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SAHPRA
The South African Health Products Regulatory Authority (SAHPRA) is the organisation in charge of regulating the use of all Health Products throughout the country. It is part of the National Department of Health. SAHPRA assumed the roles of both the Medicines Control Council (MCC) as well as the Directorate of Radiation Control (DRC) which were housed at the National Department of Health (NDoH). SAHPRA was constituted as an independent entity that reports to the National Minister of Health through its board. History As of the Substance Act of 1965, The Medicines Control Council (MCC) and Directorate of Radiation Control (DRC) was formed. As of 2018, the South African Health Products Regulatory Authority (SAHPRA) was created to replace the MCC and DRC Covid-19 Vaccines Oxford–AstraZeneca (AZD1222) On 6 February 2021, SAHPRA approved the Oxford–AstraZeneca COVID-19 vaccine. After a clinical trial proved to not be effective for mild to moderate illness caused b ...
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COVID-19 Vaccination In South Africa
COVID-19 vaccination in South Africa is an ongoing immunisation campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country. On 17 February 2021, South Africa started its national vaccination program against COVID-19. The program will go through in phases, prioritizing healthcare and frontline workers and then those over the age of 60. According to health officials, South Africa has administered 31,439,128 vaccine doses across the country as of 28 February 2022. South Africa has accepted delivery of 3 different vaccines, Janssen (Johnson & Johnson), Pfizer-BioNTech and Oxford-AstraZeneca, administering both Janssen and Pfizer-BioNTech, with the Oxford-AstraZeneca vaccine suspended, after a small study cast doubt on its effectiveness against the Beta variant. Background Rollout strategy Registration As of 20 October 2021, registration ...
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Pfizer–BioNTech COVID-19 Vaccine
The Pfizer–BioNTech COVID-19 vaccine ( INN: tozinameran), sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in people aged five years and older in some jurisdictions, twelve years and older in some jurisdictions, and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months i ...
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COVID-19 Pandemic In South Africa
The COVID-19 pandemic in South Africa is part of the ongoing pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On 5 March 2020, Minister of Health Zweli Mkhize had confirmed the spread of the virus to South Africa, with the first known patient being a male citizen who tested positive upon his return from Italy. On 15 March 2020, the President of South Africa, Cyril Ramaphosa, declared a national state of disaster, and announced measures such as immediate travel restrictions and the closure of schools from 18 March. On 17 March, the ''National Coronavirus Command Council'' was established, "to lead the nation's plan to contain the spread and mitigate the negative impact of the coronavirus". On 23 March, a national lockdown was announced, starting on 27 March 2020. The first local death from the disease was reported on 27 March 2020. On 21 April, a 500 billion rand stimulus was announced in response ...
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Department Of Health (South Africa)
The Department of Health is the executive department of the national government that is assigned to oversee healthcare in South Africa. The Office for Health Standards and Compliance was established in 2014. History In 1910, when the Union of South Africa was established, healthcare professionals were almost unanimously in favour of centralising the administration of health under a minister of public health. At the time, healthcare was within the purview of the Ministry of the Interior, whose Minister at the time Jan Smuts was uninterested in healthcare and of the opinion that the government should not create any more departments. The Public Health Bill of 1919 provided for a separate health portfolio but did not create a separate department; the resultant portfolio remained under the control of the Ministry of the Interior. National Health Services Commission, 1942-44 As part of a "developmental agenda", a commission chaired by Dr Henry Gluckman was organised to report an ...
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Government Company
A state-owned enterprise (SOE) is a government entity which is established or nationalised by the ''national government'' or ''provincial government'' by an executive order or an act of legislation in order to earn profit for the government, control monopoly of the private sector entities, provide products and services to citizens at a lower price and for the achievement of overall financial goals & developmental objectives in a particular country. The national government or provincial government has majority ownership over these ''state owned enterprises''. These ''state owned enterprises'' are also known as public sector undertakings in some countries. Defining characteristics of SOEs are their distinct legal form and possession of financial goals & developmental objectives (e.g., a state railway company may aim to make transportation more accessible and earn profit for the government), SOEs are government entities established to pursue financial objectives and develop ...
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Gauteng
Gauteng ( ) is one of the nine provinces of South Africa. The name in Sotho-Tswana languages means 'place of gold'. Situated on the Highveld, Gauteng is the smallest province by land area in South Africa. Although Gauteng accounts for only 1.5% of the country's land area, it is home to more than a quarter of its population (26%). Highly urbanised, the province contains the country's largest city, Johannesburg, which is also one of the largest cities in the world. Gauteng is the wealthiest province in South Africa and is considered as the financial hub of not only South Africa but the entire African continent, mostly concentrated in Johannesburg. It also contains the administrative capital, Pretoria, and other large areas such as Midrand, Vanderbijlpark, Ekurhuleni and the affluent Sandton. Gauteng is the most populous province in South Africa with a population of approximately 16.1 million people according to mid year 2022 estimates. Etymology The name ''Gauteng'' is derived ...
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Oxford–AstraZeneca COVID-19 Vaccine
The Oxford–AstraZeneca COVID19 vaccine, sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for prevention of COVID-19. Developed in the United Kingdom by Oxford University and British-Swedish company AstraZeneca, using as a vector the modified chimpanzee adenovirus ChAdOx1. The vaccine is given by intramuscular injection. Studies carried out in 2020 showed that the efficacy of the vaccine is 76.0% at preventing symptomatic COVID-19 beginning at 22 days following the first dose, and 81.3% after the second dose. A study in Scotland found that, for symptomatic COVID-19 infection after the second dose, the vaccine is 81% effective against the Alpha variant (lineage B.1.1.7), and 61% against the Delta variant (lineage B.1.617.2). The vaccine is stable at refrigerator temperatures and has a good safety profile, with side effects including injection-site pain, headache, and nausea, all generally resolving within a few days. More rarely, ...
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Janssen COVID-19 Vaccine
The Janssen COVID19 vaccine, sold under the brand name Jcovden, is a COVID19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company Johnson & Johnson. It is a viral vector vaccine based on a human adenovirus that has been modified to contain the gene for making the spike protein of the SARS-CoV-2 virus that causes COVID19. The body's immune system responds to this spike protein to produce antibodies. The vaccine requires only one dose and does not need to be stored frozen. Clinical trials for the vaccine were started in June 2020, with phaseIII involving around 43,000 people. On 29 January 2021, Janssen announced that 28 days after a completed vaccination, the vaccine was 66% effective in a one-dose regimen in preventing symptomatic COVID19, with an 85% efficacy in preventing severe COVID19 and 100% efficacy in preventing hospitalization or death caused by the disease ...
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Medicines And Related Substances Act
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in multiple ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the order of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically (such as IVIG), gene therapy, monoclonal antibodies and cell therapy (for instance, stem cell therapies). Other w ...
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Expanded Access
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. These programs go under various names, including early access, special access, or managed access program, compassionate use, compassionate access, named-patient access, temporary authorization for use, cohort access, and pre-approval access. In general the person and their doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicines regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit. In some countries the government will pay for the drug or ...
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COVID-19 Vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. In January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by March 2020, the global pharmaceutical industry announced a major commitment to address COVID19. In 2020, the first COVID19 vaccines were developed and made available to the public through emergency authorizations and conditional approvals. Initially, most COVID19 vaccines were two ...
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COVID-19 Pandemic
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identified in an outbreak in the Chinese city of Wuhan in December 2019. Attempts to contain it there failed, allowing the virus to spread to other areas of Asia and later worldwide. The World Health Organization (WHO) declared the outbreak a public health emergency of international concern on 30 January 2020, and a pandemic on 11 March 2020. As of , the pandemic had caused more than cases and confirmed deaths, making it one of the deadliest in history. COVID-19 symptoms range from undetectable to deadly, but most commonly include fever, dry cough, and fatigue. Severe illness is more likely in elderly patients and those with certain underlying medical conditions. COVID-19 transmits when people breathe in air contaminated by droplets and ...
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