Single-dose Sputnik Light gets nod for phase 3 trials
New Delhi: In an important development, the single-dose Covid-19 vaccine Sputnik Light has received approval from the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) to conduct phase 3 bridging trials in India.
According to the apex drug controller, the committee has noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of the persistence of antibodies in the participants. Notably, last year, Hyderabad-based Dr Reddy's Laboratories had partnered with the Russian Direct Investment Fund (RDIF) to conduct phase 3 trials of the vaccine. After the company submitted safety, immunogenicity and efficacy data, the SEC granted permission for conducting the trials in India.
However, as per sources, the first batch of Sputnik vaccine, which has been manufactured by Panacea Biotec, has been sent for quality and safety validation and the enrollment of participants for the trial may begin soon. According to the manufacturers of Sputnik Light, the vaccine has shown the efficacy of 79.4 per cent and if it is approved in India, Sputnik Light would be the first single-dose vaccine to be used in the country.