Last Updated on October 31, 2021 by The Health Master
Dr Reddy’s on Friday said it plans to launch separate clinical trials of the single shot Sputnik Light vaccine on children as well as using it as a booster for other vaccines.
The company said it plans to begin both the trials in November.
The drug maker said it is in the midst of finalising the protocol to begin the trials on children and adolescents which will have two cohorts one for 12-18 years and 2-12 years age groups.
“The dosing requirement is likely to be different for two cohorts,” said Deepak Sapra, CEO of API & Services, Dr Reddy’s, to media. Sputnik Light is also being tested on children in Russia against C-19.
On booster, the company said it has finalised the protocol. The company intends to use the booster with a gap of six months.
The company is currently conducting a phase-3 bridging trial for the single shot Sputnik Light vaccine, and said it plans to submit the data to the regulator in November to seek approval.
Despite soft demand for the vaccine in the private market, Dr Reddy’s said it still believes Sputnik is a relevant product for the company. Around 1.1 million Sputnik doses have been administered. India administered 1.09 billion doses as on November 29.
“The future of Sputnik is Sputnik Light which will be a single dose vaccine, .. in addition the booster and the pediatric (use) are the two other components of lifecycle strategy. Besides India we are also in discussions with our partner (RDIF) to take Sputnik to several other countries in Latam, Africa and Asia Pacific,” Sapra added.
Sapra said the company is having discussions with the government on supply of the locally manufactured Sputnik Light vaccine. The company said out of six manufacturing sites producing Sputnik V, four have begun manufacturing on the first component, and only two have initiated the second component.
Dr Reddy’s Laboratories, which holds the sole distribution rights for the first 250 million doses of the Sputnik V and Sputnik Light vaccines in India, as per its agreement with the Russian Direct Investment Fund.
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