The TLDR: The Russians just cut a deal to supply 100 million doses of their vaccine nicknamed Sputnik V. Its India partner will also conduct Phase 3 trials of the vaccine in the country. The problem: the vaccine already has a bad rep. And the prospect of thousands of Indians taking this particular jab isn’t exactly comforting.

First, tell me about the deal

It was struck between The Russia Direct Investment Fund—which is funding the vaccine—and Hyderabad-based Dr Reddy’s Laboratories. Dr Reddy’s will conduct phase three trials in India with a few thousand participants—and distribute 100 million vaccines. According to RDIF: “They are meant for population-wide general use—a mass vaccination campaign.”

All this, of course, requires government approval—both for the trials and for the vaccination campaign. 

Point to note: This is the second major international deal to test and supply a vaccine in India. The first is the Oxford vaccine partnership between Serum Institute of India and AstraZeneca (which we explained here). 

Ok, what about this vaccine?

Who: The vaccine is being developed by the Gamaleya Institute of Epidemiology in partnership with the Russian Defence Ministry—and it is funded by the Russian Direct Investment Fund (RDIF).

What: It is a two-part vaccine—an initial jab and then a booster shot. Here’s how it works:

• The vaccine genetically modifies two strains of the common cold virus—adenovirus 5 and adenovirus 26. 
• The aim: engineer these weakened cold viruses to produce the ‘spike protein’ of the coronavirus. 
• Translation: the coronavirus is covered with spikes that allow it to penetrate human cells. These viruses will produce the genetic material associated with those spikes, but not the actual coronavirus.
• When these viruses enter the body, it produces antibodies and protective T cells—which will help protect a person when exposed to the actual virus. 

Doesn’t sound that controversial…

Yes, Sputnik isn’t that different from other vaccine candidates. The Oxford vaccine uses a chimpanzee adenovirus. China-based CanSino’s version is based on adenovirus 5, while Johnson & Johnson uses adenovirus 26.

But the testing process adopted by Russia—and the data from initial trials—have raised big red flags.

What’s wrong with the data?

First, a quick recap: Testing of any new drug goes through three stages of trials. Stage 1: test it on animals to make sure it is safe. Stage 2: test it on a small group of people to see if it triggers an immune response. Stage 3: test it on large sets of diverse populations in multiple locations to make sure it works on all kinds of people—and is truly safe. These are the trickiest and where the real problems show up. The Hindu has more on the potential complications of Stage 3 testing.

The announcement: On August 11, President Putin triumphantly announced that Russia has developed the first Covid vaccine, i.e Sputnik V. He said: “I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks.” Problem: it hasn’t.

The testing: As of now, the vaccine has only undergone Stages 1 and 2 of testing. And at the time of Putin’s announcement, the data from initial tests had not been publicly shared. It sparked immediate worries that Putin was more invested in claiming nationalist glory than developing a safe vaccine. More worrying: The Russian government’s claim that they are ready to start manufacturing in September—and roll out mass vaccinations as early as October. 

All this without any Stage 3 testing—which was only rolled out last month! Its results won’t be available until November.

The data: from Stages 1/2 was finally published in The Lancet on September 4. It seemed to show that the vaccine was safe and triggered a strong immune response. But, but, but it also revealed serious weaknesses in Russia’s human trials:

• The sample size was way too small to draw any conclusions. In fact, it has only been tested on 76 people! In comparison, the Oxford vaccine was tested on 1,100 people in the initial stages. 
• Most of the participants were young—which doesn’t tell us anything about how it will work on older people.
• The testing was not double-blinded or randomised. In an effective trial, neither the doctor nor the recipient knows whether she is getting the drug or the placebo.
• And the trials didn’t last long enough (only 42 days) to ensure the vaccine ensures long-term immunity.
• The scientific consensus: "The design and size of [an early] study is not anywhere near sufficient for widely recognized standards of approval.”

The biggest red flag: Within days of its publication, a group of scientists pointed to serious flaws in the “questionable data” in an open letter. For starters, the researchers had not provided access to the original numerical data. And their summaries had strange “patterns”—as in different participants had the exact same numbers. As a leading Indian virologist explains:

“The points raised [by the 16 scientists] are valid. Without access to the actual data, the points and patterns on the graphs look too similar at multiple places. This raises concern about the data, and therefore the way this vaccine was tested.”

The most telling fact: In a survey of Russian doctors and health specialists, 52% said they were not ready to be vaccinated—of which 66% cited insufficient data and 48% said it was developed too fast.

The bottomline: Atanu Biswas sums it up best in The Hindu:

“Thus, the Russian vaccine at the moment seems to be a lethal game of chance, such as the Russian roulette. In this dangerous game, a bullet is loaded into one chamber of a revolver, the cylinder is spun, and then the trigger is pulled while pointing the gun at one’s own head.”

Reading list