Russia registers the "first vaccine" against covid-19 3:17
(CNN Spanish) - Vladimir Putin announced this Tuesday on Russian state television that his country registered what could be the world's first coronavirus vaccine, amid questions about the process they followed to develop it.
The Pan American Health Organization (PAHO) ruled this Tuesday on the vaccine saying there is still not enough information.
"At this point, we do not have all the relevant information about the Russian vaccine, it is impossible to make an evaluation at this time," said Jarbas Barbosa, deputy director of PAHO.
"WHO is in contact with the Russian regulatory authorities to review all the data, and only after that assessment will it be possible to see if the vaccine meets all the criteria," he added.
Here's what we know, and don't know, about the Russian coronavirus vaccine:
"Sputnik V"
The Russian government has referred to the development of the vaccine as "a Sputnik moment", referring to the Soviet Union's 1957 launch of the world's first satellite, hence its name "Sputnik V". It was developed by the Moscow-based Gamaleya Institute. Although it is the first against the coronavirus registered in the world - the registration is made before the Ministry of Health of Russia - the country has not made public data on its tests and processes. CNN cannot verify its claimed safety or efficacy.
Vaccines are developed in 3 phases, according to the US Centers for Disease Control (CDC): in the first, a small group receives the vaccine, in the second, that group is expanded including participants who have the characteristics of the people for whom the vaccine is designed, and in the third the vaccine is given to thousands of people to test its efficacy and if it is safe.
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Russia said it would carry out that last phase after state registration. As explained on the official website of the vaccine, before the clinical trials they did tests on "different types of animals, including two types of primates."
Phase 1 and 2 were completed on August 1, 2020, the website explains. “All the volunteers feel fine, no unintended or unwanted side effects were observed. The vaccine induced a strong antibody response and a cellular immune response. Not a single participant in the clinical trials was infected with COVID-19 after receiving the vaccine, "they add.
Based on this information, the efficacy of the vaccine was confirmed by antibody tests.
For Dr. Elmer Huerta, specialist in Public Health and contributor to CNN en Español, the point that generates mistrust is that Russia has claimed that it has already registered the vaccine for commercial use but evidence is still lacking.
“They are calling this the first vaccine without that phase (Phase 3). They have said: we are going to study in Mexico, Brazil… how is it possible that they license something for mass use and at the same time say that they are going to study. It is rare, in short, and that is why for me there is no confidence that the vaccine is safe or effective, "explains Huerta.
The doctor compares the Russian vaccine process to that of Pfizer, Moderna and Oxford, the vaccines leading the way at the moment. These vaccines, says Huerta, "have phase 1 published, phase 2 in publication, and we know they are beginning phase 3 and we will have that at the end of the year."
Vaccines against influenza or hepatitis could help against covid-19 0:32How does the Russian vaccine work?
According to the official website, it is a vaccine of two vectors of an adenovirus, which are those that cause common colds in humans. These adenoviruses are modified so that they do not have the gene responsible for reproduction. The Russian vaccine is two doses, the second is given within 21 days of the first.
'The adenovirus gene, which causes the infection, is removed while inserting a gene encoding a protein from another virus peak. This inserted element is safe for the body, but it still helps the immune system to react and produce antibodies, which protect us from infection, ”they explain on their website.
The Gamaleya center says that using adenoviruses it has managed to develop three registered vaccines approved by the Russian Ministry of Health and that it has an international patent for one of those vaccines. According to a 2018 WHO document, a Gamaleya center Ebola vaccine completed phase 4 with no adverse results.
MIRA: Russia says it registered its vaccine against covid-19 while its safety is doubted
What would be the risks of the Russian vaccine?
(Andrey Rudakov / Bloomberg via Getty Images)
Phase 3 of the vaccine is crucial because it shows in large numbers of people that it has a positive and safe effect. For Dr. Huerta, “the danger is that it has unimaginable adverse side effects. For example, severe immune disorders.
Dr. Huerta cites the 1976 case, when a swine flu vaccine was approved that caused 45 million 450 people to develop Guillain-Barré syndrome, a rare neurological disorder in which the immune system attacks the body's nervous system by mistake.
Putin said in a teleconference on Tuesday that the vaccine had undergone the necessary controls, and went further by stating that one of his daughters had received the vaccine. He said he had a slightly higher temperature, but then he felt better.
«For me, this has three spheres: the medical-scientific, where it is a mystery, nothing is known about safety or effectiveness. Then politics: they politicized it by putting Sputnik on it. And finally that of public relations: Putin never talks about his children, why now? ", Says Huerta.
Critics agree with Dr. Huerta that the news of the vaccine comes at a time when Russia wants to show itself as a global scientific force.
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As CNN learned in late July, Russia claimed that at least 20 nations and some US companies had expressed interest in the Russian vaccine, including Brazil and Mexico.
According to the official website, Phase 3 clinical trials will be conducted in several countries, including Saudi Arabia, India, the Philippines and Brazil. In addition, they affirm that mass production of the vaccine will also begin in countries in which they have partnerships with local funds, including South Korea, India, Cuba, Brazil, among others.
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We asked the experts: would they get the Russian vaccine?
"I would not wear it," replies Dr. Huerta, "there is no data, no information." Dr. Sanjay Gupta, CNN's chief medical correspondent, says "of course not" he would get the vaccine. "I don't know anything about this vaccine," he adds.
Former US FDA Commissioner Dr. Scott Gottlieb said "I would not wear it, certainly not outside of a clinical trial."
The race for the vaccine
There are at least 25 coronavirus vaccines in clinical trials and about 139 candidates in preclinical phases, says the WHO.
Due to the urgency of achieving a vaccine to stop the pandemic that already exceeds 20 million cases of coronavirus globally, some companies have accelerated the development process of vaccines, doing phase 1 and 2 in parallel.
Putin says his daughter received the "Sputnik V" vaccine 2:44"What Moderna and Oxford are doing is an economic risk, not a health risk," explains Dr. Huerta about the difference between these companies and the Russian vaccine, which will continue to do Phase 3 studies while the vaccine is already registered. The companies at the forefront of the vaccine race have started churning out doses as testing continues. If the clinical trials do not yield favorable results, and the vaccine cannot be approved, the loss will be for the companies.
coronavirus Russia Vaccine