As expected, Vladimir Putin’s announcement that his country has become the first country in the world to approve a Coronavirus vaccine fails to win applause. The Russian president announced the great news on Tuesday – “As far as I know, a vaccine against a new Coronavirus infection has been registered this morning, for the first time in the world.”
To convince the world that the Russian-developed vaccine is safe, effective and has undergone proper testing, President Putin claimed that one of his two adult daughters had taken part in an experiment and received 2 shots of the vaccine. However, he didn’t disclose which of his two daughters – Maria or Katerina – received the so-called vaccine.
Putin said that initially his daughter had a temperature of 38 degrees Celsius (100.4 Fahrenheit) on the day of the first vaccine injection, but it dropped to just 37 degrees (98.6 Fahrenheit) on the following day. After the second shot she again had a slight increase in temperature, but then it was all over. The president said – “She’s feeling well and has a high number of antibodies.”
The Russian vaccine has cleared regulatory approvals in record time, less than 2 months of human testing – sparking concerns that Moscow was rushing just to win the trophy ahead of the United States. The name of the vaccine, “Sputnik V” (referring to the earth satellite that Russia sent into space in 1957 before the US could launch one) suggests that Russia has rushed to claim victory.
The final-stage testing – Phase 3 trial – typically involves tens of thousands of people and can take months to conclude. This is the only way to prove if an experimental vaccine is safe and really works. In the U.S. the Phase 3 testing requires studies of 30,000 people. To make matters worse, Russia has shared very little information about its earlier trials.
Interestingly, Russia’s Ministry of Health issued a registration certificate for the vaccine that has been tested in just 76 people. The certificate allows the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, to be given to “a small number of citizens from vulnerable groups.”
But the certificate also says that the vaccine cannot be used widely until 1 January 2021 – suggesting that the approval was probably given in advance, ahead of a larger clinical trial that could only complete by the end of this year. The Russian registration certificate gives few details about the vaccine, which is being manufactured by Binnopharm in Zelenograd.
Some analysts believed that like U.S. President Donald Trump, who desperately needs a Covid-19 vaccine to win the coming November re-election, Putin too is trying to score a “domestic victory” after mismanaging Russia’s outbreak. Russia has the fourth highest number of confirmed Covid-19 cases in the world, with over 900,000 cases and 15,260 deaths.
So far, Moscow has only undergone rapid Phase 1 and 2 clinical trials on a small number of people. Phase-3 trials reportedly will only begin later this week. Yet, amazingly, Russia has announced a full-scale production of the “Sputnik V” vaccine in September. Putin’s decision to grant approval before the completion of final trials has raised criticisms among some experts.
German Health Minister Jens Spahn said Russia’s Covid-19 vaccine can be “dangerous” because it had not been sufficiently tested. He warned that the vaccine could backfire if it turns out to be unsafe or ineffective. He said – “It can be dangerous to start vaccinating millions, if not billions, of people too early because it could pretty much kill the acceptance of vaccination if it goes wrong.”
Spahn explains – “It’s not about being first but it’s about having an effective, tested and therefore safe vaccine.” Although Putin and other Russian officials have said the Sputnik V vaccine is completely safe, the fact remains that only about 10% of clinical trials are successful. Therefore, it’s understandable why scientists think Moscow may have put national prestige above safety.
But Russia has rubbished criticisms that it had rushed to create a half-baked vaccine. Defending the newly announced vaccine, it said the work on the vaccine actually started more than 6 years ago. Moscow claimed that years of studies to develop a vaccine for Ebola and MERS had helped its scientists to create the vaccine against the Covid-19 Coronavirus.
Kirill Dmitriev, CEO of Russia’s sovereign wealth fund RDIF, which is backing the vaccine, said – “We were just fortunate that the Coronavirus was very close to MERS, so we pretty much had a ready-to-go vaccine on MERS.” RDIF also said it has already received preliminary applications for over 1 billion doses of the vaccine from 20 countries.
Apparently, Russia plans to rollout the vaccine to high-risk people, such as frontline medical workers, before a mass vaccination of Russians begins in October. Thereafter, the vaccine will be made available to other countries around November. Meanwhile, WHO (World Health Organization) said all vaccine candidates should go through full stages of testing before being rolled out.
Countries such as U.A.E (United Arab Emirates), Philippines, Brazil, Mexico and Saudi Arabia that are taking part in clinical trials conducted by Russia are expected to receive the Sputnik V vaccine. Praising Russia’s efforts in developing a “free” Covid-19 vaccine, Philippines President Rodrigo Duterte has offered himself to be the guinea pig for the controversial vaccine.
President Duterte told his people in a televised speech – “When the vaccine arrives, I will inject it publicly. Experiment with me, that’s fine. If it works for me, it will work for everyone. I will tell President Putin that I have huge trust in your studies in combating COVID and I believe that the vaccine that you have produced is really good for humanity.”
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August 13th, 2020 by financetwitter
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