[125], Positive results from an interim analysis were announced on 15 November 2020. 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. [310][311], On 21 May 2020, the FDA made public the cease-and-desist notice it had sent to North Coast Biologics, a Seattle-based company that had been selling a purported "nCoV19 spike protein vaccine". Not so fast, some scientists warn", "Dozens to be deliberately infected with coronavirus in UK 'human challenge' trials", "Key criteria for the ethical acceptability of COVID-19 human challenge studies", "Principles and considerations for adding a vaccine to a national immunization programme", "A review of the changes to the licensing of influenza vaccines in Europe", "Making vaccines: Licensure, recommendations and requirements", "Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States", "TGA grants provisional determination for COVID-19 vaccine", "TGA grants second provisional determination for a COVID-19 vaccine", "EMA starts first rolling review of a COVID-19 vaccine in the EU", "EMA starts second rolling review of a COVID-19 vaccine", "EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines", "EMA considerations on COVID-19 vaccine approval", "EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L. [201] In mid-2020, estimates from two surveys were that 67% or 80% of people in the U.S. would accept a new vaccination against COVID‑19, with wide disparity by education level, employment status, race, and geography. Världshälsoorganisationen uttalade i februari att ett vaccin inte skulle bli tillgängligt på mindre än 18 månader. [219], A challenge study begins by simultaneously testing a vaccine candidate for immunogenicity and safety in laboratory animals and healthy adult volunteers (100 or fewer), something normally a sequential process using animals first. The formula, officially known as ‘Gam-COVID-Vak,' was developed by the Gamaleya National Research Center in the Russian capital. [298][299], mRNA vaccine technologies in development may be difficult to manufacture at scale and control degradation, requiring ultracold storage and transport. Koronavírusy sú veľké obalené vírusy (80-120 nm), ktoré obsahujú jednovláknovú RNA (ribonukleovú kyselinu). [305] Tracking system technologies for packaging are being used by manufacturers to trace vaccine vials across the supply chain,[278] and to use digital and biometric tools to assure security for vaccination teams.[293][307]. [263], In June, the Serum Institute of India (SII) – a major manufacturer of global vaccines – reached a licensing agreement with AstraZeneca to make 1 billion doses of vaccine for low-and-middle income countries;[261] of which half of the doses would go to India. Différentes approches sont explorées pour forcer l'organisme à développer une réponse immunitaire permettant d'éliminer le virus SARS-CoV-2 : l'utilisation de formes atténuées ou inactivées du coronavirus, de virus anodins modifiés génétiquement pour exprimer une protéine du coronavirus, de protéines du coronavirus, ou d'acides nucléiques insérés dans des cellules humaines pour y produire des protéines virales[1],[2]. [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. [222], The process requires manufacturing consistency at WHO-contracted laboratories following GMP practices. D'après Moncef Slaoui, opération « Warp Speed », la campagne de vaccination contre le coronavirus doit démarrer dès le 11 décembre 2020. Alors que les candidats vaccins n'ont pas encore terminé les tests cliniques, différents pays ont déjà passé des commandes aux industriels producteurs, sous réserve que l'efficacité et l'innocuité des vaccins soient démontrés. 40 millions de doses ont été commandées pour ce vaccin parmi 350 millions de doses commandées par le Royaume-Uni[164]. [274][276][281] RFID technologies are being implemented to track and authenticate a vaccine dose from the manufacturer along the entire supply chain to the vaccination.
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