Covid-19 Vaccine Tracker/India News: India is probably going to approve Oxford/AstraZeneca’s coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities, two sources with knowledge of the matter told Reuters on Tuesday.
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This could be the first country to give the regulatory green light for British drugmaker’s vaccine because the British medicine regulator continues to look at data from the trials.
India, the world’s biggest vaccine-making country, wants to start out inoculating its citizens next month and is additionally considering emergency use authorisation applications for vaccines made by Pfizer Inc and native company Bharat Biotech.
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Getting vaccines to the world’s second-most populous country with one among the very best infection rates also will be an enormous step within the battle against the pandemic.
The AstraZeneca-Oxford shot is taken into account vital for lower-income countries and people in hot climates because it's cheaper, easier to move and may be stored for long periods at normal fridge temperatures.
India's Central Drugs Standard Control Organization (CDSCO) first reviewed the three applications on Dec. 9 here and sought more information from all the businesses , including from Serum Institute of India (SII), which is making the AstraZeneca shots.
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SII, the world's biggest vaccine manufacturer, has now provided all the info , the 2 sources said. The authorities were still expecting more details from Pfizer, a government health adviser told here a news briefing on Tuesday, while one among the sources said additional information was expected from Bharat Biotech.
Both sources said Indian health officials were in direct contact with their British counterparts over the AstraZeneca shot which there have been “strong indications” an approval would come by next week.
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The expected approval comes after data from AstraZeneca’s late-stage trials within the UK and Brazil released earlier this month showed the vaccine had efficacy of 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose.
The Indian regulator is merely considering the 2 full-dose regimen of the shot despite it showing a lower success rate, the sources said.
“Serum is ready,” said one of the sources. “Initially, we may get around 50 million to 60 million doses.”
The sources declined to be named as deliberations were ongoing and therefore the timeline could change.
CDSCO chief V.G. Somani didn't immediately respond to a request for comment. Bharat Biotech and Pfizer declined to comment, while SII didn't immediately answer an email seeking comment.
India has not yet signed a vaccine supply affect any company, but SII has already stockpiled quite 50 million doses of the AstraZeneca shot and plans to form a complete of 400 million doses by July.
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