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MOSCOW: Russia is so confident in its COVID-19 vaccine that it will take some legal responsibility if something goes wrong, rather than requiring buyers to bear all the risk, the head of the state fund financing the project told Reuters.
The decision leaves the vaccine’s state-backed developers open to potentially expensive compensation claims in the event of unexpected side effects. It’s something that many vaccine manufacturers have tried to avoid, asking for full compensation, full protection against liability claims, from the nations they sell to.
The approach is different than in many places in the world. In the United States, for example, responsibility for COVID-19 vaccines has been fully transferred to the United States government. This protects developers because widespread inoculation against disease is seen as a benefit to society.
With the global vaccine race on the rise and dozens of candidates being tested in humans, Russia’s ‘Sputnik-V’ vaccine supporters see responsibility as a key battleground as they aim to capture market share.
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“Russia is so confident in its vaccine that it has not asked for full compensation and this is an important differentiating factor against any Western vaccine,” said Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF), the sovereign state investment fund. that supports the vaccine.
“They all ask for full compensation for legal risks.”
Dmitriev did not say whether buyers of the Russian vaccine would be asked to take partial responsibility and did not elaborate on the indemnity clauses. His representatives said he had nothing more to add.
However, the health secretary of the Brazilian state of Bahia, which plans to buy 50 million doses of the vaccine from Russia, told Reuters that the legal risks would be borne by Russian entities.
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Vaccine developers around the world are compressing years of development into months, increasing the possibility of unexpected consequences and making the issue of compensation claims a key point in supply agreement negotiations.
For example, British drugmaker AstraZeneca, which has developed a vaccine with the University of Oxford, has received full protection against future liability claims from many countries with which it has signed supply agreements, a senior executive told Reuters in July.
Dmitriev’s comments came after some scientists raised concerns about the safety and efficacy of Sputnik-V, the use of which was approved by the Russian government before completing large-scale human trials.
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Sputnik-V was developed by the Gamaleya Institute in Moscow, a state research body. The RDIF, which markets the vaccine abroad, will assume some of the legal risks in the supply contracts together with the pharmaceutical companies in the fund’s portfolio that are producing the injection.
“We are confident in the long-term consequences,” Dmitriev said. “We are putting our money where our mouth is by not asking for full compensation in the associations that we create in different countries.”
So far, RDIF has announced agreements to supply just over 200 million doses, half to Latin America and half to India. The fund says it has orders for up to 1 billion doses.
Fábio Vilas-Boas, health secretary for the Brazilian state of Bahia, which is placing the order for 50 million doses, told Reuters that the legal risks would be borne by the Russian pharmaceutical companies that produce and supply the vaccine.
“In the event of any adverse event, nothing will prevent people who feel harmed from filing a class action lawsuit against any of the pharmaceutical companies,” said Fábio Vilas-Boas, who negotiated the evidence and letter of intent with RDIF.
Neither Bahía nor Paraná, a Brazilian state that plans to conduct Sputnik-V trials with 10,000 volunteers, have signed contracts for the supply of the vaccine, according to Vilas-Boas de Bahía and the chief of staff of the governor of the state of Paraná, Guto Silva , who also negotiated with the Russian side.
So far, the agreements have been formalized only in memorandums of understanding, as the contracts await approval of the vaccine by Brazil’s health regulators.
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VOLUNTEER INSURANCE
Russia has staked its scientific reputation on the results after approving the vaccine for home use before mass testing began, becoming the first country to license a COVID-19 vaccine.
The last-stage trials, known as Phase Three, are currently underway in Russia, with at least 40,000 volunteers participating. The first results are expected in October or November.
Volunteers in their phase three trial are unpaid, but their insurance is covered, including a 2 million rubles ($ 26,430) payment in the event of death, a volunteer told Reuters.
RDIF also expects to test the vaccine abroad, with plans already in place with the Indian pharmaceutical company Dr Reddy’s and with the Brazilian state of Paraná, both pending regulatory approval.
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Many people involved in the development of Sputnik-V, including Dmitriev, have tried the jab on themselves in an attempt to convince the world of the safety of a Russian-made vaccine.
Dmitriev said he was not concerned about the risk of compensation claims against RDIF.
“We know it will not happen. Because the vaccine has been studied for decades,” he said.
“We know we won’t have … billions and billions of liabilities because we have a proven platform and they don’t,” he said. “Simple.”
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