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Re: Great find Nibbana…On Aug 14, 2021, this is what Poonawala had said: https://www.hindustantimes.com/cities/pune-news/once-parent-company-gets-clearance-from-us-fda-we-ll-get-approval-for-covavax-cyrus-poonawalla-101628870934084.html “Novavax is a very good product, however, unless we get the licence to launch it we cannot do so. The American parent company has got some issues with the US FDA which should be cleared by the end of year. Once they get the licence, we will get the licence. We will also try to get it approved before the parent company if possible.” Nov 28, 2021 https://indianexpress.com/article/india/serum-institute-dcgi-nod-for-covid-vaccine-covovax-7645421/ Govt panel seeks additional data from SII, says Covovax not yet been approved in country of origin// *It = SEC/DCGI "It has sought correct status of the phase 3 clinical trials in USA and UK along with up to date on the safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the US, UK and other overseas phase 3 studies with data from phase 3 study in India, besides review status of the application with regulatory authorities of the US and the UK" ---------------------------------------------------------------------- What I interpret from above and their official document, is DCGI focusing on the fact that it is not approved by FDA / MHRA, and if EMA approves it will be difficult for them to not approve. So I believe they are waiting for EMA/MHRA approval. |
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Msg # | Subject | Author | Recs | Date Posted |
153112 | Re: Great find Nibbana… | GlobalHealth | 4 | 11/29/2021 1:44:59 PM |