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India regulators grant permission for emergency use for COVID-19 vaccines manufactured by Serum Institute of India

Pune 06th January 2021 – Serum Institute of India (SII), the world’s largest vaccine manufacturer, has partnered with AstraZeneca, for manufacturing and the supply of the COVID-19 vaccine to the Indian Government but also to a large number of low and middle-income countries. The COVID-19 vaccine based on the ChAdOx1 construct from the University of Oxford’s Jenner Institute, has been granted emergency use authorization for the active immunization of adults in India as well as in Argentina, Dominican Republic, El Salvador, Mexico and Morocco. The approval in India will enable to supply India and a large number of countries around the world.

“The emergency licensure in India marks an important milestone for all of us – said Adar Poonawalla, Chief Executive Officer, Serum Institute of India (SII). The regulatory decisions are welcoming and encouraging towards ensuring equitable access to a safe, immunogenic, and affordable vaccine for millions of people worldwide. The pandemic of 2020, however devastating – brought public and private institutions, health authorities, governments of various countries, and most importantly the global communities together to pose a resilient front against the virus. We would like to thank all the stakeholders at various levels who have continually supported and motivated us to fortify our commitment of health for all”, he added. The vaccine can be stored, transported and handled at normal refrigerated conditions (two to eight degrees Celsius) for at least six months and administered within existing healthcare settings. SII 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.

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