Myth Busted: Russia Completes Human Trials of COVID-19 Vaccine

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Just a couple of days ago, the web was flooded by the news of a brand new Russian Coronavirus vaccine that has completed human trials. Many read this news and rejoiced thinking that after all this while, we will finally be able to step out in public without the fear of being infected.

However, those who read the news story in detail may have noticed something fishy. For starters, many reports said that the first stage of human testing of the Coronavirus vaccine started on 18th June.

When you factor in the time it takes to notice the effects of the administered vaccines in humans, getting a vaccine ready for rollout less than a month after starting human trials seems like an impossible undertaking.

Further research revealed that there is more to the story. Let’s look at the facts:

The Original Story

Originally reported by the Russian news agency TASS, the news story said that a vaccine candidate developed by Sechenov University.

The news reported quoted Sechenov University Center for Clinical Research on Medications head and chief researcher Elena Smolyarchuk saying “The research has been completed and it proved that the vaccine is safe. The volunteers will be discharged on 15 July and 20 July.”

However, what many news reports conveniently failed to mention was the sample size of the COVID-19 vaccine test.

In two groups of 20 and 18 respectively, patients were vaccinated with the vaccine developed by Russia’s Gamaleya National Research Center for Epidemiology and Microbiology.

The first batch, consisting of 18 patients, was administered the vaccine on June 18th and the second batch, consisting of 20 patients were vaccinated on June 23rd.

After the administration of the vaccine, test subjects spent 28 days in isolation and will remain under medical observation for the next six months.

Despite the extremely limited sample size of this human trial, Russia has approved the vaccine to be circulated among its population. Gamaleya’s Director Alexander Gintsburg is hoping that the vaccine will ‘enter civil circulation’ on August 12th. He also expects private companies to begin mass-producing the vaccine in September.

The Vaccine Development Process

The vaccines for recent epidemics like Ebola, Malaria, and Dengue took over four years to develop. So how did this Russian institute develop the Coronavirus vaccine in such a short time?

The brief answer is, they didn’t.
When developing a vaccine, the developers have to pass through four stages. In the first stage, the vaccine is tested on animal subjects to test its toxicity, safety, immunogenicity, and effectiveness. Once a vaccine passes these trials, it is then deemed fit for human trials.

Human trials are done in three stages. In the first stage, the vaccine is administered to a small group of human test subjects (usually around 40). At this stage, the objective is to test the ‘safety and tolerability’ of the vaccine in human subjects. This stage is called stage one of human trials.

In the second phase of human testing, the vaccine is administered to a slightly larger group of human test subjects. Since by this stage, it is already determined that the human body can tolerate the vaccine, it is further tested for efficiency and immunogenicity.

This means, in the second stage, it is observed whether or not a vaccine is generating the desired immune response within the bodies of the test subjects. As you can probably imagine, patients need to be monitored days and weeks (and sometimes months) on end to gauge the effects of the vaccine on their bodies.

Thus, the second stage of vaccine development is one of the most difficult and time-consuming stages to get through.

After a vaccine has passed both these stages, it still has to go through the third phase of human trials. At this stage, the vaccine is administered to several test subjects, usually a few thousand. These test subjects are sourced from different countries, areas, and communities. Administering the vaccine to a large population and then monitoring its effects can take several months.

This is why the process of developing vaccines is a long drawn one and most vaccines take several years to develop.

While world governments, medical research organizations, and even pharmaceutical companies are all devising ways to speed up the development of a Coronavirus vaccine, the process is bound to take more time than one month.

The Russian Vaccine Is Far From Ready

Keeping these standards of human trials in mind, we can ascertain that the Russian vaccine, which has been tested on less than 40 human test subjects, hasn’t even managed to fulfill all the requirements for the first stage of human trials.

It is worth noting that many of the 125+ global vaccine candidates have surpassed the first stage of human trials successfully. However, only two candidates have successfully made it past the second stage of human trials. These are Sinovac, a vaccine being developed by China with the help of Oxford University and Astra-Zeneca’s viral vector vaccine that is being developed in the US.

In other words, the news of the Russian vaccine ‘successfully’ completing human trials may not have been untrue, but it sure was displayed in the wrong light by many major media houses across the globe.

While most of us have been eagerly waiting for the news of a vaccine being successfully developed, sharing and consuming fake, or in this case, misleading news stories can have serious repercussions.

At a time when there are new developments taking place in regards to the COVID-19 situation every day, it is everyone’s responsibility to be critical about the news they are sharing within their circles.

Therefore, the next time you read a news related to development in regards to the Coronavirus Pandemic, make sure you do your research before sharing it with anyone.

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