RECKLESS ROLLOUT
Russia’s controversial ‘world first’ coronavirus vaccine ‘causes swelling, pain, fever and severe itching’, experts warn
RUSSIA'S controversial "world first" coronavirus vaccine "causes swelling, pain, fever, and severe itching", experts have warned.
The claims come amid concerns that Russia skipped normal clinical trials as part of an attempt to become the first country in the world to approve a vaccine.
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The jab is to be marketed as Sputnik V, a reference to the crafts used by Russia during the Space Race, which included the first satellite ever launched into space.
It was developed by the Gamaleya Research Institute of Epidemiology and Microbiology, a government-run facility in Moscow.
But the jab has so far been tested on only 38 volunteers, while a drug would normally be tested on hundreds or even thousands of people before being approved.
Registration documents for the vaccine submitted in Russia say the trials were conducted in just 42 days and that it is not yet clear whether the drug produces a reliable immune response.
“The protective capacity is currently unknown," one stated.
“The duration of the protection is unknown. No clinical studies have been conducted to study the epidemiological effectiveness.”
Speaking yesterday, Putin said: "I know that it works quite effectively, it forms a stable immunity and, I repeat, has passed all the necessary checks."
Among the 38 participants, 144 so-called adverse events were recorded.
Most passed “without consequences”, but 31 were ongoing by the 42nd day of the study.
Among the possible side effects are swelling, pain, hyperthermia - a high body temperature - and itching at the place of injection.
Many participants reported asthenia - physical weakness or lack of energy - fever, decreased appetite, headaches, diarrhoea, a sore throat, pain in the oropharynx (a part of the throat), nasal congestion, and a runny nose.
The outcome of 27 adverse events were said to be still unknown.
“It is not possible to more accurately determine the incidence of AEs due to the limited sample of study participants,” the makers of the vaccine said.
President Putin yesterday claimed that one of his two daughters has already been administered with the vaccine.
It is not clear which of the two is supposed to have received the jab, but one, Maria Vorontsova, 35, works as a medical researcher.
WHAT ARE THE SIDE EFFECTS OF SPUTNIK V?
Details have emerged about the range of possible side effects from Russia's coronavirus vaccine.
Among the most severe listed were swelling, pain, hyperthermia - a high body temperature - and itching at the place of injection.
Others reported included asthenia - physical weakness or lack of energy - fever, and decreased appetite.
Further symptoms said to have been experienced by trial participants included headaches, diarrhoea, a sore throat, pain in the oropharynx (a part of the throat), nasal congestion, and a runny nose.
The drug is also not recommended for under-18s, over 60s, or pregnant and lactating women because its "efficacy and safety" for these groups have not been studied.
Guidelines also say it should be used with caution by people with a range of other conditions, including chronic diseases of the kidneys and liver, diabetes, epilepsy, diseases of the cardiovascular system, immunodeficiency, autoimmune diseases, allergic reactions, atopy, eczema, and anyone with a history of strokes.
The vaccine’s interaction with other drugs has not yet been studied.
Recent months have seen scientists around the world racing to produce a vaccine, seen as a necessary step on the path towards easing lockdowns.
Russian officials have claimed that the vaccine was delivered so quickly because it is a "copycat" of one developed for the Ebola virus five years ago, but leading medical authorities have raised concerns.
A statement by Russia's own Association of Clinical Trials Organisations read: "Fast-tracked approval will not make Russia the leader in the race.
"It will just expose consumers of the vaccine to unnecessary danger."
Speaking recently, Dr Anthony Fauci, the White Houses top coronavirus advisor, said: “I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering it to anyone.
“Claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best.”
Reports suggest the Chinese government has also begun providing doses of a vaccine to members of its military before full safety testing has been completed.
Professor Francois Balloux of University College London’s Genetics Institute called Russia's approval of the vaccine "reckless and foolish".
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“Mass vaccination with an improperly tested vaccine is unethical,” he said.
“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.”
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