Russian president Vladimir Putin has announced the country will begin administering a Covid-19 vaccine to bring the virus under control.
He’s so confident about the vaccine – the first in the world approved for widespread human use – he’s allowed his daughter to receive it.
‘I know it has proven efficient and forms a stable immunity,’ Putin said. ‘We must be grateful to those who made that first step very important for our country and the entire world.’
But scientists around the world are condemning the decision amid concerns the vaccine has been fast-tracked without the proper safety protocols.
‘I think there is enough general background data on recombinant Adenovirus based vaccines to assume the vaccine itself will be safe at the usual doses,’ explained Ian Jones, a professor of virology at the University of Reading.
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‘The bigger risk, however, is that the immunity generated is not sufficient to give protection, leading to continued virus spread even among immunised individuals. And although only a possibility, less than complete protection could provide a selection pressure that drives the virus to evade what antibody there is, creating strains that then evade all vaccine responses.
‘In that sense, a poor vaccine is worse than no vaccine. Careful virus tracking will therefore need to accompany any early release.’
Russia’s regulatory approval of its ‘Sputnik V’ vaccine paves the way for mass use before the final stages of clinical trials are completed, which is what scientists are alarmed over.
The next stage of the tests, commonly known as a Phase III trial, will involve thousands of participants.
According to the World Health Organisation (WHO), there are more than 100 possible Covid-19 vaccines currently being developed around the world, with at least four in the Phase III human trials.
This stage is normally considered an essential precursor before a vaccine can receive regulatory approval.
‘So far, it is reported that the Russian vaccine has undergone less than two months of human testing in a total of 38 people. It appears to be at Phase I or II,’ said Peter Openshaw, professor of experimental medicine at the National Heart & Lung Institute, Imperial College London.
‘According the news sources, there is a Phase III trial of 1,600 people planned. That’s not actually very large for a vaccine trial and would assume a high rate of infection in the volunteers. How would that be achieved, given that rates that are reported from Russia are currently low?
‘This raises a concern that the experimental vaccine is being given to the Russian elite before it has undergone full testing in a formal clinical trial. Treatments (and possibly vaccines) might sometimes be given on ‘compassionate’ grounds, but only in very limited circumstances. The apparent use of this vaccine in people who are not at very high risk of exposure to SARS-CoV-2 or death from COVID, raises significant concerns.’
The vaccine developed by the Gamaleya Institute in Moscow with assistance from Russia’s Defence Ministry uses a different virus — the common cold-causing adenovirus — that’s been modified to carry genes for the ‘spike’ protein that coats the coronavirus, as a way to prime the body to recognize if a real COVID-19 infection comes along.
The Health Ministry said in a statement Tuesday that the vaccine is expected to provide immunity from the coronavirus for up to two years, citing its experience with vaccines made with similar technology.
Russian health workers treating coronavirus patients have also been offered the chance to volunteer as part of the study.
Officials say large-scale production of the vaccine will start in September, and mass vaccination may begin as early as October.
As of yesterday, the nation has recorded 15,131 deaths from Covid-19 and 897,599 cases of the virus, following a rise of 4,945 new cases in the last 24 hours.
The World Health Organisation has urged that all vaccine candidates go through full stages of testing before being rolled out, and said Tuesday it is in touch with the Russian scientists and ‘looks forward to reviewing’ Russia’s study data.
Experts have warned that vaccines that are not properly tested can cause harm in many ways — from harming health to creating a false sense of security or undermining trust in vaccinations.
Dr Anthony Fauci, a top infectious disease specialist in the US, said the approval stage of a vaccine is typically based on scientific data that demonstrates its ‘safety and efficacy’.
He said last week: ‘I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing I think is problematic at best.’
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