Vladimir Putin‘s coronavirus vaccine was waved through after tests on only 38 people and causes side-effects including pain and swelling, according to official paperwork.
The much-trumpeted Russian drug was registered after just 42 days of research, Fontanka news agency says – and its effectiveness is said to be ‘unknown’.
One of the documents submitted for registration says that ‘no clinical studies have been conducted to study the epidemiological effectiveness,’ despite Putin’s claims that the vaccine has passed ‘all the necessary tests’.
There are also questions about the vaccine’s ability to create sufficient antibodies, after Putin said his own daughter had already developed them after being injected.
Vladimir Putin claims Russia has a coronavirus vaccine and says one of his daughters has already been injected – prompting widespread scepticism
A researcher in Russia works with a coronavirus vaccine at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow last week
Russia has made the vaccine race a matter of national prestige and has named the product ‘Sputnik V’ after the former Soviet space satellites, prompting fears that safety will be compromised for the sake of Russia’s image.
Scientists yesterday criticised Putin for the ‘reckless and foolish’ move which they say could make the pandemic worse if the vaccine proves dangerous or ineffective.
While Putin said his daughter had suffered no side effects worse than a high temperature, Fontanka claimed there were a long list of ‘adverse events’ (AEs) which occurred ‘frequently and very often’.
‘It is not possible to more accurately determine the incidence of AEs due to the limited sample of study participants,’ said the Gamaleya Research Institute which produced the vaccine.
In the 38 healthy adult human volunteers who were tested, 144 separate adverse events were recorded, it was reported.
Most passed ‘without consequences’, but on the 42nd day of the study, 31 of these side-effects were still ongoing.
The outcome of 27 adverse events were said to be still unknown to the developer.
Among the side effects are swelling, pain, hyperthermia – a high body temperature – and itching at the place of injection.
Common manifestations were reported as physical weakness or lack of energy, malaise, fever, decreased appetite, headaches, diarrhoea, nasal congestion, a sore throat, and runny nose.
Tests appeared to show that on the 42nd day after vaccination, volunteers had antibodies at below the average levels.
Putin said one of his daughters Maria (left) and Katerina (right) had been injected with a coronavirus vaccine. Reports in Russia say it was the younger Katerina who was inoculated
Medical workers in protective gear prepare to draw blood from volunteers participating in a trial of a coronavirus vaccine at the Budenko Main Military Hospital outside Moscow
The vaccine is also not permitted for those under 18 or over 60 due to lack of research so far on its impact.
It is not recommended for pregnant and lactating women because its ‘efficacy and safety have not been studied.’
Nor have the vaccine’s interaction with other drugs and its effect on the ability to drive vehicles been studied.
It should be used with ‘caution’ for those with a range of conditions including chronic diseases of the kidneys and liver, diabetes, epilepsy, and people with a history of strokes, diseases of the cardiovascular system, immunodeficiency, autoimmune diseases, allergic reactions, atopy, and eczema.
Another warning read: ‘There are no specific antidotes to the drug. The risk of overdose is extremely low as the vaccination will be administered by trained health personnel.
‘But in case of an accidental overdose, toxic and allergic reactions are possible.’
The vaccine is also extremely sensitive to external influences and should be stored frozen, at a temperature not higher than -18C, the documents say.
Before use, it must be kept at room temperature, but not longer than 30 minutes.
Before the injection – it should be mixed by gently shaking.
The head of the Gamaleya Institute, Alexander Gintsburg, told Interfax:’When we finish the post-registration phase, which we are just starting now, we are legally entitled to submit documents to test this vaccine on children.’
But Fontanka said the Gamaleya documentation ‘does not look as encouraging as the statements of Vladimir Putin and Minister of Health Mikhail Murashko’.
Russia has suffered nearly 900,000 coronavirus cases, but the daily infection rate has been slowly falling for several months
Russia has suffered 15,131 deaths in the pandemic and frequently sees more than 100 new fatalities per day
Today’s disclosures follow a wave of criticism from scientists over the haste with which is has been registered, before it has undergone so-called Phase III trials.
‘Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,’ said Russia’s Association of Clinical Trials Organisations.
Putin said one of his daughters had taken the vaccine.
She had a temperature of 38C on the day of the first vaccine injection, and this dropped to 37C a day later, he said.
‘She’s feeling well and has a high number of antibodies,’ he boasted.
Professor Francois Balloux of University College London’s Genetics Institute, slammed the Russian move.
‘This is a reckless and foolish decision,’ he said. ‘Mass vaccination with an improperly tested vaccine is unethical.’
He warned: ‘Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.’
Putin has two adult daughters and he did not specify which one was vaccinated, but Otkrytie Media reported it was Ekaterina – known as Katerina – Tikhonova.
She had the vaccination at a very early stage of its development, it was claimed.
Katerina, 33, uses the surname of her maternal grandmother, which for many years hid her identity as Putin’s daughter.
The former acrobatic dancer holds a doctorate from prestigious Moscow State University after completing a study on helping cosmonauts and pilots to orientate themselves in difficult conditions.