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Sputnik V: Why Experts Are Alarmed At "Reckless" And "Naive" Russian COVID-19 Vaccine

2020-08-13T23:39:59.081Z


Putin assured, without offering details, that the first approved vaccine in the world has demonstrated to work "with the sufficient effectiveness". The drug, however, missed crucial phase three and experts warn of a fundamental danger.


By Denise Chow - NBC News

Russia has a vaccine against the coronavirus. Whether it works or not is anyone's guess.

Russian President Vladimir Putin announced earlier this week that his country had approved a vaccine against COVID-19, thus becoming the first nation in the world to reach this milestone. But the news has been met with strong skepticism, and experts are expressing concern that the experimental vaccine has not yet completed clinical trials designed to test its safety and efficacy.

Putin promoted the new vaccine, which Russia dubbed Sputnik V , saying it has been shown to work "effectively enough." However, by skipping the phase three trials, which are crucial to showing that a potential vaccine can successfully prevent infections and not produce serious side effects, it is too early to know if this or any other of those occurring in the future. mundo is currently ready to be used in patients.

"The Russian bet on vaccines is reckless and naive, whether it works or not," Francois Balloux, a biologist at the Institute of Genetics at University College London in the UK, wrote on Twitter Tuesday.

Russian President Vladimir Putin has assured that the vaccine offers lasting immunity against the coronavirus, despite having skipped phase three of clinical trials. Reuters

Scientists around the world have worked tirelessly to develop a vaccine against the coronavirus, which is seen as a crucial step in bringing the planet back to normal. The rush has forced the scientific community to accelerate a process that generally takes years, and that should not skip the appropriate tests and security protocols.

That rush has already sparked some concern that vaccines that reach the public are safe and effective, especially given the large body of misinformation circulating online about the coronavirus. The introduction of the Russian vaccine could further complicate the broad discussion about coronavirus vaccines.

Undermine public trust

One of the biggest concerns about getting a new vaccine approved before clinical trials are completed is that it could jeopardize public confidence in the vaccine development process, according to Ayfer Ali, a professor at the Warwick School of Business. in the UK, which specializes in drug research.

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"There is a lot of mistrust in vaccines for various reasons and we don't want to feed that," he said, "being first is not really important. If there is a vaccine that ends up having serious side effects, we won't be able to convince people to trust it, and possibly not other vaccines either, so we really don't want to make a mistake here. "

In a statement released Tuesday, the World Health Organization said it is "in contact with Russian scientists and authorities, and hopes to review the details of the trials."

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Few details are known about the Russian vaccine so far, but its approval was based only on the first two phases of clinical trials, which are designed to conduct early assessments of whether a potential vaccine can induce an immune response and whether it is safe to administer. in humans.

Russia has said it intends to conduct phase three trials of its already approved vaccine later this month, but did not provide much additional information . The tests will be conducted in Russia, the United Arab Emirates and Saudi Arabia, according to Kirill Dmitriev, director of the Russian Direct Investment Fund, the body that funds the research.

The importance of phase three

Phase three trials focus on the efficacy of the candidate vaccine, by studying whether it can actually prevent infections. This step is also designed to assess whether a potential vaccine is safe, by significantly expanding the pool of study participants and monitoring any adverse side effects.

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"In phase three, you can start testing thousands or tens of thousands of people to begin to understand the rare side effects," said Eleanor Riley, Professor of Immunology and Infectious Diseases at the University of Edinburgh in Scotland. "If you only vaccinate a few hundred people, this will not happen," he added.

Skipping that stage of research, or conducting it without proper controls, makes it extremely difficult to assess whether a vaccine is safe and effective, he said.

When is an emergency approval recommended?

It is not known what criteria Russian regulators used to judge the performance of the new vaccine. In the United States, these standards are set by the Food and Drug Administration (FDA).

The agency has said that any potential coronavirus vaccine will need to be at least 50% effective to be approved , meaning the vaccine would need to prevent infections in at least 50% of the people who receive it.

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Riley said there are cases in which emergency approval of an experimental vaccine may be appropriate, but that given the current state of the coronavirus pandemic, this consideration will likely not apply. In 2018, for example, an Ebola vaccine was used in the Democratic Republic of the Congo before clinical trials were completed.

"In that case, the risk of getting the vaccine was less than the risk of getting Ebola and dying," Riley said.

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The fatality rate from Ebola is much higher than that of COVID-19, the disease caused by the coronavirus. In the case of this pandemic, there are other effective public health measures that can slow the spread of the pathogen.

"I don't think anyone can reasonably argue that we are in the same kind of emergency situation with the coronavirus," he said, referring to the Ebola outbreak, "there are reasons to do phase three trials as quickly as possible, but those are reasons. socioeconomic rather than public health ".

Source: telemundo

All news articles on 2020-08-13

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