This article is part four in a series of explainers on vaccine development and distribution.
Part one focused on how vaccines work to protect our bodies from disease-carrying germs.
Part two focused on the ingredients in a vaccine and the three clinical trial phases.
Part three focused on the ste...ps from completing the clinical trial phases through to distribution.
This document outlines the different types of vaccines.
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Interim guidance 2 march 2021
Current use of drugs to prevent COVID-19 is variable, reflecting large-scale uncertainty. Numerous randomized trials of many different drugs are underway to inform practice. This first version of the Drugs to prevent COVID-19: A WHO living guideline contains new inform...ation and a recommendation on hydroxychloroquine. It follows the publication of six trials synthesized in a living network meta-analysis (NMA).
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10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto...r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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The paper provides the rationale for these recommendations, which are based on analyses of data from the TRACT trial.
The Global Programme to Eliminate Lymphatic Filariasis (LF) is using mass drug administration (MDA) of antifilarial medications to treat filarial infections, prevent disease and interrupt transmission. Almost 500 million people receive these medications each year. Clinical trials have recently shown... that a single dose of a triple-drug combination comprised of ivermectin, diethylcarbamazine and albendazole (IDA) is dramatically superior to widely used two-drug combinations for clearing larval filarial parasites from the blood of infected persons. A large mul-
ticenter community study showed that IDA was well-tolerated when it was provided as MDA. IDA was rapidly advanced from clinical trial to policy and implementation; it has the potential to accelerate LF elimination in many endemic countries.
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Sleeping sickness is controlled by case detection and treatment but this often only reaches less than 75% of the population. Vector control is capable of completely interrupting HAT transmission but is not used because of expense. We conducted a full scale field trial of a refined vector control tec...hnology. From preliminary trials we determined the number of insecticidal tiny targets required to control tsetse populations by more than 90%. We then carried out a full scale, 500 km2 field trial covering two HAT foci in Northern Uganda (overall target density 5.7/km2). In 12 months tsetse populations declined by more than 90%. A mathematical model suggested that a 72% reduction in tsetse population is required to stop transmission in those settings. The Ugandan census suggests population density in the HAT foci is approximately 500 per km2. The estimated cost for a single round of active case detection (excluding treatment), covering 80% of the population, is US$433,333 (WHO figures). One year of vector control organised within country, which can completely stop HAT transmission, would cost US$42,700. The case for adding this new method of vector control to case detection and treatment is strong. We outline how such a component could be organised.
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DOI: 10.5772/intechopen.102891Little progress has been made since the 1960s and 19. 70s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and opera...tional challenges in the clinical drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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Despite a historical association with poor tolerability, a comprehensive review on safety of antileishmanial chemotherapies is lacking. We carried out an update of a previous systematic review of all published clinical trials in visceral leishmaniasis (VL) from 1980 to 2019 to document any reported ...serious adverse events (SAEs).
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Manufacturers:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) ir...respective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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May 9, 2022.Since the onset of the COVID-19 pandemic, a large number of clinical trials have been planned and developed to assess the effectiveness and safety of various interventions that could prevent hospitalizations and progression to severe disease in people infected with SARS-CoV-2. Currently,... the WHO and the PAHO recommend the use of corticosteroids, tocilizumab, baricitinib, and casirivimab e imdevimab (the latter in seronegative COVID-19 patients) and propose the use of sotrovimab, casirivimab/imdevimab, and molnupiravir in patients with non-severe illness who are at high risk for complications
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WHO strongly recommends discontinuation of the nerve tissue vaccine, and replacement with modern concentrated and purified cell culture derived vaccines (CCDV) and embryonated eggbased rabies vaccines.
These vaccines must comply with WHO criteria for potency and innocuity following satisfactory ass...essment in humans during well-designed field trials
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The pharmacological treatment of heart failure has evolved over the last three decades since the demonstration of the effect of angiotensinconverting enzyme inhibitors on major cardiovascular events in patients with heart failure with reduced ejection fraction. Composite analysis of heart failure wi...th reduced ejection fraction trials and the recent identification of newer drug treatments show early benefits on the major cardiovascular outcomes, ushering in a change of the treatment strategy; from a ‘sequential’ initiation of the treatments to a ‘simultaneous’ initiation to harness the early benefits. The adoption and implementation of these changes at the bedside have been dismal in many healthcare settings. Papua New Guinea, like many other lower-to-middle-income countries, is facing many barriers that impact on the care of heart failure patients. It needs to adopt and implement these changes to provide evidence-based treatment for its people with heart failure with reduced ejection fraction.
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Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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The International Classification of Functioning, Disability and Health, known more commonly as ICF, provides a standard language and framework for the description of health and health-related states. Like the first version published by the World Health Organization for trial purposes in 1980, ICF is... a multipurpose classification intended for a wide range of uses in different sectors. It is a classification of health and health-related domains -- domains that help us to describe changes in body function and structure, what a person with a health condition can do in a standard environment (their level of capacity), as well as what they actually do in their usual environment (their level of performance).
These domains are classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. In ICF, the term functioning refers to all body functions, activities and participation, while disability is similarly an umbrella term for impairments, activity limitations and participation restrictions. ICF also lists environmental factors that interact with all these components.
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Clinical management standard operating procedures.
Ebola virus disease (EVD) is a life-threatening multisystem illness associated with fever and gastrointestinal (GI) symptoms that frequently leads to hypovolaemia, metabolic acidosis, hypoglycaemia, and multi-organ failure. The prolonged 2013–201...6 EVD outbreak in West Africa allowed for an evolution of care such that by outbreak end many patients received individualized and optimized supportive care (oSoC), including volume resuscitation, symptom control, laboratory and bedside monitoring of glucose, electrolyte levels and organ dysfunction, as well as rapid detection and treatment of co-infections, potentially contributing to the downward trend in the case fatality rate (CFR).
This guidance should serve as a foundation for oSoC that should be followed to ensure both the best possible chance for survival and allow for reliable comparison of investigational therapeutic interventions as part of a randomized controlled trial. This guideline provides recommendations for the management of adults and children.
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Wits Reproductive Health and HIV Institute (Wits RHI) is involved in an effort to curb the COVID-19 pandemic that is facing South Africa and the world at large. Prof. Helen Rees is a member of the team advising the Health Minister on COVID-19 (MAC). She is part of the Clinicians Group, the Research ...group and the Incident Management Team (IMT). Prof. Rees is Co-Chair of the South African arm of the Solidarity study
This is a World Health Organisation (WHO) coordinated trial that will generate high quality evidence on COVID-19 treatment options. Prof Helen is also the International Coordinator for the global Crown Coronation study. This study is aimed at looking at strategies to protect healthcare workers.
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This document updates the earlier version published in April 2020. In recent weeks, information on the potential use of chloroquine or hydroxychloroquine for the treatment of people with COVID-19 has been disseminated in academic journals and public media. Although there are now ongoing clinical tri...als testing the efficacy and safety of several medicines for COVID-19, as of the date of this document, there is a lack of quality evidence to demonstrate chloroquine and/or hydroxychloroquine are effective in the treatment of COVID-19. Evidence is recently emerging via small studies with sub-optimal methodologies that are conflicting.
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High levels of storage iron may increase malaria susceptibility. This risk has not been investigated in semi-immune adolescents. We investigated whether baseline iron status of nonpregnant adolescent girls living in a high malaria transmission area in Burkina Faso affected malaria risk during the fo...llowing rainy season. For this prospective study, we analysed data from an interim safety survey, conducted six months into a randomised iron supplementation trial. We used logistic regression to model the risk of P. falciparum infection prevalence by microscopy, the pre-specified interim safety outcome, in relation to iron status, nutritional indicators and menarche assessed at recruitment.
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Early data from US biotech Moderna has revealed that its Covid-19 vaccine candidate is 94.5 per cent effective, raising hopes that a range of immunisations will be available to help end the pandemic.
The interim analysis of the vaccine, currently known as mRNA-1273, comes after 95 trial particip...ants contracted Covid-19, including just five who were given the coronavirus jab.
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BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379
Rapid Recommendation and visual graph. This is the fifth version (update 4) of the living guideline (BMJ 2020;370:m3379). When citing this article, please consider adding the update number and date of access for clarity. The publication of the RE...COVERY and REMAP-CAP randomised controlled trials triggered this guideline update, resulting in a strong recommendation for interleukin-6 (IL-6) receptor blockers (tocilizumab or sarilumab) in patients with severe or critical covid-19.
Prior recommendations: (a) A recommendation not to use ivermectin in patients with covid-19, regardless of disease severity, except in the context of a clinical trial; (b) a strong recommendation against the use of hydroxychloroquine in patients with covid-19, regardless of disease severity; (c) a strong recommendation against the use of lopinavir-ritonavir in patients with covid-19, regardless of disease severity; (d) a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19; (e) a conditional recommendation against systemic corticosteroids in patients with non-severe covid-19; and (f) a conditional recommendation against remdesivir in hospitalised patients with covid-19.
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