Sputnik V Covid vaccine Approved By Russia despite testing safety concerns.
Russia has approved a controversial Covid-19 vaccine for widespread use after less than two months of human testing, including a dose administered to one of Vladimir Putin’s daughters.
Kirill Dmitriev, the head of the country’s RDIF sovereign wealth fund, said the vaccine would be marketed abroad under the brand name Sputnik V with international agreements to produce 500m doses and requests for 1bn doses from 20 countries.
The vaccine’s name evokes the world’s first satellite to be launched into orbit, Sputnik, during the cold war space race, which was also seen as a competition for international prestige.
The development was hailed by President Putin as evidence of Russia’s scientific prowess, but the truncated testing regime has raised eyebrows elsewhere for skipping phase 3 large-scale safety trials, which usually take months. Instead, phase 3 trials will be conducted in parallel with mass production of the vaccine, including in Brazil.
While the approval paves the way for 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. Russia has registered 897,599 coronavirus cases, the fourth highest number in the world, and 15,131 deaths.
Mass production of the vaccine was likely to begin soon, Putin said. Doctors and teachers would be offered immunisation first, with the vaccine made available for medics from late August or September, and the drug would go into general use from January 2021. Vaccination would be voluntary, Putin said.
However, some public sector workers expressed scepticism over the vaccine’s safety and pointed out that Russia’s healthcare system was badly underfunded and run down.
“I don’t trust the government. There’s no way I’m taking the vaccine,” said one Moscow teacher, who declined to be named.
Speaking at a government meeting on state television, Putin said the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had 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 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,” Putin said.
He said his daughter had a temperature of 38C on the day of the first vaccine injection, and it dropped to just over 37C 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 a 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.
Prof Alexander Gintsburg, the head of the Gamaleya Institute, said vaccination would start while the phase 3 trials continued. He said that initially there would only be enough doses to conduct vaccinations in 10 to 15 of Russia’s 85 regions, according to the Interfax news agency.
Gintsburg raised eyebrows in May when he said he and other researchers had tried the vaccine on themselves.
Human studies started on 17 June among 76 volunteers. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder. Some in the first half were recruited from the military, which raised concerns that service personnel may have been pressed to participate.
Russia’s health minister, Mikhail Murashko, said the vaccine was safe, efficient and produced high levels of antibodies among volunteer testers. “None of them had serious complications from immunisation,” Murashko said, adding that immunity might last up to two years.
Experts have been suggesting that any vaccines may be only partially effective, and may not give equal protection to all, given how little is known about genetic and other susceptibilities to the virus.
The World Health Organization has said all vaccine candidates should go through full stages of testing before being rolled out. Experts have said vaccines that are not properly tested can cause harm in many ways, from a negative impact on health to creating a false sense of security or undermining trust in vaccinations.
Underlining anxiety over the Russian testing regime, the US health and human services secretary, Alex Azar, said that is was more important to have a safe and effective vaccine than to be the first to produce one.
Speaking during a visit to Taiwan, Azar said: “The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective for the American people and the people of the world.”
There are also concerns that if a vaccine turns out to have limited efficacy it could undermine other social measures to suppress the disease. More widely, any subsequent safety issues with the Russian vaccine could embolden anti-vaxxers, many of whom have stuck to their beliefs during the 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 them.