The Russian coronavirus vaccine hailed by President Vladimir Putin is not certain to work and has side effects including swelling, fever and pain, according to scientists who developed the drug.
Mr Putin announced on Tuesday that Russia had approved the world’s first vaccine against the virus, saying his own daughter had taken part in clinical trials. Officials said the vaccine would be offered to medics as early as this month and rolled out to the general population from October.
But documents on an official Russian health ministry website said the vaccine had been tested on too few volunteers over too short a time to draw conclusions about its effectiveness, and described a number of side effects.
“Adverse events...were met frequently or very frequently,” according to the report from Moscow’s Gamaleya Institute, which developed the vaccine.
“It is not possible to define the occurrence of adverse events more accurately because of the limited number of participants in the research.” Thirty-eight volunteers took part in the trials over 42 days.
Side effects included swelling, hyperthermia, lethargy, headaches, itching at the vaccination site, decreased appetite, diarrhea and cold-like symptoms. Over the course of the trials, 144 “adverse events” were recorded, more than 30 of which were ongoing.
No research was conducted into how it might react with other medicines, and nothing in the report backed up officials’ earlier claims that the drug would provide immunity for two years.
Mr Putin said his daughter had experienced a slight increase in body temperature after receiving the vaccine, but the next day was back to normal and had a “high number of antibodies”.
“I know it works effectively, forms strong immunity, and has passed all the needed checks,” the president said. Other officials announced there had been preliminary orders for more than a billion doses from 20 countries.
Moscow hailed its speedy development as an example of its medical prowess, naming the vaccine “Sputnik V” in a nod to the Cold War space race. But scientists in Russia and abroad have criticised a lack of testing and transparency.
The World Health Organization remained sceptical about the Russian vaccine, saying on Wednesday it was “not ready at the moment to say there is a vaccine that has undergone the experiments we request for the assessment that it is ready for use worldwide".
British researchers said the rush to roll out the vaccine was “reckless and foolish,” while the German government also raised doubts.
Others have highlighted that the vaccine has yet to pass Phase III clinical trials, which typically take months and involve thousands of people.
Such trials, which require a certain rate of participants catching the virus to observe the vaccine's effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
More than 100 possible vaccines are being developed around the world to try to stop the Covid-19 pandemic. At least four are in final Phase III human trials, according to the WHO.
Russia has officially registered more than 900,000 infections and 15,000 deaths from coronavirus, a lower proportion than other badly hit nations. Officials have denied suggestions they are underreporting figures.