[2] An immunological adjuvant is a substance formulated with a vaccine to elevate the immune response to an antigen, such as the COVID‑19 virus or influenza virus. [14] The WHO also implemented Covid‑19 Vaccines Global Access (COVAX) for coordinating global vaccine development, the vaccine pillar of Access to COVID-19 Tools (ACT) Accelerator in collaboration with GAVI and the Coalition for Epidemic Preparedness Innovations (CEPI). Browse Sputnik for breaking news and top stories on politics, economy, social media and the most viral trends. [4] [5] Fue desarrollado por el Instituto de Investigación de Epidemiología y Microbiología Gamaleya y reg Vaccines have been produced against several animal diseases caused by coronaviruses, including as of 2003 infectious bronchitis virus in birds, canine coronavirus, and feline coronavirus. [80] Phase III trials typically involve more participants at multiple sites, include a control group, and test effectiveness of the vaccine to prevent the disease (an "interventional" or "pivotal" trial), while monitoring for adverse effects at the optimal dose. [298][299], mRNA vaccine technologies in development may be difficult to manufacture at scale and control degradation, requiring ultracold storage and transport. For example, the Pfizer/BioNTech vaccine BNT162 must be shipped and stored at −70 °C (−94 °F), must be used within five days of thawing, and has a minimum order of 975 doses, making it unlikely to be rolled out in settings other than large, well-equipped hospitals. Vedi la guida al trasferimento e assicurati che la voce sia elencata qui. [16] Previous projects to develop vaccines for viruses in the family Coronaviridae that affect humans have been aimed at severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). [197] Specifically, an adjuvant may be used in formulating a COVID‑19 vaccine candidate to boost its immunogenicity and efficacy to reduce or prevent COVID-19 infection in vaccinated individuals. Les sociétés pharmaceutiques développant les vaccins bénéficient d'une immunité juridique dans différents pays, dont les États-Unis, afin d'éviter d'être poursuivies en justice en cas d'effets secondaires[135],[136]. Approval for Its Coronavirus Vaccine", "Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization", "A COVID-19 vaccine will need equitable, global distribution", "COVID-19 pandemic reveals the risks of relying on private sector for life-saving vaccines, says expert", "Oxford, AstraZeneca COVID-19 deal reinforces 'vaccine sovereignty, "AstraZeneca unveils massive $750M deal in effort to produce billions of COVID-19 shots", "Top U.S. scientists left out of White House selection of COVID-19 vaccine short list", "The equitable distribution of COVID-19 therapeutics and vaccines", "U.S. secures 300 million doses of potential AstraZeneca COVID-19 vaccine", "U.S. likely to get Sanofi vaccine first if it succeeds", "The unequal scramble for coronavirus vaccines – by the numbers", "If a coronavirus vaccine arrives, can the world make enough? As of December 2020, 59 vaccine candidates were in clinical research: namely 42 in Phase I–II trials and 17 in Phase II–III trials. [60] Several companies plan to initially manufacture a vaccine at low cost, then increase costs for profitability later if annual vaccinations are needed and as countries build stock for future needs. The Brazilian state of Bahia has also signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and plans to buy 50 million doses to market in northeastern Brazil. [246], In the United States, the FDA may grant emergency use authorization (EUA) for a COVID‑19 vaccine before full evidence from a Phase III clinical trial is available about its safety and efficacy, but this hastened process has been criticized for its political misuse, potential for lowered standards, and increased antivaccine sentiment in the US population during 2020. WHO works with national agencies to monitor inspections of manufacturing facilities and distributors for compliance with GMP and regulatory oversight. Deux phénomènes rendent plus difficile le travail d'élaboration d'un vaccin fiable contre certains virus et notamment les virus à ARN qui mutent très vite : la « facilitation de l'infection par des anticorps », et le phénomène de « péché originel antigénique » (aussi dit « effet Hoskins »). [33], Having been created to monitor fair distribution of infectious disease vaccines to low- and middle-income countries,[263][269] CEPI revised its equitable access policy that was published in February to apply to its COVID‑19 vaccine funding: 1) "prices for vaccines will be set as low as possible for territories that are or may be affected by an outbreak of a disease for which CEPI funding was used to develop a vaccine;" 2) "information, know-how and materials related to vaccine development must be shared with (or transferred to) CEPI" so that it can assume responsibility for vaccine development if a company discontinues expenditures for a promising vaccine candidate; 3) CEPI would have access to, and possible management of, intellectual property rights (i.e., patents) for promising vaccines; 4) "CEPI would receive a share of financial benefits that might accrue from CEPI-sponsored vaccine development, to re-invest in support of its mission to provide global public health benefit"; and 5) data transparency among development partners should maintain the WHO Statement on Public Disclosure of Clinical Trial Results, and require results to be published in open-access publications. [41][74], In the haste to provide a vaccine on a rapid timeline for the COVID‑19 pandemic, developers and governments are accepting a high risk of "short-circuiting" the vaccine development process,[40] with one industry executive saying: "The crisis in the world is so big that each of us will have to take maximum risk now to put this disease to a stop". [215][216][218] Following the challenge, the volunteers would be monitored closely in clinics with life-saving resources, if needed. [266][287][288] Pre-orders from the UK government for 2021 were for five vaccine doses per person, a number dispiriting organizations like the WHO and GAVI which are promoting fair and equitable access worldwide, especially for developing countries. [45], On 4 June, a virtual summit was coordinated from London, UK, among private and government representatives of 52 countries, including 35 heads of state from G7 and G20 nations, to raise US$8.8 billion in support of the Global Alliance for Vaccines and Immunisation (GAVI) to prepare for COVID‑19 vaccinations of 300 million children in under-developed countries through 2025. L'urgence sanitaire a obligé les autorités à raccourcir grandement le délai. Een vaccin is een middel dat, na toediening of inenting, mens of dier langdurig beschermt tegen een infectieziekte voor een specifiek schadelijk micro-organisme (hoofdzakelijk tegen virussen en sommige bacteriën), in de medische microbiologie pathogeen genaamd. [58] Belgium, Norway, Switzerland, Germany, and the Netherlands have been major contributors to the CEPI effort for COVID‑19 vaccine research in Europe. [266] After joining COVAX in October, China shared that it would produce 600 million vaccine doses before the end of 2020 and another one billion doses in 2021, although it was unsure how many would be for the country's own population of 1.4 billion. Le génome du SARS-CoV-2 étant proche de celui du SARS-CoV, les chercheurs espèrent pouvoir bénéficier des recherches commencées sur le SARS-CoV, puis abandonnées quand l'épidémie s'est éteinte. Contre le SARS-CoV-2 elle est considérée comme pouvant provisoirement protéger des groupes à risque, dont le personnel médical[160]. – Bo Burnham Prelude A Covid 19 vaccine has been registered in Russia. [35] Also in April, CEPI estimated that as many as six of the vaccine candidates against COVID‑19 should be chosen by international coalitions for development through Phase II–III trials, and three should be streamlined through regulatory and quality assurance for eventual licensing at a total cost of at least US$2 billion. Le nombre de ces pré-commandes dépasserait largement les 5 milliards de doses[141]. [273][274][275] Addressing the worldwide challenge faced by coordinating numerous organizations – the COVAX partnership, global pharmaceutical companies, contract vaccine manufacturers, inter- and intranational transport, storage facilities, and health organizations in individual countries – Seth Berkley, chief executive of GAVI, stated: "Delivering billions of doses of vaccine to the entire world efficiently will involve hugely complex logistical and programmatic obstacles all the way along the supply chain. Dr. Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. [15] Individual countries producing a vaccine may be persuaded to favor the highest bidder for manufacturing or provide first-service to their own country. [30][41][259] The collaboration of the University of Oxford with AstraZeneca (a global pharmaceutical company based in the UK) raised concerns about price and sharing of eventual profits from international vaccine sales, arising from whether the UK government and university as public partners had commercialization rights. "Not a … The Blueprint listed a Global Target Product Profile (TPP) for COVID‑19, identifying favorable attributes of safe and effective vaccines under two broad categories: "vaccines for the long-term protection of people at higher risk of COVID‑19, such as healthcare workers", and other vaccines to provide rapid-response immunity for new outbreaks. [284], Other logistics factors conducted internationally during distribution of a COVID‑19 vaccine may include:[273][285][286], A logistics shortage in any one step may derail the whole supply chain, according to one vaccine developer. You might assume that 95 out of every 100 people vaccinated will be protected from Covid-19. "[276], As an example highlighting the immensity of the challenge, the International Air Transport Association stated that 8,000 747 cargo planes – implemented with equipment for precision vaccine cold storage – would be needed to transport just one dose for people in the more than 200 countries experiencing the COVID‑19 pandemic. Certaines compagnies aériennes — comme EasyJet et Japan Airlines et Ryanair — estiment qu'elles ne rendront pas une telle vaccination obligatoire. [12][205] Host-("vaccinee")-related determinants that render a person susceptible to infection, such as genetics, health status (underlying disease, nutrition, pregnancy, sensitivities or allergies), immune competence, age, and economic impact or cultural environment can be primary or secondary factors affecting the severity of infection and response to a vaccine. [59] The vaccine development initiatives at the University of Oxford and Imperial College of London were financed with GB£44 million in April. [215][216][217] Challenge studies have been implemented previously for diseases less deadly than COVID‑19 infection, such as common influenza, typhoid fever, cholera, and malaria. [205] Elderly (above age 60), allergen-hypersensitive, and obese people have susceptibility to compromised immunogenicity, which prevents or inhibits vaccine effectiveness, possibly requiring separate vaccine technologies for these specific populations or repetitive booster vaccinations to limit virus transmission. [38][72] The WHO, CEPI, and GAVI have expressed concerns that affluent countries should not receive priority access to the global supply of eventual COVID‑19 vaccines, but rather protecting healthcare personnel and people at high risk of infection are needed to address public health concerns and reduce economic impact of the pandemic. [90] An efficacy of less than 60% may result in failure to create herd immunity. [1][204] The vaccine technology platform (for example, viral vector vaccine, spike (S) protein vaccine or protein subunit vaccine), vaccine dose, timing of repeat vaccinations for the possible recurrence of COVID‑19 infection, and elderly age are factors determining the risk and extent of ADE. For potential therapeutic drugs for COVID-19, see, Partnerships, competition, and distribution, One or more candidates in Phase II or Phase II–III trials. [40], In April, the UK government formed a COVID‑19 vaccine task force to stimulate British efforts for rapidly developing a vaccine through collaborations of industry, universities, and government agencies across the vaccine development pipeline, including clinical trial placement at UK hospitals, regulations for approval, and eventual manufacturing. Différents projets de passe port sont à l'étude: Un article de Wikipédia, l'encyclopédie libre. [281][304], Medicines are the world's largest fraud market, worth some $200 billion per year, making the widespread demand for a COVID-19 vaccine vulnerable to counterfeit, theft, scams, and cyberattacks throughout the supply chain. [237] If successful through the stages of clinical development, the vaccine licensing process is followed by a Biologics License Application which must provide a scientific review team (from diverse disciplines, such as physicians, statisticians, microbiologists, chemists) a comprehensive documentation for the vaccine candidate having efficacy and safety throughout its development. De nombreuses organisations utilisent des génomes publiés pour développer d'éventuels vaccins contre le SARS-CoV-2[36],[37]. Sputnik V. Lingua; Segui; Modifica ; Questa voce è stata proposta per il trasferimento al progetto Wikinotizie. ", "WHO 'backed China's emergency use' of experimental Covid-19 vaccines", "Russia Is Slow to Administer Virus Vaccine Despite Kremlin's Approval", "Bahrain latest country to vaccinate frontline workers with COVID-19 shot", "FDA may be risk-averse to grant emergency use for a Covid-19 vaccine; political pressure and hazy EUA standards are factors", "Mistrust of a coronavirus vaccine could imperil widespread immunity", "Biopharma leaders unite to stand with science", "Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine", "Exclusive: Pfizer CEO Discusses Submitting the First COVID-19 Vaccine Clearance Request to the FDA", "Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate", "VRBPAC December 10, 2020 Meeting Announcement", "Emergency Use Authorization for Vaccines Explained", "Covid Pfizer vaccine approved for use next week in UK", "Moderna Applies for Emergency F.D.A. [22][25] As of March 2020, there was one (DNA based) MERS vaccine which completed Phase I clinical trials in humans,[26] and three others in progress, all of which are viral-vectored vaccines: two adenoviral-vectored (ChAdOx1-MERS, BVRS-GamVac), and one MVA-vectored (MVA-MERS-S). [256][257], Until a vaccine is in use for the general population, all potential adverse events from the vaccine may not be known, requiring manufacturers to conduct Phase IV studies for postmarketing surveillance of the vaccine while it is used widely in the public. Culture et sociét é Entreprises et produits. ; Spoetnik, een mixdrankje met Exota. [228][229][230], In November 2020, the EMA published a safety monitoring plan and guidance on risk management planning (RMP) for COVID-19 vaccines. Sputnik Engineering AG est une société suisse spécialisée dans le développement, la production, la distribution et la maintenance d’onduleurs photovoltaïques. [141] Johnson & Johnson announced, on 23 October, that they are preparing to resume the trial in the US.[142][143]. Dans le cadre d'une recherche vaccinale concernant le MERS-CoV en cours depuis 2012, l'institut Pasteur pourrait utiliser et adapter ces vaccins pour SARS-CoV-2[52]. Cette nouvelle provoque un envol des bourses mondiales. [223] Generally, all EU states follow regulatory guidance and clinical programs defined by the European Committee for Medicinal Products for Human Use (CHMP), a scientific panel of the European Medicines Agency (EMA) responsible for vaccine licensure. It's been named ‘Sputnik … [40], The European Commission organized and held a video conference of world leaders on 4 May 2020, at which US$8 billion was raised for COVID‑19 vaccine development. [240] A rolling review process for the Moderna vaccine candidate was initiated in October by Health Canada and the European Medicines Agency,[241] and in November in Canada for the Pfizer-BioNTech candidate. [43][44] Toujours d'après lui, la Commission refuserait de publier les noms des membres de l’équipe de négociation et, d'après des éléments des contrats ayant fuité, les entreprises pharmaceutique risquent de décider elles-mêmes du prix des vaccins malgré les subsides reçus et les contrats contiendraient une clause libérant les entreprises pharmaceutiques de toute responsabilité financière en cas d’effets secondaires[131]. Ett coronavaccin är ett tänkt vaccin mot Sars-Cov-2, det virus av coronatyp som orsakar sjukdomen Covid-19. En mars 2020, un vaccin MERS (basé sur l'ADN) a achevé sa période d'essais cliniques de phase I chez l'homme[20] et trois autres en cours, tous étant des vaccins à vecteur viral, deux à vecteur adénoviral (ChAdOx1-MERS, BVRS -GamVac), et un vecteur MVA (MVA-MERS-S)[21]. [222], The process requires manufacturing consistency at WHO-contracted laboratories following GMP practices. [2][15][33][68] For example, successful COVID‑19 vaccines would likely be allocated first to healthcare personnel and populations at greatest risk of severe illness and death from COVID‑19 infection, such as the elderly or densely-populated impoverished people. A COVID‑19 vaccine is any of several different vaccine technologies intended to provide acquired immunity against coronavirus disease 2019 (COVID‑19). Ce risque est d'autant plus important que le nombre de malades dans le monde est élevé. [2] On 4 May 2020, the WHO organized a telethon which received US$8.1 billion in pledges from forty countries to support rapid development of vaccines to prevent COVID‑19 infections. [52] On 22 July, China additionally announced that it plans to provide a US$1 billion loan to make its vaccine accessible for countries in Latin America and the Caribbean. [30][258][259][260] The corporate investment and need to generate value for public shareholders raised concerns about a "market-based approach" in vaccine development, costly pricing of eventual licensed vaccines, preferred access for distribution first to affluent countries, and sparse or no distribution to where the pandemic is most aggressive, as predicted for densely-populated, impoverished countries unable to afford vaccinations. [223], In October 2020, the CHMP started 'rolling reviews' of the vaccines known as COVID‑19 Vaccine AstraZeneca and BNT162b2. [215][218][216] Beginning in January 2021, dozens of young adult volunteers will be deliberately infected with COVID‑19 in a challenge trial conducted in a London hospital under management by the UK government COVID-19 Vaccine Taskforce. Le 9 novembre 2020, Pfizer, qui mène la course dans l'industrie occidentale, annonce que le candidat vaccin contre le COVID-19 qu'il prépare en partenariat avec BioNTech est efficace à 90 %[4]. La dernière modification de cette page a été faite le 2 décembre 2020 à 19:30. Sputnik V countries.png 1,425 × 625; 53 KB Вакцина Спутник V.jpg 800 × 400; 34 KB Вакцинация медицинских работников Москвы от COVID-19 (20).jpg 1,600 × 1,067; 152 KB Dans certains pays comme la France et l'Angleterre, le débat concernant l'importance d'une vaccination collective et la liberté individuelle de refus est ravivé[126],[127]. [204][205], The effectiveness of new vaccine is defined by its efficacy. Suite à l'annonce du vaccin, Yannick Jadot, l'ancien candidat EELV à l'élection présidentielle, demande à ce que le vaccin soit obligatoire[128]. [222], In October 2020, the Australian Therapeutic Goods Administration (TGA) granted provisional determinations to AstraZeneca Pty Ltd in relation to its COVID‑19 vaccine, ChAdOx1-S [recombinant] and to Pfizer Australia Pty Ltd in relation to its COVID-19 vaccine, BNT162b2 [mRNA]. Aşı adayı, Rusya Sağlık Bakanlığı tarafından 11 Ağustos 2020'de duyuruldu. Prelude. Vous pouvez également préciser les sections à actualiser en utilisant {{section à actualiser}}. [221], A vaccine licensure occurs after the successful conclusion of the clinical trials program through Phases I–III demonstrating safety, immunogenicity at a specific dose, effectiveness at preventing infection in target populations, and enduring preventive effect. A vacina foi registrada em 11 de agosto de 2020 pelo Ministério da Saúde da Federação Russa. Гам-КОВИД-Вак) znana również jako Sputnik V (ros. Glass vial makers prepare for COVID-19 vaccine", "3 applications for RFID in the fight against COVID-19", "Ramping Up COVID-19 Vaccine Fill and Finish Capacity", "Swiss factory rushes to prepare for Moderna Covid-19 vaccine", "Tools and approaches to ensure quality of vaccines throughout the cold chain", "Is freezing in the vaccine cold chain an ongoing issue? Plusieurs vaccins pour animaux ont aussi été produits contre diverses maladies à coronavirus, notamment contre le virus de la bronchite infectieuse chez les oiseaux, le coronavirus canin et le coronavirus félin[6]. Certaines compagnies aériennes souhaitent rendre obligatoire la vaccination de leurs passagers internationaux. [209], Having an insufficient number of skilled team members to administer vaccinations may hinder clinical trials that must overcome risks for trial failure, such as recruiting participants in rural or low-density geographic regions, and variations of age, race, ethnicity, or underlying medical conditions. Eu Europe, les vaccins candidats auprès de l'EMA sont ceux des sociétés Pfizer/BioNTech, Moderna et AstraZeneca/Université d’Oxford[163]. ", "Coronavirus vaccine pre-orders worldwide top 5 billion", "China Commits to Producing 600 Million Vaccine Doses by the End of 2020", "Vaccine makers turn to microchip tech to beat glass shortages", "With COVID-19 vaccines coming, SiO2 injects $163M into vial production plant", "Bottlenecks? Le 8 avril, pas moins de 115 vaccins différents étaient en projet sur l'ensemble du globe, dont 78 activement ; 16 projets étaient entrés en phase pré-clinique et 5 en Phase I[48].
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