Russia Approves Coronavirus Vaccine ahead of completing tests

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The country became the first in the world to approve a possible vaccine against the virus, despite warnings from the global authorities against cutting corners.

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Russia (Russian: Росси́я, tr. Rossiya, IPA: [rɐˈsʲijə]), or the Russian Federation, is a transcontinental country located in Eastern Europe and Northern Asia. Covering an area of 17,125,200 square kilometres (6,612,100 sq mi), it is the largest country in the world by area, spanning more than one-eighth of the Earth’s inhabited land area, stretching eleven time zones, and bordering 16 sovereign nations. The territory of Russia extends from the Baltic Sea in the west to the Pacific Ocean in the east, and from the Arctic Ocean in the north to the Black Sea and the Caucasus in the south. With 146.7 million inhabitants living in the country’s 85 federal subjects, Russia is the most populous nation in Europe and the ninth-most populous nation in the world. Russia’s capital and largest city is Moscow; other major urban areas include Saint Petersburg, Novosibirsk, Yekaterinburg, Nizhny Novgorod, Kazan, Chelyabinsk and Samara.
The East Slavs emerged as a recognisable group in Europe between the 3rd and 8th centuries AD. The medieval state of Rus’ arose in the 9th century. In 988 it adopted Orthodox Christianity from the Byzantine Empire, beginning the synthesis of Byzantine and Slavic cultures that defined Russian culture for the next millennium. Rus’ ultimately disintegrated into a number of smaller states, until it was finally reunified by the Grand Duchy of Moscow in the 15th century. By the 18th century, the nation had greatly expanded through conquest, annexation, and exploration to become the Russian Empire, which became a major European power, and the third-largest empire in history, stretching from Norway on the west to Canada on the east. Following the Russian Revolution, the Russian SFSR became the largest and leading constituent of the Soviet Union, the world’s first constitutionally socialist state. The Soviet Union played a decisive role in the Allied victory in World War II, and emerged as a recognised superpower and rival to the United States during the Cold War. The Soviet era saw some of the most significant technological achievements of the 20th century, including the world’s first human-made satellite and the launching of the first humans in space. Following the dissolution of the Soviet Union in 1991, the Russian SFSR reconstituted itself as the Russian Federation and is recognised as the continuing legal personality and a successor of the USSR.Following the constitutional crisis of 1993, a new constitution was adopted and Russia has been governed as a federal semi-presidential republic. Vladimir Putin became acting president on 31 December 1999 after Boris Yeltsin resigned and was elected president in March 2000. Since then, he has dominated Russia’s political system as either president or prime minister. His government has been accused by non-governmental organisations of numerous human rights abuses, authoritarianism and corruption. In response, Putin has argued that Western-style liberalism is obsolete in Russia, while maintaining that the country is still a democratic nation.The Russian economy ranks as the fifth-largest in Europe, the eleventh-largest in the world by nominal GDP and the fifth-largest by PPP. Russia’s extensive mineral and energy resources are the largest such reserves in the world, making it one of the leading producers of oil and natural gas globally. The country is one of the five recognised nuclear weapons states and possesses the largest stockpile of nuclear warheads. Russia is a major great power, as well as a regional power, and has been characterised as a potential superpower. The Russian Armed Forces have been ranked as the world’s second most powerful, and the most powerful in Europe. Russia hosts the world’s ninth-greatest number of UNESCO World Heritage Sites, at 29, and is among the world’s most popular tourist destinations. It is a permanent member of the United Nations Security Council and an active global partner of ASEAN, as well as a member of the Shanghai Cooperation Organisation (SCO), the G20, the Council of Europe, the Asia-Pacific Economic Cooperation (APEC), the Organization for Security and Co-operation in Europe (OSCE), the International Investment Bank (IIB) and the World Trade Organization (WTO), as well as being the leading member of the Commonwealth of Independent States (CIS), the Collective Security Treaty Organization (CSTO) and a member of the Eurasian Economic Union (EAEU).

Russia Approves Coronavirus Vaccine Before Completing Tests

About Approves

In this video screen grab made available by Moscow’s Sechenov Medical University, a volunteer receives the vaccine as part of clinical trials.
In this video screen grab made available by Moscow’s Sechenov Medical University, a volunteer receives the vaccine as part of clinical trials.Credit…Sechenov Medical University Press Office, via Getty Images

Andrew E. Kramer

  • Aug. 11, 2020Updated 1:50 p.m. ET

MOSCOW — Russia has become the first country in the world to approve a vaccine for the coronavirus, President Vladimir V. Putin announced on Tuesday, though global health authorities say the vaccine has yet to complete critical, late-stage clinical trials to determine its safety and effectiveness.

Russia Approves Coronavirus Vaccine Before Completing Tests

Mr. Putin, who told a cabinet meeting on Tuesday morning that the vaccine “works effectively enough,” said that his own daughter had taken it. And in a congratulatory note to the nation, he thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”

The major powers are locked in a global race for a vaccine that President Trump, Mr. Putin and China’s president, Xi Jinping, are treating as a proxy war for their personal leadership and competing national systems. The United States, with an effort called Operation Warp Speed, and China have poured billions into the pursuit, and health officials worry that Russia is trying to snatch a victory by cutting corners.

Russia’s minister of health, Mikhail Murashko, has said the country will begin a mass vaccination campaign in the fall, and said on Tuesday that it would start with teachers and medical workers this month.

But by skipping large-scale clinical trials, the Russian dash for a vaccine has raised widespread concern that it is circumventing vital steps in order to score global propaganda points. Russia’s vaccine sped through early monkey and human trials with apparent success. But Moscow was cautioned just last week by the World Health Organization not to stray from the usual methods of testing a vaccine for safety and efficacy.

Beyond that, the United States, Canadian and British governments have all accused Russian state hackers of trying to steal vaccine research. Russian officials have denied the accusations, and say their vaccine is based on a design developed years ago by Russian scientists to counter the Ebola virus.

A vaccine is seen as the most likely avenue for defeating the novel coronavirus and alleviating a worldwide health crisis that has killed at least 734,900 people and decimated national economies. Western regulators have said repeatedly that they do not expect a vaccine to become widely available before the end of the year at the earliest.

Around the world, more than 30 vaccines — out of a total of more than 165 under development — are now in various stages of human trials. Currently, eight vaccines have entered the final phase of mass human testing, including ones produced by Moderna in the United States, Oxford University and AstraZeneca in Britain and several Chinese companies.

Some of those Chinese companies have been accused of cutting corners themselves. One offered the vaccine to employees at the national oil company, while another has teamed up with the People’s Liberation Army to conduct human trials.

In Moscow, the announcement was greeted with a mixture of national pride and nagging doubts by Russians who have been schooled by experience to treat such boasts with a healthy dose of skepticism.

Lidiya Ivleva, 70, a retired nurse out for a walk in a Moscow park Tuesday afternoon, embodied both sentiments. While calling the vaccine “a great achievement” for Russian scientists, she said she would not rush to get it herself because of the “hasty” testing.

“Those who fear the pandemic more will take it first, and good for them,” she said. If in a year or so it is clearly shown to be safe, she said, then she will reconsider.

Vaccines generally go through three stages of human testing before being approved for widespread use. The first two phases test the vaccine on relatively small groups of people to see if it causes harm and stimulates the immune system. The last phase, known as Phase 3, compares the vaccine to a placebo in tens of thousands of people.

The Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct Phase 3 trials.

That final phase, however, is the only way to know with statistical certainty whether a vaccine can prevent an infection, and how effective it is. And because it tests a much larger group of people, a Phase 3 trial can also detect more subtle adverse effects of a vaccine that earlier trials could not.

Experts warn that, among other things, a faulty vaccine could actually render those inoculated more vulnerable to severe forms of Covid-19, the disease caused by the virus, a potential disaster that can be ruled out only through extensive testing on human volunteers.

Image“It works effectively enough, forms a stable immunity and I repeat, it has gone through all necessary tests,” President Vladimir V. Putin said.
“It works effectively enough, forms a stable immunity and I repeat, it has gone through all necessary tests,” President Vladimir V. Putin said.Credit…Aleksey Nikolskyi/Sputnik, via Reuters

The Russian vaccine uses two strains of adenovirus that typically cause mild colds in humans. Scientists genetically modified them to cause infected cells to make proteins from the spike of the new coronavirus, officials have said.

The approach is similar to the one used in a vaccine developed by Oxford University and AstraZeneca that is now undergoing Phase III tests in Britain, Brazil and South Africa.

The W.H.O. is in close contact with the Russian authorities and discussing proper procedures, Tarik Jasarevic, a spokesman for the organization, told reporters in Geneva on Tuesday. But he emphasized that obtaining the organization’s seal of approval would require “rigorous review of safety and efficacy data” derived from clinical trials.

The Russian Ministry of Health did not respond to detailed written questions sent last week about human trials and research into potentially harmful side effects.

Russia’s announcement of a potential vaccine well ahead of the Western timeline of the end of the year could provide a welcome respite for Mr. Putin from a string of bad news.

Over the past year he has seen a steady decline in his approval ratings, which had soared to more than 80 percent after the annexation of Crimea in 2014. Now, with Russian troops bogged down in Syria and Libya, foreign adventures have lost their appeal for most Russians.

Mr. Putin has also stumbled in domestic affairs. He was uncharacteristically passive in the spring as Russia erupted into one of the world’s hot spots for the coronavirus pandemic. And he has had no answers for the economic malaise enveloping the country, as the pandemic has flattened prices for oil and other natural resources that are the main engine of the Russian economy.

Russia has already used the vaccine race as a propaganda tool, even in the absence of published scientific evidence to support its claims as the front-runner. The vaccine, for example, was branded Sputnik V, recalling the pride of the first Soviet satellite launch.

For the last several months, state television has promoted the idea that Russia is leading the competition. In May, it reported that the first person in the world to be vaccinated against the virus was a Russian researcher who had injected himself even before monkey trials had been completed.

Russia also tested the vaccine on soldiers, raising concerns about consent, though the Ministry of Defense said that all the soldiers had volunteered.

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 and vaccine manufacturing, Hek293 began with cells taken from an aborted fetus, raising objections from abortion opponents that may come into sharper focus if the vaccine is used widely.

Kirill Dmitriev, the head of a government-controlled fund that invested in the vaccine, denied in a conference call with journalists on Tuesday that Russia had cut corners on testing, or that it had stolen intellectual property to get ahead.

Mr. Dmitriev said Russia relied on a formidable legacy of research into viruses and vaccines in the Soviet Union, and had focused on established technologies, like the approach already used for the Ebola vaccine.

He contrasted that history with Trump administration’s Operation Warp Speed program, which is financing research by Pfizer and Moderna for a genetic vaccine and supporting a variety of other experimental technologies. The Russian vaccine, he said, is “more proven, on a larger number of people, than any of the new technologies that people are trying.”

If successful, the vaccine could become a geopolitical boon for Russia, recalling the Soviet Union’s mass exports of cheap vaccines to the developing world during the Cold War. Russia has already received orders for 1 billion doses from 20 countries and plans to manufacture the vaccine in Brazil, India, South Korea, Saudi Arabia and Cuba, according to the Gamaleya Institute.

If Russian scientists have taken an unorthodox route to the coronavirus vaccine, it would not be the first time. Back in the 1950s, a team of researchers tested a promising, and ultimately successful, polio vaccine on their own children.

Reporting contributed by Nick Cumming-Bruce in Geneva and Katie Thomas in New York.