Exclusive: India likely to approve AstraZeneca vaccine by next week- sources

By Neha Arora and Krishna N. Das
NEW DELHI (Reuters) - India is expected to approve Oxford / AstraZeneca's emergency coronavirus vaccine by next week after its local maker submitted additional data requested by authorities, two knowledgeable sources told Reuters on Tuesday .
This could be the first country to give the UK drugmaker's vaccine the green light as the UK Medicines Agency continues to examine data from the studies.
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India, the world's largest vaccine-making country, plans to start vaccinating its citizens next month and is also considering applications for emergency use approval for vaccines from Pfizer Inc and local company Bharat Biotech.
Bringing vaccines to the world's second most populous country with one of the highest rates of infection will also be a huge step in the fight against the pandemic.
The AstraZeneca Oxford shot is considered important for lower income countries and hot climates because it is cheaper, easier to transport and can be stored for longer periods of time at normal refrigerator temperatures.
The Indian Central Drugs Standard Control Organization (CDSCO) examined the three applications for the first time on December 9th. Https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=MTI3NQ= = and sought more information from all companies, including the Serum Institute of India (SII) that takes the AstraZeneca recordings.
SII, the world's largest vaccine manufacturer, has now provided all the data, the two sources said. Authorities are still waiting for more details from Pfizer, a government health adviser told https://in.reuters.com/article/health-coronavirus-india-cases/india-to-track-down-arrivals-from-britain - To try to stop the new virus strain, idINKBN28W0DC? il = 0 held a press conference on Tuesday while one of the sources said additional information was expected from Bharat Biotech.
Both sources said Indian health officials were in direct contact with their UK counterparts over the AstraZeneca shot and that there were "strong indications" that approval would come next week.
The expected approval comes after data from AstraZeneca's late-stage studies in the UK and Brazil, released earlier this month, showed the vaccine was 62% effective in two full-dose subjects and half 90% in a smaller subgroup. then a full dose.
Indian regulators are only considering the two-full-dose regimen of the shot, though it has a lower success rate, according to the sources.
"Serum is ready," said one of the sources. "At first we can get around 50 to 60 million cans."
The sources declined to be named as deliberations were still ongoing and the schedule might change.
CDSCO boss V.G. Somani did not immediately respond to a request for comment. Bharat Biotech and Pfizer declined to comment, while SII did not immediately respond to an email requesting a comment.
India has not yet signed a contract to supply vaccines with any company, but SII has already stocked more than 50 million doses of the AstraZeneca shot and plans to deliver a total of 400 million doses by July.
(Reporting by Krishna N. Das and Neha Arora, editing by Louise Heavens)

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