Originally published 2020-08-12.
On 11 August 2020, President Vladimir Putin announced that Russia had registered the world's first Covid-19 vaccine, developed by Moscow's Gamaleya Research Institute and branded Sputnik V. The approval came before any large late-stage (phase 3) trial had been completed: at that point the vaccine had been tested in only 76 volunteers in two small early trials. Scientists and the World Health Organization warned that safety and effectiveness had not been shown.
Months later, a phase 3 trial published in The Lancet reported about 91.6% efficacy against symptomatic illness. So the vaccine did turn out to work, but the way it was approved remains a textbook example of why the order of steps in drug regulation matters. This is what happened, and what came after.
What Russia announced in August 2020
Putin made the announcement at a televised government meeting. He told officials that a coronavirus vaccine had been registered in Russia that morning, called it a world first, and said one of his daughters had taken part in testing and had a brief, mild fever. The registration was conditional: the Health Ministry approved it with the requirement that larger studies continue after the vaccine was already in use.
Health Minister Mikhail Murashko said vaccination would be voluntary and would start with groups at higher risk of exposure, especially medical workers and teachers. The plan at the time was to begin wider civilian use within months.
The official name was Gam-COVID-Vac. The brand name, chosen by Russia's sovereign wealth fund (RDIF), recalls Sputnik 1, the Soviet satellite that became the first artificial object in orbit in 1957. The choice made the space-race comparison deliberate.
How Sputnik V works
Sputnik V is a viral vector vaccine, the same broad type as the Oxford-AstraZeneca and Johnson & Johnson shots. It uses harmless, non-replicating adenoviruses (common cold viruses) to carry the gene for the coronavirus spike protein into the body's cells, which then prompt an immune response.
Its distinctive feature is that the two doses, given 21 days apart, use two different adenoviruses: type 26 for the first shot and type 5 for the second. The idea is that the immune system is less likely to attack the second carrier virus before it can deliver its cargo. A single-dose version, Sputnik Light, later used only the first component.
Why skipping phase 3 alarmed scientists
Vaccine trials normally move through three stages. Phase 1 tests safety in a few dozen people, phase 2 checks immune responses and dosing in hundreds, and phase 3 enrols tens of thousands, comparing vaccinated people with a placebo group to see whether the vaccine actually prevents disease and to catch rarer side effects. In summer 2020 the leading Western candidates, including the Oxford vaccine and Moderna's, had only just begun their phase 3 studies.
Russia's approval came after phase 1 and 2 data from 76 participants, and those results had not yet been published. Researchers such as Francois Balloux, Paul Offit and Peter Openshaw said publicly that registering a vaccine without efficacy data was premature and risky. A WHO spokesperson noted that any vaccine would need rigorous review of its safety and efficacy data before prequalification. Svetlana Zavidova, head of a Russian association of clinical trial organisations, wrote to the health minister urging a delay and warned that trial rules are "written in blood."
At the time Russia had reported close to 900,000 confirmed cases, among the highest totals in the world, and there was strong political pressure to be first.
What the trials later showed
The early-phase results were published in The Lancet in September 2020. A large randomised, placebo-controlled phase 3 trial, planned for about 40,000 volunteers in Moscow, began afterwards. Interim results published on 2 February 2021 reported 91.6% efficacy against symptomatic Covid-19 after the second dose, with similar figures in older adults.
Real-world studies were broadly encouraging. Data from Argentina, Mexico, the UAE and Moscow pointed to strong protection against hospitalisation and death, though protection against infection was lower against the Delta variant.
There were also open questions. In May 2021 independent statisticians wrote to The Lancet pointing to data inconsistencies and implausibly uniform efficacy across age groups; the authors said these were typing errors that had been corrected. Some researchers called for a fuller investigation in 2022. At home, Russia's vaccination drive was widely reported to have been held back by public hesitancy.
Global approvals, rejections and politics
Sputnik V became a major tool of Russian diplomacy. Argentina and Belarus authorised it in December 2020, and Hungary became the first EU country to do so in January 2021. By spring 2021 dozens of countries had approved it, including India, Iran, the Philippines and Turkey. Licensed production was set up in several countries, including India and Brazil.
Other regulators were more cautious. The European Medicines Agency began a rolling review in March 2021 but never approved it, and the WHO did not add it to its emergency use list. Brazil's regulator, Anvisa, initially rejected imports in April 2021, citing concerns about replicating adenovirus in some batches and incomplete data; Gamaleya disputed the findings. In Slovakia, a secret purchase of doses helped trigger the resignation of Prime Minister Igor Matovič, and most of the doses were later returned.
After Russia's invasion of Ukraine in February 2022, Western sanctions on RDIF further limited the vaccine's reach. By then fewer than 2.5% of vaccinated people worldwide had received a Sputnik V dose.
What the Sputnik V story teaches
- Order matters. A vaccine can turn out to be effective and still have been approved too early. Phase 3 evidence exists to show that before mass use, not after.
- Transparency builds trust. Unpublished data, later corrections and limited access for inspectors made foreign regulators and many Russians hesitant, even after positive results.
- Being first is not the same as being best. Several vaccines approved later reached far more people worldwide.
- Personal decisions belong with a doctor. Anyone with questions about Covid-19 vaccines, including which ones are available and suitable for them, should talk to a doctor.
Sources: Wikipedia: Sputnik V COVID-19 vaccine; CNBC, 2 February 2021: Sputnik V 91.6% effective in late-stage trial, The Lancet says; Svetlana Zavidova quoted by Business Today.
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