Russia authorizes single-shot Sputnik Light; to be produced in India
Health officials in Russia have authorized a single-shot COVID-19 vaccine, Sputnik Light, the developers of the shot said on Thursday. The vaccine has been developed by Russia's Health Ministry, the Gamaleya National Research Center of Epidemiology and Microbiology, and the Russian Direct Investment Fund (RDIF). India will be among the countries where this new shot will be produced in the coming months.
The vaccine's developers said in a statement that Sputnik Light has demonstrated 79.4% efficacy, according to an analysis of data gathered 28 days after the shot was administered under Russia's mass vaccination drive between December 2020 and April 2021. The Gamaleya Center has also demonstrated during laboratory testing that Sputnik Light is effective against all new strains of the coronavirus.
Phase I and II of the safety and immunogenicity study of Sputnik Light had demonstrated that it can elicit the development of antigen-specific IgG antibodies in 96.9% of individuals on the 28th day after vaccination. It elicits the development of virus-neutralizing antibodies in 91.67% of individuals on the 28th day after immunization. No serious adverse events were recorded after vaccination with Sputnik Light.
After 28 days of vaccination, an infection rate of 0.277% was recorded among vaccination subjects. The infection rate among unvaccinated adults was 1.349% among unvaccinated subjects. The interim results of Phase III trials are expected in May.
RDIF CEO Kirill Dmitriev said, "Sputnik Light makes a greater booster shot with other vaccines. We are doing trials with AstraZeneca but it can also be used with others. It can be a booster shot to upgrade other vaccines for all mutations, subject to additional trials." The vaccine's cost will be under $10 globally. It can also be stored at temperatures of 2-8°C.
Speaking at a press conference, Dmitriev said Sputnik Light resulted in "100% protection against severe infections." "Sputnik V will be the core vaccine while Sputnik Light will be cheaper and more affordable, and ensure that more people can be vaccinated quickly. Sputnik Light will be registered in several countries by next week and we are talks with regulators in several countries," he said.
Dmitriev further said Sputnik Light works well against all existing mutations of the coronavirus as it "includes all the mutations in its code." Sputnik Light can also be used as a booster shot for other vaccines and trials are currently underway with AstraZeneca, he said.
"We hope that the 64 countries that have registered Sputnik V (the two-dose vaccine) will also register Sputnik Light," Dmitriev said. He said they have partnerships with over 20 producers—who will make both versions of the vaccine—in 10 countries including India, South Korea, and China. Sputnik V has been granted approval for emergency use by India's drug controller.