A Subject Expert Committee that advises the Drugs Controller General of India has asked Dr. Reddy’s Laboratories to submit data from Phase III clinical trial of Sputnik Light being carried out in Russia for grant of Marketing Authorisation (MA) of the single dose vaccine against COVID-19.
The panel said this observing that there was no need for a separate Phase III trial of Sputnik Light in India since the safety and immunogenicity data has been generated during the two-dose Sputnik V trial in India. Sputnik Light is the first component of Sputnik V and its efficacy is said to be 79.4%.
“The firm should present the safety, immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light that is being carried out in Russia for considering the proposal for grant of MA in the country,” the SEC meeting on Wednesday recommended to Dr. Reddy’s Laboratories.
Brand custodian of Sputnik vaccine in India, the Hyderabad-based pharma major had presented the Phase III clinical trial protocol as well as the interim safety and efficacy data generated from Phase I/II clinical trial in Russia while seeking the MA.
“Sputnik Light is same as component-I of Sputnik V. The firm has already generated safety and immunogenicity of component-I in the country,” the SEC said, noting that Phase III efficacy trial is on in Russia and the efficacy data was yet to be generated. As the safety and immunogenicity data of component-I in Indian population has already been generated in another trial, there seems to inadequate justification in conducting a separate similar trial, the expert committee said.
Sputnik V is the third vaccine approved for use by India and Dr. Reddy’s had launched a limited pilot launch of the vaccine in May.
