Russia will seek authorisation from SA’s medicines regulator for its single-shot Sputnik Light coronavirus vaccine after a study showed it is 70% effective at preventing transmission of the Delta variant three months after inoculation.
Sputnik Light is the first component of the two-shot Sputnik V vaccine, developed by the Gamaleya National Research Centre of Epidemiology and Microbiology with backing from the Russian Direct Investment Fund (RDIF). It has been authorised as a stand-alone vaccine in more than 15 countries, while Sputnik V has been approved in 70 countries.
The new data, announced on Wednesday, comes as Russia struggles to get its vaccines approved by the key agencies that the SA Health Products Regulatory Authority (Sahpra) works with closely, including the World Health Organisation, the US Food and Drug Administration and the European Medicines Agency. It is also battling to gain traction in markets where shots made by Pfizer, AstraZeneca and Moderna are well-established and in some cases are already being offered as boosters.
Lamar International, the local representative for the vaccines, was preparing to submit a dossier to the South African Health Products Regulatory Authority (Sahpra) for Sputnik Light, operations director Naz Gamieldien said.
RDIF said in a statement that the study included 28,000 participants who received a single dose of Sputnik Light in July 2021 in Moscow and were compared with 5.6-million unvaccinated people. The study has yet to be published in a peer review journal, but is expected to be published in the health sciences preprint server MedRxiv later this week.
The efficacy of Sputnik Light as a booster shot against Delta would be close to the efficacy of the Sputnik V vaccine, which had a demonstrated 83% efficacy against infection and more than 94% against hospitalisation, the RDIF said.
“We believe Sputnik Light is positioned to be a universal booster for many vaccines, given its incredibly high efficacy against Delta,” said RDIF CEO Kirill Dmitriev. But it could also be used as a stand-alone shot, he said.
Gamaleya Centre deputy director Denis Logunov said Sputnik Light had outperformed many double-shot vaccines, including mRNA jabs.
“The Delta variant is one of the most common and dangerous strains. The data analysis presented by the Gamaleya Center demonstrates that Sputnik Light remains highly effective months after vaccination,” he said. “The results obtained during the study significantly exceed those of some other vaccines, as previously published in scientific media.”
Dmitriev said the RDIF aimed to manufacture more than 700-million doses of Sputnik V and Sputnik Light, but more than half the production would take place outside Russia.
“We are not trying to have a monopoly or have huge market share in any country we go to. We believe each country needs different vaccine technologies and producers as this reduces risk,” he said.
RDIF had entered into technology transfer agreements with more than 20 pharmaceutical manufacturers, and expected the jabs would be produced in at least another 10 countries, he said.
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