The Russian Direct Investment Fund (RDIF) claimed that its Covid-19 vaccine Sputnik Light, a single dose shot or the first dose component of Sputnik V vaccine shows 70 per cent efficacy against the Delta variant of the Sars-CoV-2 virus. In people under 60 years, the vaccine is even more effective at 75 per cent, the RDIF said.
The developer of the vaccine, Gamaleya Center, has submitted an article analysing Sputnik Light's efficacy against the Delta variant, to the medRxiv preprint server for health sciences for publication this week.
Speaking to the media from Moscow, Kirill Dimitriev, CEO, RDIF, said, “Sputnik Light has demonstrated a superior efficacy compared with some two-shot vaccines, which have shown a major decline in efficacy against the Delta variant to less than 50 percent five months after injection.”
Standalone use of Sputnik Light also provides much higher efficacy against severe disease and hospitalisations, RDIF claimed. “The analysis was conducted based on data from 28,000 participants who had received a single dose of Sputnik Light, compared with a control group of 5.6 million individuals who were not vaccinated. The data used in the study was collected in July 2021 in Moscow,” it said in a statement.
The two-dose Sputnik V vaccine shows efficacy over 83 per cent against infection and over 94 per cent against hospitalsation.
Dimitriev said that Sputnik Light can thus act as a booster shot for even those who have been vaccinated with other vaccines like mRNA candidates. “We are working with AstraZeneca, Sinopharm and Moderna to test a mix-and-match approach of two different vaccines,” he added.
RDIF has 20 manufacturing partners across 10 countries and almost 50 percent of the Sputnik vaccine production happens outside Russia.
As such in India, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation has recommended the conduct of Phase III clinical trials of Russia’s single dose COVID-19 vaccine Sputnik Light in September. Dr Reddy’s Laboratories (DRL), RDIF’s partner here had presented updated safety, immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct the clinical trial in India.
The SEC has asked DRL to assess primary endpoints of the trials at day 42, 90 and 180 and interim analysis can be conducted at the day 42 as this data was not generated during the Sputnik V trial in India after the first dose, which was stated to be available up to day 21 only.
Sputnik V has got emergency use authorization in India. Meanwhile, Hetero has got permission to export 4 mn doses of Sputnik V out of India.