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Expert Review of Clinical Pharmacology May 2021The COVID-19 pandemic has created a public health crisis, infected millions of people, and caused a significant number of deaths. SARS-CoV-2 transmits from person to... (Review)
Review
INTRODUCTION
The COVID-19 pandemic has created a public health crisis, infected millions of people, and caused a significant number of deaths. SARS-CoV-2 transmits from person to person through several routes, mainly via respiratory droplets, which makes it difficult to contain its spread into the community. Here, we provide an overview of the epidemiology, pathogenesis, clinical presentation, diagnosis, and treatment of COVID-19.
AREAS COVERED
Direct person-to-person respiratory transmission has rapidly amplified the spread of coronavirus. In the absence of any clinically proven treatment options, the current clinical management of COVID-19 includes symptom management, infection prevention and control measures, optimized supportive care, and intensive care support in severe or critical illness. Developing an effective vaccine is now a leading research priority. Some vaccines have already been approved by the regulatory authorities for the prevention of COVID-19.
EXPERT OPINION
General prevention and protection measures regarding the containment and management of the second or third waves are necessary to minimize the risk of infection. Until now, four vaccines reported variable efficacies of between 62-95%, and two of them (Pfizer/BioNTech and Moderna) received FDA emergency use authorization. Equitable access and effective distribution of these vaccines in all countries will save millions of lives.
Topics: Antiviral Agents; COVID-19; COVID-19 Vaccines; Humans; Infectious Disease Incubation Period; Public Health Administration; SARS-CoV-2
PubMed: 33705239
DOI: 10.1080/17512433.2021.1902303 -
The Journal of Pharmacy Technology :... Feb 2022Professional regulatory authorities play a critical role in protecting public interest. Yet, there is a growing view that trust in regulatory authorities may be on the...
Professional regulatory authorities play a critical role in protecting public interest. Yet, there is a growing view that trust in regulatory authorities may be on the decline. Awareness has been identified as important for maintaining trust. However, research that examines public awareness and trust in pharmacy regulatory authorities (PRAs) is lacking. This research explores public awareness and trust of PRAs and presents recommendations to enhance PRA communication strategies. An online survey was conducted with the Nova Scotia (Canada) public in 2020. Adopting classifications from the Communications literature, 3 media generations were explored: newspaper, television, and the Internet. The χ test of independence and Kruskal-Wallis test were adopted to explore differences between the generations. Six hundred sixty-two usable surveys were obtained. Over 80% of those surveyed were aware of the existence of the PRA. Those who had heard of the PRA were most aware of its operational responsibilities and less aware of its governance. The Internet Generation was more aware that the PRA includes members of the public in its decision making than expected and showed increased trust toward the PRA versus the other media generations. The findings should help inform PRA communication plans and set baselines to assess whether such plans enhance awareness. Future studies should explore additional aspects of PRA awareness and trust, perform comparisons across pharmacy jurisdictions, and develop and test models of the relationship between PRA awareness and various dimensions of institutional trust.
PubMed: 35141726
DOI: 10.1177/87551225211051593 -
Frontiers in Medicine 2022The field of regulatory affairs deals with the regulatory requirements for marketing authorization of therapeutic products. This field is facing a myriad of forces... (Review)
Review
The field of regulatory affairs deals with the regulatory requirements for marketing authorization of therapeutic products. This field is facing a myriad of forces impacting all aspects of the development, regulation and value proposition of new therapeutic products. Changes in global megatrends, such as geopolitical shifts and the rise of the green economy, have emphasized the importance of manufacturing and supply chain security, and reducing the environmental impacts of product development. Rapid changes due to advances in science, digital disruption, a renewed focus on the centrality of the patient in all stages of therapeutic product development and greater collaboration between national regulatory authorities have been accelerated by the COVID-19 pandemic. This article will discuss the various trends that are impacting the development of new therapies for alleviating disease and how these trends therefore impact on the role of the regulatory affairs professional. We discuss some of the challenges and provide insights for the regulatory professional to remain at the forefront of these trends and prepare for their impacts on their work.
PubMed: 36698838
DOI: 10.3389/fmed.2022.1082384 -
Clinical Microbiology and Infection :... Sep 2022Oral drugs against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have received emergency use authorization for the treatment of mild-to-moderate COVID-19... (Review)
Review
BACKGROUND
Oral drugs against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have received emergency use authorization for the treatment of mild-to-moderate COVID-19 in non-hospitalized patients who are at high risk for clinical progression.
OBJECTIVES
To provide a clinical practice overview of first-generation oral antiviral agents against SARS-CoV-2.
SOURCES
References for this review were identified through searches of PubMed, Google Scholar, bioRxiv, medRxiv, regulatory drug agencies, and pharmaceutical companies' websites up to 16 February 2022.
CONTENT
Molnupiravir and nirmatrelvir and ritonavir have been authorized for use in nonhospitalized individuals with mild-to-moderate COVID-19 who are at high risk for progression. In clinical trials, molnupiravir reduced the frequency of hospitalization or death by 3% (relative risk reduction 30%), and nirmatrelvir and ritonavir by 6% (relative risk reduction 89%). Their use in clinical practice requires early administration, review of drug-drug interactions (nirmatrelvir and ritonavir), considerations of embryo-fetal toxicity (molnupiravir), and compliance with ingestion of a high number of pills. Knowledge gaps include the efficacy of these agents in vaccinated, hospitalized, or immunosuppressed individuals with prolonged SARS-CoV-2 persistence.
IMPLICATIONS
First-generation oral antivirals represent progress in therapeutics against SARS-CoV-2, but also pose new challenges in clinical practice. Further advances in the development of new drugs are required.
Topics: Antiviral Agents; Cytidine; Humans; Hydroxylamines; Pharmaceutical Preparations; Ritonavir; SARS-CoV-2; COVID-19 Drug Treatment
PubMed: 35545195
DOI: 10.1016/j.cmi.2022.04.015 -
Current Topics in Microbiology and... 2022In the past 20 years, the mRNA vaccine technology has evolved from the first proof of concept to the first licensed vaccine against emerging pandemics such as... (Review)
Review
In the past 20 years, the mRNA vaccine technology has evolved from the first proof of concept to the first licensed vaccine against emerging pandemics such as SARS-CoV-2. Two mRNA vaccines targeting SARS-CoV-2 have received emergency use authorization by US FDA, conditional marketing authorization by EMA, as well as multiple additional national regulatory authorities. The simple composition of an mRNA encoding the antigen formulated in a lipid nanoparticle enables a fast adaptation to new emerging pathogens. This can speed up vaccine development in pandemics from antigen and sequence selection to clinical trial to only a few months. mRNA vaccines are well tolerated and efficacious in animal models for multiple pathogens and will further contribute to the development of vaccines for other unaddressed diseases. Here, we give an overview of the mRNA vaccine design and factors for further optimization of this new promising technology and discuss current knowledge on the mode of action of mRNA vaccines interacting with the innate and adaptive immune system.
Topics: Animals; COVID-19; Models, Animal; mRNA Vaccines; COVID-19 Vaccines; Vaccine Development
PubMed: 33591423
DOI: 10.1007/82_2020_230 -
Clinical Microbiology and Infection :... Oct 2023Persistent and resistant infections caused by bacteria are increasing in numbers and pose a treatment challenge to the medical community and public health. However,... (Review)
Review
BACKGROUND
Persistent and resistant infections caused by bacteria are increasing in numbers and pose a treatment challenge to the medical community and public health. However, solutions with new agents that will enable effective treatment are lacking or delayed by complex development and authorizations. Bacteriophages are known as a possible solution for invasive infections for decades but were seldom used in the Western world.
OBJECTIVES
To provide an overview of the current status and emerging use of bacteriophage therapy and phage-based products, as well as touch on the socioeconomic and regulatory issues surrounding their development.
SOURCES
Peer-reviewed articles and authors' first-hand experience.
CONTENT
Although phage therapy is making a comeback since its early discovery, there are many hurdles to its current use. The lack of appropriate standardized bacterial susceptibility testing; lack of a simple business model and authorization for the need of many phages to treat a single species infection; and the lack of knowledge on predictable outcome measures are just a few examples. In this review, we explore the possible routes for phage use, either based on local specialty centres or by industry; the current status of phage therapy, which is mainly based on single-centre or single-bacterial cohorts, and emerging clinical trials; local country-level frameworks for phage utilization even without full authorization; and the use of phage-derived products as alternatives to antibiotics. We also explore what may be the current indications based on the possible availability of phages.
IMPLICATIONS
Although phages are emerging as a potential treatment for non-resolving and life-threatening infections, the models for their use and production still need to be defined by the medical community, regulatory bodies, and industry. Bacteriophages may have a great potential for infection treatment but many aspects still need to be defined before their routine use in the clinic.
PubMed: 37866680
DOI: 10.1016/j.cmi.2023.10.018 -
Allergologie Select 2023Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most... (Review)
Review
Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level. The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.
PubMed: 38143937
DOI: 10.5414/ALX02413E -
Investigative Radiology Jan 2020The purpose of this manuscript is to review the successive regulatory actions and decisions following the initial publication by Kanda and colleagues in 2014 regarding... (Review)
Review
OBJECTIVES
The purpose of this manuscript is to review the successive regulatory actions and decisions following the initial publication by Kanda and colleagues in 2014 regarding gadolinium retention in the human brain after multiple gadolinium-based contrast agents (GBCAs) administrations.
MATERIALS AND METHODS
Starting from 2014, the actions and decisions made by all regulatory authorities were collected and summarized region by region. Volumes of GBCA sales in 2018 per region and main countries are also presented as an indicator of patients' exposure to those products.
RESULTS
All regulatory authorities agreed on the absence of evidence of any harmful effect of gadolinium retention in humans. However, based on the same amount of preclinical and clinical evidence available in adults and children, regulatory authorities used different approaches resulting in different actions and decisions regarding the labeling and market authorizations of GBCAs, as well as the specific actions requested to the manufacturers.
CONCLUSIONS
The manufacturers of GBCAs had to face different situations according to the countries, due to the different positions and expectations from regulatory agencies. They have adapted their responses to the different positions of the regulatory agencies and conducted specific preclinical and clinical investigations to provide the expected evidence. It is also their responsibility to continuously monitor the benefit-risk balance of the products and to propose risk minimization measures to the regulatory agencies.
Topics: Adult; Brain; Child; Contrast Media; Drug Hypersensitivity; Female; Gadolinium; Health Policy; Humans; Internationality; Male; Patient Safety
PubMed: 31725063
DOI: 10.1097/RLI.0000000000000605 -
Disaster Medicine and Public Health... Jul 2022Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency,...
Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency, regulatory authorities ensured timely, safe, and equitable access to the vaccine.This article aims to outline the roles of the Tunisian regulatory authority, the Directorate of Pharmacy and Medicines (DPM) at the Ministry of Health, in registration and procurement of the COVID-19 vaccine.Requirement to grant the Exceptional Provisional Authorizations of Marketing (EPAM) for COVID-19 vaccines was 27 days versus 869 days for conventional marketing authorizations (MAs). The DPM has optimized its activity through: early dialogue with manufacturers, online submission, the use of distance communication technologies. It has demonstrated unprecedented flexibility through the continuous and rolling review approach.Regulatory authorities in Tunisia and around the world have partnered with manufacturers to speed up administrative procedures while ensuring the quality, safety, and efficacy of vaccines.
PubMed: 35899949
DOI: 10.1017/dmp.2022.200