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Regulatory clearance for Sinopharm, Sputnik V held up

16 February 2021 12:00 am - 0     - {{hitsCtrl.values.hits}}

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  • State Minister says Sri Lanka awaits page 3 clinical trial data from manufacturers
  • We will start giving jabs to people in Colombo and Gampaha very soon
  • Places order for 500,000 AstraZeneca vaccines
  • We have friendly relationship with these two countries. Therefore, we can avoid such a shortage

By Kelum Bandara

Regulatory clearance for Sinopharm and Sputnik V Covid-19 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.   


 Earlier, China announced that it had reserved 300,000 doses of Sinopharm vaccines to be donated to Sri Lanka upon clearance by the Sri Lankan authorities.   


Prof. Jayasumana said Sri Lanka had planned to import 500,000 more Oxford –Astra Zeneca vaccines for mass inoculation. The stock will be despatched to Sri Lanka in batches.   


‘We will start giving jabs to people in Colombo and Gampaha very soon,” he said.  

 

  • Earlier, China announced that it had reserved 300,000 doses of Sinopharm vaccines to be donated to Sri Lanka upon clearance by the Sri Lankan authorities

 

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