Russia approves coronavirus vaccine despite testing safety concerns

Russia has approved a controversial Covid-19 vaccine for widespread use after less than two months of human testing, and administered a dose to one of Vladimir Putin’s daughters.

The development was hailed by the president as evidence of Russia’s scientific prowess, but the truncated testing regime has raised eyebrows elsewhere for skipping so-called Phase 3 large-scale safety trials, which usually take months.

While the approval paves the way for mass inoculations in Russia, which has been hit hard by the coronavirus pandemic, it is unlikely to accelerate the pace of efforts to produce a vaccine for use in the west, where licensing requirements are more stringent.

Russian authorities have said that medical workers, teachers and other at-risk groups will be the first to be inoculated, planned to begin in October.

Russian officials have treated the race to produce a vaccine as akin to the cold war space race, leading to suggestions in some quarters that international prestige had been given precedence over safety.

Speaking at a government meeting on state television, Putin said the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters, appearing to confirm a report by Bloomberg that the families of some members of Russia’s elite had been given early preferential access to the vaccine, perhaps as early as April.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.

Putin said that his daughter had a temperature of 38C on the day of the first vaccine injection, and then it dropped to just over 37C on the following day. After the second shot she again had a slight increase in temperature, but then it was all over.

“She’s feeling well and has high number of antibodies,” Putin added. He didn’t specify which of his two daughters, Maria or Katerina, had received the vaccine.

Phase 3 trials are used to detect rare side effects and also to measure how effective a vaccine is in the broadest sample of a population.

Experts have been sounding the alarm that any vaccines to emerge may be only partially effective, and may not give equal protection to all, given how little is known about different genetic and other susceptibilities to the virus.

Among concerns about rushing to mass inoculation is that if the vaccine turns out to have limited efficacy it could undermine other social measures for suppression of the disease.

More widely, any subsequent safety issues with the Russian vaccine could embolden anti-vaxxers, many of whom have stuck to their beliefs despite the coronavirus pandemic.

Regulators around the world have insisted that the rush to develop Covid-19 vaccines will not compromise safety. But recent surveys show growing public distrust in governments’ efforts to rapidly produce such a vaccine.

Russian health workers treating Covid-19 patients will be offered the chance of volunteering to be vaccinated soon after approval, a source told Reuters last month.

More than 100 possible vaccines are being developed around the world. At least four are in final Phase 3 human trials, according to World Health Organization data.