Modern Australian
Men's Weekly

.

Russia's coronavirus vaccine hasn't been fully tested. Doling it out risks side effects and false protection

  • Written by Kylie Quinn, Vice-Chancellor's Research Fellow, School of Health and Biomedical Sciences, RMIT University

On Tuesday, Vladimir Putin announced Russia was the first country to register a vaccine offering “sustainable immunity” against SARS-CoV-2, the virus that causes COVID-19.

Developed by the Gamaleya Research Institute in Moscow, it’s been registered with the Russian Health Ministry and approved for emergency use only.

But there are concerns it will soon be rolled out across the Russian population, far beyond emergency use. This has prompted discussion about the “race” towards a COVID-19 vaccine.

While speed is important, ensuring a vaccine is effective and safe is much more critical. The consequences of doling out a potentially unsafe and ineffective vaccine could be wide-reaching.

Read more: Vaccine progress report: the projects bidding to win the race for a COVID-19 vaccine

Data about the trials has not been published

The Gamaleya Research Institute announced it registered a SARS-CoV-2 vaccine with the Russian Health Ministry, the local regulatory body that determines which medicines can be used in Russia. This vaccine is called “Sputnik V” and the Institute has indicated it’s approved for emergency use. An emergency use approval generally means a vaccine could be offered to people at very high risk of infection, such as health-care workers, but not the general civilian population.

The Institute had previously registered this vaccine for a Phase I/II trial (to assess safety and immune responses in humans), initially with just 38 people. Senior Russian officials said it induced a strong immune response and no “serious complications” in this trial. This isn’t too surprising, as published data from human clinical trials for other similar vaccines have shown strong immune responses and no serious complications.

However, the data from the trial of Sputnik V has not been published and there is no data that indicates the vaccine would actually protect, as Phase III studies (requiring thousands of volunteers to demonstrate efficacy and detect rare side-effects) haven’t been performed.

The Institute did announce a Phase III trial for Sputnik V will begin on August 12 in Russia and several other countries. However, many scientists (including Russian researchers) expressed concern the vaccine will soon be used in large civilian vaccination campaigns, which wouldn’t usually be the case with an approval for emergency use.

Two vials of a Russian coronavirus vaccine The vaccine was registered by the Russian Health Ministry for emergency use, even though Phase III trials haven’t been completed. Also, data from the Phase I and II trials hasn’t been fully released or peer-reviewed. Alexander Zemlianichenko Jr/Russian Direct Investment Fund/AP/AAP

What are the risks

If we go back to the analogy of a “race”, we should stop thinking of vaccine development as the 100-metre sprint. Instead, think of it more like the pentathlon. In the pentathlon, each section the athlete completes contributes to their overall score and cannot be missed. If we try to run this race against COVID-19 without each section, we could end up with a vaccine which has not been properly tested, which could be unsafe and would be unethical. And then we all lose.

The risks of advancing into mass vaccination without proper testing are significant. If a vaccine is released but side-effects emerge, the consequences include both the health impacts and deterioration in trust from our community. If the vaccine does not protect individuals from infection, those who have been vaccinated could falsely believe they are protected.

Our system of methodical series of clinical trials has been designed, oftentimes with hard-won lessons, to avoid oversights and build essential data on safety, immunity and protection with vaccines.

As stated by the US Health and Human Services secretary, Alex Azar:

The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective for the American people and the people of the world.

Development takes time and we need to be realistic with our timelines and expectations.

Testing a vaccine is rigorous

When countries consider introducing a vaccine, the following information is examined:

  • how safe is the vaccine?

  • how well does the vaccine work?

  • how serious is the disease the vaccine would prevent?

  • how many people would get the disease if we did not have the vaccine?

This information is collected during each phase of the clinical trials (Phase I, II and III), with a particular focus on vaccine safety at each step. Developing this package of information can take years, but there have been cases when timelines were condensed.

For example, testing for an Ebola vaccine was condensed down to five years due to a critical need for a vaccine in the midst of ongoing epidemics. Regardless of this urgency, each clinical trial phase was still completed.

Phase III clinical trials are especially critical to assess safety in a large group of people, because certain rare side effects may not be identified in earlier, smaller trials. For example, if a vaccine-related side effect only occurred in one in every 10,000 people, the trial would have to enrol 60,000 volunteers to detect it.

In general, vaccines are more thoroughly tested than any other medicine. We administer vaccines to healthy people, so safety is the key priority, and we administer vaccines to large numbers of people, so rare side-effects must be identified.

Putin receives a report from the Healthcare minister about registration of a coronavirus vaccine Vladimir Putin said the vaccine ‘works effectively enough’. But scientists have learned over many years to rigorously test vaccines. If they are going to be injected into millions of people, they need to be both safe and effective. Alexei Nikolsky/Sputnik/Kremlin POOL/EPA/AAP

What’s in this vaccine?

This type of vaccine is called a viral vector. With viral vectors, we trick our immune system with a bait-and-switch; we take a harmless virus, modify it so it can’t replicate, and include a target from the surface of the SARS-CoV-2 virus. The vaccine looks like a dangerous virus to the immune system, so the immune response is relatively strong and targeted against SARS-CoV-2, but the virus can’t cause disease.

Sputnik V is unusual because it uses two different viral vectors, one after the other, in what we call a “prime boost”. The first is called Ad26, which is similar to a COVID-19 vaccine being developed by Johnson&Johnson, and the second is called Ad5, which is similar to a COVID-19 vaccine being developed by CanSino Biologics. This prime boost should generate a relatively strong immune response, but we don’t know for sure.

Viral vectors are also a relatively new technology. There have been a number of large clinical trials with viral vectors for HIV, Malaria, Tuberculosis and Ebola, but only one for Ebola has ever been approved for use in the general population.

Read more: The vaccine we're testing in Australia is based on a flu shot. Here's how it could work against coronavirus

Authors: Kylie Quinn, Vice-Chancellor's Research Fellow, School of Health and Biomedical Sciences, RMIT University

Read more https://theconversation.com/russias-coronavirus-vaccine-hasnt-been-fully-tested-doling-it-out-risks-side-effects-and-false-protection-144347

Powering Shepparton’s Businesses: Expert Commercial Electrical Services You Can Count On

When it comes to running a successful business, having reliable, compliant, and efficient electrical systems is non-negotiable. From small retail ou...

Maximise Efficiency: Cleaner Solar Panels for Optimal Performance

Solar panels are a smart investment in energy efficiency, sustainability, and long-term savings—especially here in Cairns, where the tropical sun ...

7 Common Air Conditioner Issues in Melbourne – And How to Fix Them

Image by freepik Living in Melbourne, we all know how unpredictable the weather can be. One moment it’s cold and windy, the next it’s a scorchin...

Powering Palm QLD with Reliable Electrical Solutions

Image by pvproductions on Freepik When it comes to finding a trustworthy electrician Palm QLD locals can count on, the team at East Coast Sparkies s...

The Smart Way to Grow Online: SEO Management Sydney Businesses Can Rely On

If you’re a Sydney-based business owner, you already know the digital space is crowded. But with the right strategy, you don’t need to shout the...

What Your Car Says About You: The Personality Behind the Vehicle

You can tell a lot about someone by the car they drive—or at least, that’s what people think. True Blue Mobile Mechanics reckon the car says a l...

The Confidence Curve: Why Boudoir Photography Is the Empowerment Trend You Didn’t Know You Needed

Boudoir photography has been quietly taking over social feeds, Pinterest boards, and personal milestones—and for good reason. It’s not just abou...

Understanding Level 2 Electricians: Why Sydney Residents Need Licenced Experts for Complex Electrical Work

When it comes to electrical work around the home or business, not all electricians are created equal. In Sydney, particularly when you're dealing wi...

Retirement Anchored in Model Boat Building for Waterford’s Doug Unsold

WATERFORD — When Doug Unsold sees his ship come in, it’s usually one he’s crafted with his own hands. The 67-year-old retiree from Waterford ...

The Science Behind Alarm Clocks and Your Circadian Rhythm

Waking up on time isn’t just about setting an alarm—it’s about working with your body, not against it. At the heart of every restful night and...

How to Use Plants to Create a Calming Atmosphere in Your Home

In today’s fast-paced world, cultivating a calm, soothing environment at home has never been more important. Whether you live in a busy urban apar...

How Maths Tutoring Can Help Students Master Maths

Mathematics can be a daunting subject for many students, often causing stress and frustration. However, maths tutoring has proven to be an effective...

Refurbished iPads Are Better Than New Ones (Here's Why)

Image by rawpixel.com on Freepik Apple's refurbished iPad program has quietly become one of the best deals in tech. While everyone obsesses over the ...

Your Guide to Finding the Right GP: What Perth City Doctors Offer Today

Choosing a General Practitioner (GP) is one of the most important health decisions you’ll make. Luckily, Perth’s vibrant CBD now hosts a new ge...

Why Every Mining Operation Needs a Robust Safety Management System

Mining is one of the backbones of the Australian economy, particularly in Western Australia. Back in 2019-20, mining contributed 10.4% of Australia...

Australian Classic Literature Enjoys Resurgence

Welcome back to the good old days of storytelling! As the modern world becomes increasingly more demanding, returning to childhood favourites offers...

How to Choose the Right Lawyers in Sydney for Your Situation

When faced with a legal issue, selecting the right legal representation can make all the difference. Whether you're dealing with a personal injury, ...

Building a Governance Model for Headless Content Management at Scale

Image by pch.vector on Freepik There's never been a better time to implement a headless content management system (CMS) to gain the flexibility and ...