Originally published 2020-07-17.
In mid-July 2020, the head of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, said Russia's COVID-19 vaccine was about to enter its final stage of testing and could be "possibly the first vaccine to be approved in the world". He was right about being first, though not in the way scientists would have wanted. Russia registered the vaccine, later branded Sputnik V, on 11 August 2020, after early trials on only 76 volunteers and before any large Phase III trial had begun.
Photo: Sputnik / Russian Defence Ministry.
What Russia announced in July 2020
The vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, with the Russian Ministry of Defence taking part in early testing on military volunteers. RDIF, Russia's sovereign wealth fund, financed and marketed it.
At the time, officials said Phase II would finish in early August and a Phase III trial would follow, partly abroad. Dmitriev said the third phase would run "not only in Russia" and that Russia expected regulatory approval in August or September. The defence ministry said no volunteers had suffered side effects, a claim that could not be checked independently because no data had yet been published.
RDIF also announced ambitious manufacturing plans: about 30 million doses at home in 2020 and around 170 million more abroad through partners, with Saudi Arabia among the countries named. Those figures were plans, not production numbers, and actual output in 2020 was reportedly much lower.
How the vaccine works
Sputnik V is an adenovirus vector vaccine. It uses harmless cold viruses that have been modified so they cannot replicate, and that carry the gene for the coronavirus spike protein. When the vector enters cells, they briefly produce the spike protein, and the immune system learns to recognise it.
Its unusual feature is that the two doses use different adenoviruses: Ad26 for the first shot and Ad5 for the second, given 21 days later. The idea is to avoid the body building immunity against the vector itself, which could weaken the second dose. A single-dose version, Sputnik Light, uses only the Ad26 component.
The approach is similar to the Oxford–AstraZeneca vaccine, which uses a chimpanzee adenovirus, and Johnson & Johnson's vaccine, which uses Ad26.
Why the race mattered so much in 2020
By mid-2020 more than a hundred vaccine projects were under way worldwide. Early serological surveys suggested that only a small share of people, often under 10% even in hard-hit places, had antibodies from past infection. Without a vaccine, reaching broad immunity through infection alone would have meant a very large number of deaths, even though estimates of the death rate among infected people varied widely at the time.
Testing a vaccine also requires the virus to be circulating. When cases fell in Britain in early summer 2020, the Oxford team expanded its trials to countries such as Brazil and South Africa, where transmission was higher. Russia said it would do something similar.
The leading Western candidates in July 2020 were the US Moderna vaccine and the Oxford University vaccine developed with AstraZeneca. Early Oxford results, published that month, showed both antibody and T-cell responses. AstraZeneca was already manufacturing at risk, with a stated aim of up to two billion doses, and there was speculation that the vaccine might be ready by autumn 2020. China had approved a CanSino vaccine for limited military use in June.
Registration before Phase III
When Russia's health ministry registered the vaccine on 11 August 2020, it did so under a conditional procedure with post-marketing requirements. President Vladimir Putin announced the decision, and the name Sputnik V was a deliberate nod to the 1957 satellite and the space race.
Scientists outside Russia were alarmed. A vaccine is normally approved only after a Phase III trial involving tens of thousands of people shows that it prevents disease and is safe in a large population. The Phase I–II results, published in The Lancet on 4 September 2020, covered just 76 participants. Outside researchers also questioned the data, pointing to suspiciously similar results across participants. A World Health Organization spokesperson said at the time that prequalification required a rigorous review of safety and efficacy data.
What the trial results later showed
The Phase III trial began in Moscow in September 2020. An interim analysis published in The Lancet on 2 February 2021 reported 91.6% efficacy against symptomatic COVID-19 after the second dose, with good results in older adults as well. Many scientists welcomed the findings as evidence that the vaccine worked.
Questions remained. In May 2021 a group of biostatisticians described discrepancies in the published data and doubted that efficacy could be so uniform across age groups. In 2022 another group argued the article should be retracted. The developers defended their data.
Where Sputnik V was used, and where it was not
Sputnik V was authorised in Russia and dozens of other countries; by 2021 it had been registered in about 70, including Argentina, Hungary, India and the United Arab Emirates. For many middle-income countries it arrived when Western vaccines were scarce.
It never won approval in the European Union. The European Medicines Agency began a rolling review in March 2021, but the process did not lead to authorisation, and the vaccine did not receive a WHO emergency use listing. Sanctions and the war in Ukraine from 2022 further reduced its international role.
What the episode teaches
Russia did become the first country to register a COVID-19 vaccine, and the vaccine itself appears to have been effective. But skipping the normal order of trials cost it trust abroad, and the arguments over its data never fully went away. Meanwhile, the Moderna, Pfizer–BioNTech and Oxford–AstraZeneca vaccines, approved after full Phase III results from late 2020, became the most widely used in Europe and North America.
The lasting lesson is that speed and credibility both matter. Being first counts for little if regulators and the public cannot see the evidence. In the end, every vaccine that helped bring the pandemic under control did so because of cooperation, transparent data and large trials, whichever country produced it.
Sources: Wikipedia: Sputnik V COVID-19 vaccine; Kirill Dmitriev's July 2020 remarks as reported by RT; photo: Sputnik / Russian Defence Ministry.
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