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Expert committee seeks info on efficacy of Sinovac against Delta variant
View(s):The Sri Lankan drug regulator’s expert committee on vaccines has requested data on the efficacy of the Chinese vaccine, Sinovac, against the variant of concern Delta (Indian variant) that is suspected to be usurping Alpha (the United Kingdom variant) in the country.
The results of genetic sequencing – by the Sri Jayewardenepura University’s Department of Immunology and Molecular Medicine – are awaited this weekend to confirm whether Delta is spreading in Sri Lanka.
Earlier, five people in Dematagoda were detected as having been infected by Delta. There are suspicions now that positive patients found at a construction site in Colombo 2, Madiwela, Polgasowita and Kahathuduwa may also be infected by this highly-transmissible variant.
On Friday, the Department of Information announced that five more areas have been placed under isolation including the Obeysekerapura Grama Niladhari division (Welikada) in the Colombo district and Olanda and Rubberwatte areas in Hendala North in the Gampaha district.
The Sunday Times understands that the expert committee of the National Medicines Regulatory Authority (NMRA) on Thursday wrote to Sinovac seeking information and data on several queries. Some of the main concerns are whether the two-dose Sinovac vaccine prevents severe disease and death.
CoronaVac – known as the Sinovac COVID-19 vaccine – is an inactivated vaccine, manufactured by the Chinese company Sinovac Biotech, which recently received emergency-use listing (EUL) by the World Health Organization (WHO).
A local company, Kelun Lifesciences (Pvt) Ltd., is planning to collaborate with Sinovac Biotech (Sinovac Lifesciences Co. Ltd.) to secure 13 million doses which are to be ‘manufactured’ – dispensed, filled, packaged and tested – at its site in Pallekele, Kandy. Kelun Lifesciences has initiated discussions with the State Ministry of Production, Supply and Regulation of Pharmaceuticals for Sri Lanka to buy the 13 million doses of Sinovac.
The Sunday Times learns that the NMRA’s expert committee had sought an explanation from Sinovac why some countries such as Chile are having major outbreaks of COVID-19, even though a sizable population has been vaccinated with Sinovac. The situation in Indonesia had also been discussed.
The newly-cobbled together expert committee – which has seen two resignations and the removal of one expert – had also held a lengthy Zoom meeting, arranged by the State Pharmaceuticals Corporation (SPC) on June 22 with a Sinovac team in China. Here too, the experts had raised many questions, while NMRA Chairperson Dr. R. Wijewantha and Chief Executive Officer (CEO) Dr. Kamal Jayasinghe had been silent observers.
The eight-member committee had comprised Dr. Ananda Wijewickrama, Dr. Rajiva de Silva, Dr. Kanthi Nanayakkara, Prof. Channa Ranasinghe, Dr. Hasitha Tissera and the new members Prof. Saroj Jayasinghe, Dr. Mahen Kotalawala and Dr. Rohitha Muthugala.
So far, the NMRA has granted EUL to AstraZeneca (on January 22); Sputnik V (on March 4); Pfizer (on May 6); and Sinopharm (on May 8).
| Dr. LakKumar Fernando out of expert panel Dr. LakKumar Fernando has been removed from the NMRA’s panel of experts on vaccines. In a ‘Letter of Appreciation’ dated June 25, which Dr. Fernando had received on Friday, the NMRA Chairperson Dr. Rasitha Wijewantha states: “I take this opportunity to thank you for your active participation………..Please be informed that your service as a member of the panel is no longer required.” When discussions were on to evaluate Sinovac, Dr. Fernando had been bypassed, it is learnt, This is while two other experts, Prof. A. Pathmeswaran and Prof. Neelika Malavige, tendered their resignation from the panel recently, pleading personal reasons. “The panel is not a fixed one and the NMRA Board can call in different experts for different evaluations depending on the vaccine or drug being evaluated and the expertise of the relevant expert,” said Dr. Wijewantha, when asked by the Sunday Times yesterday. He added that Dr. Fernando had been part of many evaluations including Sinopharm. | |