NMRA approval for Sinovac: Three experts resign from expert panel
Three of the eight-member Expert Advisory Panel for COVID-19 vaccines of Sri Lanka’s drug regulator resigned yesterday, soon after the National Medicines Regulatory Authority (NMRA) Board granted approval for the use of the Chinese vaccine, Sinovac, on Friday.
The letter of resignation signed by immunologist Dr. Rajiva de Silva, virologist Dr. Kanthi Nanayakkara and respiratory physician Prof. Channa Ranasinghe, cites the reason for their resignation as the disregard of the NMRA Board for the advice of the Vaccine Advisory Panel and overruling of scientific opinion, the Sunday Times understands.
The advisory panel has been riddled with troubles including removals, resignations and new members being appointed.
On June 9, the advisory panel had been split in half at an urgent meeting to decide whether at least 2 million doses of Sinovac should be approved for use in Sri Lanka.
The Sunday Times understands that the full panel had "agreed" at that meeting that Sinovac is the "least effective vaccine" against Delta -- as no data had been submitted at that time -- which may very soon be the dominant variant in the country.
One group had said that “limited” approval with conditions should be granted to import a limited stock of Sinovac to be administered to a population which could be followed up, while the other group had disagreed.
The Sinovac documents had also clearly stated that after six months of getting Sinovac's two doses, a booster would also be required, it is learnt.
While the World Health Organisation (WHO) has granted emergency-use listing (EUL) for Sinovac and the global vaccine initiative, COVAX, has said that it would secure stocks of the vaccine, from around the world, meanwhile, came reports of re-thinking by some countries.
Malaysia’s health ministry has reportedly announced that it will stop using Sinovac once its current supplies end, as other Southeast Asian countries have said they are looking to mix and match the Chinesemade shots with those from western manufacturers.
According to reports, Thailand is set to give an AstraZeneca jab to those who had got a first dose of Sinovac; Thailand has announced a plan to mix and match vaccines produced in China and ones developed by western manufacturers; Indonesia challenged by a serious outbreak is looking at a booster shot for those vaccinated with both doses of Sinovac; and in Singapore, this vaccine has been available only privately.
This was as a study by a team from the University of Hong Kong published in the Lancet Microbe journal on Friday stated that there could be a need for “alternative strategies” (booster doses) for those given Sinovac. Compared to the Pfizer vaccine, the Sinovac vaccine elicited a “markedly” lower virus neutralising antibody level, they said and suggested the possible need for booster doses for Sinovac recipients.
Chilean clinical trial researchers had also recommended a third dose of the jab on the grounds that participants showed their protecting antibody levels were lower after six months and lower still against the Delta variant.
By statistical definition it is impossible to achieve herd immunity ( where 70- 75% of the population needs to be immune) against COVID- 19 through Sinovac is the thinking among experts, if the vaccine is only 50% efficacious. Then herd immunity would be an impossible dream and the virus would continue to circulate and mutate.
The two-dose CoronaVac – known as the Sinovac COVID-19 vaccine – is an inactivated vaccine, manufactured by the Chinese company Sinovac Biotech.
The Sunday Times earlier reported that there were moves to import as many as 13 million doses of Sinovac.
A local company, Kelun Lifesciences ( Pvt) Ltd., is planning to collaborate with Sinovac Biotech (Sinovac Lifesciences Co. Ltd.) to secure these 13 million doses which are to be ‘ manufactured’ – dispensed, filled, packaged and tested – at its site in Pallekele, Kandy.