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Has Russia registered the world's first COVID vaccine?

 

Russia registered the world's first new coronavirus vaccine? 

Not only did the third phase trial fail, even the second phase was suspended. 

Putin announced that the first nCOVID vaccine was officially registered in Russia. He also said that one of his daughters had received the injection. Is the era of humanity conquering the new crown coming? Xiao Shier picked up the ins and outs behind it and found that the WHO didn't seem to say that.

Until the latest WHO report on August 10, it was still marked as "in clinical phase I."

 

Russia registered the world's first new crown vaccine, and it has been used on one of Putin's two daughters

On August 11, at a working meeting with government members, Russian President Putin suddenly threw out this explosive news. He said that this newly developed vaccine is "very effective, can form a stable immunity, and has passed all tests."

 

The Russian president immediately revealed that one of his daughters had been vaccinated, and even uncharacteristically, he shared with colleagues and media reporters the details of his daughter’s reaction after being vaccinated: her body temperature rose to 38 degrees after the first vaccination. 

The next day, it was still slightly higher than 37 degrees. After the second injection, the body temperature rose a little, and there were no other reactions after that, and now I "feel good".

 

Also Refer: Vaccine Development Encyclopedia


The number of details revealed in a short paragraph is almost equivalent to the sum of the daughters Putin has talked about in the previous thirty years, but when it comes to the new crown vaccine, even Putin’s daughter tried the medicine, but it failed to stop the Questions from all directions.

Completely different from the usual practice, although this vaccine named "Satellite V" has been successfully registered in the mouth of the president, it has not published any research papers on effectiveness and safety, and has not published clinical trial data.

 

After Putin proudly announced that "as far as I know, this is the world's first registered new crown vaccine", the global medical community is not only not optimistic about this "result", but is even reporting fierce criticism.

 

It may just be a coincidence, but Russia, which named the vaccine "satellite", this time I am afraid it really put a satellite.

 

Phase III of Coronavirus Vaccine Trial bypassed by Russia

Before August 11, the number of new coronavirus vaccines under development worldwide reached nearly 200 (according to different statistics, the total number ranges from 170 to 218), and according to the World Health Organization's August 10 report on the progress of global vaccine development.

There are 28 vaccines that are considered to have the possibility of success and have entered clinical trials. 


There are a total of 6 vaccines that have entered clinical trials (large-scale volunteer trials), namely: 

  1. Oxford University and Aspen Joint development by Likang Company
  2. China Kexing Company
  3. Wuhan Institute of Virology
  4. Joint Development of Beijing Institute of Virology and Sinopharm Group 
  5. Joint Development of American Moderna Company and American National Institute of Allergy and Infectious Diseases Development
  6. Joint development by German BioNTech, Fosun Pharma and Pfizer

 The list does not include the "satellites" that Russia has just registered.


Screenshots of the six vaccines that have entered phase III clinical trials / WHO vaccine development report.

 

Russian-made vaccine is still in Phase I clinical / Screenshot of WHO vaccine development report

 

The reason for this situation is very simple: because "satellite" has not yet entered the third phase of clinical trials. 

Unlike Putin's high-profile announcement at the meeting, the new vaccine "satellite" is far from "passing all tests" until the latest WHO notification on August 10, it was still marked as "in clinical phase I." 

The first phase clinical trial is mainly for safety evaluation, and the second phase clinical trial is the effectiveness evaluation. 

That is to say, this is a product that has not been tested on a large scale, and even the effectiveness has not been verified.

 

Does first registering drugs without Phase III trials also occur in Western countries?

Russian Health Minister Murashko said that the third phase of the trial will be arranged after registration is passed, and the number of volunteers participating in the trial will reach "thousands." 

He also pointed out that similar practices of first registering drugs without Phase III trials also occur in Western countries.

 

The medical profession does not agree with this approach. Prior to this, Landmeier, the representative of the World Health Organization, had already proposed to the Russian government that he hoped that Russia would "follow the vaccine production recommendations," especially the need to publish official clinical trial data first. 


Registration of Satellite vaccine by Russia

On August 10, the day before the registration of "Satellite", the Russian Association of Clinical Trial Organizations submitted the latest open letter to the Russian Ministry of Health, calling on the Ministry of Health to stop the practice of pre-approving vaccine registration.

"This is a pioneer in vaccination. The so-called heroic paradigm of the times is a relic, and the standard that modern medicine follows is to reduce human risks."

 

The Ministry of Health’s response was ambiguous. On the one hand, it emphasized that the association did not understand the results of the preliminary clinical trials and therefore had no reason to come to a conclusion. On the other hand, it also stated, “Of course, it will not violate the law. impossible."

 

Putin announced the registration of the new vaccine at the live conference / video screenshot


Less than 24 hours later, Putin was informed that the new vaccine had been successfully registered, and quickly announced the good news to the outside world. 

Minister of Health Murashko further explained that in the current clinical trials, all volunteers who received the new vaccine injection produced high titers of antibodies to the new coronavirus, and none of them had serious complications.

The vaccine has been prepared in large quantities. Preparations for production, and teachers, medical staff and the elderly have been listed as the target groups for vaccination. 

As for the Phase III clinical trial that has caused serious concern from the outside world, it will start on August 12, the day after the registration is completed. 

The Ministry of Health said that the third phase of the trial will not only be carried out in Russia, but also in the Philippines, Saudi Arabia and the UAE.

 

Do vaccines need to go through the second phase of the trial?

Generally speaking, vaccines need to go through the second phase of the trial to initially determine the effective dose, and then the design of the third phase can be started. 

With almost no effective data released to the outside world, the progress and efficiency of Russian vaccine research and development have become unclear. Solve the mystery.

 

Prior to this, the world’s fastest-growing vaccine came from Oxford University. A paper published in The Lancet on July 20 had recorded the results of its clinical trials on 1,077 volunteers. 

In addition, the German BioNTech company targeted The 29,481-person trial started in April this year. 

At the end of July, the Chinese company Coxing and Moderna of the United States successively started two phase III clinical trials that are expected to involve 8,870 and 30,000 people, respectively.

 

Who is participating in the COVID vaccines trial?

In fact, surrounding the vaccine and the "antidote" of the new crown, Russia is not the first time that the international medical community has caused vigilance.

 

In April this year, the Association of Clinical Trial Organizations mentioned in its open letter to the Moscow Health Bureau that according to the information they have, the Moscow Health Bureau is studying the use of hydroxychloroquine as a drug to prevent coronavirus, and Moscow City’s first-line medical staff are required to quantify.

Take the drug to verify whether it has a preventive effect against the new coronavirus. 

Although it seems ambitious, the content and implementation of this plan have undergone several changes in a few weeks, and it was not even registered as a "clinical trial" at the time of application.

 

Brazil used chloroquine (similar to hydroxychloroquine in action and mechanism)

At that time, Brazil's trial of using chloroquine (similar to hydroxychloroquine in action and mechanism) to treat the new crown had resulted in 11 deaths, and the clinical safety of hydroxychloroquine and chloroquine aroused global vigilance. 

Association of Clinical Trial Organizations


However, in Russia, in addition to the fact that the dose of the drug clearly exceeds the recommended range without an explanation, whether the medical staff required to take hydroxychloroquine is "voluntary" is still a controversial issue-the Association of Clinical Trial Organizations mentioned that the agency received direct complaints from front-line medical staff, saying that the medication was a helpless move after being forced.

 

Group photo of Gammali Center Director Kingston (left), Deputy Director Rogunov (middle) and Russian Minister of Health Murash (right) / Russian Ministry of Health
Group photo of Gammali Center Director Kingston (left), Deputy Director Rogunov (middle) and Russian Minister of Health Murash (right) / Russian Ministry of Health

 

Also, this is only the first open letter from the organization on the issue of new crown prevention. A month later, the alarm sounded again. 

This time the subjects of the experiment were the staff of the Gammali Center, the Russian-made vaccine research and development institution.

They injected themselves with a vaccine that is still in the initial stage of the trial. Similar to the Moscow Health Bureau, the Gammali Center also does not recognize this attempt as a "clinical trial."

 

The Association of Clinical Trial Organizations bluntly stated in its open letter that, in the agency’s view, the root cause of this series of problems is “the wrong message sent by the national leadership”, because Putin had instructed the cabinet at a government meeting in mid-April. 

To shorten the clinical research time of the new crown vaccine, thus "set an unattainable goal." “Nine pregnant women were gathered in the same room and they were unable to give birth after a month,” the agency wrote.

 

Has Russian development of Vaccines stopped?

Russia's development of vaccines has not stopped. In mid-June, the Russian Ministry of Health signed a license for clinical trials of the new crown vaccine, and the first batch of volunteers received the injection on June 18. 

Public information shows that there are 76 participants in the existing clinical trials, of which at least half are from the military. 

On July 20, TASS released the second batch of 20 military volunteers' rehabilitation and discharge video. The screen showed that all volunteers were young and middle-aged, and most of them were men.

 

A video of volunteers discharged from the hospital released by TASS, all volunteers in this group are young and middle-aged people / screenshots of the video
A video of volunteers discharged from the hospital released by TASS, all volunteers in this group are young and middle-aged people / screenshots of the video


The current "Rules for Clinical Trials" adopted by the Russian Ministry of Health clearly stipulates the "vulnerable groups" in clinical trials. Due to their disadvantaged position, these groups can only be allowed to participate when there are no other candidates to choose from. 

Trials, and additional protection must be given: The listed “vulnerable groups” include university students, hospital and laboratory staff, employees of pharmaceutical companies and developers, prisoners, and military personnel who have been accused of participating in the new vaccine trial process in the past few months The people in are precisely within this range.

 

Earlier, some Western media reported that Russia’s political and business elites have been given the opportunity to vaccinate the trial stage vaccine since April, and hundreds of people have received the injection. 

If Putin’s information about his daughter has received the new vaccine before registration Judging from the injection statement, the news seems to have been verified to a certain extent But shortly after the report was released, it was refuted by the Russian Ministry of Health, which emphasized that for the new vaccine, only officially registered volunteers can participate in the trial.

 

Race against time for COVID19 Vaccine Development

From a horizontal perspective, the Russian Ministry of Health is not even the one who is most anxious to launch a vaccine: 

On July 21, the First Deputy Minister of the Russian Ministry of Defense Salikov declared optimistically that the Russian-made new crown vaccine is "ready." 

Resulting in the Ministry of Health having to say a few hours later to clarify that the vaccine is still in the process of clinical trials. 

On August 11, Russian Deputy Prime Minister Grikova said that officials hoped that the mass vaccination of medical staff would be carried out this year. It starts in September or even the end of August.

 

For the new coronavirus vaccine under development, how long will it take for a rigorous Phase III clinical trial? 

The current test duration declared by Kexing Company is 14 months (July 2020-September 2021), and the German BioNTech Company is 12 months (April 2020-April 2021, but the study completion date is expected to be 2022 November), the United States Moderna company is 27 months (July 2020-2022 October).

 

As of press time, there have been more than 900,000 confirmed cases of new crown in Russia, and there has been an increase of 5,102 cases in the past 24 hours. 



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Name: Gwynneth May

Educational Qualification: MBBS, MD (Medicine) Gold Medalist

Profession: Doctor

Experience: 16 Years of Work Experience as a Medical Practitioner

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