There are growing concerns over Sri Lanka’s moves to order 13 million doses of the Chinese Sinovac vaccine with serious doubts emerging in some other countries of its effectiveness against the Delta (Indian) variant. Sri Lanka has been administering the AstraZeneca, Sputnik V and Sinopharm vaccines with a stock of Pfizer jabs expected this week. [...]

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Experts question move to order 13m doses of Sinovac amidst efficacy concerns

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There are growing concerns over Sri Lanka’s moves to order 13 million doses of the Chinese Sinovac vaccine with serious doubts emerging in some other countries of its effectiveness against the Delta (Indian) variant.

Sri Lanka has been administering the AstraZeneca, Sputnik V and Sinopharm vaccines with a stock of Pfizer jabs expected this week.

Worries over Sinovac – granted emergency-use listing by the World Health Organization (WHO) this month – came as Indonesia reported more than 350 doctors and medical workers catching COVID-19 despite receiving that jab. Dozens have been hospitalized.  

Experts question the plan for Sri Lanka to enter into an agreement with a company called Kelun Lifesciences (Pvt) Ltd to secure 13mn Sinovac doses which are set to be manufactured – that is, dispensed, filled, packaged and tested – at its site in Pallekele.

On June 11, the company sought confirmation from the State Minister of Production, Supply and Regulation of Pharmaceuticals on how many “dosages” of CoronaVac – which is Sinovac Lifesciences Co. Ltd’s vaccine – it should produce for Sri Lanka.

In a letter signed by its Chairman V. Nadarajah, Kelun Lifesciences states that it’s a “key condition” of Sinovac Lifesciences for a guaranteed purchase quantity, the minimum purchase order being 13mn vaccine doses.

On June 13, Kelun Lifesciences writes that payment for the first 3mn doses will have to be made in advance. For the 10 million doses, payment must be through “an irrevocable LC/Advance”. In an irrevocable letter of credit, the terms and conditions can neither be amended nor cancelled.

This letter indicates that the Minister, Prof. Channa Jayasumana, has been offering “positive encouragement and initiative” towards the company’s plans to manufacture Sinovac in Pallekele. It states that the import of necessary machinery and laboratory equipment was initiated, with arrival expected at the end of this month.

Crucially, the letter also reveals the price disclosure terms laid down by Sinovac: “They have said that if the price in the agreement is disclosed to the public or spoken about in public it will be subjected for termination of the agreement or they will take legal action against us. Sir, this is because we are getting a very competitive price for Sri Lanka.”

Kelun Lifesciences also asks if the irrevocable LC will be in dollars, whether the payment to the company will be in dollars and whether a Treasury guarantee is forthcoming.

Research has shown that both doses of AstraZeneca and Pfizer give an estimated vaccine effectiveness (protection) against the symptomatic Delta variant disease of 67% and 88%, respectively, the Sunday Times understands. Even though there are “modest” reductions in protection, these vaccines remain effective against Delta.

The WHO, meanwhile, stated that results showed Sinovac prevented symptomatic disease in 51% of recipients and prevented severe COVID-19 and hospital stays.

Arguing that this means there would be a further drop in its effectiveness when it comes to variants – amidst reports of “breakthrough infections” in Sinovac vaccinated persons in Indonesia and Chile – the experts questioned whether Sri Lanka should invest in this jab when there were doubts about its protection against severe disease.

The continued emergence of virus variants will put pressure on the efficacy of vaccines, they pointed out. Evidence suggests that those vaccines starting with highest efficacy to the original SARS-CoV-2 still retain good efficacy against variants, although this may drop a few percentage points.

“But those vaccines with weaker effectiveness essentially become even weaker down to marginal levels of protection in the face of variants,” said one expert, stressing that this was why Sri Lanka should focus on securing vaccines with the highest efficacy.

If it becomes necessary to buy a few million doses of Sinovac – in the absence of other options – to tide over short-term needs, the expert said, it may be understandable. But to commit to what is the weakest of the vaccines in excess of 13 million doses would be “extremely unwise”.

Documents handed over says company

Kelun Lifesciences (Pvt.) Ltd said it has presented necessary documents to the State Ministry for Production, Supply and Regulation of Pharmaceuticals which has conveyed that it would discuss with the Treasury and respond.

The Chairman of Kelun Lifesciences, V. Nadarajah, said on Friday that he met State Minister Dr. Channa Jayasumana and Secretary Dr. R.M.S.K. Ratnayake on June 16 to speak about the company’s role as a contracted manufacturer.

The State Pharmaceutical Manufacturing Corporation (SPMC) has got the agency for Sinovac and would be applying for registration from the National Medicines Regulatory Authority (NMRA), he said, adding that the filling of vaccines would be handled by his company.

Asked about Sinovac’s efficacy issues in Indonesia, Mr. Nadarajah said they had contacted the manufacturer. The latter had stated that they had requested the countries in which Sinovac was being administered to carry out studies. Indonesia had reported an efficacy of around 94%.

“We will check with the manufacturer,” he said, when asked about reports that people who had got both doses of the vaccine were getting severe disease.

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