By: Vladimir Isachenkov & Daria Litvinova
Russia on Tuesday became the first country to approve a coronavirus vaccine, a move that was met with international skepticism and unease because the shots have only been studied in dozens of people.
President Vladimir Putin announced the Health Ministry’s approval and said one of his two adult daughters already was inoculated. He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness.
“I know it has proven efficient and forms a stable immunity,” Putin said. “We must be grateful to those who made that first step very important for our country and the entire world.”
However, scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before final-stage testing could backfire. What’s called a Phase 3 trial — which involves tens of thousands of people and can take months — is the only way to prove if an experimental vaccine is safe and really works.
By comparison, vaccines entering final-stage testing in the U.S. require studies of 30,000 people each. Two vaccine candidates already have begun those huge studies, with three more set to get underway by fall.
“Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,” said Russia’s Association of Clinical Trials Organizations, in urging government officials to postpone approving the vaccine without completed advanced trials.
While Russian officials have said large-scale production of the vaccine wasn’t scheduled until September, Deputy Prime Minister Tatyana Golikova said vaccination of doctors could start as early as this month. Officials say they will be closely monitored after the injections. Mass vaccination may begin as early as October.
“We expect tens of thousands of volunteers to be vaccinated within the next months,” Kirill Dmitriev, chief executive of the Russian Direct Investment Fund that bankrolled the vaccine, told reporters.
The vaccine developed by the Gamaleya Institute in Moscow with assistance from Russia’s Defense Ministry uses a different virus — the common cold-causing adenovirus — that’s been modified to carry genes for the “spike” protein that coats the coronavirus, as a way to prime the body to recognize if a real COVID-19 infection comes along.
That’s a similar technology as vaccines being developed by China’s CanSino Biologics and Britain’s Oxford University and AstraZeneca — but unlike those companies, Russian scientists haven’t published any scientific information about how the vaccine has performed in animal tests or in early-stage human studies.
Dmitriev said even as Russian doctors and teachers start getting vaccinated, advanced trials are set to start Wednesday that will involve “several thousand people” and span several countries, including the United Arab Emirates, Saudi Arabia, the Philippines and possibly Brazil.
The Associated Press couldn’t find documentation in the Russian Health Ministry’s records indicating that permission to start the advanced trials was granted. The ministry has not responded to a request for comment.
Putin said one of his daughters has received two doses, and had minor side effects such as slight fever, and is now “feeling well and has a high number of antibodies.” It wasn’t clear if she was one of the study volunteers.
The Health Ministry said in a statement Tuesday that the vaccine is expected to provide immunity from the coronavirus for up to two years, citing its experience with vaccines made with similar technology.
However, scientists around the world have been cautioning that even if vaccine candidates are proven to work, it will take even more time to tell how long the protection will last.
“The collateral damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably,” Imperial College London immunology professor Danny Altmann said in a statement Tuesday.
The World Health Organization said all vaccine candidates should go through full stages of testing before being rolled out. Experts have warned that vaccines that are not properly tested can cause harm in many ways — from harming health to creating a false sense of security or undermining trust in vaccinations.
Becoming the first country in the world to approve a vaccine was a matter of national prestige for the Kremlin as it tries to assert the image of Russia as a global power. Putin repeatedly praised Russia’s effective response to the outbreak in televised addresses to the nation, while some of Moscow’s top officials – including the country’s prime minister and Putin’s own spokesperson – became infected.
And the U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs. Russia has denied involvement.
Russia has so far registered 897,599 coronavirus cases, including 15,131 deaths.
The Gamaleya Institute’s director, Alexander Gintsburg, raised eyebrows in May when he said that he and other researchers tried the vaccine on themselves before the start of human studies.
Those trials started June 17 with 76 volunteers. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder. Some in the first group were recruited from the military, which raised concerns that servicemen may have been pressured to participate. The test was declared completed earlier this month.
“It’s a too early stage to truly assess whether it’s going to be effective, whether it’s going to work or not,” Dr. Michael Head, senior research fellow in global health at the University of Southampton.
It’s not Russia’s first controversial vaccine. Putin has bragged that Russian scientists delivered an Ebola vaccine that “proved to be the most effective in the world” and “made a real contribution to fighting the Ebola fever in Africa.” However, there is little evidence either of the two Ebola vaccines approved in Russia was widely used in Africa. As of 2019, both of those vaccines were listed by the WHO as “candidate vaccines.”
Worldwide Virus Cases Top 20 Million
It took six months for the world to reach 10 million confirmed cases of the coronavirus. It took just over six weeks for that number to double.
The worldwide count of known COVID-19 infections climbed past 20 million on Monday, with more than half of them from just three countries: the U.S., India and Brazil, according to the tally kept by Johns Hopkins University.
The average number of new cases per day in the U.S. has declined in recent weeks but is still running high at over 54,000, versus almost 59,000 in India and nearly 44,000 in Brazil.
The severe and sustained crisis in the U.S. — over 5 million cases and 163,000 deaths, easily the highest totals of any country — has dismayed and surprised many around the world, given the nation’s vaunted scientific ingenuity and the head start it had over Europe and Asia to prepare.
South Africa, Colombia, Mexico, Peru, Argentina, Russia and the Philippines round out the list of the top 10 countries contributing the most new cases to the global tally since July 22, according to an Associated Press analysis of Johns Hopkins data through Monday.
The real number of people infected by the virus around the world is believed to be much higher — perhaps 10 times higher in the U.S., according to the Centers for Disease Control and Prevention — given testing limitations and the many mild cases that have gone unreported or unrecognized.
In other developments, Russia on Tuesday became the first country to approve a vaccine against the virus. While a proven coronavirus vaccine would be an epic medical breakthrough, the move raised alarms among scientists because the shots have not been subjected to large-scale testing in humans. They have only been studied in dozens of people, not the thousands typically involved.
Some of the worst-hit nations have been those whose leaders have downplayed the severity of COVID-19, undercut the advice of health experts and pushed unproven remedies.
President Donald Trump, Brazil’s President Jair Bolsonaro and Mexican President Andrés Manuel López Obrador, for example, all rarely wear masks and have resisted calls for strict lockdowns. Trump and Bolsonaro have promoted the anti-malaria drug hydroxychloroquine, even though studies have shown it to be useless against the virus, with potentially deadly side effects.
In the U.S., Mexico and Brazil, testing has been criticized as inadequate. While the U.S. has ramped up testing in recent months, Americans have faced discouragingly long lines and delays in getting the results. In Mexico, 47% of tests are coming back positive, suggesting that only seriously ill people are getting screened.
Contact tracing, which has helped authorities in other countries get a handle on the spread, has also been criticized as insufficient in all three countries.
The U.S., with about 4% of the world’s population, accounts for about 25% of the known coronavirus infections and 22% of the deaths.
Mexico has reported nearly 500,000 cases and more than 50,300 deaths, but the president’s point man on the epidemic, Assistant Health Secretary Hugo López-Gatell, said a full lockdown would prove too costly for people with little savings and tenuous daily incomes.
“We do not want a solution that would, in social terms, be more costly than the disease itself,” he said.
Cases have begun to rise significantly in Caracas, Venezuela, perhaps one of the world’s least-prepared cities to face the pandemic.
The country has been under a lockdown since March, but limited testing, open defiance of quarantine measures and the return of tens of thousands of Venezuelan migrants from countries with higher caseloads have resulted in a steady expansion that is starting to overwhelm hospitals with scarce supplies.
“What has been successful in other countries is massive testing and isolating the population that is sick,” said Domingo Subero, 66, an engineer worried about the situation in Caracas. “Here, neither of those two things is happening.”
Elsewhere around the world, New Zealand, which has been praised for quickly getting the virus under control, reported the first cases of local transmission in the country in 102 days. Prime Minister Jacinda Ardern said four cases were discovered in a single Auckland household.