President Vladimir Putin announced on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing.
The vaccine still though 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.
Clinical trials of the vaccine began on June 18 and included 38 volunteers. All of the participants developed immunity. The first group was discharged on July 15 and the second group on July 20.
Russian health workers treating COVID-19 patients will be the first who will be offered the vaccinated in the coming weeks.
Regulatory approval paves the way for the mass inoculation of the Russian population and authorities hope it will allow the economy, which has been battered by fallout from the virus, to return to full capacity.
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 of Sputnik 1, the world’s first satellite.
The vaccine will be marketed under the name ‘Sputnik V’ in foreign markets.
Dmitriev said Russia had already received foreign requests for 1 billion doses. International agreements had been secured to produce 500 million doses annually, with the vaccine also expected to be produced in Brazil.
He said clinical trials were expected to start soon in the United Arab Emirates and the Philippines.
But only about 10% of clinical trial are successful, and the speed at which Russia has moved, approving a vaccine before the final stages of trials to test safety and efficacy are over, has worried some scientists, who fear Moscow may be putting national prestige before safety.
Speaking at a government meeting on state television, Putin dismissed those concerns, saying the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters.
“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.
He said he hoped mass production would start soon.
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 III human trials, according to WHO data.
Vaccine development is a multi phase process. In phase 1, the number of participants are small. It sees whether the vaccine is safe for humans or not. In phase 2, the number of participants are many and it involves to evaluating its efficiency. In the final phase, the vaccine is injected on thousands and its results are studied for months.
The clinical trial phase can last up to 18 months.
Adding the timeline for regulatory approvals any vaccine could takes upto three years before it hits markets. However, authorities around the world are fast-tracking potential vaccine trials in the light of the pandemic. Globally the target date is set for early 2021.