The statement of the President of Russia Vladimir Putin that his country has developed the “first” vaccine against the new coronavirus SARS CoV-2, which causes the disease covid-19, has sparked criticism and a skeptical evaluation. Why such a reaction? What are the arguments of scientists skeptical towards the Russian vaccine? Why, in their opinion, the vaccine could become a Pandora’s box, not a lifeline?
As reported by AFP, the vaccine, dubbed “Sputnik IV” was developed by the National research centre of epidemiology and Microbiology named Gamalei, Russian Ministry of health, and the letter “V” denotes the first letter of the word “vaccine” in several languages.
First of all, any new drug or vaccine must undergo clinical trials, which are experiments carried out to collect data regarding the safety and efficacy of these drugs. Must go through many stages and procedures to gain permission to release a drug on the market.
The phases of clinical trials in humans
First stage:
Lasts for several months involving a small number of healthy volunteers (20 to 100 people).
Tests are conducted to determine the effects of drugs or vaccines on the human body: how it is absorbed, distributed and excreted from the body. At this stage also examines the side effects that occur if you exceed the dosage of the drug.
Second stage:
Can last from several months to two years. In the process studied the effectiveness of the drug with up to several hundred patients.
The third stage:
Includes randomized trials involving from several hundred to several thousand patients, that is, involves more extensive testing. After the completion of the third stage pharmaceutical company can request permission of a relevant Agency for the sale of the drug.
Fourth stage:
Once the drug is approved, it is compared with other medicines already on the market, and also study its long-term efficacy and impact on quality of life of the patient.
Studies in the fourth stage can end with the withdrawal of the drug from the market or restrict its use.
What stage clinical trials reached a Russian vaccine?
Russian vaccine based on adenoviral vectors. Vectors are the carriers that carry the genetic material of another virus in the cell. The genetic material of adenoviruses that cause infection, deleted and inserted material with the code for a protein from another virus.
A method using adenovirus also uses the University of Oxford.
On the website new Russian vaccine, States that before commencing clinical trials of the vaccine have completed all the preclinical stage, evaluating the efficacy and safety of the drug, including tests on different species of laboratory animals, including two species of primates.
According to the website, the first and second stages of clinical trials was completed on 1 August. All volunteers have passed the tests, and there was no unexpected, dangerous, or undesirable effects. On the contrary, the Russian, the vaccine stimulates the production of a large number of antibodies and demonstrated the effectiveness, in terms of cellular immunity. None of the participants current clinical trials became infected with the coronavirus after vaccination. The efficiency of the Russian vaccine also confirmed by high-precision tests.
Russian vaccine registered in the database of the who as passing the first test phase, however, the national welfare Fund, which is involved in its development, confirmed that the third phase of clinical trials started last Wednesday.
According to Russian Ministry of health, developed the vaccine allows you to create long-lasting immunity with immune response for two years.
Criticism of the Russian vaccine
1. From the start of the trials national research centre of epidemiology and Microbiology named Gamalei was accused of violating standard protocols to ensure maximum acceleration of the process of receiving vaccines.
2. The vaccine has been criticized for the lack of passing to the third phase of clinical trials.
3. While Russia has not published a detailed report with the results of their tests, which would allow to verify the reported data.
4. Permission to issue the drug on the market before will be presented the results of major clinical studies are contrary to accepted international practice in this area.
5. Francois Points out, University College London, commented on the decision to start to use the Russian vaccine: “It is irresponsible and reckless decision. Mass vaccination drug which has not passed the appropriate testing is unethical”. Specialist warned that any problems in the course of the campaign on vaccination of the population will have “catastrophic” consequences from the point of view of the impact of the drug on the health of vaccinated people and the popularity of the idea of vaccination in the General population.
According to Score, the Russian step lacks meaning, since any product that did not pass the test properly, can lead to catastrophic consequences.
6. French virologist Marie-Paule Kieny, a former Deputy Director General of the world health organization, told AFP: “the Russian statement is premature, since we do not know whether this will prevent the vaccine (or any other) disease covid-19 or what will be the duration of the immune response. I believe that in fact after a few weeks or months after the first dose it will be gone”.
7. Daniel Flore, Deputy head of the technical Committee on vaccines of the main Department of health of France, said that a too rapid tests can be a threat from the point of view of safety of the drug. According to the official, one of the highlights is the guarantee that the vaccine will not cause exacerbation of disease in vaccinated people.
According to him, this happened with the monkeys in the course of attempts to develop vaccines against MERS-CoV and SARS from the family of coronaviruses, which belongs to the current coronavirus.
The aggravation of the disease in humans was observed in 60-ies of the last century, when it was withdrawn from circulation some of the measles vaccine, and bronchiolitis for children.
For his part, Professor of immunology at Imperial College London Danny Altman said, “the collateral damage from the release of unsafe and ineffective vaccines insurmountable exacerbate our current problems”.
8. Dr. Anthony Fauci, Director of the National Institute of allergic and infectious diseases of the United States, has serious doubts about the safety and the efficiency of the Russian vaccine. According to him, he sees no evidence that would convince him that the vaccine is actually ready.
9. As stated yesterday, the Minister of health of Germany Jens span, Russian vaccine was not properly tested.
10. Jarbas Barbosa, assistant Director pan American health organization, said on Tuesday that who has not received enough information about the Russian vaccine to assess its effectiveness.
11. On Wednesday, the Ministry of health of Iran urged to be careful to the Russian vaccine, and the official representative of the Ministry Kianush Jahanpur tweeted: “Until the completion of all clinical trials use vaccines like the opening of Pandora’s box” (“box of evil” according to Greek mythology), and therefore potentially dangerous.”
12. The Minister of health Alex Azar has expressed doubts about the Russian vaccine, and said that data from the first clinical trials in Russia were not disclosed because they were not transparent.
