NEW DELHI: President
on Tuesday said that
had become the first country in the world to grant regulatory approval to a
vaccine ‘Sputnik V’ after less than two months of human testing.
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.
However, the announcement has raised eyebrows across the world.Concerns about speed and data* The speed at which Russia is moving to roll out the Covid-19 vaccine has prompted international scientists to question whether Moscow is putting national prestige before solid science and safety.
* Russia has not yet published any scientific data from its first clinical trials. The WHO’s list of vaccine candidates in human testing still lists the Gamaleya product as in Phase 1 trials.
Phase III trial yet to be completed* A phase III or what we call final-stage study, usually involves tens of thousands of people, which is the only way to prove if an experimental vaccine is safe and really works.
* However, the vaccine’s approval by the Russian health ministry comes before the start of a larger trial III involving thousands of participants.
* Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
* The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drugmakers in Russia this week had urged the health ministry to postpone approval until that final trial had been successfully completed.
WHO says approval needs rigorous safety review* TheWorld Health Organizationhas said that any WHO stamp of approval on a Covid-19 vaccine candidate would require a rigorous safety data review, after Russia announced it had approved a vaccine.
* “We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine,” the United Nations health agency’s spokesman Tarik Jasarevic said.
* “Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data,” he said.
* The WHO had last week warned that Russia should not stray from the usual methods of testing a vaccine for safety and effectiveness.
Experts raise concerns* Some experts are skeptical that the trials, which must study potential side effects on different types of people, can be completed that quickly.
* “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.”
* 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”.
* “I’m worried that Russia is cutting corners so that the vaccine that will come out may be not just ineffective, but also unsafe,” said Lawrence Gostin, a global public health law expert at Georgetown University. “It doesn’t work that way. … Trials come first. That’s really important.”
, the top US infectious disease specialist, questioned the fast-track approach 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,” he said.
Hacking allegations* The governments of the United States, Canada and Britain have all accused Russian state hackers of attempting to steal vaccine research, casting a shadow over Russia’s claim.
* Russian officials have denied the accusation and said their leading vaccine is based on a design developed by Russian scientists to counter Ebola years ago.
Not the first “controversial” vaccine* It’s not the first controversial vaccine Russia developed. Putin mentioned earlier this year that Russian scientists delivered an Ebola vaccine that “proved to be the most effective in the world” and “made a real contribution to fighting the Ebola fever in Africa.”
* In 2019, the WHO considered the 2015 vaccine along with several others for use in Congo, but didn’t pick it. It pointed out that it had been approved for emergency use after Phase 1 and 2 trials, but not Phase 3.
* Russia’s health ministry authorized two Ebola vaccines for domestic use — one in 2015 and another one in 2018 — but there is little evidence either was widely used in Africa.
Russia hails it as ‘historic’ moment* Kirill Dmitriev, head of Russia’s sovereign wealth fund, hailed the development as a historic “Sputnik moment”, comparable to the Soviet Union’s 1957 launch ofSputnik 1,