President Vladimir Putin said Russia cleared the world’s first Covid-19 vaccine for use and hopes to begin mass inoculation soon, even before clinical testing has finished.
“The first registration has taken place,” Putin said Tuesday at a televised government meeting, adding that one of his daughters has already been given the vaccine. “I hope that we can soon begin mass production.”
The move clears the way for widespread use of the vaccine among Russia’s population, with production starting next month, although it may take until January to complete trials. Medical workers could begin receiving the drug by the end of the month, Deputy Prime Minister Tatyana Golikova said at the meeting.
The announcement represents a propaganda coup for the Kremlin amid a global race to develop vaccines against the coronavirus pandemic and accusations that Russian hackers sought to steal international drug research. The disease has killed nearly 750,000 people, infected more than 20 million and crippled national economies. Companies including AstraZeneca Plc and Moderna Inc. are still conducting final-stage trials of their vaccines in studies that are expected to soon yield results.
Russia indicated how it regards the development, naming the vaccine Sputnik V in a nod to the Soviet Union’s achievement in launching the world’s first satellite into space in 1957.
Yet the speed with which the vaccine has received regulatory approval has drawn criticism, with a local association of multinational pharmaceutical companies calling the rushed registration dangerous.
“This is a political decision by Putin so he can claim that Russia was the first in the race to develop a Covid-19 vaccine,” said Svetlana Zavidova, executive director of Russia’s Association of Clinical Trials Organizations. “I can’t understand why Russia needs to build this Potemkin village.”
The vaccine is being developed by Moscow’s Gamaleya Institute and the Russian Direct Investment Fund, which have said it is undergoing Phase 3 trials, the final stage of testing during which it is given to thousands of people to determine its fitness for use. A World Health Organization database lists the vaccine as still only in Phase 1 testing, the earliest stage.
RDIF chief Kirill Dmitriev dismissed criticism that the developers haven’t published peer-reviewed results to date during a press conference Tuesday.
Test Data
“Following Russian regulations, they can publish it easier after the registration,” Dmitriev said about data from the initial trials, adding that the results are “incredibly impressive” and will be published soon.
RDIF will be able to produce more than 500 million doses a year in five countries, with mass immunizations in Russia planned to begin in October, Dmitriev said.
RDIF plans to conduct Phase 3 clinical trials in Saudi Arabia, the United Arab Emirates, Brazil, India and the Philippines, according to the Sputnik V website. Mass production is lined up in India, South Korea, Brazil, Saudi Arabia, Turkey and Cuba, it said, with at least 20 countries interested in obtaining supplies.
WHO spokesman Christian Lindmeier said last week that all vaccine candidates should adhere to established practices and finish clinical trials before being made widely available.
The Russian candidate is a viral vector vaccine based on a human adenovirus — a common cold virus — fused with the spike protein of SARS CoV-2 to stimulate an immune response and is similar to one developed by China’s CanSino Biologics.
