Russia's Single-Dose Sputnik Vaccine Gets Approval Without Completing Safety Testing
Russia has approved a single-dose version of its two-dose Sputnik V vaccine without completing safety testing under scientific protocols, the Associated Press reported.
Under Russian authorities' approval, the new Sputnik Light vaccine will be marketed and given separately alongside the country's existing COVID-19 vaccines. Human testing of Sputnik Light began in January.
Studies on human trials of Sputnik Light are still underway and the dose is the same as Sputnik V's first dose.
Sputnik V will be Russia's primary vaccine, according to Russian Direct Investment Fund (RDIF) CEO Kirill Dmitriev, whose organization backs the vaccine financially.
He said Sputnik Light will be exported "to our international partners to help increase the rate of vaccinations in a number of countries in the face of the ongoing fight with the pandemic and new strains of coronavirus."
"As Sputnik Light is the first shot of Sputnik V vaccine, its safety is proven through extensive clinical trials of both Sputnik V and Sputnik Light," an RDIF spokesperson told Newsweek on Thursday. "Sputnik V and its first shot Sputnik Light also extensively demonstrated safety in vaccinations of more than 20 million people around the world."
Sputnik Light is the fourth vaccine Russia has created and approved alongside EpiVacCorona and CoviVac.
Dmitriev said Thursday in a statement that "the single dose regimen solves the challenge of immunizing large groups in a shorter time, which is especially important during the acute phase of the spread of coronavirus, achieving herd immunity faster."
For more reporting from the Associated Press, see below.
"It's nice to know that this range of tools (against COVID-19) is expanding," Russian President Vladimir Putin said.
Russian authorities argued that approving Sputnik Light could accelerate the process of achieving herd immunity against the coronavirus.
Russian Health Minister Mikhail Murashko said authorizing a fourth jab will help speed up the process of forming herd immunity against the virus. Most scientists believe at least 70% of a population needs to be immunized to achieve herd immunity against COVID-19, but the exact threshold is still unknown.
Russia faced criticism last year for authorizing Sputnik V before advanced trials had even started and for offering it to medical workers while those trials were underway. The criticism was blunted by a study published in February in the British medical journal The Lancet, which said the vaccine appeared safe and 91% effective against COVID-19 based on a trial involving about 20,000 people in Russia.
EpiVacCorona and CoviVac also received regulatory approval before completing large-scale testing. No data on the efficacy of the vaccines has been released.
Despite having several vaccines available and being one of the first countries to start immunizing its population, Russia is currently lagging behind a number of nations in terms of its vaccination rates.
According to Deputy Prime Minister Tatyana Golikova, 13.4 million people in Russia, or just 9% of Russia's population of 146 million, had received at least one dose of a COVID-19 vaccine as of Thursday, while 9.4 million—6% of the population—have been fully vaccinated.
Experts have questioned whether Russia will be able to meet the government's targets of vaccinating 30 million people by mid-June and nearly 69 million by August.
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