This story is published as part of a series investigating how the Sputnik V vaccine compares to other Covid-19 preventatives.
- The burger patty: How not to run a vaccine clinical trial
- The basting
- The lettuce
- The burger buns
Parts three and four will be published on 23 August 2021
Welcome to the landing page of our Sputnik V Series.
In June, we started doing research for an article that would explain how well Russia’s Sputnik V vaccine works and to gauge whether it would be suitable for use in South Africa’s Covid vaccine roll-out.
Soon enough, we realised that Sputnik V had flouted the rules of every part of the system that produces scientific research.
We’ve come to think of the different components of the research system as if they were the ingredients of a hamburger.
That’s also how we’ve approached this series.
Each article takes a look at one “ingredient” of the science burger, and then at how Sputnik V measures up.
The anatomy of a burger
Burger ingredients each function well on their own, but when they join forces for the good of the burger, each one’s role is amplified.
Part one: The burger patty
Ground beef is the star of the traditional burger. Its scientific equal, in our view, is the raw data that scientists collect during their research.
But you can’t just slap a bit of mince onto a burger, you need some sort of binder, and a bit of seasoning, at least, before you can call it a patty.
Just the same, the raw data on its own is not good enough.
You need a well designed study protocol, which is the guidebook researchers use to plan the trial. That’s the binder you use so that the patty will keep its shape.
Next, you need all of this to culminate in a well-run clinical trial which produces trustworthy results — the seasoning of the patty.
- How does the Sputnik burger patty measure up?
Neither the preclinical data, raw data of the trial, or the study protocol were made public. Not to mention how the early trials were run. For instance, the participants were not randomised in the first two phases, which means there wasn’t an equal distribution of participants (by age, sex, et cetera) in both groups. In addition, these studies were unblinded, a tool that ensures trial runners don’t treat participants differently depending on which intervention they receive during the study.
Part two: The basting
Upgrade your burger with some basting, for extra flavour and moisture. Similarly, the peer review process enhances the credibility of a clinical trial, doubly so if the paper is published in a prestigious academic journal.
- How good is Sputnik’s basting?
A bit gross. The vaccine was approved before there was any available data from the trials on how well the vaccine worked.
When the trial results were eventually reported in The Lancet, scientists raised the alarm about a litany of red flags they saw in the report.
The paper had undergone peer review for a prestigious journal such as The Lancet. But this opened the discussion up to how the accelerated peer-review process that became the norm during the Covid pandemic could leave room for bad science to slip through.
Part three: The lettuce
Nobody likes a soggy burger bun. So, reach for a crispy lettuce leaf to help the burger keep its structural integrity and to keep the basting under control.
Enter medicines regulators (alias: lettuce) who review raw data, peer review and clinical trials submitted to them by manufacturers to determine whether a medicine is safe for public use. They also keep tabs on safety standards at manufacturing plants where the medicines are made.
- How crispy is the Sputnik burger’s lettuce?
Wilted at best.
Sputnik V has been approved for use in over 60 countries, but none of these have reputable regulators — like the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA has not received an application from the Gamaleya Institute.
Moreover, the World Health Organisation hasn’t made a decision about the jab yet since they’re awaiting additional data from the Gamaleya Institute.
Part three coming on Monday
Part four: The burger buns
Soft and perishable as they are, burger buns represent the public’s safety and their trust in medicines.
If the burger is not assembled correctly or is missing an ingredient, you risk the whole thing falling to pieces in your hands. Likewise, all parts of the burger are essential to the trustworthiness of research and medical interventions like vaccines.
All of these ingredients of the burger rely on the integrity of individual researchers. If you use bad meat to make your patty then the entire burger is compromised. Wilted lettuce doesn’t do the burger any favours either.
- What about the Sputnik burger buns?
A bit mouldy, if we’re honest.
For starters, the Russian people themselves are not too keen on the vaccine, which is perhaps the strongest indication of the erosion of public trust and the impact of the political situation on vaccine hesitancy.
An independent survey indicated more than 60% of Russian people are not willing to get the jab.
All in all, the lack of transparency in every part of the process surrounding Sputnik V has likely undermined both the public’s and the scientific community’s trust in the vaccine.
Part four coming on Monday
Overall burger rating: Unappetising.