Will COVID-19 vaccines be safe? Will all the COVID-19 candidate vaccines be successful? What are the different phases a vaccine must go through to be approved? This document provides responses to the most frequently asked questions about candidate vaccines and access to COVID-19 vaccination.
The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the use of placebo controls and unblinding of trial participants in current and future COVID-19 vaccine trials. This... policy brief was developed by the WHO Access to COVID-19 Tools (ACT) Accelerator Ethics & Governance Working Group, to provide guidance for researchers, sponsors, regulators, research ethics committees, and policy-makers, on these and related issues.
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The report presents current information (updated to September 2015) on candidate vaccines, therapies and medical devices for Ebola and gives an overview of completed and on-going trials.
The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-...clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
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The authors state that researchers, governments and global agencies should proceed with particular care in the evaluation of candidate SARS-CoV-2 vaccines in LMICs, with effective communication to build trust and avoid generation of vaccine hesitancy. Vaccine efficacy is often highly variable betwee...n high-resource and low-resource settings
Archives of Disease in Childhood, vol.106 Issue 2
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This tracker, developed by the Vaccine Centre at the London School of Hygiene & Tropical Medicine, will follow COVID-19 vaccine candidates as they progress through the development pipeline. We will update it weekly. An overview of the different vaccine types as well as the phases of clinical develo...pment is provided in the Summary tab.
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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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Scientists and researchers managed to produce vaccines to protect against COVID-19. Vaccine candidates have recently been approved in some countries and are in the approval process in others, yet misinformation about the safety and effects of any future vaccine is already threatening its rollout. In... this report, we catalogue the top myths about a COVID-19 vaccine that have appeared in NewsGuard’s ratings of more than 6,000 news and information sites worldwide.
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La stratégie continentale commune africaine pour COVID-19 est sous-tendue par la nécessité de limiter la transmission, de prévenir les décès et de réduire les dommages associés. La participation des nations africaines aux essais cliniques est une étape essentielle pour garantir la productio...n de données suffisantes sur la sécurité et l'efficacité des candidats vaccins les plus prometteurs parmi les populations de la région.
Bien que l'activité actuelle des essais cliniques COVID-19 sur le continent soit limitée, l'Afrique possède une expérience et des capacités considérables pour mener des essais cliniques de vaccins préventifs contre toute une série de maladies, et de nombreuses organisations du continent travaillent sans relâche pour aider à préparer des essais supplémentaires sur des vaccins COVID-19 potentiels.
Disponible en anglais, français et portugais
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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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Chikungunya fever (CHIKF) is an emerging infectious disease caused by an alphavirus transmitted by Aedes spp. mosquitoes. Because mosquito control programs are not highly efficient for outbreak containment, vaccines are essential to reduce the burden of disease. Although no licensed vaccine against ...CHIKF is yet available, many highly promising candidates are undergoing preclinical studies, and a few of them have been tested in human trials of phase 1 or 2. Here, we review recent findings regarding the need for a CHIKF vaccine and provide an update on vaccines nearing or having entered clinical trials. We also address needs to tackle bottlenecks to vaccine development—including scientific and financial barriers—and to accelerate the development of vaccines; several actions should be taken:
(i) design efficacy trials to be conducted during the course of outbreaks;
(ii) evaluate the opportunity for adopting the “animal rule”for demonstration of efficacy for regulatory purposes;
(iii) strengthen the collective commitment of nations, international organizations, potential donors and industry;
(iv) stimulate public and/or private partnerships to invest in vaccine development and licensure; and
(v) identify potential markets for an effective and safe CHIKF vaccine.
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This threat assessment addresses the implications of the ongoing Marburg virus disease (MVD) outbreak in
Rwanda for the European Union/European Economic Area (EU/EEA). MVD is a severe disease in humans and,
although uncommon, it has the potential to cause epidemics with significant case fatality. ...All recorded MVD
outbreaks to date have originated in Africa. MVD is not an airborne disease and is considered not to be
contagious before symptoms appear. Direct contact with the blood and other body fluids of infected people
and animals or indirect contact with contaminated surfaces and materials like clothing, bedding and medical
equipment is required for transmission. The risk of infection is minimised when proper infection prevention and
control precautions are strictly followed. There is no approved treatment or vaccine for MVD; however, several
pharmaceuticals and candidate MVD vaccines are under investigation.
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Visit the Ebola Outbreak page on NEJM.org for a collection of articles and other resources, including powerful, personal essays with first-hand reporting from caregivers in the field, an interactive graphic with information on past and present Ebola outbreaks, and an audio interview with NIAID Direc...tor Dr. Anthony Fauci about the current epidemic and the promise of candidate vaccines and therapies. The page also offers clinical reports and management guidelines, and will be updated as more information on this world health crisis becomes available. FREE!
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27 September 2022
These WHO interim recommendations for use of the Novavax NVX-CoV2373 vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
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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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the COVID-19 Vaccine BIBP/ Sinopharm, th...e Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorization for the vaccine (see scenario #1) and the specification is 0.5ml/dose, 1 dose/vial; or 2 doses/vial; or 5 doses/vial. As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1.
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the Sinovac COVID-19 vaccine (Vero Cell ...[Inactivated]) – CoronaVac, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorisation for the vaccine (see scenario #1). As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1
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COVID Reference 23 May 2021
7 June 2021
The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisat...ion’s (WHO) African Vaccine Regulatory Forum (AVAREF) to enable and provide support for an effective regulatory framework for COVID-19 Vaccines in Africa.
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