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.
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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
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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.
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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.
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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 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 efficacy.
3. A therapeutic v...accine to improve TB
treatment outcomes
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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.
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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.
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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.
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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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23 Dec 2020. The aim of this document is to provide an update on the knowledge surrounding the role of children in the transmission of SARS-CoV-2 and the role of schools in the COVID-19 pandemic, based on the experience in the EU from August–December, 2020. This document also addresses transmissio...n to and from staff in school settings, school-related mitigation measures including risk communication, testing, contact tracing and the efficacy of partial and full school closures. This document draws upon and updates evidence presented in the previous report from ECDC on this topic, which was published on August 6, 2020
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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 efficac...y 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.
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BMJ Global Health, Vol. 4 (2019) no.2
Antibiotic resistance is threatening global health, development and food security; however, measures for assessing and communicating the threat of resistance are lacking. The Drug Resistance Index (DRI) allows for global assessment of the relative efficacy of ...countries’ antibiotic therapy.
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Disinfection of drinking-water supplies has been one of the most significant public health advancements of the last century with respect to reducing waterborne disease.
Although chlorine has been used as the disinfectant of choice for public drinking-water supplies for the past century, a numbe...r of emerging or alternative compounds are used or are being considered for the disinfection of drinking-water.
This series reviews the state of the knowledge on the application, efficacy and toxicity of bromine, iodine and silver as drinking-water disinfectants.
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Recent systematic reviews and meta-analysis of the impact of chemical-based mollusciciding (King et al., 2015, Sokolow et al., 2016) have concluded that regular mollusciciding is likely to contribute significantly towards elimination of schistosomiasis in high-risk areas. The WHO roadmap’s new foc...us on “transmission control, wherever possible” (WHO, 2012a) reinforces the need to promote intermediate-host snail control to prevent schistosomiasis transmission.
This operational manual is intended to facilitate the reintroduction of practices and protocols for use of molluscicides in the field in schistosomiasis control programmes. It is complemented by guidelines on the laboratory and field testing of the efficacy of molluscicides for schistosomiasis control (WHO, 2017 [in preparation]).
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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This document was prepared in response to a need to review and potentially update the current recommendations for the antibiotic treatment of both inpatient and outpatient management of severe acute malnutrition (SAM). The current recommendations (Table 1) are based on guidelines published in 2013 i...n the WHO Pocketbook for Hospital Care for Children, and the 2013 update on SAM (outpatient management). The global threat of increasing antimicrobial resistance and new data on efficacy and safety profiles requires a re-review of the current evidence to ensure recommendations are the most appropriate. The evidence base for the use of antibiotics in children presenting with uncomplicated SAM has been recently enlarged.
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14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man...ufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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Glob Ment Health (Camb). 2015; 2: e12. Published online 2015 Jul 14. doi: 10.1017/gmh.2015.10
Low and middle income countries (LMICs) are facing an increase of the impact of mental health problems while confronted with limited resources and limited access to mental health care, known as the ‘me...ntal health gap’. One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care. We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs.
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West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation where the participants concluded that in the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to of...fer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluat-
ed for safety and efficacy in humans as potential treatment or prevention
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