The one-component vaccine Sputnik Light has been certified by the Drug Controller General of India (DCGI), the vaccine's investor - the Russian Direct Investment Fund (RDIF) stated.
"Authorisation of Sputnik Light in India is another major step in the successful cooperation between Russia and India in the fight against COVID. Sputnik Light has proven to be safe and effective both as a standalone vaccine and a universal booster shot to vaccines of other producers, helping to induce a stronger immune response as compared to two shots of the same vaccine. The heterologous boosting approach using Sputnik Light is the solution to increase the efficacy and duration of other vaccines, including against the Omicron variant", RDIF CEO Kirill Dmitriev said.
According to a study by the Gamaleya Centre, Sputnik Light provides strong protection against COVID, including the Omicron strain. A preliminary study by the vaccine manufacturer has found that Sputnik Light as a booster significantly increases virus-neutralising activity against Omicron, which is comparable to the titers observed after Sputnik V against the wild-type virus, and is associated with high levels of protection.
Dr Reddy's Laboratories, a major partner of the RDIF in India, has also conducted local clinical trials of Sputnik Light in India. The results of the trials contributed to the regulator's decision to certify the vaccine.
Per the data collected by the Lazzaro Spallanzani National Institute for Infectious Diseases in Italy and results of other studies, heterologous ("mix & match") boosting with Sputnik Light is the best solution to increase other vaccines' efficacy.
A vial labelled "Sputnik V coronavirus disease (COVID-19) vaccine" is seen in this illustration picture taken on 2 May 2021.
© REUTERS / DADO RUVIC
The RDIF has also filed for registration of Sputnik M, a vaccine for adolescents aged 12-17, which was registered by the Russian Health Ministry in November 2021. If approved by Indian regulators, Sputnik M could become the first registered vaccine for adolescents in the country.
Sputnik Light, which has so far been approved in over 30 countries with a total population of over 2.5 billion, as well as Sputnik V, which is authorised in 71 countries, were created on the basis of a human adenoviral vector platform. The latter has been widely used in immunology for the past three decades.