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    Serum Institute to apply for emergency licence for Covishield vaccine in next 2 weeks, says Adar Poonawalla

    Serum Institute to apply for emergency licence for Covishield vaccine in next 2 weeks, says Adar Poonawalla

    Serum Institute to apply for emergency licence for Covishield vaccine in next 2 weeks, says Adar Poonawalla
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    By CNBCTV18.com  IST (Published)

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    Serum Institute of India (SII), the world's largest vaccine producer, is in the process of applying for emergency use licensure for its COVID-19 vaccine candidate Covishield in the next two weeks.

    Serum Institute of India (SII), the world's largest vaccine producer, is in the process of applying for emergency use licensure for its COVID-19 vaccine candidate Covishield in the next two weeks.
    SII's Chief Executive Officer Adar Poonawalla on Saturday said that the company is in active discussions with the Indian government on the pricing and distribution of potential COVID-19 vaccines.
    The formal deal on vaccine supplies will only be after emergency approval in India and successful completion of UK trials, he informed at a virtual press conference.
    His comments come following Indian Prime Minister Narendra Modi's visit to the Serum Institute of India's campus in the city of Pune.
    "We discussed the plan, the implementation plan which will happen only after the emergency use licence, that is granted based on the data that will have to be submitted. We are in the process of submitting that officially to the Drug Controller of India ..." Poonawalla said at the presser.
    "Covishield vaccine supplies will be first for distribution in India, followed by COVAX countries, mainly Africa," Poonawalla said adding that the ongoing clinical trials were more than enough to prove the vaccine's efficacy.
    Serum Institute has partnered with global players including AstraZeneca and Novavax Inc to run domestic trials on their vaccine candidates and produce the vaccines if they secure approvals.
    Further, Poonawalla said that the Novavax COVID-19 vaccine, which SII will be manufacturing and distributing in India and other markets, was 2-3 months behind Covishield in the development process.
    "Once they also announce their efficacy results, we will do a short bridge study in India," he said.
    The other COVID-19 vaccine candidate Codagenix would take a year to reach the stage of licensure and will start phase-1 trial in the UK in December, he said.
    On the efficacy of the vaccine, Poonawalla said that the ongoing clinical trials were more than enough to prove the vaccine's efficacy.
    "There was a bit of confusion in the communication. That's not going to affect the emergency use licensure in the UK, and it should not affect India at all," Poonwalla said.
    It is to be noted that the interim efficacy analysis released by Astrazeneca showed 62 percent efficacy for the full dose regimen. The data from Covishield Phase 3 trials in India has not been released yet.
    Poonawalla said SII is manufacturing 50-60 million doses per month, and from January it would increase the production to 100 million doses per month.
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