MOSCOW — It was with great fanfare that President Vladimir Putin and other officials announced this month that 1 billion doses of a Russian vaccine for the new coronavirus would soon be rolled out, supposedly putting an end to the worst pandemic in a century.
But rather than taking a bow for saving the world with their vaccine, which they call Sputnik V, Russian health officials have found themselves on the defensive.
“Some foreign colleagues, who must have felt certain competition and competitive edges of Russia’s product, have been trying to express opinions that we find totally groundless,” the minister of health, Mikhail Murashko, told a news conference in Moscow.
Most of those “opinions” are based on the fact that Sputnik V has not been tested in late-stage, large, randomized control trials that are critical in establishing a vaccine’s safety and effectiveness. By skipping such trials, Russia is potentially endangering people to score propaganda points, health experts warn.
“If we wanted to take the chance of hurting a lot of people or giving them something that doesn’t work, we could start doing this, you know, next week if we wanted to,” said Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and the United States’ leading infectious disease expert.
Russian scientists have dismissed such criticism as sour grapes. Alexander Gintsburg, the director of the Gamaleya Institute, the scientific body that designed the vaccine, said the pushback was merely “a fight for market share” of coronavirus vaccines.
“We are certain we have the best, most tested and most effective vaccine in the world,” said Kirill Dmitriev, the head of a state-controlled investment fund financing the vaccine. “Our competitors understand this perfectly and fear a strong position of Russia in the vaccine market.”
The world’s major powers are racing to develop and produce a vaccine that, if successful and accepted by their own citizens and other countries, will earn geopolitical and economic benefits for the winner, along with prestige. The US has poured billions of dollars into an effort called Operation Warp Speed.
Currently, eight vaccines are further along than Russia’s in late-stage trials, including ones produced by Moderna in the US, by Oxford University and AstraZeneca in Britain, and several in China.
Vaccines generally go through three stages of human testing before they can gain approval. The first two phases test the vaccines on small numbers of people to see whether they stimulate an immune response or cause harm.
The last phase compares the vaccine to a placebo in tens of thousands of people, to determine whether it works in preventing disease. The final phase could also highlight potentially disastrous side effects, such as rendering those inoculated more vulnerable to severe forms of COVID-19. Russia began late-stage trials this month, after approving the vaccine.
Dmitriev, the investor in the vaccine, has said that Russian scientists had confidence in it because they had used the same approach on a successful Ebola vaccine. And starting last September, just months before the pandemic began, they had fortuitously been studying in clinical trials a vaccine against Middle East respiratory syndrome, which is caused by a similar coronavirus. Russia is in talks on exporting the vaccine or licensing production with 20 countries, including Brazil, Cuba, the Philippines and Saudi Arabia.
The Ministry of Health said the first doses would go to Russian medical workers and teachers, and Putin said one of his daughters had already taken the vaccine.
But even Russian doctors have been reluctant customers.
The chair of the ethics committee in the Ministry of Health, Dr. Alexander Chuchalin, quit as the ministry was in the process of approving the vaccine. Reached by telephone, Chuchalin declined to comment.
In an online survey, only 24 percent of 3,040 doctors said they would administer the new vaccine to their patients.
Four Russian trade unions representing doctors and teachers have recommended their members not take the vaccine.
The Kremlin approved it prematurely in a “political decision” for purposes of prestige and to revive the economy, said Anastasia Vasilyeva, the director of one of the unions, Doctor’s Alliance, which is affiliated with a Russian political opposition group.
“Doctors are not stupid,” she said in an interview. “They understand what an untested medicine can do.”
The unusual route to approval has roots in Russia’s long history of vaccine development. In the 1950s, a family of Russian scientists tested an ultimately successful polio vaccine on their own children.
In 1969, Dr. Alexander Butenko quickly designed a vaccine against Crimean-Congo hemorrhagic fever to quell an outbreak in southern Russia. He injected himself first, following a Russian tradition for medical scientists, then tested it on a small number of people. Soviet health authorities approved the vaccine to halt the spread of the disease though it had not undergone late-stage clinical trials. In that case, the vaccine worked.
Such rapid approval “isn’t just done for sporting interest,” said Butenko, who is now retired. “It’s always done in a crisis,” when the risks of a new vaccine are weighed against the harm from an epidemic.
So far, scientists have found no indications that vaccines against the new coronavirus could cause an enhancement of the disease, Johan Neyts, a professor of virology at the University of Leuven in Belgium, said in a telephone interview. “But this is something that should be kept in mind.”
One reason for concern, he noted, is a decades-old study by Dutch virologists who developed an experimental vaccine against a strain of coronavirus that infects cats. When the animals were subsequently exposed to the feline virus, they died more quickly than cats given a placebo.
In their study, published in the Journal of Virology in 1990, the researchers called it “early death syndrome.”
“This is one of the main reasons everyone is vigilant,” Neyts said.
c.2020 The New York Times Company