For every press release breathlessly proclaiming breakthroughs in developing a vaccine for COVID-19, there have been words of caution from medical experts who maintain that such a vaccine will take many more months before it becomes available to the public.
But nothing compares to the world-beating claim issued by Russian President Vladimir Putin on Tuesday that the Gamaleya Institute in Moscow has a vaccine ready for injection. Putin proudly said that his own daughter has taken it and feels fine with “high antibodies.”
The Russian president’s personal testimony is certainly inspiring, but falls somewhat short of scientific standards for such things. Anecdotal evidence is not enough; proper clinical trials must be undertaken to demonstrate that a vaccine is safe and effective. Phase Three trials require tens of thousands of human subjects, something that cannot be done overnight.
Russian officials know this too, and have said that Phase 3 will begin this week in the UAE, Saudi Arabia, the Philippines and possibly Brazil. But, they say, voluntary vaccinations are ready to go.
Deputy Prime Minister Tatyana Golikova said the vaccination of doctors could start as early as this month, according to the state-owned TASS Russian News Agency. Mass vaccination could kick off in October, and the production of more than 500 million doses for an eager global market is already gearing up.
Russia’s own experts reacted negatively: “Fast-tracked approval will not make Russia the leader in the [vaccine] race, it will just expose consumers of the vaccine to unnecessary danger,” Russia’s Association of Clinical Trials Organizations said Monday, urging officials to wait for advanced trials to be completed.
The criticism centers not only on the premature use of the vaccine, dubbed “Sputnik V,” but on the opacity of the rollout. If Russia has been guilty of disinformation abroad, it is guilty of non-information on the vaccine. To date, no data from its first clinical trials have been made available for the scientific community to evaluate.
“It is not possible to know if the Russian vaccine has been shown to be effective without submission of scientific papers for analysis and then there may be problems on data quality,” Keith Neal, emeritus professor of the epidemiology of infectious diseases of the University of Nottingham, said in a statement.
Francois Balloux, a geneticist at University College London, went further: “This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population,” he said in a statement distributed by the U.K. Science Media Centre.
In order to accelerate the process, Russia had to controvert its own scientific standards by passing a law in April that eliminated the requirement for Phase 3 trials to be conducted before approval, CNN reported.
The official Russian response to criticism of its rogue behavior in the rush to Sputnik V has been disheartening if not surprising.
Russian Health Minister Mikhail Murashko said that allegations the vaccine was unsafe were groundless and motivated by competition, Interfax news agency reported.
Kirill Dmitriev, the chief executive of Russia’s sovereign wealth fund RDIF, which is backing the vaccine, said that Western — and specifically U.S. — criticism of the vaccine was biased.
“It (the announcement) really divided the world into those countries that think it’s great news … and some of the U.S. media and some U.S. people that engage in major information warfare on the Russian vaccine,” he told CNBC on Wednesday.
The name Sputnik V deliberately recalls the Cold War era race for space, in which the then-Soviet Union alarmed the U.S. with its successful Sputnik I in 1957, the first artificial Earth satellite.
But Sputnik V is not Sputnik I. Unlike Sputnik I, which created a virtual panic in the U.S. about the Soviets getting ahead technologically, and thereby militarily, the reaction in this case has been highly critical. While vaccine research proceeds with all due urgency, there is no clamor to “catch up with the Russians” as there was then.
Rather, the alarm has been of a different kind. Daniel Salmon, director of the Institute for Vaccine Studies at Johns Hopkins University, called the news “really scary. It’s really risky.” Dr. Scott Gottlieb, the former FDA commissioner, told CNBC that he would “certainly not” take the Russian vaccine outside of a clinical trial where patients are closely monitored.
If, in the end, Sputnik V does complete Phase 3 successfully, so much the better. The world will be grateful for a tool with which to defeat the pandemic at an early date. In the meantime, we will look to more responsible sources for a vaccine for COVID-19.