After Russian President Vladimir Putin announced that his country had developed "the first" vaccine against the emerging "SARS Cove 2" virus that causes Covid-19 disease, a storm of criticism and skepticism erupted in this Russian announcement, so why? What are the arguments of skeptical scientists about the Russian vaccine? And why do skeptics think that the vaccine may be the "Pandora" box of evils and not the lifeline?

The vaccine, called "Sputnik V", was developed by the Russian National Center for Epidemiology and Microbiology, and the letter "V" stands for the first letter of the word vaccine in several languages, according to Agence France-Presse.

First of all, any new drug or vaccine must undergo clinical trials, which are experiments that are conducted to collect data related to the safety and effectiveness of new drugs and devices, and include many steps and stages to obtain approval before the drug or device is put on the market.

Phases of human clinical trials:

The first stage

It can take several months to complete, and involves a small number of healthy volunteers (20 to 100).

The study is designed to determine the effects of a drug or device on humans, including how it is absorbed, metabolized and excreted. This phase also looks at the side effects that occur with increasing dose levels.

The second phase

The effectiveness of the drug is tested, and it can last from several months to two years, and involve up to several hundred patients.

third level

It involves randomized tests involving several hundred to several thousand patients, that is, it is extensive. Once the third stage is completed, the drug company can request approval of the relevant administration to market the drug.

The fourth stage

It is conducted after the drug has been approved, and aims to compare it with other drugs already on the market, to monitor its long-term effectiveness and its impact on the patient's quality of life.

Phase IV studies may lead to drug withdrawal from the market or restrictions on its use.

At what stage of clinical trials did the Russian vaccine reach?

The Russian vaccine is based on adenoviral vectors. "Vectors" are carriers that can deliver genetic material from another virus in a cell. The genetic material for the adenoviruses that causes the infection is removed, while a gene carrying a "code" for a protein is inserted from another virus.

The technique for using an adenovirus is also chosen by the University of Oxford.

The website for the new Russian vaccine says that, before the start of clinical tests, the vaccine completely passed all pre-clinical stages, in terms of efficacy and safety, and this included experiments on different types of laboratory animals, including two primates.

He adds that the first and second stages of clinical tests were concluded on August 1. And all volunteers passed the tests well, and no unexpected, dangerous or unwanted phenomena were recorded, and the latest vaccine had a strong response in terms of antibodies and also in terms of cellular immunity. No participant in the current clinical test has contracted the Coronavirus after receiving the vaccine. The high efficacy of the vaccine has also been confirmed with high-precision tests.

The Russian vaccine is listed in the first stage in the World Health Organization's database, however, the Russian sovereign wealth fund co-developing it confirms that the third phase of clinical trials will start today, Wednesday.

The Russian Ministry of Health confirms that its vaccine allows "the formation of long-term immunity", with the ability to continue the immune response for "two years".

What are the criticisms of the Russian vaccine?

1- Since the beginning of the research, the Gamalia Center has been accused of violating standard protocols with the aim of accelerating the scientific mechanism to the maximum.

2- The vaccine has been criticized for not completing its third phase of clinical trials.

3- So far, Russia has not published detailed studies of the results of its experiments that would allow verification of the results announced.

4- Allowing a drug to be administered before the results of large clinical studies are presented to it conflicts with the usual international procedure.

5- Francois Ballou of University College London said about the decision to start using the Russian vaccine, “It is an irresponsible and reckless decision. Mass vaccination using a vaccine that has not been well tested is unethical,” warning that any problem with the vaccination campaign It will have "catastrophic" implications in terms of the effect of the vaccine on the health of the vaccinated persons and the adherence to vaccination among the general population.

Palu added that the Russian advertisement "lacks awareness and meaning", because any product "has not been properly tested ... may have catastrophic results."

6- French virologist Marie-Paul Kenny, former deputy director-general of the World Health Organization, told AFP that "this announcement is premature because we do not know yet whether this vaccine (or any other vaccine) will prevent Covid-19" or "what He will have the duration of the immune response "considering that it is not actually" in a person for more than a few months or weeks "after the first doses.

7- Daniel Fleurier, Vice President of the Vaccine Technical Committee attached to the French High Authority for Health, said that conducting experiments very quickly "could pose a problem" in terms of safety, adding that "one of the main points will be evidence that the vaccine is unlikely to cause an exacerbation." Disease "in vaccinated persons, as opposed to its target.

He adds that this happened in monkeys "during attempts to develop vaccines against MERS-Cove and SARS," two other viruses from the coronavirus family to which the emerging corona virus belongs.

The phenomenon of exacerbation of the disease in humans was also observed in the sixties of the last century, with some measles vaccines that were withdrawn from circulation, and against bronchiolitis in children, which were abandoned.

For his part, Professor of Immunology at Imperial College London Danny Altman said, "The collateral damage of an unsafe and effective vaccine may exacerbate our current problems in an insurmountable way."

8- Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States, seriously doubted the safety and efficacy of the Russian vaccine, and added that he had not heard any evidence that would convince him that the vaccine was actually ready.

9- German Health Minister Jens Young said today, Wednesday, that the Russian vaccine has not been tested adequately.

10- Garbas Barbosa, Assistant Director of the Pan American Health Organization, said Tuesday that the World Health Organization has not received enough information about the Russian vaccine to evaluate it.

11- The Iranian Ministry of Health today, Wednesday, urged caution about the Russian vaccine, and the spokesperson, Kianush Jahanpur, wrote on Twitter, "Before all clinical trials are completed, the use of vaccines is like opening a Pandora's box" (the Evil Box according to Greek mythology) and thus potentially dangerous. " According to the German news agency quoted him.

12- US Secretary of Health Alex Azar on Wednesday expressed doubts about the Russian vaccine, and said that the data for the first trials in Russia had not been disclosed, considering that they were not transparent.