Mounting evidence suggests Sputnik COVID vaccine is safe and effective

Russia’s COVID-19 vaccine, Sputnik, has been the subject of fascination and controversy since the Russian government authorized its use last year, before early-stage trial results were even published. Evidence from Russia and many other countries now suggests it is safe and effective — but questions remain about the quality of surveillance for possible rare side effects.

Sputnik V — also known as Gam-COVID-Vac — was the first COVID-19 vaccine to be registered for use in any nation, and it has since been approved in 67 countries, including Brazil, Hungary, India and the Philippines. But the vaccine — and its one-dose sibling Sputnik Light — has yet to receive approval for emergency use from the European Medicines Agency (EMA) or the World Health Organization (WHO). Approval by the WHO is crucial for widespread distribution through the COVID-19 Vaccines Global Access (COVAX) initiative, which is providing doses for lower-income nations.

Developed by scientists at the Gamaleya National Research Center of Epidemiology and Microbiology in Moscow, the vaccine was authorized for use by the Russian Ministry of Health on 11 August 2020, more than a month before phase I and II trial results were published, and before the phase III trial had even begun.

The scientific community greeted Russian President Vladimir Putin’s announcement of the vaccine’s registration with outrage. “If the government’s going to approve a vaccine before they even know the results of the trial, that does not build confidence,” said epidemiologist Michael Toole at the Burnet Institute in Melbourne, Australia.

Access to full data

Some of that concern was allayed when the phase III trial results¹, published in February by the vaccine’s developers, suggested that it is 91.6% effective at preventing symptomatic COVID-19 infection and 100% effective at preventing severe infection. However, some scientists criticized the authors for failing to provide access to the full raw data from the early-stage trials, and also voiced concerns about changes in the vaccine’s administration protocol and inconsistencies in the data.

Researchers highlight ‘questionable’ data in Russian coronavirus vaccine trial results

The authors responded by saying that they had provided the regulatory authorities with all the data necessary for obtaining approval, and that the data included with the paper² were enough for readers to confirm the reported vaccine efficacy. They also addressed the protocol queries, and said numerical inconsistencies were “simple typing errors that were formally corrected”.

Despite the absence of approval from the EMA or the WHO, several countries, including South Korea, Argentina and India, are already manufacturing Sputnik V. And India plans to pump out at least 850 million doses, to help speed up the vaccination of its embattled population. Many other countries, such as Hungary and Iran, are importing Sputnik V, and it has become a key plank of their vaccination campaigns.

But it hasn’t all been plain sailing. Brazil’s health regulator rejected an application to import Sputnik V in April over concerns at a lack of data on safety, quality and effectiveness. That decision was reversed in June, but the vaccine has been approved only for healthy adults.

Two viral vectors are better than one?

Sputnik V is an adenovirus vaccine, which means that it uses an engineered adenovirus — a family of viruses that generally cause only mild illness — as a delivery mechanism for inserting the genetic code for the SARS-CoV-2 spike protein into human cells.

It is similar to the Oxford–AstraZeneca and Johnson & Johnson vaccines. But instead of using one engineered adenovirus, as those two vaccines do, Sputnik V uses different adenoviruses, called rAd26 and rAd5, for the first and second doses, respectively.

Dmitry Kulish, a biotechnology researcher at the Skolkovo Institute of Science and Technology in Moscow, who is not involved in the development of Sputnik V, says the scientific reasoning would have been to increase efficacy. The two adenoviruses have slightly different methods of introducing their genetic material into a host cell, he says, which would theoretically improve the success rate of getting the viral genetic material where it needs to go.

The two preliminary studies from the vaccine developers, published in September 2020², involved 76 healthy adults who received the two doses with different viral vectors three weeks apart. All participants produced antibodies to the SARS-CoV-2 spike protein, and adverse events reported were mainly mild pain at the injection site, fever, headache, fatigue and muscle aches — adverse events typical of other SARS-CoV-2 vaccines.

Can Cuba beat COVID with its homegrown vaccines?

Nature 595, 339-340 (2021)

doi: https://doi.org/10.1038/d41586-021-01813-2

Related Articles

• Can Cuba beat COVID with its homegrown vaccines?

• Six months of COVID vaccines: what 1.7 billion doses have taught scientists

• China’s COVID vaccines are going global — but questions remain

• Researchers highlight ‘questionable’ data in Russian coronavirus vaccine trial results

Subjects

• Epidemiology
• Vaccines
• SARS-CoV-2

Latest on:

Epidemiology

Why a teenager’s bird-flu infection is ringing alarm bells for scientists

News Explainer 20 NOV 24

Diabetes risk soars for adults who had a sweet tooth as kids

News 31 OCT 24

Lethal Marburg virus is on the rise in Rwanda: why scientists are worried

News 08 OCT 24

Vaccines

This malaria vaccine is delivered by a mosquito bite

News 20 NOV 24

Evolving antibody response to SARS-CoV-2 antigenic shift from XBB to JN.1

Article 07 NOV 24

Mumps is rising in some nations — but a fresh dose of vaccine might help

Research Highlight 14 OCT 24

SARS-CoV-2

US trust in scientists plunged during the pandemic — but it’s starting to recover

News 14 NOV 24

Design of customized coronavirus receptors

Article 30 OCT 24

How long COVID could lift the fog on neurocognitive disorders

Nature Index 02 OCT 24