On Tuesday, Russian President Vladimir Putin announced that his country had approved a vaccine for coronavirus, making it the first country in the world to do so.
“I know it has proven effective and forms a stable immunity,” Putin said, adding that his daughter had been inoculated. “We should be grateful to those who made this first step very important for our country and the entire world.”
The announcement was met with skepticism internationally, and not just because the rapid announcement of Russian faxes seems politically motivated. (It is called “Sputnik V, “a nod to the space race.) Rather, scientists are skeptical because this vaccine has only been tested on 76 volunteers, and there is not much published data on the vaccine. AP News, half of the volunteers were injected with a vaccine in liquid form and the other half received the vaccine via a soluble powder. These threads began on June 17 and were done earlier in August. The results have yet to be published.
Because most vaccine studies take years and involve tens of thousands of volunteers and lengthy studies, scientists have questioned the effectiveness and safety of the Russian coronavirus vaccine.
“The news announcement is undoubtedly politically motivated, and there is essentially not enough information provided to form a truly solid conclusion,” said Joel Ernst, Chief of the Department of Experimental Medicine at the University of California, San Francisco. (UCSF), to Salon.
The vaccine was created by the Gamaleya Research Institute of Epidemiology and Microbiology, and the scientific name of the vaccine is called Gam-COVID-Vac Lyo. According to the Russian registration certificate, 1.5 million doses of the vaccine can be produced each year. The vaccine is a combination of two adenoviruses constructed with a coronavirus gene. The vaccine is said to lose two years of immunity to the new coronavirus that causes COVID-19. According to Science journal, that estimate is based on faxes that Gamaleya has made using similar technology.
In recent months, the United States, Canadian and British governments have accused Russian hackers of trying steal fax research, an accusation that Russian officials have denied.
In contrast, in the United States, faxes must go through four phases of testing before they can be approved. [Read more about what each “phase” entails.] Phase 3 trials are the most important phase in drug development; that phase focuses on effectiveness, and includes tests on thousands of people.
However, the approved Russian vaccine did not reach this stage, a fact that affects many experts here in the United States. Russia has yet to publish its Phase 1 and 2 trial data.
“There is no way in the world that they would have data on the vaccine as effective in preventing COVID-19,” Ernst said. “It would be impossible for them to know that given the information provided so far.”
Dean Blumberg, head of pediatric infectious diseases and associate professor in the Department of Pediatrics at the University of California, Davis, told Salon that a lack of published data means a lack of public awareness of possible side effects. According to Science magazine, a press release from the Russian government on the vaccine simply stated that there were no serious effects.
Blumberg said jumping from Phase 2 to a broad release of the vaccine was risky.
“It’s a gamble, and so, rolling the dice and hoping it works, that it’s safe and that it’s effective,” Blumberg said. “They might win, but it’s also very risky.”
Blumberg said that by approving the vaccine and distributing it before completing Phase 3, it jeopardizes both the safety and effectiveness of the vaccine.
“There can be rare or unusual adverse effects after immunization that are only picked up with large-scale studies,” Blumberg said. “If there is something that occurs in one in every 500 immunizations or one in every thousand or that occurs in a specific subpopulation, such as older men with mild renal disease, then you will not pick that up in Phase 2 studies.”
One reason for testing a broad scale is to prevent immune responses in some of the population. As Blumberg explained, a nightmare scenario is that patients who are vaccinated with a shaken vaccine later develop coronavirus and have a much stricter case than if they were not vaccinated.
Some of these harsh immune responses may include the cytokine storm. In adults a cytokine storm occurs when the immune system overreacts and floods the body with the anonymous signaling molecules. During a cytokine storm, patients are at risk of dying from their own immune system. Cytokine storm has been documented in some severe COVID-19 cases.
In children, the most severe COVID-19 cases have been manifestations of pediatrics multisystem inflammatory syndrome (MIS-C) that appears to be an inflammatory response. Such a condition could be the end result of vaccinating children with a slightly tested coronavirus vaccine. With effect from 6 August of the Centers for Disease Control and Prevention (CDC) has received reports of 570 confirmed cases of MIS-C and 10 deaths.
“If you design a vaccine … you can design it to go in different ways in terms of the immune response,” Blumberg said. In some cases, Bluberg said, “it is possible that if you give the vaccine before someone is infected, they may have more of an inflammatory reaction. Then it may not prevent infection, however [would] cause more of an inflammatory response. “
This could, Blumberg explained, lead to worse clinical outcomes in adults and could increase the risk of MIS-C in children.
Ernst, who is also an immunologist at UCSF, said that distributing a vaccine that still has to go through the proper tests is the risk of backfiring and puts everyone at greater risk of becoming infected.
“If you tell a whole group of people that they’re vaccinated and that they do not otherwise care about themselves, and that the vaccine really does not lead to productive immunity, then you have a colossal mess on your hands because you ‘They’ ‘have abused people to think they were protected, and then they will get sick and they will transmit the infection to other people,’ said Ernst.
Ultimately, Ernst said, he fears that this “reckless” approach in Russia could increase fears in the United States and reduce the chances of people getting the vaccine. A recent survey found that only two-thirds of Americans would get a coronavirus vaccine.
“It could just increase the problem of vaccination here in the United States,” Ernst said. “If something goes wrong, or if there’s just a suspicion raised by the nature of things done in another country and some people extrapolate that, like the way things are done here, then there’s an extra reason for worries. “
According to the fax tracker at The New York Times, more than 165 vaccines have been developed worldwide; 31 faxes are in human studies. Leading Infectious Disease Specialist Dr. Anthony Fauci has been cautious about the vaccine of Russia. Hy sei that “claims of having a vaccine, ready to distribute before you do testing [is] problematic, at best. “
