Health agency officials outside of Russia are skeptical of Russian President Vladimir Putin’s announcement that scientists have successfully created a vaccine that provides immunity to the coronavirus, including National Institute of Allergy and Infectious Diseases Director Anthony Fauci, who has expressed doubts about the country’s testing methods.
Putin made the announcement that the country registered a vaccine Tuesday morning on August 11, saying, “We should be grateful to those who have taken this first step, which is very important for our country and the whole world,” the Wall Street Journal reported. The vaccine is named “Sputnik V,” after the satellite Russia launched to beat the U.S. in the space race.
Russia, according to the Johns Hopkins University dashboard, has the fourth-most cases (895,691), but it has reported a fairly low number of deaths (15,103) compared to other countries with high case rates.
Russia’s Vaccine Was Allegedly Granted Approval After Less Than Two Months Of Human Testing
Russia developed the vaccine at Russia’s Gamaleya Institute for Epidemiology and Microbiology using adenoviruses, according to the Washington Post.
Adenoviruses are common viruses that cause cold and flu-like symptoms and tend to more severely affect those with weak immune systems as well as preexisting respiratory and cardiac diseases, according to the Centers for Disease Control and Prevention (CDC). In vaccine development, they are being used to trigger an infection reaction, which will cause the body to create coronavirus spike proteins which can then “train our bodies to detect and terminate any real SARS-CoV-2 infections before the virus wreaks havoc,” Chemical and Engineering News reported.
This is a similar approach that many other countries’ vaccine developers have taken, including U.S.-based researchers. However, many of those drugs are still waiting to finish going through all three CDC recommended testing phases before registering their vaccines for wide use.
Reuters reported that Russia developed the vaccine after less than two months of testing on humans.
Amid questions of whether the vaccine was developed according to proper protocols, National Institute of Allergy and Infectious Diseases Director Anthony Fauci expressed concern. “I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” he said.
Aljazeera reported that an assistant director at the World Health Organization, Jarbas Barbosa, has said their officials had “not received enough information on the Russian COVID-19 vaccine to evaluate it.”
Health Agency Leaders Are Questioning Whether Russia Cut Corners To Develop ‘Sputnik V’
The controversy is over whether the alleged vaccine went through “phase 3” trials, which the CDC defines as the point when “the vaccine is given to thousands of people and tested for efficacy and safety.” In a more detailed explanation, the Food and Drug Administration describes phase 3 as when “hundreds or thousands of volunteers participate. Vaccinated people are compared with people who have received a placebo or another vaccine so researchers can learn more about the test vaccine’s safety and effectiveness and identify common side effects.”
The New York Times has reported, “The Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct Phase 3 trials.”
Russian officials, including Kirill Dmitriev, who is the head of the Russian Direct Investment Fund that has been financing Russia’s vaccination development efforts, dismissed all concerns. However, he essentially admitted phase 3 testing had not been conducted, saying, “We will have tens of thousands of people already vaccinated like this in August,” according to the Washington Post. Dmitriev also said that the country planned phase 3 trials in Russia as well as Saudi Arabia, the United Arab Emirates and potentially Brazil (the leader of the country’s state of Paraná has said it wants to begin producing the vaccine in November) and the Philippines.
And in a show of confidence, Putin alleged that one of his daughters had already been given a dose of the vaccine, the Journal reported.
However, several health officials have said that there is great danger of unknown long-term side effects, whether its rates of effectiveness are accurate and other factors which cannot be assessed without the phase 3 trial being conducted.
The director of Georgetown University’s O’Neill Institute for National and Global Health Law, Lawrence Gostin, told the Wall Street Journal that Putin’s announcement was “reckless.”
It’s really reckless, and sets a deeply disturbing precedent that it’s all right to cut corners, it’s all right to ignore ethics, it’s all right to ignore international legal standards in a search for a vaccine. That could be disastrous.
“Using it in (the) general population before the results of Phase 3 trials are fully studied is a gamble,” said Konstantin Chumakov of the Global Virus Network, according to the Washington Post.
Dmitriev has said that the country had received applications from 20 countries for more than 1 billion doses of the vaccine, the Post reported.
Russia’s Pursuit To Be The First Country To Mass-Produce A Vaccine Has Been Mired In Controversy
According to the New York Times, although the Ministry of Defense reported that they tested the vaccine on soldiers who volunteered (just 50, according to the Washington Post), others have been skeptical of the claim that the testing was done voluntarily. Yet others have noted that testing healthy, able-bodied soldiers would produce skewed results in terms of the vaccine’s potential side effects on elderly people and interactions with other medicines needed for chronic conditions (such as insulin, for example).
In addition, American, British and Canadian governments have alleged that Russian agents were attempting to hack into their health agencies and steal their data on vaccine development, the Times reported. According to The Hill, National Security Agency Cybersecurity Director Anne Neuberger released a statement about the activities of the hacking group called APT29 or “Cozy Bear” with alleged ties to Russia:
The National Security Agency (NSA), along with our partners, remains steadfast in its commitment to protecting national security by collectively issuing this critical cybersecurity advisory as foreign actors continue to take advantage of the ongoing COVID-19 pandemic.
APT29 has a long history of targeting governmental, diplomatic, think-tank, healthcare and energy organizations for intelligence gain so we encourage everyone to take this threat seriously and apply the mitigations issued in the advisory.
Financial analysts such as Neuberger Berman’s Kaan Nazli have said that they believe Russia’s rush to be first was not only politically motivated but also financially important; the Wall Street Journal reported that after the announcement, the value of the ruble rose along with liquid stocks on Moscow’s Exchange.
In regards of the vaccine, its development and its potential effectiveness, Dmitriev has accused other countries’ criticisms as being purely political: “For countries, it’s difficult to acknowledge that, ‘How is it possible that Russia, which has been always shown as this backward, authoritarian country, can do this?’” Dmitriev reportedly said a week ago.
And after acknowledging that the process may warrant some criticism and stating that the country would eventually publish all of its findings, Dmitriev said he believes other counries are treating the announcement as a political development: “We feel that some politicians who are negative toward Russia are attacking Russia regardless of what Russia is doing,” he said.