2021-01-06 08:38:02 AZN AstraZeneca
01/06/21 01/0608:38 01/06/2108:38 | AstraZeneca's COVID vaccine gets emergency use authorization in 5 more countriesThe company states: "AstraZeneca's COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. The vaccine was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world. AstraZeneca has partnered with Serum Institute of India (SII), the world's largest vaccine manufacturer, for the supply of the vaccine to the Indian Government but also to a large number of low and middle-income countries. AstraZeneca has already submitted a substantial data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency, as part of an ongoing rolling review process and will continue to work closely with the EMA to seek approval in the coming weeks. AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries during this health crisis and has ongoing rolling reviews with many other regulatory authorities around the world. AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals." |
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