RUSSIAN President Vladimir Putin announced on Tuesday that the world's first COVID-19 vaccine had been registered in his country. The breaking news was published by all the world media.
Putin admitted that the vaccine had not yet passed all clinical trials, but still claimed it was safe and "effective enough". In order to convince Russians, and the rest of the world, in the effectiveness of the vaccine, he announced that his daughter was among the first to be vaccinated.
"One of my daughters has already received the vaccine. Following the vaccination, she had a slight fever, but her temperature was back to 37°C on the second day," Putin stated.
According to the announcements from the Russian government, the vaccine will be available to health workers starting September and other citizens starting January.
A Cold War-like race
The vaccine was named "Sputnik V" to remind the world that Russia was the first to launch the Sputnik satellite into space during the Cold War in 1957. At the same time, this name clearly shows that the placement of the vaccine on the market is a matter of prestige and politics for Russia and Putin.
It is interesting that, despite concerns about its safety and effectiveness, about 20 countries expressed interest in the vaccine, as well as some American companies.
More than a hundred teams and companies are currently working on the development of the COVID-19 vaccine worldwide. The development is mainly based on three methods.
mRNA-based vaccines
One of the newer methods used in the last couple of decades, and also in the current fight against COVID-19, are the mRNA-based vaccines.
In vaccine development, an mRNA that enables the virus to produce a characteristic protein by which the organism can recognize and block the virus is selected. An example of that is the Spike protein by which the SARS-CoV-2 virus binds to receptors on human cells, and enters their membranes.
Recombinant vaccines
The virus protein can also be produced in a non-dangerous microorganism, such as yeast cells. The protein is then purified in large quantities, and a vaccine is formed using an enhancer that enhances the immune response, such as aluminum compounds. This type of vaccine is called a recombinant vaccine.
A vaccine based on a harmless virus - the method that Russians used
The third method includes inserting part of the code to make the Spike protein into a live but safe virus, such as adenovirus, which commonly causes colds. Such a living but harmless virus can elicit a strong immune response.
The Russian vaccine is based on this third method - genetic code has been inserted into adenovirus to create the Spike protein.
Three phases of clinical trials
The biggest problem in that the Russian vaccine is that it has not gone through all the stages of clinical research. The vaccine was developed by the Gamaleya Institute in Moscow and received approval after less than two months of human trials.
One of the important reasons why vaccines cannot be developed faster is because they cannot be tested on sick people, which means they must be absolutely safe. Currently, a dozen manufacturers worldwide are conducting third phase trials with tens of thousands of volunteers.
The first phase of the research mostly tests the safety of the vaccine, but it also records the immune system's reaction. It is very important to monitor whether there is desirable immunogenicity and whether there are side effects or toxicity.
In the second phase, the vaccine's effectiveness is tested on a larger and more diverse sample of people of different age groups, genders, etc.
In the third phase, the vaccine's immunogenicity and side effects are tested on a much larger population. Experts who develop a vaccine must show that it is effective and safe against natural disease at this stage.
Each of these phases of research can last from three to six or even more months. If the vaccine successfully passes three phases of clinical trials, regulatory agencies may approve it for use.
After the vaccine is put into use, the fourth phase of clinical trials is usually carried out by constantly collecting information on the use of the vaccine, side effects, and duration of protection.
However, the Russian Ministry of Health issued the approval before the third phase of clinical trials.
Dr. sc. Stribor Markovic
What are the problems with the Russian vaccine?
Stribor Markovic, Ph.D., a master of pharmacy who was the director of quality control in the production of vaccines and blood products, says that there are some negatives and some positives regarding the Russian vaccine.
"Adenovirus-based vaccines have a certain weakness that was shown in an HIV vaccine study," Markovic says.
"The HIV vaccine was also based on the adenovirus. However, the immune systems of many people who got the vaccine reacted to the structure of the adenovirus itself, rather than to the addition of an HIV code. Thus, the effectiveness of the vaccine was significantly reduced, and this approach was abandoned. We can't know if this will happen with this vaccine without conducting large-scale studies, or without an extensive third phase of clinical research," explains our expert.
Markovic says that one of the critical problems in Russia's approval of the vaccine is that it has been approved for the entire population.
"Since the vaccine has not passed all the necessary tests, there is not enough data to show how well the vaccine protects at-risk groups," Markovic said.
Markovic therefore considers this step to be motivated by politics:
"It is clear here that this step was motivated by politics and national vanity. I think the West has a smarter approach, conducting the third phase of clinical trials before the vaccine is approved in order to confirm effectiveness on a large sample of people."
Potential positive sides of the Russian vaccine
It is also possible that more vaccines will prove to be effective – not only the Russian vaccine but also mRNA-based vaccines and recombinant vaccines.
Markovic says that the studies and subsequent monitoring of the vaccine will show how safe a vaccine is and how strong and long-lasting the immunity it gives is.
"It is not possible to know whether the Russian vaccine will be safe, but it probably won't have severe side effects since experience shows that adenovirus-based vaccines generally do not have them. Finally, the price of the vaccine is also important. The vaccine should be affordable enough for people in poorer African, Asian, and Latin American countries," Markovic said.
Our expert believes that regulatory agencies in the West are very unlikely to approve the Russian vaccine as it has not gone through all the rigorous phases of clinical trials.
"Even if the vaccine proves to be epidemiologically good in practice, many questions would remain. In the West, manufacturers have very high standards. Every detail is monitored - how the vaccine is produced, what preservatives are used, how many doses are used, etc.," reminds our expert.
Markovic says Russia's success could have interesting sociological consequences.
"There are a lot of people who have a certain antagonism towards the West and at the same time certain sympathies towards Russia. I wouldn't be surprised if some of them, who have been critical of vaccines so far, change their minds because the first vaccine comes from Russia," says Markovic.
European and US regulators will not approve the vaccine
Markovic says Russia's acceleration of the vaccine development was clearly a political decision.
"This does not mean that this vaccine is bad. It may be the best in the world, but without thorough clinical trials, it will be difficult to place it on the West market," he says.
The expert from the large pharmaceutical company we contacted agrees with him.
"It is a very interesting but also an awkward situation from the perspective of vaccine development. The biggest problem is the non-transparency of clinical trials. It is theoretically possible to conduct the second and third phases of clinical trials simultaneously. But the problem is that in this case, there is no transparent documentation to show that trials have been conducted," said the scientist, who wished to remain anonymous.
"I don't see how the Russians could get permission to register their vaccine in the EU," the scientist said.