Drugs Controller General of India (DGCI) has granted emergency use permission to single-dose Sputnik Light Covid-19 vaccine in India, tweeted Union Health Minister Dr Mansukh Mandaviya

This is the ninth Covid-19 vaccine approved in India.

Two days ago, an expert panel of the Central Drug Standard Control Organisation (CDSCO), had recommended granting restricted Emergency Use Authorisation (EUA), to the single-shot Covid-19 vaccine Sputnik Light, subject to conditions.

Sputnik Light is the same as component-1 of Sputnik V.

According to an official source, in light of the recommendations made during an SEC meeting on January 31, Dr Reddy's Laboratories presented its proposal for grant of permission to import Sputnik Light for a restricted use in an emergency situation and booster-dose vaccination, along with the analysis of the latest safety and efficacy data, including its benefits against the Omicron variant of the Covid-19.

 "The Subject Expert Committee (SEC) on Covid-19 of the CDSCO, noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the ongoing phase-3 clinical trial interim data from Russia," the source said.

Sputnik Light is based on recombinant human adenovirus serotype number 26 (the first component of Sputnik V). A one-shot vaccination regimen of Sputnik Light provides for ease of administration and helps to increase efficacy and duration of other vaccines when used as a booster shot.

Clinical studies and the real-world data in many countries have demonstrated Sputnik Light is a safe and effective vaccine when used both on a standalone basis and as a booster.

A study in Argentina on heterogeneous regimens combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino has demonstrated that each “vaccine cocktail” combination with Sputnik Light provided higher antibody titer on 14th day after administering the second dose as compared to original homogenous (same vaccine as first and second dose) regimens of each of the vaccines.

Sputnik Light will add to India’s national vaccine portfolio and join Sputnik V, which was approved in the country in April 2021. India is the leading production hub for Sputnik V.

Sputnik V and Sputnik Light are based on a safe and effective human adenoviral vector platform and have not been associated with rare serious adverse events following vaccination, such as myocarditis or pericarditis. The highest safety and efficacy of Sputnik V and Sputnik Light was demonstrated in more than 30 studies and real-world data from more than 60 countries.

Sputnik V has been authorized in 71 countries with total population of over 4 bn people. To facilitate the necessary production capacities, RDIF has reached agreements with the leading Indian pharmaceutical companies, including Serum Institute of India - the world’s largest vaccine producer, as well as Gland Pharma, Dr Reddy’s, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen.