Jan 3 (Reuters) - India's drugs regulator gave final approval on Sunday for the emergency-use of a COVID-19 vaccine developed by AstraZeneca and Oxford University. Britain, El Salvador and Argentina have also approved the vaccine. Once front-runners in a global race to develop a vaccine, the AstraZeneca and University of Oxford partnership has been overtaken by Pfizer and German partner BioNTech, whose vaccine is already being used in Britain and the United States. The following are details of the Oxford-AstraZeneca vaccine effort: TYPE OF VACCINE * Called AZD1222 or ChAdOx1 nCoV-19, the vaccine is a recombinant viral vector vaccine, meaning a virus is used as a means of delivering the vaccine. * It will be branded COVISHIELD in India and is being manufactured there by partner Serum Institute of India. * It uses a weakened version of a chimpanzee common cold virus that encodes instructions for making proteins from the novel coronavirus to generate an immune response and prevent infection. DOSAGE, PROTECTION DURATION AND STORAGE * India has authorised a two full-dose regime. * UK authorisation recommends two-dose regime given between four and 12 weeks apart. * Two regimens are being tested: one in which recipients get two full doses, and another with half a dose followed by a full dose. * The half-dose first regimen was found to be 90% effective in a subset of trial subjects. The success rate was 62% with the originally planned two full doses, based on interim data. * In December, Oxford said the vaccine has a better immune response when a two full-dose regime is used, citing data from early trials. * Immune response could last at least a year. * The vaccine should be effective against the new coronavirus variant, and studies are under way to fully probe the impact of the mutation. * The vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months, making it logistically easier to transport than Pfizer's vaccine. * AstraZeneca aims to supply millions of doses in the first quarter to Britain and is working with the UK government for first vaccinations to begin early in the new year. EXPECTED DOSAGE PRICE * Serum Institute of India has said it would price the vaccine at 250 rupees (about $3) per dose for India's government and many other countries and at 1,000 rupees for the private market. * Pricing in Britain is unknown so far. * Italy's health ministry said in June the vaccine would cost about 2.5 euros ($2.80) per dose in Europe. * AstraZeneca has said it will be able to manufacture the vaccine at a few dollars per dose. * Pricing in Latin America is not expected to exceed $4 per dose. * Sources told Reuters it could cost $4 to $5 per dose in Bangladesh. * Costs in other regions have not yet been disclosed. * AstraZeneca has said it would not profit from the vaccine during the pandemic, but a report from the Financial Times in October showed the company can declare when it considers the pandemic to have ended in its deals for the vaccine. * AstraZeneca will look to profit from wealthier countries at the "appropriate time". TESTING AND DATA * Trials combining the vaccine with Russia's Sputnik V will start by the end of the year, and Russia wants to jointly produce the new vaccine if it is proven to be effective. * Vastly divergent performance with different dose regimens has called for more clarity on the vaccine's efficacy which averaged 70.4%, well below vaccines from Pfizer and Moderna, but above the 50% threshold set by many regulators. * Serum Institute of India will continue to test a two full dose regimen of the vaccine. * AstraZeneca had to pause global trials on Sept. 6 after an unexplained illness in a participant. * Trial of the vaccine in the United States resumed in October after other countries had ended their pause. * AZD1222 produces an immune response in both old and young adults, and also led to lower adverse responses among the elderly, AstraZeneca said in October. * The vaccine also accurately follows genetic instructions programmed into it by its developers, according to an analysis by independent scientists. * Brazil said in October that a trial volunteer had died. * A source told Reuters the Brazilian trial would have been suspended if the volunteer who died had received the COVID-19 vaccine, although the death was reported to be a suicide. * In July, data from early-stage trials published in The Lancet showed the vaccine was safe and produced an immune response. GLOBAL TRIALS Below are other regions where testing of the vaccine is being carried out or planned: (In alphabetical order of regions) REGION STAGE OF STATUS VOLUNTEERS DATA EXPECTED DEVELOPMENT COMPLETION Brazil Phase III Recruiting, 10,300 First data Sept. 2021 (bit.ly/2GAeB4K) restarted anticipated published in (bit.ly/2I4BNIz) after pause , with late in early participant November September s aged 18 years and older Chile Unknown Wrapped up 2,000 Unknown Unknown recruitment enrolled China Unknown To begin Unknown Unknown Unknown India Phase II/III Ongoing, 1,600 Not In seven months restarted anticipated available from August (bit.ly/3nAwXTC) after pause , with in early participant September s aged 18 years and older Japan Phase I/II Active, not 256 Not Nov. 2021 (bit.ly/3nAnImj) recruiting. anticipated available Restarted , with after pause participant in early s aged 18 September years and older Kenya Phase Ib/II Ongoing 400 Not In approximately anticipated available two years (bit.ly/362fsUy) , with participant s aged 18 years and older, and will only enrol healthcare workers Peru Unknown To begin Unknown Unknown Unknown Russia Phase III Suspended, 100 Not March 2021 (bit.ly/36NKpxr) on hold anticipated applicable till , with Russian participant approval s aged 18 following years and pause in older September Russia, in Unknown To begin Unknown Unknown Unknown (bit.ly/2KljQ9F) combination number of with Sputnik adults aged V 18 and older South Africa Phase I/II Active, not 2,130 First data Dec. 2021 (bit.ly/2Gy8mhS) recruiting. enrolled, was Restarted with both anticipated after pause HIV-uninfec in Q4 2020, in early ted adults but the September and people principal living with investigator HIV told Reuters that efficacy results may not be ready for months UK Phase I/II Active, not 1,090 Initial data Oct. 2021 (bit.ly/3n81UxJ) recruiting enrolled, readout in (bit.ly/2HY2pe5) with July 2020 participant s aged between 18 and 55 UK Phase II/III Recruiting, 12,390 First data Sept. 2021 (bit.ly/34EOHVj) restarted anticipated published in (bit.ly/2HSU37G) after pause , with late in early participant November September s aged 18 years and older. Also includes HIV infected adults in one group. Previously included children above 5 years of age. U.S. with Phase III Recruiting, 40,000 First data Feb. 2023 (bit.ly/30O4XCl) global sites restarted anticipated anticipated in late , with in H1 2021 October participant after pause s aged 18 in early years and September older DATA AND REGULATORY TIMELINE * The lead developer had said in July the vaccine could be rolled out by year-end, but the delivery and testing timeline has since been pushed back. * Data read-out submitted to regulators across the world to seek approval. * Experts have predicted a safe and effective vaccine could take 12-18 months to develop, even at the record speeds. REGULATORY REVIEWS AND APPROVALS (Most recent first) REGION/REGULATOR REVIEW STATUS TYPE OF FORMAL FURTHER APPROVAL/APPLICATION APPLICATION India/Central Approved Review launched in Submitted by Drugs Standard after December and Serum Control accelerated approval for Institute and Organisation review two-dose regime approved Argentina/Nationa Approved for Approval for the Approved l Administrator emergency use vaccine to be for Food and administered to Medical people over the age Technology of 18 in two doses between four and 12 weeks apart, as per UK greenlight. El Approved Approval based on Approved Salvador/National evidence provided by Directorate of the developer, Medicines emergency use permissions authorised by other countries. Britain/Medicines Approved for Approved in late Submitted and and Healthcare emergency use December after Approved Products rolling review was Regulatory Agency launched in Oct Chile/Public Under review Application for Submitted Health Institute emergency use Brazil/Anvisa Under review Application will be Expected to for two-dose regimen be submitted by Fiocruz on Jan. 15 Mexico/COFEPRIS Under review Expected to request Not submitted emergency authorization in January United States/ Under review Likely be authorised Not submitted Food and Drug for emergency use in Administration April Canada/Health Rolling Review launched in Not submitted Canada submission Oct, there is still information and data to be provided for review Europe/European Rolling Review launched in Not submitted Medicines Agency review for Oct, is seeking more conditional data and it could be approval months before an approval is given * The World Health Organization expects to make decisions on whether to give emergency use approval to COVID-19 vaccines, including AstraZeneca's, its chief scientist said in December. TARGET DOSES/GLOBAL CAPACITY OF SUPPLY * More than 3 billion doses are planned. * The company will have as many as 200 million doses by the end of 2020, and 700 million doses could be ready globally as soon as the end of the first quarter of 2021. * AstraZeneca is keeping the vaccine frozen in large containers and will only add a final ingredient, put it into vials and refrigerate it when the vaccine gets closer to approvals. TIE-UPS * Even before studies showed any signs of efficacy, AstraZeneca had signed several supply and manufacturing deals around the world. * It also joined forces with IQVIA to speed up testing. * AstraZeneca has been granted protection from future liability claims related to the vaccine by most of the countries with which it has struck supply agreements, a senior executive told Reuters in July. SUPPLY DEALS (Most recent first) REGION/GROUP DOSES FUNDING EXPECTED FURTHER DELIVERIES Indonesia 50 million Undisclosed First batch expected to be available by first half of 2021 Malaysia 6.4 million Undisclosed Unknown Colombia 10 million Undisclosed Unknown Philippines 2.6 million Undisclosed Shipment expected in May Thailand Addition under Previously First batch further agreement approved budget expected to be unknown, of 6 billion available in {nL4N2IC2R6] previously 26 baht ($199 mid-2021 million doses million) Bangladesh 30 million from Undisclosed "Whenever the Serum Institute of vaccine is ready" India Argentina 22 million Undisclosed Depends on trials being successful and obtaining necessary approvals Chile 14.4 million Undisclosed Unknown Spain 31.6 million as Undisclosed Between Dec. 2020 part of a European and June 2021 Union scheme Switzerland 5.3 million Undisclosed Unknown Canada Up to 20 million Undisclosed Unknown doses Australia "Enough" for Undisclosed Unknown population of 25 million, free of cost European 300 million, with 750 million By end-2020 Union option of euros for 300 additional 100 million doses million Latin Initially produce Estimated at First half 2021 America, 150 million doses, $600 million excluding and eventually for the first Brazil make at least 400 150 million million doses Japan 120 million doses Undisclosed 30 million doses by March 2021 China Aims for annual Undisclosed By end-2020 production capacity of at least 100 million doses this year, and at least 200 million doses by the end of next year South Korea 20 million Undisclosed Shipments would begin no later than March, and vaccinations may start in the first half of next year Russia Unknown Undisclosed Unknown Israel Unknown Undisclosed Unknown Brazil Initially receive $356 million Unknown 100 million doses Serum One billion, Undisclosed 400 million before Institute of unspecified number end-2020 were India of doses will go expected to India previously Epidemic 300 million $750 million, Some before end- response with $383 from 2020 group CEPI CEPI and Vaccine alliance GAVI United 300 million $1.2 billion Was earlier States expected by Oct. 2020 United 100 million 84 million 4 million in 2020. Kingdom pounds Earlier about 30 million doses were expected with initial deliveries [nL8N2IO2YJ by Sept/Oct. 2020. Initial supply to come from Europe. MANUFACTURING DEALS (Most recent first) FIRM BASED IN DEAL VALUE FOR FURTHER CSL Ltd Australia Undisclosed Additional 20 million requested by Australian government, approximately 30 million doses already being manufactured Halix B.V. Netherlands Undisclosed Commercial manufacture of the vaccine Siam Thailand Undisclosed Manufacture and supply Bioscience, the vaccine in Thailand SCG and other nations in Southeast Asia Albany U.S. Undisclosed Produce millions of Molecular doses through sterile Research finishing services at its manufacturing plant in Albuquerque, New Mexico Oxford UK 15 million Unknown doses for Biomedica pounds to large-scale commercial reserve manufacture under manufacturin expanded deal g capacity, further 35 million pounds plus costs payable in certain situations Catalent U.S. Undisclosed Making the drug substance used in the vaccine at its Maryland facility. AZ's second deal with firm Foundation of Mexico Undisclosed Latin American supply Mexican with Argentina, billionaire excluding Brazil, could Carlos Slim reach 250 million mAbxience of Argentina Undisclosed Initially producing 150 the INSUD million doses for Latin Group America, excluding Brazil Kangtai Bio China Undisclosed Annual production capacity of at least 100 million doses this year, and at least 200 million doses by end-2021 Emergent U.S. $174 million Undisclosed doses in BioSolutions second deal with AZ SK Bioscience South Korea Undisclosed Undiluted solutions of the vaccine until early 2021 R-Pharm Russia Undisclosed Unknown doses Daiichi Japan Undisclosed Unknown doses Sankyo Fundação Brazil $127 million About 30 million doses Osvaldo Cruz (Fiocruz) Symbiosis Scotland Undisclosed Clinical trial supply Pharmaceutica l Cobra U.S. Undisclosed One million doses per Biosciences month Catalent U.S. Undisclosed Vial filling and packaging capacity at its manufacturing facility in Anagni, Italy Emergent U.S. $87 million 300 million doses BioSolutions Serum India Undisclosed One billion doses for Institute of low and middle-income India countries. 400 million before end-2020 were expected previously Oxford UK Undisclosed Manufacturing unknown Biomedica number of doses (Sources: Reuters reporting, media releases, clinical trial registers, regulatory bodies, medical journals, World Health Organization) (Reporting by Pushkala Aripaka, Tanishaa Nadkar and Aakash Jagadeesh Babu in Bengaluru; Editing by William Maclean, Patrick Graham and Carmel Crimmins)
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