FACTBOX-AstraZeneca's potential coronavirus vaccine

by Reuters
Tuesday, 1 September 2020 12:43 GMT

* For FACTBOX on vaccines and treatments, click: (Updates with Oxford Biomedica deal expansion and other news) Sept 1 (Reuters) - AstraZeneca has expanded its agreement with Oxford Biomedica to mass-produce its COVID-19 potential vaccine, the cell therapy firm said on Tuesday. Drugmakers are racing to combat the pandemic, which has killed more than 850,000 people and infected over 25 million. There are no approved vaccines for COVID-19, but AstraZeneca's vaccine is widely seen as one of the leading candidates, with reports that the United States is aiming for a fast-track approval before the November presidential election. The company has been granted protection from future product liability claims related to the vaccine by most of the countries with which it has so far struck supply agreements, a senior executive told Reuters. Below are the main details of the vaccine and its supply and production deals. TYPE * The shot, called AZD1222 or ChAdOx1 nCoV-19, is a recombinant viral vector vaccine developed by the University of Oxford. * It was licensed to AstraZeneca in April. * The vaccine candidate uses a weakened version of a chimpanzee common-cold virus that encodes instructions for making proteins from the novel coronavirus to build immunity. PROTECTION DURATION * The shot is likely to provide protection for about a year, and the company is leaning towards a two-dose strategy for the potential vaccine. EXPECTED COST * AstraZeneca says it will be able to manufacture the vaccine at a few dollars per dose. * Pricing in Latin America, while still not final, is not expected to exceed $4 per dose, said AstraZeneca's Mexico head. * India's Serum Institute said it will price the shot at $3 per dose for the country and other emerging economies. * According to Italy's health ministry, an AZD1222 shot would cost about 2.5 euros ($2.8) per dose in Europe. * AstraZeneca does not expect to profit from the vaccine candidate during the pandemic. * Costs in other regions have not been disclosed. TRIALS * AstraZeneca said on Monday it has begun enrolling adults for a U.S.-funded, 30,000-subject late-stage study of the vaccine. * AstraZeneca's CEO said good data had come in so far on the vaccine, after early-stage trials showed it was safe and produced an immune response. * Trials at different stages are underway in Britain, Brazil, South Africa, United States and India. Trials are planned in Japan and Russia as well. * Talks are ongoing with Mexico, and a smaller early-stage study is being conducted in South Africa to see how the vaccine works in those with HIV. TIMELINE * Data could be given to regulators this year. * The vaccine could be rolled out by year-end, but there is no certainty of that, the lead developer said in July. * Data from late-stage studies is expected around September. * Delivery of the first doses is expected between September and October. * Experts have predicted a safe and effective vaccine could take 12-18 months to develop. TARGET DOSES * 3 billion. TIE-UPS * Even before conclusive evidence of the vaccine's success or failure, AstraZeneca has signed deals to produce and supply the shot. With U.S. backing, the company also tied up with IQVIA in July to speed up trials. MANUFACTURING DEALS (Most recent first) FIRM BASED IN DEAL VALUE FOR FURTHER Oxford UK 15 million Unknown doses [nL4N2FY Biomedica pounds for 2E4] upfront to large-scale reserve commercial manufacturi manufacture ng under capacity, expanded deal further 35 million pounds plus costs payable until end of 2021 Catalent U.S. Undisclosed Making the [nL4N2DS drug 2XW] substance used in the vaccine at its Maryland facility. AZ's second deal with firm Foundation Mexico Unknown Latin [nL1N2FF of Mexican American 01U] billionaire supply with Carlos Slim Argentina, excluding Brazil, could reach 250 million mAbxience of Argentin Unknown Initially [nL1N2FF the INSUD a producing 150 01U] Group million doses for Latin America, excluding Brazil Kangtai Bio China Unknown Annual [nL4N2F8 production 2GT] capacity of at least 100 million doses this year, and at least 200 million doses by the end of next year Emergent U.S. $174 Undisclosed [nL3N2EY BioSolutions million doses in 2LF] second deal with AZ SK South Unknown Undiluted [nL3N2ES Bioscience Korea solutions of 288] the vaccine until early next year R-Pharm Russia Unknown Unknown doses [nL5N2EO 2S4] Daiichi Japan Unknown Unknown doses [nL4N2E3 Sankyo 19J] Fundação Brazil $127 About 30 [nL1N2E4 Osvaldo Cruz million million doses 03I] (Fiocruz) Symbiosis Scotland Undisclosed Clinical [nL4N2E1 Pharmaceutic trial supply 2U2] al Cobra U.S. Undisclosed One million [nL8N2DT Biosciences doses per 1YB] month Catalent U.S. Undisclosed Vial filling [nL4N2DS and packaging 2XW] capacity at its manufacturing facility in Anagni, Italy Emergent U.S. $87 million 300 million [nL4N2DO BioSolutions doses 2U1] Serum India Undisclosed One billion [nL4N2DH Institute of doses for low 3LY] India and middle-income countries, with 400 million before end of 2020 Oxford UK Undisclosed Manufacturing [nL4N2DL Biomedica unknown 1B3] number of doses SUPPLY DEALS (Most recent first) REGION/FIRM DOSES FUNDING DELIVERIES FURTHER Australia "Enough" Undisclosed Unknown [nL4N2FK for 44P] populati on of 25 million, free of cost European 300 336 million By end of [nL8N2FT Union million, euros as 2020 5QW] with downpayment option , overall of price addition undisclosed al 100 million Latin Initiall Estimated First half of [nL1N2FF America, y at $600 2021 01U] excluding produce million for Brazil 150 the first million 150 million doses, doses and eventual ly make at least 400 million Japan 120 Undisclosed 30 million [nL4N2F9 million doses by 2XN] doses March 2021 China Aims for Unknown By end of [nL4N2F8 annual 2020 2GT] producti on capacity of at least 100 million doses this year, and at least 200 million doses by the end of next year South Korea Unknown Unknown Unknown [nL3N2ES 288] Russia Unknown Unknown Unknown [nL5N2EO 2S4] Israel Unknown Unknown Unknown [nL5N2ER 4TW] Brazil Initiall 1.9 billion Unknown [nL1N2F8 y reais 2TN] receive ($339 100 million) million doses France, 300 750 million By end of [nL8N2DQ Germany, million, euros for 2020 0GG] Italy and with 300 million the option doses Netherlands of under addition Inclusive al 100 Vaccines million Alliance (IVA) Italy (part 75 185 million By end of [nL8N2DS of IVA) million euros 2020 2XO] Serum One Unknown 400 million [nL4N2DH Institute of billion, before the 3LY] India unspecif end of 2020 ied number of doses will go to India Epidemic 300 $750 Some before [nFWN2DH response million million, end of 2020 0DK] group CEPI with $383 and Vaccine from CEPI alliance GAVI United 300 $1.2 By Oct [nL4N2D3 States million billion 1M3] United 100 Unknown By Sept/Oct [nRSU597 Kingdom million 2Na] AstraZeneca is also in talks with Spain. (Sources: Reuters reporting, press releases) ($1 = 0.8850 euros) ($1 = 0.8156 pounds) ($1 = 5.6107 reais) (Reporting by Pushkala Aripaka in Bengaluru; Additional reporting by Tanishaa Nadkar; Editing by Jan Harvey, Mark Potter and Louise Heavens)

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