development and authorization of the tozinameran (BNT162b2) vaccine. The BNT162b2 vaccine is a lipid nanoparticle-encapsulated mRNA that encodes for SARS-CoV-2 spike protein, the main site for neutralizing antibodies. Once it binds with the host cells, the lipid nanoparticles enable the transfer of the RNA, causing S antigens' expression of the SARS-CoV-2, conferring immunity. The vaccine is administered as a 2-dose regime 21 days apart for individuals 16 years and older. Pfizer-BioNTech's BNT162b2 vaccine was the first candidate to receive FDA-Emergency Use Authorization (EUA) on December 11, 2020. During phase 2/3 clinical trials, 95% efficacy was reported among 37,706 participants over the age of 16 who received the BNT162b2 vaccination; additionally, 52% efficacy was noted 12 days following the administration of the first dose of BNT162b2, reflecting early protection of COVID-19. The BNT162b2 vaccine has exhibited 100% efficacy in clinical trials of adolescents between the ages of 12 and 15. Clinical trials in pregnant women and children under the age of 12 are expected to also exhibit promising results. This review article encompasses tozinameran (BNT162b2) vaccine journey, summarizing the BNT162b1 and BNT162b2 vaccines from preclinical studies, clinical trial phases, dosages, immune response, adverse effects, and FDA-EUA.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Clinical Trials as Topic/methods , Drug Approval/methods , SARS-CoV-2/drug effects , Animals , Antibodies, Neutralizing/drug effects , Antibodies, Neutralizing/metabolism , COVID-19/epidemiology , COVID-19/metabolism , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/metabolism , Clinical Trials as Topic/legislation & jurisprudence , Drug Approval/legislation & jurisprudence , Drug Evaluation, Preclinical/methods , Exanthema/chemically induced , Female , Humans , Male , SARS-CoV-2/metabolism , Spike Glycoprotein, Coronavirus/drug effects , Spike Glycoprotein, Coronavirus/metabolism , Vaccination/legislation & jurisprudence , Vaccination/methods
7.
Eur J Health Law ; 27(5): 425-450, 2020 10 21.
Article in English | MEDLINE | ID: covidwho-1088350

ABSTRACT

The COVID-19 pandemic has severely disrupted non-coronavirus clinical trials. In the case of life-threatening diseases, such as cancer, this is particularly dangerous, as treatment cannot simply be stopped. In the EU, guidelines for the management of ongoing studies were issued; however, national coordination is still lacking. This article aims to raise awareness on the struggle of managing ongoing clinical trials in the EU during the pandemic. The goals are to bring attention, from a legal and regulatory point of view to the difficulties faced by those involved in clinical research, and to critically position the current hurdles against the backdrop of the existing legal and ethical framework. We investigated the EU guidance and the national approaches of all EU/EEA Member States, and critically discussed selected issues. We argue that the crisis may be an opportunity to foresee meaningful changes in the EU clinical trials framework post-COVID-19.


Subject(s)
Clinical Trials as Topic/legislation & jurisprudence , Clinical Trials as Topic/organization & administration , Pandemics , Research Design/standards , Research/legislation & jurisprudence , Research/organization & administration , COVID-19/prevention & control , Ethics, Research , European Union , Humans
9.
Clin Pharmacol Ther ; 110(2): 311-320, 2021 08.
Article in English | MEDLINE | ID: covidwho-1051201

ABSTRACT

For the development of coronavirus disease 2019 (COVID-19) drugs during the ongoing pandemic, speed is of essence whereas quality of evidence is of paramount importance. Although thousands of COVID-19 trials were rapidly started, many are unlikely to provide robust statistical evidence and meet regulatory standards (e.g., because of lack of randomization or insufficient power). This has led to an inefficient use of time and resources. With more coordination, the sheer number of patients in these trials might have generated convincing data for several investigational treatments. Collaborative platform trials, comparing several drugs to a shared control arm, are an attractive solution. Those trials can utilize a variety of adaptive design features in order to accelerate the finding of life-saving treatments. In this paper, we discuss several possible designs, illustrate them via simulations, and also discuss challenges, such as the heterogeneity of the target population, time-varying standard of care, and the potentially high number of false hypothesis rejections in phase II and phase III trials. We provide corresponding regulatory perspectives on approval and reimbursement, and note that the optimal design of a platform trial will differ with our societal objective and by stakeholder. Hasty approvals may delay the development of better alternatives, whereas searching relentlessly for the single most efficacious treatment may indirectly diminish the number of lives saved as time is lost. We point out the need for incentivizing developers to participate in collaborative evidence-generation initiatives when a positive return on investment is not met.


Subject(s)
Antiviral Agents/pharmacology , COVID-19 , Clinical Trials as Topic , Research Design , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19/mortality , Clinical Trials as Topic/legislation & jurisprudence , Clinical Trials as Topic/organization & administration , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Drug Approval/legislation & jurisprudence , Europe , Humans , Patient Selection , Public Opinion , Standard of Care
10.
Cytotherapy ; 23(1): 10-11, 2021 01.
Article in English | MEDLINE | ID: covidwho-1002742

ABSTRACT

Attempts to streamline environmental procedures for those products containing or consisting of genetically modified organisms (GMOs) among the European Union (EU) Member States are ongoing but still need to be further developed. These procedures can be complex, resource-intensive and time-consuming. Some candidate vaccines currently under development for COVID-19 include genetically modified viruses, which may be considered GMOs. Given the public health emergency caused by the COVID-19 outbreak, on July 15, 2020, the European Parliament approved a temporary derogation of the European environmental requirements to facilitate that those clinical trials with GMOs intended to treat or prevent COVID-19 can start as soon as possible in Europe. This measure has been very controversial, since it could entail risks to human health and the environment, and could be seen as unfair for other products targeting unmet medical needs. With the adoption of this measure, the bottlenecks and obstacles for the development of innovative GMO-based medicines in the EU that the environmental legislation entails have become even more evident.


Subject(s)
COVID-19 Vaccines/genetics , COVID-19/epidemiology , COVID-19/prevention & control , Clinical Trials as Topic/legislation & jurisprudence , Organisms, Genetically Modified , Pandemics/prevention & control , SARS-CoV-2/genetics , SARS-CoV-2/immunology , COVID-19/virology , Europe/epidemiology , European Union , Humans , Risk Assessment
11.
Med Sci (Paris) ; 36(4): 303-307, 2020 Apr.
Article in French | MEDLINE | ID: covidwho-811536

ABSTRACT

TITLE: L'éthique des essais thérapeutiques. ABSTRACT: La pandémie de COVID-19 a conduit certains acteurs reconnus de la médecine à renoncer aux méthodes codifiées de la recherche médicale au profit d'affirmations établies dans l'urgence et sans réelle évaluation scientifique. Autant l'on peut comprendre que certains praticiens recourent à ce qui leur est ainsi proposé, autant cette confusion entre action dans l'urgence et recherche scientifique serait lourde de conséquences si elle venait à se généraliser, et cela à de multiples points de vue : image et rôle de la science, qualité et éthique de la recherche médicale et en fin de compte sort des malades soumis à des traitements mal évalués. Ce sont ces questions qui motivent la mise au point qui suit sur les questions d'éthique associées de longue date aux « essais thérapeutiques ¼, cette procédure rationnelle d'acquisition dans les meilleurs délais d'informations fiables sur les avantages et les risques des traitements dont on envisage l'éventuelle utilisation.


Subject(s)
Clinical Trials as Topic/ethics , Ethics, Medical , COVID-19 , Clinical Trials as Topic/legislation & jurisprudence , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Emergency Medical Services/ethics , Emergency Medical Services/history , Emergency Medical Services/legislation & jurisprudence , Emergency Medical Services/methods , History, 21st Century , Humans , Informed Consent/ethics , Informed Consent/legislation & jurisprudence , Informed Consent/standards , Knowledge , Legislation, Medical , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , Quality Improvement , Quality of Health Care/ethics , Quality of Health Care/legislation & jurisprudence , Research Design/legislation & jurisprudence , Research Design/standards , Therapies, Investigational/ethics , Therapies, Investigational/standards
12.
Rom J Morphol Embryol ; 61(1): 277-281, 2020.
Article in English | MEDLINE | ID: covidwho-694465

ABSTRACT

PURPOSE: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014∕536, the Directive 2001∕20∕EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. BACKGROUND: The Directive 2001∕20∕EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.


Subject(s)
Clinical Trials as Topic/ethics , Clinical Trials as Topic/legislation & jurisprudence , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Ethical Review , Ethics, Research , Health Policy , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , COVID-19 , Ethics Committees , European Union , Humans , Informed Consent , Pandemics , Patient Safety , Public Health , Research Design
13.
Clin Pharmacol Ther ; 108(4): 703-705, 2020 10.
Article in English | MEDLINE | ID: covidwho-526620

ABSTRACT

As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID-19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk-1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight "pandemic best regulatory practices." These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency-thus contributing to ending this pandemic as quickly, effectively, and safely as possible.


Subject(s)
Betacoronavirus , Drug and Narcotic Control/legislation & jurisprudence , Pandemics/legislation & jurisprudence , Practice Guidelines as Topic , COVID-19 , Clinical Trials as Topic/legislation & jurisprudence , Clinical Trials as Topic/standards , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Humans , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , Practice Guidelines as Topic/standards , SARS-CoV-2
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