Regulatory clearance for Sinopharm, Sputnik V held up

16 February 2021 08:32 am

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)