Russia is the first country to announce the approval of a COVID-19 vaccine, without completing clinical trials
Russian President, Vladimir Putin, declared that a locally developed vaccine for COVID-19 (Sputnik V) has been approved after just two months testing on humans. President Putin further insisted the vaccine passed all the required checks, and admitted that he has even administered the vaccine to his daughter.
Global health authorities are concerned for the effectiveness and safety of the drug, as it is yet to complete late-stage clinical trials.
Without specifying which of his two daughters took the test, Putin said: “I think in this sense she took part in the experiment.
“After the first injection her temperature was 38 degrees, the next day 37.5, and that was it. After the second injection her temperature went up slightly, then back to normal.”
Officials have said they plan to start mass vaccination in October.
In a statement from the UK Science Media Centre, Francois Balloux from University College London, said: “This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. 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.”
According to the vaccine’s registration certificate, of the 38 participants who received the vaccine, all produced antibodies against the SARS-CoV-2 spike protein – including neutralising antibodies that inactivate viral particles.
These findings are similar to other early-stage trial results of other COVID-19 vaccines. The side effects of fevers, headaches and skin irritation were also similar.
The race for a vaccine
Over 200 COVID-19 vaccines are currently in development worldwide, of these, several are already in phase three trials. However, experts suggest that the earliest these vaccines could be approved is still months away.
The major powers, including the US and China, are also racing to produce a vaccine against COVID-19. The US has set up an effort called Operation Warp Speed, and China have spent billions on developing an effective vaccine.
The Food and Drug Administration (FDA) in the US can legally approve the use of medicines before completion of efficacy trials through an emergency use authorisation. Since the announcement of the Russian vaccine, there are concerns that President Trump will make a similar move to Russia and push for a COVID-19 vaccine to help his re-election prospects.
Alexey Chumakov, a researcher at a Moscow institute, said regulations in Russia are easily bent: “The strictness of Russian laws is compensated by the fact that it’s not necessary to follow them.’”
Chumakov also said the Russian scientific community also has a shrinking community of virologists who could help make important decisions about the COVID-19 vaccine. “There’s so little science left in Russia after the last 30 years that not many people are eager to say anything against the trend. It’s very easy to make a vaccine but very difficult to properly test it and show that it works. This is really a gamble and I don’t know how this can be decided in advance.”
Russia’s COVID-19 cases have risen to be the fourth largest in the world at 902,701, after officials reported 5,102 new infections.
