iStock/ipopbaBY: LUCIEN BRUGGEMAN
(MOSCOW) — In the global race for a coronavirus vaccine, Russia declared it just claimed the gold medal. But some Western scientists worry it’s far too early to know if they’re seeing only fool’s gold.
President Vladimir Putin declared Tuesday that Russia had registered the world’s first vaccine, with plans in place for mass injections by October, despite reportedly scant testing.
The announcement was swiftly and roundly dismissed in the West, where experts decried the rollout as reckless and accused Moscow of prioritizing political expediency over responsible science.
In his effort to return Russia to the glory days of Soviet science, experts warned that Putin’s hasty announcement could, should the gamble fail, carry devastating implications not only within Russian borders but for wider global health.
Here are four key takeaways:
Limited testing, skirting international safety standards
Fewer than 100 people have reportedly been injected with Russia’s vaccine candidate – mostly soldiers and, according to Putin, one of his daughters – a figure far below internationally recognized standards for determining whether a vaccine is safe and effective.
As such, critics immediately took issue with Putin’s assurance Tuesday that their Moscow’s vaccine has “passed all necessary testing.”
“I think in the United States we would demand a much bigger trial to be confident that the vaccine was safe in the sense that it didn’t have an uncommon side effect and at least effective to some extent in the short term,” Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said Tuesday on “Good Morning America.”
Multiple vaccine candidates being developed in the U.S. and the United Kingdom, for example, are already in a Phase 3 trial with plans to test at least 30,000 volunteers – and include the use of placebos to help determine if the vaccines truly perform well. Several of these vaccines have already been tested in dozens, or even hundreds, of volunteers in prior Phase 1 and 2 studies.
Dr. John Brownstein, an epidemiologist with Harvard and the Boston Children’s Hospital and an ABC News contributor, said Americans should feel relief that a vaccine with as little vetting as Russia’s would never pass muster in the U.S.
“We rely on a rigorous framework for testing the safety of vaccines in this country,” Brownstein said. “Rushing the process as was done in Russia would not fly given our essential approval process. We need large Phase 3 efficacy trials to examine true efficacy and uncover rare but potentially harmful side effects.”
Cold War throwback to Soviet ‘glory days’
If anyone doubted that Russia’s vaccine push involved some geopolitical motives, look no further than its name. Dubbed “Sputnik V,” the vaccine’s namesake is an explicit reference to the Soviet Union’s Space Race triumph — Sputnik being the name of the first satellite launched into orbit in 1957, more than a decade before the U.S. put a man on the moon.
Moscow’s rapid rollout and invocation of the famous satellite make clear that national pride is at the core of its controversial breakthrough – “a throwback to the glory days of the Soviet Union,” according to Dr. Ali Nouri, president of the Federation of American Scientists. While the vaccine may be about health, the high-profile and speedy rollout has other aims.
“Today, for Russia, this vaccine candidate has become the new Space Race, so to speak,” Nouri said.
Nouri said Putin’s vaccine announcement “puts politics ahead of science and medicine” as part of an effort to return Russia to its status as a world superpower.
“It’s clear that whichever country produces the first workable vaccine is going to help them with respect to soft power on the global stage,” Nouri said.
He pointed to efforts by the United States to develop and distribute the smallpox vaccine in the 1950s and, more recently, the Ebola outbreak, as examples of how leadership in curing disease can prove beneficial in global standing, in addition to the tangible benefits of curing the disease.
“Contributing aid in crises around the world helps our image and helps our soft power, and it’s good for America,” Nouri said. “The intent of Russia in this case is the same.”
Will Russia’s move ‘goad’ U.S. into speeding up vaccine rollout?
At least one expert, former U.S. Food and Drug Administrator Dr. Scott Gottlieb, is questioning Russia’s broader motives.
“Russia was reported to be behind disinformation campaigns to sow doubts in U.S. about our COVID vaccines; and today’s news that they ‘approved’ a vaccine on the equivalent of Phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines,” Gottlieb tweeted Tuesday morning.
Experts have long been wary of President Donald Trump’s inclination toward politicizing science, and several said they are watching closely for his reaction to the Russian announcement.
Some said they fear the rigor in the American search for a vaccine could be marred by political pressure from the top, although U.S. scientists working on the various vaccines say they feel confident in the process.
Responding to Putin’s announcement, U.S. Secretary of Health and Human Service Alex Azar dismissed any competitive sentiment and reiterated the federal government’s commitment not to roll out an untested product.
“The point is not to be first with the vaccine,” Azar said Tuesday on “Good Morning America.” “The point is to have a vaccine that is safe and effective for the American people and the people of the world.”
Brownstein did not suspect that Putin’s announcement will alter the vaccine process in the U.S. But he said he anticipates that American officials will be closely observing what happens in Russia.
“We can always learn something from how other countries are deploying the vaccine and identify any pitfalls,” Brownstein said.
A potential blow to vaccine confidence
Perhaps the most pervasive concern among American researchers about Putin’s vaccine rollout is what will happen if the Russian product fails. Aside from the potential for scores of Russians to become ill, a faulty product could rattle the American public’s confidence in vaccine safety, which is already in a troublingly fragile state, several experts said.
“If Russia puts out a vaccine that generates some level of adverse events or complications, that risks undermining public confidence in vaccines here in the United States,” Brownstein said. “That would be a massive disaster.”
Recent polling indicates that a troubling amount of Americans are already skeptical of vaccines. In June, an ABC News/Washington Post poll released found that 27% of adults are unlikely to get a prospective coronavirus vaccine if one is developed. Last year, the World Health Organization cited “vaccine hesitancy” as one of its top 10 threats to global health.
Some experts fear even a minor snag in Russia could be detrimental for efforts to tame the virus.
“Stories of an unsafe or ineffective vaccine in one place in the world can impact individuals in another place in the world,” Nouri said. “So if things don’t go well, this is not something that necessarily is going to be confined to Russia.”
“We can’t cut corners here,” Brownstein concluded. “It’s not right for public health, but it will also undermine our ability to control this pandemic.”
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