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No impact of USFDA move on Covaxin in India: VK Paul

Paul said that every country has its own benchmarks, and welcomed the USFDAs decision to ask Bharat Biotech to apply for a full Biologics License Application (BLA) instead of an EUA. “Indias drug regulator was satisfied with the data that the Hyderbad-based vaccine maker produced. We are happy as we have gone through their safety data,” Niti Aayogs Paul said
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covaxin: Bharat Biotech's partner seeks full approval for Covaxin in US

This follows the recommendation of the USFDA and it means that, subject to regulatory approvals, it will take a longer time for Covaxin to be launched in the US. Submission of a BLA represents pursuit of full approval for the vaccine, rather than initial approval under an emergency-use authorization.
Shankar Musunuri Drug Administration Health Canada Bharat Biotech Us Food And Drug Administration ஆரோக்கியம் கனடா

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Detailed text transcripts for TV channel - CNN - 20210611:08:23:00

Olds. pfizers eua was expanded for 12 to 15 year olds late last month, about a quarter of that age group has now had at least one shot. >> susceptible -- >> reporter: more than half the residents in these eight states are now fully vaccinated. nationwide its just over 42%. >> we knew it was going to get harder as this effort went on but one thing we have learned more clearly than anything else is that this vaccination effort will moved at the speed of trust. >> reporter: trust with dose of incen...
Age Group One Shot Vaccination Effort Mark Mcclellan Delta Variant Cash Isn T

Detailed text transcripts for TV channel - CNN - 20210611:20:43:00

Other members of the committee completely disagreed and pushed hard for authorization for its under 12. one top advisers reminded the committee that covid can still kill children and has killed a couple hundreds in the united states. you spoke with dr. meissner. what did he have to say? >> well,y was -- it was very interesting conversation, jake. he was framing this as weve got to real be careful about the risks and the benefits which is an obvious thing to be saying. you get an eua because the ...
Co Vid Couple Hundreds

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