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AZ/Oxford University COVID-19 vaccine wins emergency approval in India

In June 2020, AZ signed a licensing deal with the Serum Institute for the vaccine

The Serum Institute of India has granted AstraZeneca/Oxford University’s COVID-19 vaccine an emergency use authorisation (EUA).

Following this approval, the Serum Institute of India – one of the world’s largest vaccine manufacturers – will begin to manufacture and supply the vaccine to the Indian government.

In June 2020, the Serum Institute signed a licensing deal with AZ to provide one billion doses of the vaccine to low- and middle-income countries.

This is of particular importance as the deal will allow for vaccination programmes in countries around the world to gain an adequate number of doses for their citizens.

Yesterday, Reuters reported that India is planning to roll out its COVID-19 vaccination programme by next week, with the government aiming to vaccinate 300 million people by July.

India’s federal health secretary said on Tuesday that 29,000 cold storage facilities across the country have been prepped, with large-scale ‘vaccination dry-runs’ having already been conducted in 125 districts.

"The emergency licensure in India marks an important milestone for all of us. The regulatory decisions are welcoming and encouraging towards ensuring equitable access to a safe, immunogenic, and affordable vaccine for millions of people worldwide,” said Adar Poonawalla, chief executive officer of the Serum Insistute.

“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. That said, 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.

In a statement AZ said that is working towards building manufacturing capacity for up to three billion doses of its Oxford University-partnered vaccine globally in 2021, on a rolling basis.

The vaccine, unlike mRNA-based COVID-19 vaccine candidates from Pfizer/BioNTech and Moderna, can be stored, transported and handled at standard refrigerator temperatures (+2°-+8° C) for at least six months.

The AZ/Oxford vaccine has now been granted emergency authorisation in a range of countries including Argentina, Dominican Republic, El Salvador, Mexico and Morocco.

The vaccine has also received temporary authorisation in the UK for emergency supply, with the first people being dosed with the vaccine in the UK on Monday.

Article by
Lucy Parsons

6th January 2021

From: Regulatory

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