Russia has given regulatory approval to the world's first Covid-19 vaccine, a mere two months after the developer's phase-three clinical testing began with plans to produce 500 million batches over the next year.
That industrial production of Sputnik V will start in September and officials claim 20 countries have expressed interest in ordering a billion doses.
World Health Organisation representative Tarik Jasarevic said that the WHO would be working closely with Russia with regard to the qualification of the vaccine, including “the rigorous review and assessment of all required safety and efficacy data” that the global body oversees.
The speed at which Russia’s vaccine has been approved confounds all previous benchmarks. The standard length of a phase-3 vaccine trial is typically between one to four years.
The move to production paves the way for mass inoculation while clinical trials to test safety and efficacy continue. The lightning-quick ratification has provoked consternation among the global science community who fear that is dangerously premature.
The unparalleled approval time highlights country's determination to win what has been called a vaccine space race. Russia has named its vaccine Sputnik V in reference to the first satellite placed in orbit during the Cold War space race.
How does Sputnik V work and is it safe?
The vaccine is based on the DNA of a Sars-CoV-2 type adenovirus - more commonly known as the common cold, the same method adopted by another Phase-3 trial run by scientists at Oxford University.
Before Russia's push to production, the most prominent research product was the Oxford trial, which is backed by British-Swedish pharmaceutical giant AstraZeneca.
In July, chair of the UK government’s taskforce Kate Bingham told Parliament that the Oxford vaccine was “well ahead of the world” and the “most advanced vaccine anywhere”.
Alexander Gintsburg, director of the Gamalweya National Research Centre which developed the vaccine, said that the coronavirus particles in the vaccine have been effectively deactivated so that they cannot multiply and harm the body.
More than 100 possible vaccines are being developed around the world to try to stop the Covid-19 pandemic. At least four are in final phase-3 human trials, according to WHO data.
Who is leading the global vaccine race?
The US leads the vaccine race overall with 39 research projects.
The American biotech company Moderna is pioneering work on a mRNA vaccine. This approach delivers genetic material to human cells that provide a 'spike' protein seen on the surface of the coronavirus. This should trigger an antibody response that allows the body to fight Covid-19.
Moderna hopes to have data from latest trials on 30,000 participants available by November. US drug maker Pfizer and German biotech company BioNTech are also conducting "promising" research along the same approach.
China ranks second on the WHO list with 20 projects. The Lancet in late May said the phase-1 trial of a potential Covid-19 vaccine developed by Chinese top military virologists showed promising results.
CanSino is poised to launch a Phase III trial of its vaccine candidate which also uses a harmless cold virus to carry genetic material from the coronavirus into the body. Meanwhile SinoPharm launched its phase three trial among 15,000 volunteers —aged 18 to 60, with no serious underlying conditions— in the UAE.
A WHO overview published last week said 165 candidate vaccines are being worked on around the world, with six reaching phase 3.
In his government address on Tuesday morning, President Vladamir Putin said the vaccine “works quite effectively, forms strong immunity and [that it] has passed all the needed checks”.
The Russian leader revealed the vaccine had even been administered to one of his daughters.
Scientists in the UK have expressed scepticism. Professor Keith Neil, epidemiologist at the University of Nottingham, believes the vaccine’s cloak of secrecy makes it impossible to know if it will be effective.
And he cautioned that even if scientific papers had been made available for analysis, then there still may have been “problems on data quality”.
Philippines President Rodrigo Duterte has said he has “huge trust” in Russia’s vaccine. He can be the “first they experiment on", he added.