August 2020, The Africa Joint Continental Strategy for COVID-19 is underpinned by the need to limit transmission, prevent deaths and reduce associated harms. Participation by African nations in clinical trials is an essential step to ensure that sufficient data is generated on the safety and ...lass="attribute-to-highlight medbox">efficacy of the most promising vaccine candidates among the region’s populations.
While current COVID-19 clinical trial activity on the continent is limited, Africa has substantial experience and capabilities to conduct clinical trials for preventative vaccines across a range of diseases, and many organizations on the continent are working tirelessly to help prepare additional trials on potential COVID-19 vaccines. As the number of candidate vaccines in the development pipeline continues to increase, it will be important for organizations responsible for managing clinical trials in the region to partner with vaccine developers to identify potential and appropriate trial locations, provide support to remove any critical obstacles impeding commencement and progress of trials, and to provide oversight ensuring that trials are conducted safely and ethically.
more
Ivermectin is an antiparasitic drug approved for the treatment of parasitic infections, including strongyloidiasis and onchocerciasis in humans. There is a reported increase in the use of ivermectin for the prevention and treatment of COVID-19 by the public in African Union Member States.
Currently..., there is:
1. No scientific evidence from pre-clinical studies on the therapeutic effect of ivermectin for the management of COVID-19;
2. No evidence of its clinical efficacy for the management of patients with asymptomatic, mild, moderate or severe COVID-19; and
3. No safety data regarding the use of ivermectin for COVID-19 in the majority of the published studies.
more
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.
more
9 June 2021
Since its launch, GLASS has expanded in scope and coverage and as of May 2021, 109 countries and territories worldwide have enrolled in GLASS. A key new component in GLASS is the inclusion of antimicrobial consumption (AMC) surveillance at the national level highlighted in this fourth G...LASS report.
The fourth GLASS report summarizes the 2019 data reported to WHO in 2020. It includes data on AMC surveillance from 15 countries and AMR data on 3 106 602 laboratory-confirmed infections reported by 24 803 surveillance sites in 70 countries, compared to the 507 923 infections and 729 surveillance sites reporting to the first data call in 2017.
The report also describes developments over the past years of GLASS and other AMR surveillance programmes led by WHO, including resistance to anti-human immunodeficiency virus and anti-tuberculosis medicines, antimalarial drug efficacy.
more
This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
more
Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strategic guidance as to WHO’s preferences for new vacci...nes in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
more
Herd immunity by mass vaccination offers the potential to substantially limit the continuing spread of COVID-19, but high levels of vaccine hesitancy threaten this goal. In a cross-country analysis of vaccine hesitant respondents across Latin America in January 2021, we experimentally tested how fiv...e features of mass vaccination campaigns—the vaccine’s producer, efficacy, endorser, distributor, and current population uptake rate—shifted willingness to take a COVID-19 vaccine. We find that citizens preferred Western-produced vaccines, but were highly influenced by factual information about vaccine efficacy. Vaccine hesitant individuals were more responsive to vaccine messengers with medical expertise than political, religious, or media elite endorsements. Citizen trust in foreign governments, domestic leaders, and state institutions moderated the effects of the campaign features on vaccine acceptance. These findings can help inform the design of unfolding mass inoculation campaigns.
more
In the face of rapid increases in the number of hospitalizations due to COVID-19 in Latin America and the Caribbean, coupled with shortages of human and material resources, including medical equipment and gases, there is a need to redesign models of care in the Region to optimize available resources... and ensure that more patients receive the quantity and quality of oxygen they need. Oxygen is included in the World Health Organization’s list of essential medicines and is used to care for patients at all levels of integrated health services networks. The efficacy of oxygen use in the treatment of patients with respiratory conditions caused by COVID-19 has been demonstrated, but there is great opportunity to improve the effectiveness of its use if it is used in a rational, sustainable, and safe way. Bearing in mind that the efficacy of a health technology is measured by its benefit under actual conditions of use, practical actions can be taken to improve the use of medical oxygen and avoid oxygen shortages. A drug is considered to be used rationally when patients receive it according to their clinical needs, in doses appropriate to their individual needs, for an appropriate period, and at a low cost to them and their community. By providing instruction on the rational use of oxygen and promoting it, negative repercussions can be avoided, such as loss of efficacy as a result of activities related to oxygen storage, distribution, and administration. Rational use of oxygen also involves controlling waste due to leaks in storage and distribution systems, use of gas at incorrect pressures, use of incorrectly adjusted flowmeters, and disconnections, among other problems. Another aspect to consider is the provision of adequate technical support for all oxygen production systems, in terms of maintenance and calibration, availability of electrical energy, and specific knowledge about these systems. For these reasons, a set of guidelines has been put together for the development of an efficient management system to deal with situations of oxygen scarcity, both now and in the future.
more
The roadmap describes the actions needed to
achieve the three development goals for TB
vaccines set by the WHO:
1. A safe, effective and affordable TB vaccine
for adolescents and adults.
2. An affordable TB vaccine for neonates and
infants with improved safety and ...hlight medbox">efficacy.
3. A therapeutic vaccine to improve TB
treatment outcomes
more
Weekly Epidemiological Record No 9, 2022, 97, 61–80
This position paper supersedes the 2016 publication, “Malaria vaccine: WHO position paper-2016.”1 It includes the updated WHO recommendations on the wider use of the RTS,S/AS01 vaccine for the reduction of malaria morbidity and mortality in ...children living in areas of moderate to high malaria transmission. It also incorporates findings from the evaluation of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP), recommended by SAGE and MPAG in 2015, and from additional studies since 2015.
This paper does not include findings on vaccine efficacy in infants first vaccinated at 6–12 weeks of age. Because of the lower vaccine efficacy observed in this age category, WHO did not recommend pilot implementation or RTS,S/AS01 vaccine introduction for these young infants. Recommendations2 on the use of RTS,S/AS01 vaccine were discussed by SAGE and MPAG during a joint session in October 2021; evidence presented at the meeting can be accessed at https://terrance.who.int/mediacentre/data/ sage/SAGE_eYB_Oct2021.pdf
more
Acupuncture has been practised for more than 2500 years in the Western Pacific Region and has become a global therapeutic method in recent decades. However, it was reportedthat acupuncturists differed by up to 25% in the acupuncture points they used, raising doubts and uncertainty regarding the ...n class="attribute-to-highlight medbox">efficacy and safety of acupuncture treatment, as well as causing difficulties in the fields of acupuncture research and education.
more
Cases of human monkeypox are rarely seen outside of west and central Africa. There are few data regarding viral kinetics or the duration of viral shedding and no licensed treatments. Two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated ...an class="attribute-to-highlight medbox">efficacy against monkeypox in animals. Our aim was to describe the longitudinal clinical course of monkeypox in a high-income setting, coupled with viral dynamics, and any adverse events related to novel antiviral therapies.
more
2nd edition. These guidelines include several notable changes from the first edition. For cutaneous leishmaniasis, ketoconazole has been removed from the list of treatment options; the number of Leishmania species for which there is strong evidence for the ...>efficacy of miltefosine has increased from two to four; and the recommendation for intralesional antimonials is now strong. For mucosal leishmaniasis there is now a strong recommendation for use of pentavalent antimonials with or without oral pentoxifylline. For visceral leishmaniasis, the strong recommendations for use of pentavalent antimonials and amphotericin B deoxycholate are now conditional.
more
The Lancet olume 395, ISSUE 10232, P1259-1267, April 18, 2020. Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifa...mpicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions.
more
On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation was to agree on the most important PPCs for drugs t...o protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
more
To support its R&D activities on Chagas disease, DNDi launched the Chagas Clinical Research Platform (CCRP). The platform brings together partners, experts, and stakeholders to provide support for evaluation and development of new treatments for Chagas disease. The patient-centred platform aims to f...acilitate clinical research, provide a forum for technical discussions, develop a critical mass of expertise, and strengthen institutional research capacities. In addition, it identifies and reviews priority needs, works towards standardization of methodology to assess drug efficacy and reviews alternatives for using current approved drugs (new schemes, doses, combination) and special scenarios (resistance).
more
Human African trypanosomiasis (HAT), or sleeping sickness, is a painful and protracted disease transmitted through the bite of infected tsetse flies and it is found in rural parts of sub-Saharan Africa. Sleeping sickness has two clinical phases but this review focuses only on treatment of the second...-stage, which is characterized by neurological changes and almost invariably fatal without treatment. There are only a few drugs currently available for second-stage sleeping sickness, all with considerable adverse events and variable efficacy.
The review includes nine trials with 2577 participants. Each trial reported different comparisons of the drugs currently available to treat second stage HAT (melarsoprol, eflornithine, nifurtimox) so no meta-analysis was possible.
more
This document focuses on the management of patients affected by gambiense HAT and
constitutes an update to the WHO therapeutic guidance issued in 2013. The main changes in recommendations concern the criteria and methods for deciding the treatment among the new set of therapeutic options and the pa...rticular conditions that apply to treatment with fexinidazole, as outlined below. Because HAT is a serious, life-threatening disease and because the efficacy of fexinidazole depends on swallowing the medicine after an appropriate intake of food as well as on completing the full 10-day
treatment schedule, the recommendations regarding fexinidazole administration are considered key elements that must be carefully followed. When the conditions listed in these guidelines are not met for any individual patient, the alternative available treatments should be prescribed.
more
A wide spectrum of disease severity has been described for Human African Trypanosomiasis (HAT) due to
Trypanosoma brucei rhodesiense (T.b. rhodesiense), ranging from chronic disease patterns in southern countries of East Africa to an increase in virulence towards the north. However, only limited d...ata on the clinical presentation of T.b. rhodesiense HAT is available. From 2006-2009 we conducted the first clinical trial program (I MPAMEL III) in T.b. rhodesiense endemic areas of
Tanzania and Uganda in accordance with international standards (ICH-GCP). The primary and secondary outcome measures were safety and efficacy of an abridged melarsoprol schedule for treatment of second stage disease. Based on diagnostic findings and clinical examinations at baseline we describe the clinical presentation of T.b. rhodesiense HAT in second stage patients from two distinct geographical settings in East Africa.
more
As of 12 December 2022, over 645 million people worldwide have been diagnosed with COVID-19, with over 6.6 million deaths (4).
The Omicron variant, which emerged in late November 2021, and its subvariants, are now the dominant circulating viruses, contributing to the ongoing surge in several countr...ies (4). Vaccination has substantially reduced case numbers and hospitalizations in many countries,but limitations in global access to vaccines mean that many populations, including those in low- and middle-income countries, remain vulnerable. Even in vaccinated individuals, uncertainties remain about duration of protection and efficacy, and the degree of crossprotection with new variants.
There remains a need for more effective treatment and management for those affected by COVID-19. The pandemic – and the
explosion of both research and misinformation – has highlighted the need for trustworthy, accessible and regularly updated living
guidelines to place emerging findings into context and provide clear recommendations for clinical practice
more