As the global coronavirus tally crossed 20 million of Tuesday, reports came from Russia of a new Covid-19 vaccine approved by the Vladimir Putin government.
With this, Russia became the first country to approve a coronavirus vaccine for use among tens of thousands of its citizens.
The race for a vaccine is heating up as nations across the globe brace for new outbreaks of the disease even while they try to restart economies battered by months of initial lockdowns to curb the spread.
While the news of a vaccine finally being discovered for the pandemic seems like good news, but the speed at which Russia has moved has worried some scientists who fear Moscow may be putting national prestige before safety.
Here is all you need to know about Russia's Covid vaccine:
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Russian President Vladimir Putin on Tuesday announced that his government had granted regulatory approval to a Covid-19 vaccine after less than two months of human testing.
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Russia has named its Covid-19 vaccine ‘Sputnik V' for foreign markets, a reference to the world's first satellite and what Moscow sees as its success at becoming the first country to approve a vaccine.
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Putin said that one of his two adult daughters had already been inoculated with the cleared vaccine, which he described as effective. “She's feeling well and has a high number of antibodies,” he said.
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The vaccine developed by the Gamaleya Institute in Moscow uses a different virus — adenovirus — that's been modified to carry genes for the “spike” protein that coats the coronavirus, as a way to prime the body to recognise when a real COVID-19 infection comes along. That's similar to vaccines being developed by China's CanSino Biologics and Britain's Oxford University and AstraZeneca.
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The vaccine is being developed by the Gamaleya Research Institute in coordination with Moscow's defence ministry. Clinical trials of the vaccine began on June 18 and included 38 volunteers. All of the participants developed an immunity. The first group was discharged on July 15 and the second group on July 20.
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The vaccine still has to complete final trials, raising concerns among some experts at the speed of its approval, but the Russian business conglomerate Sistema has said it expects to put it into mass production by the end of the year.
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Kirill Dmitriev, head of the country's RDIF sovereign wealth fund, said Russia had already received requests from more than 20 countries for 1 billion doses of its newly-registered Covid-19 vaccine. According to officials, large-scale production of the vaccine will start in September, and mass vaccination may begin as early as October.
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However, the vaccine's approval by Russia's health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial. Usually, regulatory approvals for public use of a vaccine are granted only after successful completion of Phase III trials.
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Advanced clinical trials for the Russian vaccine are set to start Wednesday. The trials study will span several countries, including the UAE, Saudi Arabia, the Philippines and possibly Brazil, and involve several thousand people. In the meantime, the vaccine will be offered to tens of thousands of people who volunteer to be vaccinated. Russian authorities have said that medical workers, teachers and other risk groups will be the first to undergo vaccination.
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The World Health Organization (WHO) and Russian health authorities are discussing the process for possible WHO prequalification for its newly approved Covid-19 vaccine, a WHO spokesman said on Tuesday. WHO had earlier said all vaccine candidates should go through full stages of testing before being rolled out.
WILL RUSSIAN VACCINE COME TO INDIA?
As Russian President Vladimir Putin announced that Russia is ready with a vaccine against coronavirus, Dr Randeep Guleria, Director AIIMS said the safety of the vaccine is most important.
“First we need to be clear that the vaccine is safe,” said Dr Guleria to India Today, adding, “The vaccine should be safe and that is the first standard the world will look at for mass-producing a vaccine against coronavirus.”
“There are other parameters like the sample size for the vaccine trials, the efficacy of the vaccine, etc. Also, if the vaccine has made antibodies, how long would they last,” said Dr Guleria.
RUSSIAN VACCINE MET WITH GLOBAL SCEPTICISM
The Russian vaccine candidate has been met with global scepticism about injections that have not completed clinical trials and were studied in only dozens of people for less than two months.
Becoming the first country in the world to develop a vaccine was 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 scientists working on it and presented the work as the envy of other nations.
Russia has so far registered 897,599 coronavirus cases, including 15,131 deaths. When the pandemic struck Russia, Putin ordered state officials to shorten the time of clinical trials for potential coronavirus vaccines.
Scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before Phase 3 trials – which normally last for months and involve tens of thousands of people – could backfire.
The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world's top drugmakers in Russia this week urged the health ministry to postpone approval until that final trial had been successfully completed.
“Fast-tracked approval will not make Russia the leader in the (vaccine) race, it will just expose consumers of the vaccine to unnecessary danger,” the ACTO said.
The World Health Organization's list of vaccine candidates undergoing human testing still lists the Gamaleya product as in preliminary safety trials, which involve giving a low dose to a small number of people.
As Russia has not yet published any scientific data from its first clinical trials, scientists both at home and abroad find these assurances hardly convincing. No vaccines have ever been developed for any coronavirus, including SARS and MERS, and new immunizations typically take years to develop.
“The collateral damage from the release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably,” Imperial College London immunology professor Danny Altmann said in a statement Tuesday.
US Health and Human Services Secretary Alex Azar also said it's more important to have a safe and effective vaccine against the coronavirus than to be the first to produce a vaccine.
The World Health Organization said all vaccine candidates should go through full stages of testing before being rolled out. Experts have warned that vaccines 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.
