Russian state says it will share legal risks of Covid-19 vaccine Sputnik-V

Russia is so confident of its Covid-19 vaccine that it will shoulder some of the legal liability should anything go wrong rather than requiring buyers to take on the full risk.

This is the message from head of the state fund that is bankrolling the project.

The decision leaves the vaccine's state-backed developers open to potentially costly compensation claims should there be any unexpected side-effects.

It is something many vaccine-makers have sought to avoid, by asking for full indemnity — complete protection from liability claims — from the nations they sell to.

This approach is different from many places in the world. In the US, for example, liability for Covid-19 vaccines has been shifted fully to the US government. This shields the developers because widespread inoculation against the disease is considered a benefit to society.

With the global vaccine race hotting up, and dozens of vaccine candidates being tested on humans, backers of Russia's "Sputnik-V" shot see liability as a key battleground as they aim to capture market share.

“Russia is so confident in its vaccine that it has not asked for full indemnity and this is a major differentiating factor versus any Western vaccine,” said Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), the state sovereign wealth fund that is backing the vaccine.

“All of them are asking for full indemnity of legal risks.”

Vaccine developers around the world are compressing years of development into months, raising the possibility of unexpected consequences and making the issue of compensation claims a key point in supply deal negotiations.

For example, British drugmaker AstraZeneca, which has developed a vaccine with Oxford University, has been granted full protection from any future liability claims by many countries with which it signed supply deals.

Dmitriev's comments came after some scientists expressed concerns about the safety and efficacy of Sputnik-V, which the Russian government approved for use before completing large-scale human trials.

Sputnik-V was developed by Moscow's Gamaleya Institute, a state research body. The RDIF, which is marketing the vaccine abroad, will shoulder some of the legal risks in supply contracts along with pharmaceutical firms in the fund's portfolio which are producing the shot.

Thus far, RDIF has announced deals to supply just over 200m doses, half to Latin America and half to India. The fund says it has orders for as much as 1bn doses.

Fábio Vilas-Boas, health secretary of Brazil's Bahia state, which has ordered 50m doses said the legal risks would be carried by the Russian pharmaceutical firms producing and supplying the vaccine.

Neither Bahia nor Paraná, a Brazilian state which plans to conduct trials of Sputnik-V on 10,000 volunteers, have actually signed contracts for supply of the vaccine.

Russia has staked its scientific reputation on the results after approving the vaccine for domestic use before mass testing had even begun, becoming the first country to license a Covid-19 vaccine.

Late-stage trials, known as Phase III, are now ongoing in Russia, with at least 40,000 volunteers taking part. Initial results are expected in October or November.

Volunteers in its Phase III trial are unpaid, but their insurance is covered, including a payout of two million roubles (R444,000) in case of death, one volunteer said.

RDIF also expects to run trials of the vaccine abroad, with plans already in place with Indian pharmaceutical firm Dr Reddy's and with Brazil's Paraná state, both pending regulatory approval.

Many people involved in the Sputnik-V's development, including Dmitriev, have tried the jab on themselves in a bid 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. — Reuters