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AstraZeneca’s COVID-19 vaccine obtains emergency use authorization in India

AstraZeneca scientist

AstraZeneca’s COVID-19 vaccine has been granted emergency use authorization in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunization of adults.

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.

“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.”

“These emergency use authorizations will soon bring the vaccine to many millions of people and are proof of our long-held commitment to broad and equitable access around the world. We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus. We would like to thank the regulators for their swift and decisive actions and our partner, Serum Institute of India, for its substantial contribution to this global effort,” says Pascal Soriot, Chief Executive Officer, AstraZeneca.

“We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus.”

AstraZeneca has already submitted a substantial data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency (EMA), 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.

In addition to the University of Oxford-led trials, the company is conducting a large trial in the US as part of a global programme. In total, the University of Oxford and AstraZeneca expect to enrol more than 60,000 participants worldwide. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

Photo: Scientist at AstraZeneca