MOSCOW — Russia plans to launch a nationwide vaccination campaign in October with a coronavirus vaccine that has yet to complete clinical trials, raising international concern about the methods the country is using to compete in the global race to inoculate the public.
The minister of health, Mikhail Murashko, said Saturday that the plan was to begin by vaccinating teachers and health care workers. He also told the RIA state news agency that amid accelerated testing, the laboratory that developed the vaccine was already seeking regulatory approval for it.
Russia is one of a number of countries rushing to develop and administer a vaccine. Not only would such a vaccine help alleviate a worldwide health crisis that has killed more than 680,000 people and badly wounded the global economy, it would also become a symbol of national pride. And Russia has used the race as a propaganda tool, even in the absence of published scientific evidence to support its claim as a front-runner.
“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States, warned a congressional hearing on Friday.
State television in Russia has for several months now promoted the idea of Russia leading the competition. In May, a government report claimed that the first person in the world to be vaccinated against the virus was a Russian researcher who had injected himself with a vaccine early in the development process.
Russia will start Phase III trials of the vaccine in early August, said Kirill Dmitriev, a senior official with Russia Direct Investment Fund, a government-controlled investor in the country’s vaccination effort. A Phase III trial is the only way to determine if a vaccine is effective.
The World Health Organization maintains a comprehensive list of worldwide vaccine trials. But there is no Russian Phase III trial on the list.
Still, a Russian regulatory agency is expected to approve the vaccine this month, Mr. Dmitriev said. That is far earlier than timelines suggested by Western regulators, who have often said a vaccine would become available no sooner than the end of the year.
“We believe it will be one of the first vaccines with regulatory approval,” Mr. Dmitriev said.
But with limited transparency in the Russian program, separating the science from the politics and propaganda could prove impossible. Critics have already drawn attention to Russia’s tradition of cutting corners in research on other pharmaceutical products and accusations of intellectual property theft.
The U.S., Canadian and British governments have all accused Russian state hackers of attempting to steal vaccine research, casting a shadow over Russia’s claim to have achieved a medical breakthrough. Russian officials have denied the accusation and say their leading vaccine is based on a design developed by Russian scientists to counter Ebola years ago.
Russia was once at the forefront in virology and vaccinations. In the Soviet era, its doctors led the world in some areas of research, but spending has shriveled in recent decades. Medicines are sometimes approved with limited or no testing.
Russian researchers have continued to advance a range of vaccines since the beginning of the pandemic. The candidate to be given in October is similar to a vaccine developed by Oxford University and AstraZeneca.
The Russian vaccine was developed by the Gamaleya Institute in Moscow. It uses two strains of adenovirus that typically cause mild colds in humans. Adenovirus vaccines are in trials in various countries. They are genetically modified to cause infected cells to make proteins from the spike of the new coronavirus.
The Gamaleya Institute tested its vaccine on soldiers, raising ethical questions about consent, though the defense ministry said all of the soldiers had volunteered. The institute’s director, Aleksandr Gintsberg, went on television in May to say he tried the vaccine on himself before announcing the completion of trials in monkeys.
“There is an escalation in the geopolitics of vaccine research,” said Cliff Kupchan, chairman of Eurasia Group, a risk consulting firm. But “what remains of the vast scientific complex of the Soviet period is a shadow of what it was,” he said.
Countries with vaccine production capacity — abundant in Russia and India — could wind up inoculating their populations by copying a successful vaccine, even if they did not in fact develop it. In April, the Serum Institute in India announced that it had plans to mass-produce a vaccine, with permission from the developer, before clinical trials had ended.
“In all likelihood, the country producing on their soil will be the first to get it, even if they don’t own it,” Mr. Kupchan said. “I don’t know how much international law and patent protection will apply here. People are pretty desperate.”
Mr. Dmitriev, of the Russia Direct Investment Fund, has attributed Russia’s research success to the Soviet Union’s once-formidable scientific study of viruses.
“We have this very significant legacy of Russia being a leader of vaccines in the Soviet time and today,” he said. “We don’t have to create many things from scratch.”
He contrasted that history with Trump administration’s Operation Warp Speed program, which is financing experimental research by Pfizer and Moderna for a genetic vaccine.
“In the last 20 years, the world took a turn toward molecular biology,” said Aydar A. Ishmukhametov, the director of the Chumakov Institute, a Russian vaccine maker. “The Russian school has preserved virology.”
Russia also has an advantage, Mr. Ishmukhametov said, in its vast, Soviet-era industrial base for growing viruses for vaccines. In the pandemic, the country has turned to a secretive laboratory in Siberia with roots in the Soviet Union’s biological weapons program, which included the study of anthrax to target humans and plant pathogens that would destroy American crops.
The laboratory, Vektor, is now testing whether viruses that cause influenza, measles or vascular stomatitis — a livestock disease — can be put to use for a coronavirus vaccine.
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Frequently Asked Questions
Updated July 27, 2020
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Should I refinance my mortgage?
- It could be a good idea, because mortgage rates have never been lower. Refinancing requests have pushed mortgage applications to some of the highest levels since 2008, so be prepared to get in line. But defaults are also up, so if you’re thinking about buying a home, be aware that some lenders have tightened their standards.
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What is school going to look like in September?
- It is unlikely that many schools will return to a normal schedule this fall, requiring the grind of online learning, makeshift child care and stunted workdays to continue. California’s two largest public school districts — Los Angeles and San Diego — said on July 13, that instruction will be remote-only in the fall, citing concerns that surging coronavirus infections in their areas pose too dire a risk for students and teachers. Together, the two districts enroll some 825,000 students. They are the largest in the country so far to abandon plans for even a partial physical return to classrooms when they reopen in August. For other districts, the solution won’t be an all-or-nothing approach. Many systems, including the nation’s largest, New York City, are devising hybrid plans that involve spending some days in classrooms and other days online. There’s no national policy on this yet, so check with your municipal school system regularly to see what is happening in your community.
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Is the coronavirus airborne?
- The coronavirus can stay aloft for hours in tiny droplets in stagnant air, infecting people as they inhale, mounting scientific evidence suggests. This risk is highest in crowded indoor spaces with poor ventilation, and may help explain super-spreading events reported in meatpacking plants, churches and restaurants. It’s unclear how often the virus is spread via these tiny droplets, or aerosols, compared with larger droplets that are expelled when a sick person coughs or sneezes, or transmitted through contact with contaminated surfaces, said Linsey Marr, an aerosol expert at Virginia Tech. Aerosols are released even when a person without symptoms exhales, talks or sings, according to Dr. Marr and more than 200 other experts, who have outlined the evidence in an open letter to the World Health Organization.
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What are the symptoms of coronavirus?
- Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
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Does asymptomatic transmission of Covid-19 happen?
- So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
The science of mass producing vaccines has deep roots here. Aleksei Chumakov, a virologist and son of the founder of the Chumakov Institute, recalled a summer job he held as a teenager chopping up kidneys harvested from African green monkeys. Even though the monkeys had been slaughtered, Mr. Chumakov said, their kidney cells lived on for many months, used to grow the polio virus in large, rotating glass cylinders.
“You kept stirring it and gradually the clumps came apart,” he said.
As scientists gained proficiency in growing so-called immortal cell lines — human or animal cells that are modified to divide indefinitely — they replaced cultures from fresh monkey kidneys.
The Chumakov Institute has used an immortal monkey kidney cell line from 1962 to grow coronavirus for a proposed vaccine using whole, inactivated viruses, which may be used as an alternative if the vaccine targeting just the spike protein fails.
The Gamaleya Institute developed its vaccine using a human cell line first cultured in 1973, known as Hek293 — the same line used in the Oxford-AstraZeneca vaccine. Like a number of other cell lines used in medical research, Hek293 began with cells taken from an aborted fetus, raising objections from abortion opponents, including Roman Catholic clerics.
The first human cell line was derived from the cancer that killed Henrietta Lacks in 1951. HeLa, as it was known, made its way into Soviet laboratories during the Cold War. Viktor Zuyev, an 91-year-old emeritus professor of virology at the Gamaleya Institute, recalled using it to cultivate flu virus.
He was unbothered by the question of ethics.
“Why not?” he said. “It is very humane to the next generation” to use a dying person’s tissue for scientific experimentation. “If it can benefit humanity,” he said, “of course it is ethical.”
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