When Russia announced this week that its highly hyperactive COVID-19 vaccine was up to 95 percent effective, it had the predictable fun news in Russia and uncertainty throughout much of Europe and North America.
“This is great news for Russia and great news for the world,” gushed Kirill Dmitriev, head of the Russian Direct Investment Fund, which is pouring countless millions of Russian tax dollars into developing the vaccine it labeled early like Sputnik V.
Whether the V stands for “five” or simply the letter “V” has never been fully explained, but either way the association is clear: the original Russian Sputnik satellite won the space race more than 60 years ago, and this new Sputnik will make Russia the first in this new race to defeat the pandemic.
With its hyperbolic announcements and ambitious schedule – some would say unachievable – the Putin government has sought to demonstrate the development of Sputnik V making Russia a vaccine superpower.
WATCHING Russia claims its COVID-19 vaccine is highly effective:
Already, among the alleged “firsts” Russia claims: the first COVID vaccine in the world to be registered; the first vaccine anywhere to be announced as part of a national vaccination campaign; and results of trials that rate it first in terms of effectiveness.
Not to get too old, when Pfizer and BioNTech became the first Western vaccine manufacturer to announce promising results, with 90 percent effectiveness, days later Sputnik V makers said their vaccine was even better – by two percentage points.
Some Western experts have felt openness about the Russian approval process, as well as a rush to register it even before trials begin, damaging the vaccine’s credibility from the outset.
Russia licensed it based on early trials involving only 76 people, but most approvals usually come after Phase 3 studies involving tens of thousands of subjects.
Even after those early results were published in the highly regarded medical journal The Lancet, a group of 37 scientists from 12 countries wrote the publication questioning the data.
Russian officials and state media pundits have decrypted the suspicion as evidence of an inherent “Western bias” against anything in Russian and accused the US and UK media of conducting a smear campaign to rob potential international customers away.
Fast forward to this week and news from Sputnik developer, Gamaleya Epidemiology and Microbiology Research Institute, of very positive results from a much larger data sample.
Russian vaccine has 91.4 percent efficacy from analysis of more than 18,000 people, says a statement on Sputnik’s website V. The vaccine’s effectiveness rose to 95 percent after 42 days.
Also, at around $ 20 US per person, Gamalyea says the Russian vaccine is one of the cheapest on the market, making it an attractive option for poorer countries with large populations.
Like the vaccine developed by Oxford University and its partner AstraZeneca, the Russian vaccine uses human adenovirus vectors, or common cold genes, to trigger an immune response in the body. An initial shot is followed by a reinforcement three weeks later.
News of the results prompted a change in tone from many Western vaccine experts.
“The data [is] is compatible with the vaccine reasonably effectively, “said Stephen Evans, professor of pharmacepidemiology at the London School of Hygiene and Tropical Medicine.
“These results are consistent with what we are seeing with other vaccines, because the really big message to global health scientists is that this disease [COVID-19] can be tackled through vaccines. “
Ian Jones, professor of virology at the University of Reading, agrees.
“I see no reason to doubt it [the results], “Jones told CBC News in an interview.
“I agree that their initial results caused consternation, but I don’t think that’s because they were not valid. They were released a little soon.
“I think it will be a useful vaccine.”
Their positive assessments are based on the knowledge that the adenovirus distribution method behind the Gamaleya-made vaccine has repeatedly proven successful.
What was unclear was whether the COVID-19 virus would be resistant, but Evans says the positive results from the other drug companies strongly suggest that the Russian vaccine is likely to perform well as well.
“We now have four vaccines that have some efficacy [on COVID-19], which is far beyond what we have ever had for an HIV or malaria vaccine, “said Evans.
A question of trust
Ultimately, it says whether a country chooses to buy the Russian-made vaccine depending on whether they have confidence in the science behind it and trust the regulators who approved it.
The Russian vaccine is being treated more suspiciously, Evans said, because the processes in the United States and Europe are far more open and transparent than they are in Russia.
“We don’t know how carefully their trials are monitored and how carefully they are reported. We don’t know that,” he said.
“But the countries that buy it buy it on trust that the Russians have produced something.”
Enrico Bucci, an Italian biologist who was part of the original group of scientists who questioned early Russian results, is among those who continue to believe that Russian developers have not been sufficiently transparent about their data.
For example, he says the claim of 91.4 percent success is based on only 39 people in the 18,000-person sample contracting COVID-19.
“The sample is too low to claim any percentage of effectiveness,” Bucci told CBC News.
Moreover, he said, it is not clear where these 39 people came from, how old they were and whether trial results in one country were mixed with those from another location.
The Oxford University / AstraZeneca vaccine – which reported a success rate of around 70 percent – has been subject to similar criticism about how data from its trials was presented, and its developers have now agreed to conduct new studies.
To date, Hungary is the only member of the European Union to register for the vaccine in Russian, although Russian media indicate that 50 nations have either signed or are in the process of signing deals for the vaccine .
On Friday, Russia announced a partnership with the Indian pharmaceutical company Hetero to produce 100 million doses of the vaccine by the end of 2021.
Canada has announced signed agreements with five vaccine manufacturers, but the list does not include Sputnik V.
Gamalyea’s initial estimates that Russia would be able to produce 200 million doses of Sputnik V by the end of next month were very optimistic. The health ministry now says it could produce two million doses, at best.
Russians are uncertain
Since the summer, the Russian Ministry of Health has been promising that a national vaccination campaign is imminent, but it has been slowly rolling out.
President Vladimir Putin said one of his daughters was among the first to receive the vaccine, although the Kremlin acknowledged this week that Putin himself has not done so.
A spokeswoman said it would be irresponsible for the head of state to take a “non-certified” vaccine, though the difference the officer was trying to make between a registered and a certified vaccine is unclear.
Moscow’s mayor has said authorities are planning to set up 300 vaccination centers in December and the plan is to make as many people in the capital as vaccinated possible.
Independent public opinion polls suggest that many Russians remain uncertain about the vaccine and whether they will actually take it. In early November, the Levada Center polling group noted that 59 percent of Russians could refuse to be vaccinated.
On Russian state television, however, criticisms or penetrating questions about any of the assumptions underlying the government’s claims about Sputnik V have been largely absent.
As is standard on TV talk shows, the discussion is framed in geopolitical terms.
Their 60 Minutes a program (not related to the US program of the same name) even quoted the WBQ News report by The National as an alleged proof of Western prejudice, with the host suggesting it was an example of “active propaganda” against Sputnik V.
In fact, the report contained comments from Professor Evans, the British expert, suggesting that the vaccine worked and was most likely effective. But his clips were cut from what was shown on Russian television.