Russia on Tuesday announced it had developed the world’s first vaccine offering “sustainable immunity” against coronavirus (COVID-19.
President Vladimir Putin said the vaccine was safe and that one of his daughters had received the inoculation, dubbed “Sputnik V” after the pioneering 1950s Soviet satellite.
“I know that it is quite effective, that it gives sustainable immunity. And I repeat, it has passed all the necessary checks,” Putin said of the vaccine developed by the Gamaleya research institute in collaboration with Moscow’s Ministry of Defence.
He told a government meeting that his daughter,who took the drug as a volunteer, feels good.
The health ministry said though clinical trials were not yet complete, final stage testing involving more than 2,000 people was billed to start today.
Western scientists, who had previously raised concerns about the speed of development of Russian vaccines, yesterday feared that Russian researchers might be cutting corners.
Agence France Presse quoted World Health Organisation’s (WHO’s) spokesman, Tarik Jasarevic, as saying the world body was in “close contact” with Russian health authorities but that it was too soon for Sputnik V” to receive any WHO stamp of approval.
“Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data,” Jasarevic said.
WHO says that 165 candidate vaccines are being worked on around the world, with six reaching Phase 3.
Russian business conglomerate, Sistema, said it expects to put Sputnik V into mass production in October.
The vaccine, according to government officials, will be administered to medical personnel and then teachers, on a voluntary basis at the end of this month or in early September.
The vaccine is administered in two doses and consists of two serotypes of a human adenovirus, each carrying an S-antigen of the new Coronavirus, which enter human cells and produce an immune response.
The platform used for the vaccine was developed by Russian scientists over two decades and had formed the basis for several vaccines in the past, including those against Ebola.
Kirill Dmitriev, head of Russia’s sovereign wealth fund, said Moscow had already received foreign requests for one billion doses. He said the vaccine is also expected to be produced in Brazil.
Dmitriev added that clinical trials were expected to start soon in the United Arab Emirates and the Philippines.
Philippine President Rodrigo Duterte expressed willingness to participate personally.
The approval by the health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.
Such trials, which require a certain proportion of participants to catch the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
However, Moscow-based Association of Clinical Trials Organisations (ACTO), a trade body representing the world’s top drugmakers in Russia, had urged the Ministry of Health to postpone approval until when final trial had been successfully completed.
In a letter to the ministry, it said there were high risks associated with registering a drug before that happened.
“It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth,” it said.
Some international experts have also questioned the speed at which Russia approved Sputnik V.
“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, Germany, 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,” Kremsner added.
When asked about Russia’s announcement by ABC News’ “Good Morning America, United States Health Secretary Alex Azar, said: “The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective.”