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India's drug regulator to meet again on Jan. 1 to discuss AstraZeneca vaccine - Metro US

India’s drug regulator to meet again on Jan. 1 to discuss AstraZeneca vaccine

FILE PHOTO: Vials of AstraZeneca's COVISHIELD, coronavirus disease (COVID-19) vaccine, are seen before they are packaged inside a lab at Serum Institute of India, Pune

NEW DELHI (Reuters) – India’s drug regulator will meet again on Friday to consider approving AstraZeneca and Oxford University’s COVID-19 vaccine for emergency use after Britain became the first country to do so, the government said https://pib.gov.in/PressReleseDetail.aspx?PRID=1684821 following a meeting on Wednesday.

India wants to start inoculating its citizens next month. It is also considering emergency-use authorisation applications for vaccines made by Pfizer Inc with Germany’s BioNTech, and by India’s Bharat Biotech.

India’s Ministry of Health and Family Welfare said the country’s Central Drugs Standard Control Organization (CDSCO) was analysing trial and other data presented by the AstraZeneca vaccine’s local partner and Bharat Biotech.

“The analysis of the additional data and information is going on,” the ministry said in a statement, adding that Pfizer had requested more time to present data.

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

SII, the world’s biggest vaccine producer, 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, which has the world’s second highest number of COVID-19 infections after the United States, plans to inoculate 300 million people in the next six to eight months. 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.

(Reporting by Nigam Prusty and Krishna N. Das; Editing by Jason Neely and Jan Harvey)

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