The Times Australia
The Times World News

.
The Times Real Estate

.

Growing evidence suggests Russia's Sputnik V COVID vaccine is safe and very effective. But questions about the data remain

  • Written by Megan Steain, Lecturer, School of Medical Sciences, Faculty of Medicine and Health, University of Sydney
Growing evidence suggests Russia's Sputnik V COVID vaccine is safe and very effective. But questions about the data remain

Russia was the first country to register a COVID vaccine, with its health ministry giving emergency approval to the Sputnik V vaccine in August 2020.

This decision was met with scepticism[1] from the international scientific community[2] because it came a month before results of phase 1 and 2 trials were published.

Growing data from clinical trials and real world rollouts suggests the vaccine is safe and very effective. But there are several outstanding questions around the vaccine, such as whether it’s associated with the very rare blood clotting condition seen with AstraZeneca’s vaccine, and how well it performs against variants of the coronavirus.

So what kind of vaccine is Sputnik V, how does it work, and what data are we missing?

How does Sputnik V work?

Sputnik V was designed by The Gamaleya National Research Center for Epidemiology and Microbiology[3]. It has its very own Twitter account[4] advertising its status as the “world’s first registered COVID-19 vaccine” and approval in 69 countries including Russia, South Korea, Argentina and the UAE.

Like the Oxford-AstraZeneca vaccine, the basis for the vaccine is a harmless form of adenovirus, one of several viruses that can cause the common cold.

The adenovirus acts as a packaging system for DNA to deliver instructions to our cells. This DNA instructs cells to make the spike protein from SARS-CoV-2. The immune system is then trained to generate an immune response to the spike protein, which provides protection against the real SARS-CoV-2 virus.

Unlike the other adenovirus-based vaccines, Sputnik V uses two different adenoviruses for the first and second dose. This is done as people can develop an immune response against the adenovirus vector used in the first shot of the vaccine, which could possibly reduce the overall effectiveness.

The two doses are separated by three weeks, rather than the 8-12 weeks[5] usually recommended for the Oxford-AstraZeneca vaccine.

Sputnik V doesn’t require the ultra-cold temperatures like the mRNA-based vaccines, which makes it an attractive candidate for many countries desperate for vaccines. Gamaleya has been open to sharing its manufacturing platform, unlike some other vaccines[6].

How well does Sputnik V work against COVID-19?

Data from the phase 1 and 2 clinical trial[7] was published in September in the highly reputed medical journal The Lancet. The data showed no major adverse reactions, and side effects that were common to the other COVID-19 vaccines. These were primarily fever, headaches and pain at the injection site.

Most impressively were the results of the larger phase 3 trial[8] published in The Lancet in February this year, which reported 91.6% efficacy against symptomatic infection. This places Sputnik on par with the mRNA vaccines by Pfizer and Moderna, for which the original efficacies were 95%[9] and 94.1%[10] respectively.

The results from the phase 3 trial also suggested a single dose was protective, with an efficacy of 79.4%. This led to the approval of “Sputnik Light” in some countries, a single dose regimen that overcomes some of the issues manufacturing[11] the second dose of Sputnik V. The two different adenoviruses used in the first and second dose of Sputnik V need to be produced using separate cell cultures. Only having to produce a single type of adenovirus streamlines the production.

Outside of these trials, a press release from Gamaleya says real world analysis of the vaccine given to nearly 3.8 million Russians reported an efficacy of 97.6%[12] against infection. This led Gamaleya to claim Sputnik V is “the world’s most effective vaccine”.

Despite the encouraging efficacy results, there are still some concerns. Both the phase 1 and 2 safety trials, and the phase 3 efficacy trials[13], have been criticised for not sharing[14] their raw data or the full details of their study design, as well as inconsistencies in the published data.

Sputnik V isn’t yet approved by the European Medicines Agency (EMA) or the World Health Organization, meaning it cannot be used by COVAX, the COVID vaccine global access initiative. Gamaleya has yet to provide the EMA[15] with all the necessary manufacturing and clinical data necessary to gain this approval.

What are the unanswered questions about Sputnik V?

There are a number of outstanding issues with the vaccine.

Of particular importance is the question of whether it’s associated with the very rare blood clotting condition[16] that’s been linked to the AstraZeneca and Johnson and Johnson vaccines, which also use adenovirus vectors.

Gamaleya claims there have been no reports of this occurring in individuals given Sputnik V. Analysis following the administration of 2.8 million doses of Sputnik V[17] in Argentina supports this. The results, announced via a press release by the Argentine health ministry, reported no deaths associated with vaccination and showed mostly mild adverse events.

And there was no indication of an association between Sputnik V and this condition in the clinical trials.

However, there hasn’t been enough published real world data to be completely confident researchers would be able to pick up on the condition if it did emerge.

It’s also unclear how well Sputnik performs against the rapidly spreading variants of concern, such as Delta. Some of these variants are partially able to escape from the immune response generated by COVID vaccines.

Read more: Why is Delta such a worry? It's more infectious, probably causes more severe disease, and challenges our vaccines[18]

Research[19] published in July examined antibodies in the blood of people vaccinated with Sputnik V to see how it performed against the Alpha, Beta, Gamma and Delta variants. It found there was a reduction in the ability of their antibodies to block infection. It’s unclear how this reduction would impact the vaccine’s effectiveness against hospitalisation and death, as we’re still waiting to see published real world data on this.

We need further studies which directly compare blood samples from people vaccinated with the different vaccines before Sputnik’s claims of being highly effective against variants[20] can be confirmed. We’ll also need to see real world analysis of its effectiveness against variants, such as that performed with Pfizer and AstraZeneca[21].

References

  1. ^ scepticism (theconversation.com)
  2. ^ international scientific community (www.statnews.com)
  3. ^ The Gamaleya National Research Center for Epidemiology and Microbiology (sputnikvaccine.com)
  4. ^ Twitter account (twitter.com)
  5. ^ 8-12 weeks (www.medicalnewstoday.com)
  6. ^ unlike some other vaccines (www.theatlantic.com)
  7. ^ 1 and 2 clinical trial (www.thelancet.com)
  8. ^ larger phase 3 trial (www.thelancet.com)
  9. ^ 95% (www.nejm.org)
  10. ^ 94.1% (www.nejm.org)
  11. ^ manufacturing (www.reuters.com)
  12. ^ 97.6% (www.prnewswire.co.uk)
  13. ^ phase 3 efficacy trials (www.thelancet.com)
  14. ^ criticised for not sharing (www.thelancet.com)
  15. ^ Gamaleya has yet to provide the EMA (www.reuters.com)
  16. ^ very rare blood clotting condition (theconversation.com)
  17. ^ 2.8 million doses of Sputnik V (www.businesstoday.in)
  18. ^ Why is Delta such a worry? It's more infectious, probably causes more severe disease, and challenges our vaccines (theconversation.com)
  19. ^ Research (www.mdpi.com)
  20. ^ claims of being highly effective against variants (www.reuters.com)
  21. ^ such as that performed with Pfizer and AstraZeneca (www.ft.com)

Read more https://theconversation.com/growing-evidence-suggests-russias-sputnik-v-covid-vaccine-is-safe-and-very-effective-but-questions-about-the-data-remain-164392

The Times Features

How to Protect Your Garden Trees from Wind Damage in Australia

In Australia's expansive landscape, garden trees hold noteworthy significance. They not only enhance the aesthetic appeal of our homes but also play an integral role in the local...

Brisbane Homeowners Warned: Non-Compliant Flexible Hoses Pose High Flood Risk

As a homeowner in Brisbane, when you think of the potential for flood damage to your home, you probably think of weather events. But you should know that there may be a tickin...

Argan Oil-Infused Moroccanoil Shampoo: Nourish and Revitalize Your Hair

Are you ready to transform your hair from dull and lifeless to vibrant and full of life? Look no further than the luxurious embrace of Argan Oil-Infused Moroccanoil Shampoo! In a...

Building A Strong Foundation For Any Structure

Building a home or commercial building can be very exciting. The possibilities are endless and the future is interesting. You can always change aspects of the building to meet the ...

The Role of a Family Dentist: Why Every Household Needs One

source A family dentist isn’t like your regular dentist who may specialise in a particular age group and whom you visit only when something goes wrong. A family dentist takes proa...

Benefits of Getting an Online Medical Certificate

Everyone has experienced it. Rather than taking a break, you drag yourself to the doctor's office, where you have to wait in lengthy lines, and then you have to hurry to get that...

Times Magazine

"Eternal Nurture" by Cara Barilla: A Timeless Collection of Wisdom and Healing

Renowned Sydney-born author and educator Cara Barilla has released her latest book, Eternal Nurture, a profound collection of inspirational quotes designed to support mindfulness, emotional healing, and personal growth. With a deep commitment to ...

How AI-Driven SEO Enhancements Can Improve Headless CMS Content Visibility

Whereas SEO (search engine optimization) is critical in the digital landscape for making connections to content, much of it is still done manually keyword research, metatags, final tweaks at publication requiring a human element that takes extensiv...

Crypto Expert John Fenga Reveals How Blockchain is Revolutionising Charity

One of the most persistent challenges in the charity sector is trust. Donors often wonder whether their contributions are being used effectively or if overhead costs consume a significant portion. Traditional fundraising methods can be opaque, with...

Navigating Parenting Arrangements in Australia: A Legal Guide for Parents

Understanding Parenting Arrangements in Australia. Child custody disputes are often one of the most emotionally charged aspects of separation or divorce. Parents naturally want what is best for their children, but the legal process of determining ...

Blocky Adventures: A Minecraft Movie Celebration for Your Wrist

The Minecraft movie is almost here—and it’s time to get excited! With the film set to hit theaters on April 4, 2025, fans have a brand-new reason to celebrate. To honor the upcoming blockbuster, watchfaces.co has released a special Minecraft-inspir...

The Ultimate Guide to Apple Watch Faces & Trending Wallpapers

In today’s digital world, personalization is everything. Your smartwatch isn’t just a timepiece—it’s an extension of your style. Thanks to innovative third-party developers, customizing your Apple Watch has reached new heights with stunning designs...

LayBy Shopping