Header Ads

Putin announces official registration of first ever coronavirus vaccine and reveals one of his own daughters has already been inoculated - despite the jab not passing clinical trials

Vladimir Putin claims Russia has a coronavirus vaccine and says one of his daughters has already been injected - prompting widespread scepticism because the jab has not yet passed clinical trials.  
The Russian leader announced today that Russia had become the first country to register a vaccine, claiming it has 'passed all the necessary tests' and offers two years of immunity against the disease.
Putin, 67, said one of his daughters had already developed antibodies against Covid-19 and said her side-effects were no worse than a high temperature. 
Governments and scientists around the world are desperate for an effective vaccine, which is seen as the only certain way of bringing the pandemic to a standstill.  
However, experts have already sounded the alarm about the effectiveness of Putin's vaccine because the usually months-long Phase III trials have not yet taken place and the WHO has not yet granted approval for the jab.
The Kremlin and its state-controlled media have turned the vaccine race into a matter of national prestige - even naming the injection Sputnik V after the former Soviet satellites - leading to fears that safety could be compromised for the sake of Russia's image. 
While small trials can show whether a vaccine is likely to be safe, much larger tests are needed to show whether it will prevent the spread of the disease - and one UK scientist warned today that there was 'no data' on the Russian vaccine.   
One expert warned that 'the damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably'. 
Vladimir Putin claims Russia has a coronavirus vaccine and says one of his daughters has already been injected - prompting widespread scepticism
Vladimir Putin claims Russia has a coronavirus vaccine and says one of his daughters has already been injected - prompting widespread scepticism 
Maria Vorontsova, Putin's daughter
Katerina Tikhonova
Putin said one of his daughters Maria (left) and Katerina (right) had been injected with a coronavirus vaccine, but did not say which one 
Speaking at a government meeting today, Putin claimed that the vaccine has undergone proper testing and been proven safe to use. 
'I would like to repeat that it has passed all the necessary tests,' he said. 'The most important thing is to ensure full safety of using the vaccine and its efficiency.' 
The Russian leader added that one of his two daughters has received two shots of the vaccine and is feeling well. 'She has taken part in the experiment,' Putin said. 
Putin said his daughter had a temperature of 100F (38C) on the day of the first vaccine injection, which then dropped to 99F (37C) on the following day. 
After the second shot she again had a slight increase in temperature, but then it was all over, Putin said. 
He did not reveal whether it was his daughter Maria or Katerina who received the vaccine. 
The Russian president said he hoped the country would soon start mass producing the vaccine - saying that 20 countries have pre-ordered a billion doses of it. 
Responding to Putin's announcement, WHO spokesman Tarik Jasarevic told reporters that the agency was discussing the next steps with Russian authorities. 
'We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine, but again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data,' Jasarevic said. 
While scientists are not totally dismissing the vaccine, several have said that there is not enough data to assess whether it is effective.  
Dr Michael Head, Senior Research Fellow in Global Health at the University of Southampton, said: 'It is unclear precisely what is actually happening with the Russian vaccine. 
'It is vital that any vaccine roll-out has the confidence of the general public, and that there is good communication of the level of effectiveness and any likely side effects. 
'At this point in time, there is no data on the Russian-led vaccine for the global health community to scrutinise. 
'There have been lessons learned from previous vaccine roll-outs, that were usurped by anti-vaccination activists and population health has greatly suffered.
'Examples include the HPV vaccine in Denmark or Japan, where uptake plunged after anti-vaccine campaigns and irresponsible comments from some scientists. 
'Health promotion and clear explanations to the general public are the bare minimum in terms of communications here.'  
Professor Keith Neal, Emeritus Professor of the Epidemiology of Infectious Diseases at the University of Nottingham, said it is 'not possible to know' whether the jab works without proper data and scientific papers.
While a small sample is enough to show whether the vaccine is safe, a much larger trial is needed to show whether it prevents infection, he said. 
'If 25,000 people were recruited in each arm then we would expect 25 cases in one month' in unvaccinated people, he said, citing Russia's infection rate. 
'Any figure less than 15 Covid-19 cases in the vaccine [groupwould be significant. Given the size of the Russian population, recruiting 50,000 people is well deliverable. Only 12,500 for two months gives the same results.'
'It is not possible to know if the Russian vaccine has been shown to be effective without submission of scientific papers for analysis and then there may be problems on data quality.' 
Russia has suffered nearly 900,000 coronavirus cases, but the daily infection rate has been slowly falling for several months
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
Russia has suffered 15,131 deaths in the pandemic and frequently sees more than 100 new fatalities per day
Professor Duncan Matthews, Professor of IP Law at Queen Mary University of London said news of progress was welcome but said '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,' he said.
Russian authorities have said that medical workers, teachers and other risk groups will be the first to be inoculated. 
Deputy Prime Minister Tatyana Golikova said that the vaccination of doctors could start as early as this month.
The Health Ministry said in Tuesday's statement that the vaccine is expected to provide immunity from the coronavirus for up to two years.  
Russia previously said that the critical Phase III trials were not due to begin until this month.  
Phase III trials usually last for months and involve thousands of people to ensure vaccine efficiency and safety. 
However, becoming the first country in the world to develop a vaccine has been a matter of national prestige for the Kremlin as it tries to assert the image of Russia as a global power. 
State television stations and other media have praised Russian scientists working on the vaccine and presented their work as the envy of other nations. 
Professor Alexander Gintsburg, head of the Gamaleya institute that developed the vaccine, raised eyebrows in May when he said that he and other researchers had already tried the vaccine on themselves.
Human studies started on June 17 among 76 volunteers, including from the Russian military. 
The U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs. Russia denied this. 
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
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
As the trials were declared completed, questions arose about the vaccine's safety and effectiveness. 
Some experts scoffed at Russian authorities' assurances that the vaccine drug produced the desired immune response and caused no significant side effects, pointing out that such claims need to be backed by published scientific data.
The World Health Organization said all vaccine candidates should go through full stages of testing before being rolled out. 
Experts warn that vaccines s that are not properly tested can cause harm in many ways - from a negative impact on health to creating a false sense of security or undermining trust in vaccinations. 
The WHO last week urged Russia to follow established guidelines and go 'through all the stages' necessary to develop a safe vaccine. 
Russia itself has suffered nearly 900,000 cases of the disease - the fourth-most in the world behind the US, Brazil and India - and more than 15,000 deaths. 
However, the infection rate has been gradually falling for months and Putin has touted Russia's response to the pandemic as superior to America's.  
More than 100 possible vaccines are being developed around the world and at least four are in final Phase III human trials, according to WHO data. 
One of these is being developed by China's Sinopharm and another by AstraZeneca and the University of Oxford.
Producers are also grappling with the question of how to massively scale up production to meet global needs.

Philippine president signs up for Putin's jab 

Philippine leader Rodrigo Duterte has lauded Russia's efforts to develop a coronavirus vaccine and is willing to participate in trials, he said last night.
'I will tell President (Vladimir) 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,' Duterte said on television late on Monday. 
Duterte says Russia is ready to provide the vaccine to the Philippines, or team up with a local firm to mass produce it.
To allay public fears, Duterte offered to be a guinea pig when the vaccine arrives and said: 'I can be the first they can experiment on.' 
His office said today that the Philippines stands ready to work with Russia on vaccine trials, supply and production. 
The Philippines has among Asia's highest numbers of coronavirus infections, which rose to 136,638 on Monday after a record daily jump of 6,958 cases.    
In July, Duterte made a plea to his Chinese counterpart to make the Philippines a priority if it develops a vaccine.  

1 comment: