Although Russian authorities received heavy criticism for approving the Sputnik V vaccine prior to the completion of Phase III clinical trials, the jab is increasingly being seen as a viable tool in the global fight against COVID-19. Sputnik V is now approved in a number of countries, but questions are still being asked as to whether it should be trusted.
The vaccine’s prospects have suffered two major blows recently. Brazil’s health regulator rejected several states’ requests to import over 30 million doses over safety concerns, and questions have been raised over the slow manufacturing pace. Russian President Vladimir Putin said in March that commitments for 700 million doses had been made, but, according to Reuters, the country had only produced 33 million vaccines and exported fewer than 15 million.
While the vaccine has not yet been authorized by the European Medicines Agency (EMA), the Russian Direct Investment Fund (RDIF), which bankrolled the research behind it, recently announced a deal to manufacture the vaccine in Europe with Swiss-based firm Adienne.
In a recent conversation with PharmaBoardroom Adienne CEO Antonio Francesco Di Narto was unequivocal on the lack of clinical trial data. “I do not have any concerns. I am very pleased that there is a COVID-19 vaccine with 91.6 percent efficacy. This data was published in The Lancet, a peer-reviewed general medical journal.”
Di Narto explained that many companies have the capability to fill and pack millions of doses, but very few can actually manufacture them. “[Adienne] appeared on the RDIF’s radar because they were looking for a company with a strong research footprint that could start from the cell all the way to the commercial product,” he said.
He praised Sputnik V’s characteristics, including being able to be stored at higher temperatures than those from Pfizer-BioNTech and Moderna. However, he warned, “there are also challenges specific to Sputnik V as it is a two-shot vaccine that uses two adenoviruses called Ad5 and Ad26. This means that manufacturing the vaccine is almost like manufacturing two different vaccines.”
Adienne’s CEO is confident about the product he has been asked to manufacture, but the international community is yet to make up its mind. This is foregrounded by the fact that, similar to the Oxford-AstraZeneca and Johnson & Johnson vaccines, Sputnik V is a viral vector vaccine, which use a modified version of a different virus to deliver instructions to cells. Both jabs have suffered setbacks in recent months.
With questions continuing to be asked on Sputnik, see below for a brief history of the vaccine’s journey so far.
Putin’s surprise announcement
In June 2020, just three months after most countries began implementing lockdowns, Russia’s Gamaleya Research Institute launched the first clinical trials of their COVID-19 vaccine candidate, then called Gam-Covid-Vac. The announcement came during the peak of the country’s first wave, when an average of 160 deaths per day were being reported.
In a surprising move, about two months later, President Vladimir Putin announced that Russia had become the first country in the world to approve a vaccine for the coronavirus. “[This is a] first, very important step for our country, and generally for the whole world,” he said.
The issue? Phase III clinical trials had not even begun.
Suddenly, Gam-Covid-Vac became Sputnik V, a reference to the world’s first artificial Earth satellite, the Sputnik 1, launched by the Soviet Union in 1957 and a testament of the Russian government’s confidence that the vaccine worked and their understanding of the “arms race” element behind the development of the vaccine. A process that traditionally takes five to ten years had been reduced to three months.
But the scientific community, and political leaders, did not buy it. “I think it’s really scary. It’s really risky,” said Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University.
Some recognized the geopolitical fight surrounding the pandemic. “This is all beyond stupid… Putin doesn’t have a vaccine; he’s just making a political statement,” said John Moore, a virologist at Weill Cornell Medical College in New York City.
The criticism appears to have worked and a few days after the initial announcement, the Russian government backtracked and explained that the approval was a “conditional registration certificate” that depended on good results from the Phase III trials.
“Where is the data?”
Similar to the Oxford-AstraZeneca and Johnson & Johnson vaccines, the Sputnik V uses two strains of adenovirus that typically cause mild colds in humans. Scientists genetically modified them to cause infected cells to make proteins from the spike of the new coronavirus.
But contrary to AstraZeneca and J&J’s vaccines, the Gamaleya Institute had not made data of the clinical trials widely available. In a normal development process, vaccine developers share these results in reports to government regulators and in peer-reviewed papers for scientific journals.
Three weeks after Putin’s surprise announcement, researchers working on the vaccine asserted that the Sputnik V yielded antibodies to the coronavirus and mild side effects.
Around the same time, on November 9, Pfizer and BioNTech released their preliminary analysis of the first COVID-19 cases; their vaccine seemed to meet the expectations.
The secrecy surrounding the data of the Sputnik V continued until, on November 11, the Russian financial company promoting the shot, the Russian Direct Investment Fund (RDIF), came up with the first concrete number: the vaccine had demonstrated 92 percent efficacy, based on preliminary results from the Phase III trial.
The approvals begin
That same month, in November, the Russian government began offering the Sputnik V within Russia in a mass inoculation campaign. Not long after, Belarus became the first outside country to register the shot.
According to German news outlet DW, the Sputnik V has been approved in 60 states today, including India, Mexico, Iran, the United Arab Emirates, Argentina and Venezuela. In Europe, Hungary and Slovakia have granted emergency approvals.
While Europe waits for EMA approval, countries in the developing world have ordered 1.2 billion doses of the Russian vaccine. And even today, there are reports that Russia has not yet made crucial primary data available to an independent drug testing authority.