Learn what scientists look for in the different phases of a clinical trial for a vaccine. What does it mean when a vaccine ...o-highlight medbox">trial is halted due to an adverse event? WHO’s Dr Kate O’Brien explains in Science in 5 this week
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the Lancet : Published Online July 31, 2015 http://dx.doi.org/10.1016/S0140-6736(15)61117-5
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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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 suf...ficient data is generated on the safety and 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.
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The Lancet. Published Online December 22, 2016 http://dx.doi.org/10.1016/S0140-6736(16)32621-6. Open Access
The Lancet, Early Online Publication, 11 July 2014
doi:10.1016/S0140-6736(14)60934-X
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Published:February 02, 2021DOI:https://doi.org/10.1016/S0140-6736(21)00234-8
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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Exciting news this week with @Pfizer reporting their mRNA vaccine is 90% effective, based on their Phase III clinical trial data. Dr. Tom looks inside the virus to break down how mRNA vaccines work,... and whether news this promising means we can finally relax.
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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) 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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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 (R...ecombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vector 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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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 ...ibute-to-highlight medbox">vaccine, currently known as mRNA-1273, comes after 95 trial participants contracted Covid-19, including just five who were given the coronavirus jab.
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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 ...edbox">vaccine for neonates and
infants with improved safety and efficacy.
3. A therapeutic vaccine to improve TB
treatment outcomes
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Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE)
This document is part three 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 ...to-highlight medbox">vaccine and the three clinical trial phases.
This document outlines the next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution.
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This article is part two 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. This article focuses on the ingredients in a ...-to-highlight medbox">vaccine and the three clinical trial phases. Part three outlines the next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution
Available in English, French, Spanish, Arabic, Chinese and Russian
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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 ...o-highlight medbox">vaccine and the three clinical trial phases.
Part three focused on the steps from completing the clinical trial phases through to distribution.
This document outlines the different types of vaccines.
Available in English, French, Spanisch, Arabic, Chinese and Russian
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COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated ... medbox">vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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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 f...or potency and innocuity following satisfactory assessment in humans during well-designed field trials
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Human African trypanosomiasis (HAT), also called sleeping sickness, is a parasitic infection that almost invariably progresses to death, unless treatment is provided. HAT caused devastating epidemics during the 20th century. Thanks to sustained and coordinated efforts during the past 15 years the nu...mber of reported cases has fallen to a historic low. Fewer than 3,000 cases were reported in 2015, and the disease is targeted for elimination by the World Health Organization. Despite recent success, HAT still poses a heavy burden on the rural communities where this highly focal disease occurs, most notably in Central Africa. Since patients are also reported from non-endemic countries outside Africa, HAT should be considered in differential diagnosis for all travellers, tourists, migrants and expatriates who have visited or lived in endemic areas. In the absence of a vaccine, disease control relies on case detection and treatment, and vector control. Available drugs are sub-optimal, but ongoing clinical trials give hope for safer and simpler treatments.
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