Russian President Vladimir Putin Approved “sputnik V” Covid-19 Vaccine Amid Huge Criticism


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Throughout the Coronavirus pandemic, the one thing which keeps us holding onto hope is that one day scientists will come up with a “Successful Vaccine”; and we can go back to normal life again. 

The race of finding the coronavirus vaccine starts among different nations soon after the pandemic hit the world.

In a surprising turn of events, Russian President Vladimir Putin announced on Tuesday that its health regulators approved the vaccine. This makes it the world’s first vaccine to get registered; production on a vast scale is expected to start in the next month. Vladimir Putin said that the vaccine is safe, and one of her daughters had already got the vaccine. Putin said on the state TV;

“A vaccine against the coronavirus has been registered for the first time in the world this morning, I know that it works quite effectively; it forms a stable immunity.”

The news faced intense criticism, and questions were raised about the safety and effectiveness of the vaccine. The vaccine has just undergone phase 1 and phase 2 clinical trials on the small group of people. Phase 3 is yet to start, but Russia is planning to start producing the vaccine in September.

RUSSIAN RESPONDS TO THE CRITICISM

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Russian health minister Mikhail Murashko brushed off the criticism on Wednesday that allegations on Vaccine safety were baseless and are just influenced by competition.

Kirill Dimitriev, who is serving as chief executive for Russia’s wealth fund, RDIF; which is also behind the Russian vaccine said that Western and specifically U.S. criticism against the vaccine are kind of twisting.

He said on Wednesday;

“This is the kind of announcement that divided the world into two countries, some are delighted on the news and some of the American people and media are just waging war against the Russian vaccine. We were not expecting anything less than that from them; our goal is not to convince the U.S. Our focus at the time was to present to the world how much we advanced on this now. It can be available for your country in November, December if it meets your regulation and the doubtful people will not get this vaccine and we can just wish them good luck in developing their own vaccine.”

However, he admits that Russia needs to share the data results of the vaccine and said that it was “genuine criticism.”

He further said;

“We agree that data has not been shared yet; we are sending the data results to one of our partners today and they will be published in August.”

Dmitriev also announced that interest of 1 billion from other countries has also been received.

“We have seen a massive interest in the Russian vaccine that is developed by the Gamaleya Institute abroad. Moreover, we have received applications in advance for almost 1 billion doses from different 20 countries. We already have the plan to manufacture 500 million does per year in five different countries, slowly pacing up the production. As for now many countries from the Middle East, Latin America and Asia have been taking a keen interest in our vaccine. We have also finalized many contracts for the purchase of the vaccine. Phase 3 trials would also start in the relevant countries.”

DEVELOPER OF RUSSIAN VACCINE

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This vaccine is developed by the Moscow based Gamelya Institute; and named as Sputnik-V. This name is in reference to the Russian surprise launch of the world’s first satellite in 1957.

The Russian registration certificate does not provide many details, but as for now, we got to know the vaccine has been manufactured by Bionnopharm in Zelenograd. This vaccine consists of two shots, comprising different versions of adenoviruses that the researchers engineered to transfer the gene on the spike of SARS-COV-2.

EXPERTS CONCERN IGNITED OVER THE VACCINE

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Experts are pitching their voice over the vaccine, as the vaccine is approved in a hassle and also not much data is available. 

The Russian government introduced a law in April that eliminates the condition of undergoing phase 3 trials, before being approved. This allows the rapid processing of the vaccine than usual.

Michael Head, Senior Research Fellow in Global Health at the University of Southampton in the UK, addressed to the Science Medical Centre and said;

“To be exact, it is unclear what is happening with the Russian vaccine. It is primarily significant that any vaccine which is coming out is trusted by the general public, and there is enough talk about the level of effectiveness and its possible side effects. As for now, there is not enough data about the Russian vaccine; which does not allow the world to study it.”

Danny Altman, Professor of Immunology at Imperial College London said that there are serious concerns about the vaccine being approved before it was sufficiently tested. He said;

“Phase 3 represents the phase in testing trials where you test the vaccine on thousands of the people to measure its efficacy and safety. The vaccine has gone through the smallest of the phase 2 trials in all of the other vaccines being talked about. At the moment, we do not have any idea whether the vaccine is safe or not.”

Anthony Fauci, the Whitehouse representative for the coronavirus, said on Wednesday that;

“He hoped that Russians would actually prove the vaccine to be safe and effective as well. I doubt they have done it about the vaccine.”

In the United     States of America, the Food and Drug Authorization FDA can approve the medicine for usage before the completion of complete efficacy trials, which is known as emergency use authorization. And it has been speculated that President Donald Trump might utilize this option for a COVID-19 Vaccine that might boost his re-election campaign in his favor. Russia’s certification process is the same as the FDA’s emergency use. But FDA also has an independent advisory committee that includes academies that reviews vaccine approval applications on a routine basis. 

Alexey Chumakov, a researcher who worked in an institute based in Moscow, said;

“The health ministry in Russia does not seek the advice of his scientific and medical community as the FDA does in America. It is not the platform that has an opinion and any internal organization. Their results might show that it works, that would be a desirable outcome. But there might still be a 20 percent chance that the vaccine can backfire.”

Chumakov further said the rules in Russia can easily be altered. He also said there is not much science left in Russia in the last 30 years and not many people complain against this either. It is not challenging to make a vaccine but to prove its effectiveness, is not considered easy, I don’t know how they decide it prior.

RUSSIA DOES NOT PROVIDE THE DATA FOR VACCINE VERIFICATION 

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Russia is making progress rapidly for the development of the COVID-19 vaccine. The initial clinical trials started on 17 June, months after the other vaccines started in the US, China, and Europe.  

Gamelya institute in Moscow has not released any safety or clinical data from its trials. This makes it almost impossible for the researchers to investigate whether it is safe and effective or not.

Russian President is conveying the message to the world that Russia is the first one to develop the vaccine and insisted that the vaccine is safe. But there is much which has to be done. Until now there has been no coronavirus vaccine that offers ultimate protection from the virus. 

OTHER TRAILS ARE IN PROGRESS

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Russia is one of the leading countries but in a hurry to produce a vaccine for coronavirus, which now infected more than 20 million people worldwide, with 730000 deaths all around the globe.

According to the WHO, World health organization; 25 vaccines are in the clinical evaluation stage and 139 others which are in the preclinical evaluation stage in terms of development.

The most prominent one of them is from the University Of Oxford And Astrazeneca and the other one from the biotech company named Moderna and the US Institute of Health. Both of these provide satisfactory results up till now and currently going through Phase 3 testing.

In June, the Chinese Government allowed the use of an experimental vaccine for the Country’s military. The vaccine is named Ad5-nCov; manufactured by the Beijing Institute of biotechnology and a vaccine company, Cansino Biologics.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF RUSSIAN VACCINE?

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As for now, it’s just known that short term side effects like fever occur once the vaccine kick starts the immune system. But major side effects can only be visible when the vaccinated person got infected with the coronavirus in real life.

One such major side effect is an antibody-dependent enhancement (ADE), this phenomenon makes the body more susceptible to infection. Vaccines such as for SARS COV, which causes major acute respiratory syndrome in the previous decade also produces ADE like effects. It is highly likely that the COVID-19 vaccine can do the same. This can emerge in phase 3 clinical trials in which a vaccine is tested on a large number of people.

Russia has denied that it is not part of the race for developing a coronavirus vaccine; and said that they want to cooperate with other nations. The hustle in making a vaccine might affect its fight against the coronavirus in the country. 

J. Stephen Morrison, working as a senior vice president at Strategic and International Studies, has said that Putin is trying to win the game at Home by pulling out the vaccine; as he is accused of not tackling the pandemic situation wisely and not being able to revive the country’s economy.

Earlier this month, Russia has denied the allegations that Russian spies hacked into the United Kingdom, Canadian and American labs to steal the ideas for the development of the coronavirus vaccine.
Russia has the fourth-highest number of Coronavirus cases as of Wednesday, with almost 900000 active cases with a death toll of 15260.


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