On Tuesday, 11th August, Russian President Vladimir Putin claimed that after less than two months of human testing, Russia had become the world’s first country to approve a COVID-19 Vaccine.
Even though this move raises concerns for many scientists since the vaccine still has to complete final trials, it is being hailed by Russia as evidence of its scientific expertise.
The vaccine is being called “Sputnik V“. The head of Russia’s Sovereign Wealth Fund, Kirill Dmitriev, compared this development to the Soviet Union’s launch of Sputnik 1, in 1957. He called it a historic “Sputnik Moment” and claimed that Russia has already received foreign requests for over a billion doses.
When people, both nationally and internationally rightly raised concerns over the speed at which Russia was moving, and doubted whether Moscow was putting National Prestige over Public safety, then Putin dismissed the concerns and said that his own daughter has been given a shot of the vaccine which was developed by Moscow’s Gamaleya Institute, and it is perfectly safe to use.
However, he did not specify exactly which of his two daughters was he talking about.
He further said, “I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks.”
A Moscow based trade body that represents the world’s top pharmaceutical firms in Russia, ACTO (Association of Clinical Trials Organizations), urged the health ministry of Russia to postpone the approval till the phase III trials are complete.
In a letter to the ministry, they stated, “It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth.”
This move by Russia has also faced International criticism by experts.
The Economic Times reported, “Duncan Matthews, a professor of intellectual property law at Queen Mary University of London, said news of a potential COVID-19 vaccine was to be welcomed, ‘but safety must be the priority’.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have fast-track approval procedures for emergency humanitarian use and we need to see evidence that Russia is adopting an equally prudent approach,’ Matthews said in an emailed comment.
‘Normally you need a large number of people to be tested before you approve a vaccine,’ said Peter Kremsner from the University Hospital in Tuebingen, currently testing CureVac’s COVID-19 vaccine in clinical trials.
‘In that respect, I think it’s reckless to do that (approve it) if lots of people haven’t already been tested.’”
On August 14th, Russia’s top respiratory doctor, Professor Alexander Chuchalin quit the Russian health ministry, after he failed to block Russia’s “Sputnik V” on safety grounds. He called this move by the Russian government’s gross violations’ of medical ethics.
On the same day, even the WHO (World Health Organization) said that it does not include the vaccine approved by Russia among the nine vaccines it considers to be in advanced stages of testing.
Dr. Bruce Aylward, a senior adviser to WHO’s director-general in a statement said, “We don’t have sufficient information at this point to make a judgment” on the Russian vaccine.
“We’re currently in conversation with Russia to get additional information to understand the status of that product, the trials that have been undertaken, and then what the next steps might be”, he further stated.
Despite the criticisms the Russian vaccine has faced, Vietnam has signed up to buy 50-150 million doses of the vaccine, as reported by Tuoi Tre Newspaper.
Israeli health minister stated that Israel will examine Russia’s vaccine and will enter negotiations if it is found to be a “serious product”.
While the Philippines said that it will launch clinical trials of Russia’s COVID19 vaccine in October and if successful it will be registered for public use by April 2021.
“Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated in the coming weeks, a source told Reuters last month”, reported Economic Times.
A survey of 3040 Russian health specialists and doctors, conducted by an app called “Doctor’s Handbook” showed that 52% were not comfortable with being vaccinated, while 24.5% agreed to be given the vaccine.
But after many criticisms, the Russian Health Minister, Mikhail Murashko, has said that Russia will publish information on pre-clinical and clinical trials by Monday, i.e. 17th August 2020.
In an interview with India Today, on 15th August, Dmitry Babich, an analyst at RIA Novosti, Moscow, said, “The vaccine is not being used as of now but has been registered. It is still in the third phase of trials, but experts have assured that the vaccine is not dangerous.”
He further said, “ it is yet to be ascertained if the vaccine is 100% efficient but certainly it is safe. The WHO will have to finally clear it to provide it for sales abroad.”
The first batch of Russia’s COVID19 vaccine will be ready for doctors to use within two weeks, as said by Russian authorities.
Sistema – A Russian business conglomerate, has said that it expects to put the vaccine into mass production by the end of the year.
– Aanandita Singh