- In the Russian vaccine, vectors serve as a kind of "container " for pathogens to be delivered to cells.
- The vaccine has not had phase 3 testing, it will be done concurrently with the vaccinations.
- The Russian Association of clinical research organizations called on the Russian Ministry of Health to postpone the registration of the coronavirus vaccine.
This week, the news of Russia developing a vaccine against Coronavirus made world news. Currently, there over 20.7 million cases of the infected and over 749,000 deaths around the globe. According Russian President Vladimir Putin, “the vaccine forms a stable immune system,” and “passed all the necessary checks.”
To emphasize his confidence in the developed drug, he added that one of his daughters had already been vaccinated. In total, 38 people were vaccinated, including several high-ranking officials and the head of the Gamalei Research Institute, where the drug was developed, Alexander Ginzburg.
Already in August-September, it is planned to start vaccination with a new drug for Russian doctors. The drug, “Gam-Covid-Vac2,” is a so-called vector vaccine. Such vaccines are created on the basis of harmless, weakened viruses (vectors), in which a gene is embedded – a small section of the genome of the disease against which the body must develop immunity, in this case, the SARS-CoV-2 coronavirus gene.
It should be noted that one of his daughters is in charge of the pharma for the Russian government. So, how true his statement is remains to be seen.
In the Russian vaccine, vectors serve as a kind of “container ” for pathogens to be delivered to cells. Once there, the genetically modified viruses multiply inside the cells and trigger an immune response. In this way, vaccines against measles, chickenpox, mumps, and rubella were created.
The Russian vector vaccine “Gam-Covid-Vak2” is based on the DNA of an adenovirus, which has the SARS-CoV-2 gene embedded in it. Adenovirus is already a known vector, and its safety has been generally verified. However, the introduction of vector vaccines can always have side effects, since the immune system can also attack the “Transporter” that delivers the coronavirus to the cells.
How safe is the new vaccine? Reliable results of human studies of the vaccine have not been published. It is only known that 38 volunteers have taken part in testing the drug since June, and that no side effects have been officially reported. Usually, the approval procedure for a new drug requires that candidate vaccines are approved for registration only after successful completion of the third phase: clinical trials.
This is a crucial stage, during which the vaccine is tested on several thousand volunteers — this is the only way to detect possible side effects of the drug. The answer to the question of how the vaccine is carried against the background of any diseases and whether it is really effective, will be available only after the completion of the third phase.
As stated in the materials published on the GRLS website, the “Gam-KOVID-VAK” vaccine is registered according to the registration procedure for drugs intended for use in an emergency, and based on limited clinical data. Therefore, its use is allowed “only in medical organizations that have the right to carry out vaccination of the population.”
Earlier, the Russian Association of clinical research organizations (AOKI), a non-profit organization that unites about 20 pharmaceutical companies, called on the Russian Ministry of Health to postpone the registration of the coronavirus vaccine developed by the Gamalei Center until the end of the third phase of clinical trials. According to the Association, accelerated registration “will expose the end users of the vaccine, citizens of the Russian Federation, to unnecessary danger.”
Moreover, the vaccine has not had phase 3 testing, it will be done concurrently with the vaccinations. Russian medication in general has horrid side effects. Russia is not a leader in the pharmaceutical field. Actually, quite the opposite. If you would like to shorten your life span, then use Russian-made medical products.
Only this summer, life support equipment was exploding in hospitals, due to faulty make. Hence, in Russia anyone can pay a bribe and get a product through, the same as in China, which would be defective. Also, in this case, it is a grandstanding position of Vladimir Putin. Thus, it is unknown, how many will end up dead after that vaccine in a year or two from now.