Russia’s New Sputnik Launch Raises Risks in Dash for COVID-19 Shots

August 17, 2020by James Paton and John Lauerman, Bloomberg News (TNS)
Alexander Gintsburg, director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Healthcare Ministry, which is working on producing a COVID-19 vaccine, on August 14, 2020 in Moscow. The vaccine is to be produced at the institute and other Russian pharmaceutical plants. It will be available to general public on January 1, 2021. (Vyacheslav Prokofyev/TASS/Zuma Press/TNS)

Russia’s decision to approve a coronavirus shot before crucial tests have shown it’s safe and effective raises worries that politics will trump public health in the quest for a vaccine.

The country’s plan to start mass inoculations as soon as October could put pressure on other governments to rush ahead of regulators and skip key steps, putting people who get the jabs at risk. Any major setback in Russia could damage confidence in vaccines.

The stakes are high in the bid to end a crisis that’s killed more than 750,000 people worldwide. The Trump administration is pushing ahead with Operation Warp Speed, an unprecedented U.S. effort to accelerate COVID-19 vaccine development and manufacturing, and a massive mobilization is underway in China to get immunizations across the line. President Vladimir Putin’s Aug. 11 announcement on Russia’s shot adds a new twist.

Any move to roll out the vaccine based on limited evidence that it works could have harmful consequences, said Paul Offit, director of the Vaccine Education Center and an infectious disease specialist at Children’s Hospital of Philadelphia.

“That could cause other leaders to say: ‘Look, they’re doing it, and that’s good enough. And if that’s good enough for them, we don’t want to lose out. We want to protect our populations too,’” he said.

History offers lessons on the importance of a rigorous approach to vaccine development, insulated from politics. Misperceptions about the safety of well established immunizations are already widespread; actual stumbles that have occurred in the field — although rare — only add to fears, and show how a botched COVID-19 shot could further distort and inflame public opinion.

Accelerated Plans

Russian officials have dismissed concerns about safety and the pace at which the country is moving. Western jealousy, they say, is fueling criticism of the vaccine, dubbed Sputnik V in a nod to the Soviet Union’s launch of the world’s first satellite sent into space in 1957. Putin said one of his daughters has already been given the shot.

Authorities said they plan to start inoculating medical workers and other risk groups by the end of the month, introducing it to volunteers who will be closely monitored, and they add that other countries are moving swiftly too. Russia last month began clinical trials for a second vaccine, developed by the Vector laboratory in Novosibirsk.

Meanwhile, developers including Britain’s AstraZeneca Plc — the University of Oxford’s partner — and U.S. biotech company Moderna Inc. are still in final-stage trials involving tens of thousands of people. Although President Donald Trump has said a vaccine may be ready by election day on Nov. 3, Anthony Fauci, the country’s top infectious disease expert, said it may take until well into 2021 for shots to reach much of the public.

Politicians aren’t just seeking a vaccine to escape the pandemic. Some could use COVID-19 shots to try to burnish their leadership credentials and bury criticism of past performance.

For Prime Minister Boris Johnson, it’s a chance to show that a Brexit-unchained U.K. can independently develop vaccines faster than the European Union. A Chinese vaccine might help Xi Jinping erase the memory of the virus’s origin. Trump needs a surprise to turn the polls as the U.S. leads the world in deaths. And Putin has an opportunity to beat the West and gain a strategic advantage. His performance ratings have slumped as Russia’s COVID-19 case tally has risen to the fourth-highest globally.

“He needs a big win,” said Stephen Morrison, director of the Center for Strategic and International Studies’ Global Health Policy Center. “His economy is flat on its back with COVID-19 and the collapse on the oil markets.”

China’s Shot

For those reasons, Putin may not be swayed by concerns about any potential adverse impact from the vaccine. China has already begun using its shot in the military, and those people are unlikely to be able to give informed, voluntary consent, according to Lawrence Gostin, a Georgetown University professor of global health law.

That may embolden other political leaders to take similar steps to bypass regulators like the U.S. Food and Drug Administration. Trump is already in some ways behind in a race where the U.S.’s two major geopolitical rivals have used their authoritarian might to sprint ahead. FDA officials have emphasized that they will clear a COVID-19 vaccine only after careful analysis, basing decisions on “good science and data.”

“I think Trump will try to influence the FDA and it will bend but won’t break,” Gostin said. “I have confidence in the FDA, but I’m very worried. I have no doubt that we could go the path of China or Russia if we didn’t have strong institutional guardrails.”

Even if he sought to move unilaterally on vaccine authorization, Trump may have boxed himself in with Warp Speed, Morrison said. The government has committed billions of dollars to companies to develop vaccines, and they’re unlikely to cooperate with a plan to distribute unproven products without testing that shows their safety, he said.

“It’s going to be much more difficult for Trump to pull off a stunt like this than Putin,” Morrison said.

Production Deals

The Russian candidate is being developed by Moscow’s Gamaleya Institute, the Defense Ministry and the sovereign Russian Direct Investment Fund, who say the vaccine is undergoing the last phase of trials. The World Health Organization lists it as still in the earliest stage.

Mass production is lined up in India, South Korea, Brazil, Saudi Arabia, Turkey and Cuba, with at least 20 countries interested in obtaining supplies, the fund said. Russia’s vaccine could help the global economy recover, according to Kirill Dmitriev, its chief executive officer.

“The countries which quickly gain access to a safe vaccine will make it through the crisis successfully, fearlessly, and with minimal losses,” he said.

As the virus spreads, there’s a risk countries reliant on bigger economies for supplies could end up accepting a product that hasn’t proved itself, said Offit, the University of Pennsylvania expert. Another concern is the impact to the global effort to fight a range of diseases if a fast-moving Russian vaccine runs into problems.

Skeptics would inevitably point to that and other cases from the past.

In 2016, the Philippines started a major drive to vaccinate children against dengue. But it was suspended after the shot, Dengvaxia, was linked to an increased risk of severe disease in some who hadn’t previously been exposed to the mosquito-borne virus.

Swine Flu

After a 1976 outbreak of swine flu in the U.S. stoked fears of a global crisis, then-President Gerald Ford announced a plan to vaccinate everyone in the country. Soon more than 40 million Americans had received shots. But it never turned into a pandemic, and some of those who had been vaccinated developed Guillain-Barre syndrome, which can cause temporary paralysis.

Any missteps with a COVID-19 inoculation developed too quickly could impact trust in a safer product that comes later, according to Heidi Larson, director of the Vaccine Confidence Project and a professor at the London School of Hygiene & Tropical Medicine.

“We have one chance to make a first impression,” she said. “If Russia’s shortcuts in the rush for a vaccine lead to an unnecessary adverse event, it may erode already fragile confidence.”

———

©2020 Bloomberg News

Distributed by Tribune Content Agency, LLC.

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