India drug regulator meets to discuss AstraZeneca vaccine: sources

An employee in personal protective equipment (PPE) removes vials of AstraZeneca’s COVISHIELD, coronavirus disease (COVID-19) vaccine from a visual inspection machine inside a lab at Serum Institute of India, in Pune, India, November 30, 2020. REUTERS/Francis Mascarenhas/File Photo

NEW DELHI – Experts at India’s drug regulator were meeting on Wednesday to consider approving an AstraZeneca/Oxford coronavirus vaccine for emergency use after Britain became the first country to do so, two sources with knowledge of the matter said.

A representative of India’s Central Drugs Standard Control Organization (CDSCO) declined to reveal the agenda of the meeting but said its minutes would be uploaded on its website within hours.

Sources earlier told Reuters the CDSCO was likely to approve the vaccine this week after its local manufacturer, Serum Institute of India (SII), submitted additional trial data.

SII, the world’s biggest producer of vaccines, has already stockpiled about 50 million doses, enough for 25 million people.

It welcomed the UK approval.

“This is great and encouraging news,” Chief Executive Adar Poonawalla said in a statement. “We will wait for the final approval from Indian regulators.”

India wants to start administering the shots starting next month and is also considering emergency use authorisation applications for vaccines made by Pfizer Inc with Germany’s BioNTech and by India’s Bharat Biotech.

India, which has the world’s second highest number of COVID-19 infections in the world after the United States, plans to inoculate 300 million people in the next six to eight months and the affordable Oxford vaccine is its biggest hope.

Though the Indian government has not yet signed a purchase agreement with SII, the company says it will focus on its home market first, and then exports, mainly to South Asian countries and Africa.



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