Dr. Reddy’s Laboratories plans to approach the Drugs Controller General of India (DCGI) seeking permission to conduct trials of Russian COVID-19 vaccine Sputnik in children as well as a booster shot for vaccinated adults.
“Planning to do this soon and expect we will be able to commence the trials in November,” CEO-API and Services Deepak Sapra said. Next month is also when the marketing partner and brand custodian of Sputnik V in India expects to submit results of clinical trials for Sputnik Light, the single dose vaccine, to the regulator.
Asserting that the vaccine — the DCGI had accorded EUA for the two-dose Sputnik V in April — continued to be relevant for India’s inoculation programme, Mr. Sapra said 1.1 million doses had been administered thus far. He, however, admitted that a mismatch in the availability of the two different components of the vaccine and supplies from Russia getting impacted posed challenges previously. However, with a clutch of firms in the country getting into manufacturing of the vaccine, majority of products would be made in India, he said during a virtual media interaction on Friday.
Of the six manufacturing sites for Sputnik in India, three had moved to manufacturing the component 1, while two were in a position to manufacture component 2. “This is in addition to supplies which are anyway available from Russia,” he said.
Sputnik Light, the first component of Sputnik V, would be the future as the single dose vaccine could help inoculate more people. On approval, it would also be used as a booster shot and for children. While the protocol for booster shot had been finalised and the company was in discussion with the DCGI for initiating the trials, for paediatric use the protocol was yet to be readied. The plan was to have two cohorts for the trial on children aged 2-12 and 12-18. The dosing requirements were likely to be different for the two groups.
To queries on the booster shot, Mr. Sapra said a six-month gap from the second dose of vaccination was being proposed. Sputnik as booster would also be for those who had taken any other COVID-19 vaccine. Dr. Reddy’s had also approached the Centre from a perspective of exploring the possibility of administering Sputnik in the national programme in the backdrop of softening of the demand for vaccines in the private healthcare sector.
The company is also hopeful of completing trials for Merck’s anti-COVID-19 oral drug Molnupiravir this fiscal. “Most of the subjects are recruited,” he said.
