MOSCOW—Russia registered the world’s first Covid-19 vaccine, President Vladimir Putin said on Tuesday, marking a milestone in the fight against the new coronavirus but amid safety concerns in the West over the country’s accelerated clinical evaluations.
The development was met with anticipation and skepticism in the country and raises questions not only about the efficacy of the Russian vaccine, which some global health officials say was developed by cutting regulatory corners, but also how the registration could alter the landscape for other Western and Asian drug companies still working toward a shot.
Some health and pharmaceutical officials in Russia and the West have expressed alarm at the speed with which scientists at Moscow’s Gamaleya Institute for Epidemiology and Microbiology developed the vaccine. Scientists employed military testing, accelerated clinical evaluations and shortened trial times in an attempt to be first with a vaccine.
Russia hopes to use it in a massive immunization program at home and to export it abroad under the name Sputnik V—a reference to the satellite it launched into orbit in the Cold War space race, beating the U.S.
“We should be grateful to those who have taken this first step, which is very important for our country and the whole world,” Mr. Putin told a government meeting Tuesday, according to a Kremlin transcript.
“I hope we can start a massive release of this vaccine soon,” he said, adding that one of his daughters had already received it.
Volunteers in a trial of a coronavirus vaccine at a military hospital outside Moscow last month.
Photo: /Associated PressCritics worry that the Kremlin is sacrificing the health of its citizens for prestige. Mr. Putin said earlier this year that he wanted a shot produced by September, adding political pressure to the search for a vaccine. Russia has recorded some 900,000 coronavirus cases, straining its health-care system, and lockdown measures were expected to have cut its economy by 10% in the second quarter.
So far, two rounds of testing have been launched for the vaccine, and a third is planned after registration, when authorities will offer voluntary vaccination of health-care workers and teachers. The health minister said previously that a rollout of the vaccine would start in October.
A medical worker in Moscow earlier this month.
Photo: Andrey Rudakov/Bloomberg NewsSeparately, Russia’s Ministry of Health in May approved a flu drug for use in fighting coronavirus after officials said preliminary testing showed hospitalized patients who took the pills recovered more quickly.
In the U.S. and Europe, vaccines are tested differently, beginning with a small group of healthy volunteers testing the shots for safety. The next stage typically evaluates whether the vaccine provides protection, usually in hundreds of people, with the third stage evaluating the vaccine in thousands of volunteers. Results are published along the way, but the development process often takes years and most promising vaccines wind up faltering during rounds of study.
Russia’s registration puts it ahead of U.S., European and Asian peers that have also been racing for a vaccine. Earlier this year, the Trump administration gave billions of dollars to pharmaceutical companies Johnson & Johnson, Moderna Inc., AstraZeneca PLC and Sanofi SA to devise a vaccine. Moderna and Pfizer have started late-stage testing.
In Russia, registration of a drug is the most important step with the Health Ministry to verify its safety and make it available for medical use, similar to approval by the Food and Drug Administration in the U.S.
Some wonder if Russia’s curtailed testing could add political pressure in other corners of the globe to imitate Moscow’s regulatory corner cutting in the hopes of more quickly getting to a vaccine.
“It’s really reckless, and sets a deeply disturbing precedent that it’s all right to cut corners, it’s all right to ignore ethics, it’s all right to ignore international legal standards in a search for a vaccine,” said Lawrence Gostin, director of Georgetown University’s O’Neill Institute for National and Global Health Law. “That could be disastrous.”
Likewise, critics say that by testing the vaccine initially on soldiers, the healthy segment of society, Russia had failed to account for the effects the shot could have on others, including older citizens with chronic diseases.
U.S. Health and Human Services Secretary Alex Azar said Tuesday on Good Morning America that it was more important to have a safe and effective vaccine against the coronavirus than to be the first to produce a vaccine.
Russia’s Gamaleya Institute, which worked jointly with the Defense Ministry, has said the expedited testing was safe because the vaccine was being developed on the basis of a previously registered inoculation against Ebola.
Earlier this year, the U.S., U.K. and Canada accused Russia of hacking into international institutions to steal Covid-19 vaccine information. Russia denied the accusations.
Russia’s Association of Clinical Trials Organizations, a non-governmental organization that counts global pharmaceutical companies among its members, has asked the health minister in an open letter to delay registration of the vaccine until all clinical trials have been completed.
“It hasn’t even completed testing with participation of even 100 people,” the letter said on the organization’s website, emphasizing the need for a third phase. “It’s exactly in the course of that phase when proof of the effectiveness can be ascertained as well as information about undesirable reactions, which the vaccine can cause in various patient groups.”
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Dr. Anthony Fauci, the U.S.’s top infectious-disease expert, said during a House Covid-19 subcommittee hearing last month that the U.S. likely wouldn’t use vaccines developed in China or Russia, voicing concerns over testing.
Kirill Dmitriev, the head of Russia’s Direct investment Fund, which partnered with Gamaleya Institute for the vaccine, said Russia had followed all the necessary procedures to ensure a safe vaccine, adding he had used the vaccine on himself and members of his family.
The vaccine has already attracted the attention of other countries, and Russia has already received requests from 20 countries, including Brazil, Indonesia, and the United Arab Emirates for one billion doses of Sputnik-V, Mr. Dmitriev said.
He acknowledged that some criticism was warranted, but said Russia would soon publish its findings on the vaccine in order to be transparent.
“We feel that some politicians who are negative toward Russia are attacking Russia regardless of what Russia is doing,” Mr. Dmitriev said.
Russia, which has registered nearly 900,000 cases since the start of the pandemic, has recently seen a daily caseload around half of what it was during the peak in May. But Russian officials have warned that a second wave could be imminent, another factor in expediting the approval of the vaccine.
Financial analysts and investors said that news of the vaccine had led market players to increase their holdings of Russian assets, driving up prices of some Russian stocks and the local currency. The ruble rose 0.8% against the dollar. Meanwhile the RTS Index, a benchmark of 50 of the most liquid stocks on the Moscow Exchange rose more than 2%.
“The authorities wanted to come up with something that was good enough for the domestic population and give them more confidence to go out as normal in the economy,” said Kaan Nazli, senior economist and portfolio manager at Neuberger Berman. “Even if it’s just better than nothing, if it’s like getting a flu shot in the fall, then it might help.”
Still, a degree of skepticism remained among some Russians, like Natalia Trofimova, a former health-care worker, who said she didn’t plan on taking the vaccine.
“I don’t believe in it,” she said.
—Drew Hinshaw in Warsaw, Anna Isaac in London and Jared S. Hopkins in New York contributed to this article.
Write to Thomas Grove at thomas.grove@wsj.com
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