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Regulatory clearance for Sinopharm, Sputnik V held up

16 February 2021 08:32 am - 9     - {{hitsCtrl.values.hits}}

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Regulatory clearance for Sinopharm and Sputnik V Covid19 vaccines has been delayed due to the absence of page 3 clinical trial data, despite previous announcement to give it as early as possible, Daily Mirror learns.

The National Medicines Regulatory Authority (NMRA) has taken up these two vaccines – Sinopharm developed by China and Sputnik V developed by Russia- for regulatory clearance.

However, State Minister of Pharmaceutical Production, Supply and Regulation Professor Channa Jayasumana attributed the delay in regulatory clearance to the absence of page 3 clinical trial data.

“We are waiting for page 3 clinical trial data on these vaccines,” he said.

Asked whether such delay would result shortages in global supply of these vaccines due to the high demand, he said such a problem would not arise since Sri Lanka maintained healthy ties with China and Russia.

“We have friendly relationship with these two countries. Therefore, we can avoid such a shortage as far as Sri Lanka is concerned,” he said.(KELUM BANDARA)


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  Comments - 9

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  • Prasad Tuesday, 16 February 2021 09:02 AM

    This is stage 3 clinical trial data and not page 3

    Michael Ranasinghe Tuesday, 16 February 2021 09:03 AM

    Mr Jayasumana ( addressing you as Professor is an insult to the genuine academics in Sri Lanka ) did you not gloat in front of the media that Sputnik will be produced in Sri Lanka ? Can you please stop you verbal diatribe and simply do your job and then talk

    Saman from Sri Lanka Tuesday, 16 February 2021 09:24 AM

    There is no need for any clinical trials. The Chinese vaccine is far superior to the inferior Indian vaccine. This could be another instance of Indian interference in our internal affairs. We are a sovereign nation.

    RoaringCreek Tuesday, 16 February 2021 10:01 AM

    Sinopharm and Sputnik V have no clearance from any indecent health organisations in the world as it has no date in stage 3 trials. Is Sri Lanka going to be the guinea pigs for China and Russia? A failed state no other.

    RoaringCreek Tuesday, 16 February 2021 10:03 AM

    If so please send your "Paniya" to Russia and China for testing and trials. In a TV show this fellow still maintains the "Paniya" can be effective. So sent it to Russia and China.

    Punchi Banda Tuesday, 16 February 2021 10:17 AM

    Chinese news is 70 people arrested for producing 4 million doses counterfeit vaccine, substantial part shipped overseas. This is what happens we we become beggars, we don’t know if what we are getting is good

    Saranga W Tuesday, 16 February 2021 10:21 AM

    No offense to both but they didn't have trial for anyone

    Jaya Amerasinghe Tuesday, 16 February 2021 11:55 AM

    Nice to see so many Sri Lankan vaccine experts have comnented on this.Govt.should consult these experts before taking a final decision on these two vaccines.

    ruwan Tuesday, 16 February 2021 02:25 PM

    this man is a disgrace to medical profession. he promoted "Paniya" audaciously and now is acting like a scientific , evidence- based man


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