scholarly journals Development of Pandemic Vaccines: ERVEBO Case Study

Vaccines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 190
Author(s):  
Jayanthi Wolf ◽  
Risat Jannat ◽  
Sheri Dubey ◽  
Sean Troth ◽  
Matthew T. Onorato ◽  
...  
Keyword(s):  
Ebola Virus ◽  
Virus Disease ◽  
Development Program ◽  
Cost Effective ◽  
The United States ◽  
Public And Private ◽  
Ongoing Work ◽  
United States Food ◽  
Zaire Ebolavirus ◽  
States Food

Preventative vaccines are considered one of the most cost-effective and efficient means to contain outbreaks and prevent pandemics. However, the requirements to gain licensure and manufacture a vaccine for human use are complex, costly, and time-consuming. The 2013–2016 Ebola virus disease (EVD) outbreak was the largest EVD outbreak to date and the third Public Health Emergency of International Concern in history, so to prevent a pandemic, numerous partners from the public and private sectors combined efforts and resources to develop an investigational Zaire ebolavirus (EBOV) vaccine candidate (rVSVΔG-ZEBOV-GP) as quickly as possible. The rVSVΔG-ZEBOV-GP vaccine was approved as ERVEBOTM by the European Medicines Authority (EMA) and the United States Food and Drug Administration (FDA) in December 2019 after five years of development. This review describes the development program of this EBOV vaccine, summarizes what is known about safety, immunogenicity, and efficacy, describes ongoing work in the program, and highlights learnings applicable to the development of pandemic vaccines.

scholarly journals Ebola Vaccine Response: An Updated Review

2020 ◽  
Vol 5 (4) ◽  
Author(s):  
Sanyaolu A ◽  
Okorie C ◽  
Abbasi AF ◽  
Prakash S ◽  
Marinkovic A
Keyword(s):  
Ebola Virus ◽  
Virus Disease ◽  
Vaccine Response ◽  
African Countries ◽  
Preventative Measures ◽  
Vaccine Trials ◽  
Proper Training ◽  
United States Food ◽  
Republic Of The Congo ◽  
States Food

Several studies have reported the successful use of vaccines on the Ebola virus disease (EVD). However, outbreaks were prevalent even with vaccine trials in progress; thus, we aimed to examine the response to vaccination. The response was evaluated by reviewing articles that reported the efficacy rates of the vaccine trials and provided situation reports from recent EVD outbreaks in major West African countries and the Democratic Republic of the Congo (DRC). The review findings indicated that the approved United States Food and Drug Administration (FDA) Ebola vaccine (rVZV-ZEBOV), as well as other investigational vaccines showed promising efficacy rates. It is also suggested that vaccination alone is not sufficient for proper prevention and treatment of EVD; therefore, it must be coupled with a multidisciplinary approach that requires proper training. These preventative measures may be the key to disrupting the next outbreak before it claims thousands of lives again.

Enactment of the Food Safety Modernization Act

2015 ◽  
Vol 6 (4) ◽  
pp. 488-501 ◽  
Author(s):  
Michaela Tarr Oldfield
Keyword(s):  
Food Safety ◽  
The United States ◽  
Third Party ◽  
Public And Private ◽  
Safety Regulations ◽  
Private Standards ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Private Actors

The United States’ Food Safety Modernization Act (FSMA) revises the US Food and Drug Administration's regulatory authority. While expanding FDA's authority, the legislation replicates and relies on private systems of standards and third party audits, albeit with modifications. This article argues that public and private actors develop food safety regulations within multiple types of institutional venues, including private standards regimes, courts, congresses, and government regulatory agencies. It examines how interactions within each of these venues are shaped by stakeholders’ interests, and how the relevant subset of interactions within these venues ultimately shaped the FSMA. The article concludes by offering insights into what consequences these interactions and outcomes may have on the roles and capacities of affected stakeholders in food safety governance.

Delirium Secondary to Lamotrigine Toxicity

2020 ◽  
Vol 15 (2) ◽  
pp. 156-159 ◽  
Author(s):  
Deborah L. Sanchez ◽  
Adam J. Fusick ◽  
Steven R. Gunther ◽  
Michael J. Hernandez ◽  
Gregory A. Sullivan ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Valproic Acid ◽  
Mental Status ◽  
The United States ◽  
Clinical Correlation ◽  
Medication Regimen ◽  
Medication Effects ◽  
United States Food ◽  
States Food ◽  
Rule Out

Background: Lamotrigine is a phenyltriazine medication that has been approved by the United States Food and Drug Administration as monotherapy and as an adjunctive agent for the treatment of seizure disorder. It was later approved by the FDA for the treatment of bipolar disorder. Lamotrigine is generally well tolerated by patients, but some serious symptoms can occur during treatment. These severe side effects include rashes and multi-organ failure. Lamotrigine has also been associated with the development of mental status changes, frequently when used concurrently with other medications that may impact the metabolism of lamotrigine. Objective: To present the case of a 65-year-old man being treated with lamotrigine and valproic acid who developed mental status changes after the addition of sertraline to his medication regimen, and to compare this case to existing cases reported in the literature. Discussion: Our case adds to the existing literature by demonstrating that patients may experience adverse medication effects despite lamotrigine levels that are normally considered to be in the therapeutic range, highlighting the importance of clinical correlation when obtaining medication levels. Conclusion: Clinicians should use caution interpreting lamotrigine levels when working up delirium, as normal levels may not rule out the development of lamotrigine toxicity.

scholarly journals The Efficacy of Convalescent Plasma Use in Critically Ill COVID-19 Patients

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 257
Author(s):  
Livius Tirnea ◽  
Felix Bratosin ◽  
Iulia Vidican ◽  
Bianca Cerbu ◽  
Mirela Turaiche ◽  
...  
Keyword(s):  
Pilot Study ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Therapeutic Option ◽  
White Blood Cells ◽  
The United States ◽  
Plasma Therapy ◽  
Reactive Protein ◽  
United States Food ◽  
States Food

Background and Objectives: On 24 March 2020, the United States Food and Drug Administration (FDA) announced the approval of convalescent plasma therapy for critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as an emergency investigational new drug. This pilot study from Romania aimed to determine if convalescent plasma transfusion can be beneficial in the treatment of selected critically ill patients diagnosed with a SARS-CoV-2 infection. Materials and Methods: Donor and receiver eligibility for critically ill coronavirus disease 2019 (COVID-19) patients was based on Romanian guidelines issued at the time of the study. Here, we describe the evolution of a total of five eligible patients diagnosed with COVID-19 who received convalescent plasma (CP) in Romania. Results: In spite of our efforts and convalescent plasma administration, three of the five patients did not survive, while the other two recovered completely. Over the course of our five-day laboratory record, the surviving patients had significantly lower values for C-reactive protein, interleukin-6, and white blood cells. Conclusions: This pilot study provides insufficient evidence to determine the efficacy of convalescent plasma use as a therapeutic option for critically ill COVID-19 patients.

scholarly journals Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273

2021 ◽  
pp. 089719002110096
Author(s):  
Shyh Poh Teo
Keyword(s):  
Vaccine Development ◽  
Safety Data ◽  
The United States ◽  
Virus Infections ◽  
Phase 3 ◽  
Vaccination Programs ◽  
Safety Surveillance ◽  
Mass Immunization ◽  
United States Food ◽  
States Food

The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer-BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb the pandemic.

scholarly journals Botulinum toxin in the management of chronic migraine: clinical evidence and experience

2016 ◽  
Vol 10 (2) ◽  
pp. 127-135 ◽  
Author(s):  
Claus M Escher ◽  
Lejla Paracka ◽  
Dirk Dressler ◽  
Katja Kollewe
Keyword(s):  
Chronic Migraine ◽  
Botulinum Neurotoxin ◽  
Prophylactic Treatment ◽  
Clinical Evidence ◽  
The United States ◽  
Headache Frequency ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
Review Reports

Chronic migraine (CM) is a severely disabling neurological condition characterized by episodes of pulsating unilateral or bilateral headache. The United States Food and Drug Administration (FDA) approved onabotulinumtoxinA (Botox®) for the prophylactic treatment of CM in 2010. It has been shown that onabotulinumtoxinA is effective in the reduction of headache frequency and severity in patients with CM. Treatment is well tolerated by the patients. This review reports on the history of botulinum neurotoxin (BoNT) in CM and presents the current clinical evidence for the use of onabotulinumtoxinA in the treatment of CM.

scholarly journals Clinical Development of Biological Response Modifiers

1994 ◽  
Vol 5 (suppl a) ◽  
pp. 5A-8A
Author(s):  
Jay P Siegel
Keyword(s):  
Adverse Reactions ◽  
Biological Response ◽  
Clinical Trial Design ◽  
The United States ◽  
Biological Response Modifier ◽  
Clinical Development ◽  
Response Modifier ◽  
United States Food ◽  
Study Population ◽  
States Food

OBJECTIVE: To present perspectives on selected issues that frequently arise during the clinical development of biological response modifier (BRM) therapies.DATA SOURCES: The perspectives and opinions presented herein were developed over several years of reviewing and consulting on the clinical development of BRM therapies at the United States Food and Drug Administration.CONCLUSIONS: BRM therapies encompass a broad spectrum of products used to treat a wide variety of diseases. Due to this diversity. most principles of clinical trial design and conduct applicable to the majority of BRMS are those that are applicable to all therapies. Nevertheless, the clinical development of BRM therapies often raises specific issues and problems in the areas of selecting animal models, defining the study population, adverse reactions, dosing and defining end-points. Over 10 years’ experience in testing biotechnology derived BRMS in clinical trials has created a database from which we can draw valuable generalizations for guidance in future studies.

Safety assessment of natural products in Malaysia: current practices, challenges, and new strategies

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Nur Azra M. Pauzi ◽  
Manraj S. Cheema ◽  
Amin Ismail ◽  
Ahmad Rohi Ghazali ◽  
Rozaini Abdullah
Keyword(s):  
Natural Products ◽  
Animal Studies ◽  
Regulatory System ◽  
The United States ◽  
Regulatory Control ◽  
Health Maintenance ◽  
Traditional Medicines ◽  
Aristolochic Acids ◽  
United States Food ◽  
States Food

Abstract The belief that natural products are inherently safe is a primary reason for consumers to choose traditional medicines and herbal supplements for health maintenance and disease prevention. Unfortunately, some natural products on the market have been found to contain toxic compounds, such as heavy metals and microbes, as well as banned ingredients such as aristolochic acids. It shows that the existing regulatory system is inadequate and highlights the importance of thorough safety evaluations. In Malaysia, the National Pharmaceutical Regulatory Agency is responsible for the regulatory control of medicinal products and cosmetics, including natural products. For registration purpose, the safety of natural products is primarily determined through the review of documents, including monographs, research articles and scientific reports. One of the main factors hampering safety evaluations of natural products is the lack of toxicological data from animal studies. However, international regulatory agencies such as the European Food Safety Authority and the United States Food and Drug Administration are beginning to accept data obtained using alternative strategies such as non-animal predictive toxicological tools. Our paper discusses the use of state-of-the-art techniques, including chemometrics, in silico modelling and omics technologies and their applications to the safety assessments of natural products.

scholarly journals Comparison of tape stripping with the human skin blanching assay for the bioequivalence assessment of topical clobetasol propionate formulations.

2010 ◽  
Vol 13 (1) ◽  
pp. 11 ◽  
Author(s):  
Wai Ling Au ◽  
Michael F Skinner ◽  
Isadore Kanfer
Keyword(s):  
Topical Corticosteroid ◽  
Human Skin ◽  
The United States ◽  
Clobetasol Propionate ◽  
Tape Stripping ◽  
Draft Guidance ◽  
Ointment Formulation ◽  
United States Food ◽  
Assay Methods ◽  
States Food

Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn. This was due to problems associated with the method and also inconsistencies and variability in the resulting data. The purpose of this study was to re-visit the tape stripping technique, incorporate refinements to reduce variability and validate the method using bioequivalence data obtained from the assessment of a topical corticosteroid cream containing 0.05% clobetasol propionate using the human skin-blanching assay. Methods: A pilot tape stripping study was conducted to establish the variability of the formulations.The bioequivalence of two different commercially available clobetasol propionate cream formulations and a clobetasol propionate ointment formulation were subsequently investigated using the tape stripping method. Results: The data from the pilot tape stripping study correlated well with data from the human skin-blanching assay. A subsequent pivotal tape stripping study confirmed bioequivalence between the two cream formulations whereas bio-inequivalence was demonstrated between the cream and ointment formulations.Conclusions: These studies show that the results from tape stripping concur with data from the human skin blanching assay and demonstrate the potential of a well-controlled tape stripping study as an option for the assessment of bioequivalence of topical corticosteroid formulations.

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