Russia has approved the world’s first Corona vaccine, according to Vladimir Putin. His own daughter has already been vaccinated, the president added. International experts, however, have serious doubts.
Russia is the first country in the world to have approved a vaccine against coronavirus for widespread use in the population. “The Russian vaccine against the coronavirus is effective and forms a consistent immunity,” Kremlin chief Vladimir Putin on F9news.
It is called “Sputnik V” and is said to commemorate the first satellite in space launched by the Soviet Union in 1957 off the United States.
The registration of the new active substance took place on Tuesday morning,4besnews reported. However, important tests are still pending, neither the efficacy nor the side effects of the vaccine can be assessed in a sound manner at present.
One of his two daughters had already been vaccinated, Putin said. She had a fever of 38 degrees after the first injection, but that quickly decreased again. “She feels good.”
The vaccine was developed by the state-run Gamaleja Institute of Epidemiology and Microbiology in Moscow. There are now more than 170 projects worldwide that are looking for Corona vaccines under high pressure.
Only a few people have received the Russian active ingredient as part of a study. Approval before the results of large clinical trials are available, contrary to the internationally standard approach. The World Health Organization (WHO) made it clear in advance: “Every vaccine must, of course, go through all the trials and tests before it is approved and delivered.” There are clear guidelines for the development of vaccines
Putin had already put pressure on Russia in the spring for Russia to develop its own vaccine as soon as possible. The head of the Russian investment fund also spoke weeks ago of an imminent “Sputnik moment”: “The Americans were surprised when they heard Sputnik’s beeping. It’s the same with this vaccine. Russia will have him first,” Kirill Dmitriev toldF9news. His fund, founded by the Kremlin, finances the production and development of the vaccine.
International experts warn
Internationally, experts warn against being too hasty. “Even in the current pandemic situation, it is imperative that all tests and evaluations are carried out with the same care as for other vaccines,” warned Klaus Cichutek, President of the Paul Ehrlich Institute in Langen, Hesse. A preparation should only be authorized “if the benefits shown clearly outweigh possible risks”. This has not yet been assessed with the vaccine in Russia.
The epidemiologist TimoUlrichs told 4besnewsthat it had not been done according to good scientific practice. It is a risk to release the vaccine now to the entire Russian population.
In the spring, Russia registered a clinical trial of the vaccine in an international database, then referred to as the “Gam-Covid-VacLyo”. It is a so-called vector vaccine. In this process, harmless viruses transport parts of the genetic material of pathogens into the body. Ideally, this then forms antibodies and sets other defense mechanisms in motion.
The Russian Ministry of Health spoke of an immunity of up to two years, which offers the remedy. Health authorities say medical staff, teachers and other at-risk groups should be the first to be vaccinated. Doctors could be ready later this month.
Putin stressed that vaccinations are voluntary. According to the authorities, mass production of the drug is scheduled to begin in September, and vaccinations are due to start in October.
The vaccine was developed by the Moscow Gamaleja Institute of Epidemiology and Microbiology. Its head Alexander Ginzburg said that the third test phase will continue even at the beginning of vaccinations. Initially, there will be enough cans to cover 10 to 15 of Russia’s 85 regions, the Interfax news agency quoted him as saying.
How Russia wants to test the active ingredient
The vaccine has so far been tested on 50 soldiers and civilians who volunteered, it said. But the much more decisive phase is the next stage, in which much larger groups of subjects are tested to see if an active ingredient actually protects against infection and what side effects occur. According to the Ministry of Health in Moscow, such a Phase III study with about 2,000 volunteers is to begin in parallel with the approval of the drug.
The approval is expected to be provisional. It can be withdrawn if the vaccine developed does not have the desired effect in the end.
Criticism from the Federal Ministry of Health
There has been criticism from the German government of the actions of the Russian authorities. In Europe, vaccine approval requires “sufficient knowledge from clinical trials to demonstrate efficacy and safety,” a spokeswoman for the Federal Ministry of Health told the newspapers of the German editorial network. The third and final clinical trial phase is “of particular importance”. Russia had approved the virus before this stage.
“A positive benefit-risk ratio of the vaccine must be demonstrated before it can be widely used,” the Department of Health spokeswoman said. In the EU, patient safety is a “top priority.”
The ministry is reportedly not currently in talks with Russian authorities on the vaccine. As a result, there is no information on licensing requirements in Russia, the conduct of such a procedure and the legal framework, the spokeswoman said.
The US is questioning the safety of the vaccine. ‘It’s not about being the first with a vaccine. It is important to have a vaccine that is safe and effective for the American people and the people of the world,” U.S. Health Minister Alex Azar said Tuesday on the sidelines of a trip to Taiwan.
“High-risk experiment in humans”
The President of the Medical Association, Klaus Reinhardt, has strongly criticized the approval of the Corona vaccine. “I consider the approval of a vaccine without the decisive third series of tests to be a high-risk experiment in humans,”
“A regular approval without the extensive data from a Phase III test with at least several thousand subjects should be considered with caution,”. During the regular tests, possible rare side effects could also be detected. Authorization is only common after the presentation of meaningful safety and efficacy data.
According to a World Health Organization (WHO) list released Monday, six vaccine candidates are currently being tested in a Phase III trial – Russian drugs are not included. But the World Health Organization (WHO) also pointed out that Russia has an “excellent tradition” in the production and use of vaccines. The WHO is in close contact with Russian health authorities, a spokeswoman said when asked. Discussions were under way on a possible “rigorous review” of all data collected on the active substance.
The Hamburg virologist Jonas Schmidt-Chanasit has expressed skepticism about the approval of the vaccine in Russia. “I am very, very reluctant to admit it. There is no published data on the vaccine so far – that is a very big difficulty,” Schmidt-Chanasit told the German Press Agency on Tuesday. So far, no scientist has been able to independently assess the vaccine.
It is absolutely essential to adhere to global standards for the study and testing of vaccines according to the guidelines of the World Health Organization (WHO), Schmidt-Chansit warned: “It is very important that you definitely use a safe vaccine and also know where there may be side effects,” said the virologist from the Bernhard Nocht Institute for Tropical Medicine in Hamburg.
If a vaccine turns out to be less effective, there is a risk of “opposite effects” – such as vaccination fatigue in the population. This was most recently the case, for example, with a vaccine against dengue fever in the Philippines. “People rightly had no confidence in the vaccine and felt like guinea pigs,” Schmidt-Chanasit said. As a result of the loss of confidence, vaccinations have decreased overall – for example, against polio or measles.
“The fact that a vaccine is fully protected is rather the exception”
“I don’t think this vaccine is better or worse than the other candidates,” Stephan Becker of the University of Marburg recently told the F9 News. The virologist therefore assumes that most of the vaccines now developed will have an effect – but it is unclear how strong it will be.
“The fact that a vaccine completely protects, i.e. prevents infection, is rather the exception.” It will be difficult to find a candidate who can avert a difficult course of Covid-19.
According to experts, only a well-effective vaccine can ultimately bring about a rapid significant turnaround in the corona pandemic without the need for strict lockdown rules. The number of globally known corona infections last rose from 15 million to more than 20 million in less than three weeks. That’s according to data from the University of Johns Hopkins in Baltimore on Monday.
In addition to the USA, Brazil and India, countries such as Russia, South Africa and Mexico are currently particularly affected.