Russia announced the registration of the first vaccine against COVID-19: the world reacted with distrust

Russian President Vladimir Putin said on Tuesday, August 11 that Russia has approved the world's first coronavirus vaccine, highlighting its belief in the controversial drug. Putin said that one of his daughters had already experienced it on herself, writes Telegraph.

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Moscow hailed the rapid development of the vaccine as a testament to medical prowess, but scientists expressed concerns about the lack of testing and transparency of the development.

Speaking at a government meeting on state television, Putin said the vaccine, developed by Moscow's Gamaleya Institute, is safe.

“I know that it works quite effectively, forms lasting immunity, and, I repeat, it has passed all the necessary tests,” he said.

Putin said that on the day of the first vaccination, his daughter had a temperature of 38 ° C, and the next day it dropped to 37 ° C.

“She is doing well and has a lot of antibodies,” he added, without specifying which of his two daughters took part in the trial.

Moscow's race to be the first to develop a vaccine against the coronavirus made headlines last month when the UK government accused Russian hackers of targeting British research in the area. The Kremlin denied the charges.

Russian health officials said the vaccine will be offered to doctors this month, and from October it will be distributed to the public on a voluntary basis.

Kirill Dmitriev, head of the Russian Direct Investment Fund, said the country has received pre-orders for more than a billion doses of vaccine from 20 countries.

The vaccine was named Sputnik V, which makes it comparable to the Cold War space race.

But scientists in Russia and abroad emphasized that the vaccine has not yet passed phase III clinical trials, which usually take months and involve thousands of people.

Such trials, which require a specific number of participants to come into contact with the virus, are generally considered important precursors to regulatory approval.

“This is a reckless and stupid decision. Mass vaccination with an incorrectly tested vaccine is unethical, said Professor Francois Balloux from the Institute of Genetics at University College London. “Any problem with the Russian vaccination campaign would be catastrophic, both because of its negative health impacts and because it would further undermine public acceptance of the vaccine.”

“It is unclear what exactly is happening with the Russian vaccine,” said Dr Michael Head, senior research fellow in global health at the University of Southampton. “It is vital that any vaccine rollout has the confidence of the wider public and that there is reliable information about the level of effectiveness and any possible side effects.” At the moment, there is no data on the vaccine created under Russian leadership for study by the global health community.”

The World Health Organization said any WHO endorsement for a Covid-19 vaccine candidate would require a thorough safety review.

The Russian Association of Multinational Pharmaceutical Companies also called for additional trials of the drug.

On the subject: The collapse of confidence: why Americans are afraid of the COVID-19 vaccine

More than 100 possible vaccines for Covid-19 are being developed around the world. According to the World Health Organization, at least four of these are in final phase III human trials.

Almost 900 cases of infection and more than 000 deaths from coronavirus are officially registered in Russia, which is less than in other hard-hit countries. Officials have dismissed suggestions that they are underreporting.

Philippine President Rodrigo Duterte welcomed Russia's development of a vaccine and said he was ready to personally participate in any trials.

“I will tell President Putin that I have great confidence in your research in the fight against Covid, and I believe that the vaccine you created is really good for humanity,” said Duterte, who has previously threatened to “shoot” lockdown breakers in his own country.

Pharmaceutical companies urged the Ministry of Health to postpone registration of vaccine against COVID-19

The state registration of the first vaccine developed in Russia against coronavirus infection COVID-19 must be postponed until the successful completion of the third phase of its clinical trials. This is stated in a letter addressed to the head of the Ministry of Health Mikhail Murashko by the Association of Clinical Research Organizations (ACOI), writes RBC.

The document, signed by the executive director of the AOKI Svetlana Zavidova, notes that participation in the tests developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamalei (NICEM) "Gam-Covid-Vak" was attended by less than a hundred people, when during the third phase of testing, drugs are usually tested on several thousand people. At the same time, it is in the third phase of trials - within the framework of large-scale clinical trials that correspond to the so-called gold standard (randomized double-blind placebo-controlled) - that information is collected not only about the effectiveness of the vaccine, but also about its safety for people with weakened immunity, with concomitant diseases etc.

“The developers directly declare that they want to vaccinate first of all, including retirees as belonging to the risk group for COVID-19. Although to date there is no data on the safety of this vaccine for the elderly, who often have a number of concomitant diseases and often - weakened immunity, ”the letter says.

The association, in which a number of large biopharmaceutical companies participate, including Bayer, AstraZeneca, Novartis, etc., also recalled that the vaccine must go through the state registration procedure as a final product that consumers will receive. Meanwhile, the mass production of the vaccine "Gam-Covid-Vak" has not yet been established and what the quality of the drug will be is unknown.

On the subject: In the United States created a vaccine against COVID-19 based on the avian plague virus

The drive to complete the development of a vaccine against COVID-19 as soon as possible is considered by AOKI to be a kind of relic of the so-called heroic paradigm characteristic of the days of the pioneers of vaccination, while modern medicine adheres to standards that reduce risks to humans.

“Many of the daring experiments of vaccine pioneers that would not be endorsed by any ethics committee today fit into the heroic paradigm. Judging by the sensational vaccine research on the staff of the Gamaleya Center before the official start of clinical trials, the developer continues to act within the heroic paradigm and considers himself entitled to deviate from the drug testing standards. Unfortunately, the role of heroes in this case is assigned to those who did not plan to play it at all - ordinary citizens of Russia belonging to the risk groups for COVID-19, ”the AOKI letter says.

The association also noted that forcing vaccine registration in order to overtake developers from other countries does not make sense, since several vaccines abroad are already undergoing the third stage of testing with the participation of tens of thousands of people.

“Accelerated registration will no longer make Russia a leader in this race, it will only expose the end users of the vaccine, the citizens of the country of the Russian Federation, to unnecessary danger,” the AOKI believes.

At the end of July, Deputy Prime Minister Tatyana Golikova said that of the more than twenty types of vaccine against COVID-19 currently being developed in Russia, two are the most promising, being developed at NICEM and SSC Vector.

The state registration of the vaccine from the Gamaleya Research Center for Electrochemistry, according to Golikova, is planned for August 2020. At the same time, after registration, another clinical study is planned, this time on a larger scale - on 1600 volunteers. The vaccine is expected to be commercialized in September.

Completion of clinical trials of the vaccine "Vector", said Golikova, is planned in September, at the same time its state registration should pass. The first batch of this vaccine is expected to be produced in October 2020.

On July 29, the head of the laboratory of vector systems based on viral genomes at the Vector Center, Ilnaz Imatdinov, said on the air of the Russia 24 TV channel that the formation of herd immunity due to the growing number of COVID-19 patients does not provide reliable protection, which requires large-scale vaccination.

The chief immunologist of St. Petersburg, director of the Pasteur Research Institute of Epidemiology and Microbiology Areg Totolyan warned that in the fall, COVID-19 may be more difficult, as the situation can be complicated by other seasonal diseases.

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