Hyderabad: In a significant development that can accelerate the launch of a single dose sputnik lights in India, the Subject Expert Committee (SEC) from the Central Medicine Standard Control Organization (CDSCO) has notified the Laboratories Dr.
Reddy that it does not need to conduct a separate phase-III trial In India for vaccines only with data from the Russian trial phase-III is enough for marketing authorization.
“After the detailed consideration of the Committee recommends that the company must present safety data, immunogenicity and the efficacy of the phase-III clinical trials of the Sputnik light that are being carried out in Russia to consider proposals for the provision of marketing authorization in this country,” said Minister of Justise SEC was held on June 30 which was uploaded on Thursday.
“As the Safety and Immunogenicity of Component 1 in the Indian population it has been produced in this country in other trials, there seems to be inadequate data and justification in conducting separate trials,” said Seconds who suggested general controller drugs from India (DCGI) , “The Committee noted that Sputnik Light is the same as component-1 Sputnik V.
Furthermore, the company has produced the safety and immunogenicity of the 1 component in the country.
The Committee also notes that the phase-III efficacy test is ongoing in Russia and the efficacy data has not been produced,” said minutes of meetings.
Dr.
Reddy, which is an Indian partner RDIF, has submitted a proposal for the administration of Sputnik light market authorization, which is a component-1 Sputnik V, along with temporary safety and efficacy data resulting from clinical test phase-i / II in Russia and has presented the protocol Phase-III clinical trials before seconds.
Sputnik Light is a single dose version of the Russian Covid-19 vaccine two doses of Sputnik V consisting of component-1 vaccine, adenoviral ad26 vaccine.
On Sputnik V, Adenoviral’s second vector AD5 is given 21 days after the first dose.
The single shot jab has shown the temporary efficacy of 79.4% in accordance with the developer of the Gamaleya Institute and Russian direct investment funds (RDIF).
The two dosage version has shown the efficacy of 97.6%, according to the real world data, said the developer, while it was 91.6% in the trial.
Dr.
Reddy has conducted a Phase-II / III study bridging at 1,600 volunteers in India before being given an emergency use authorization for two doses of JAB Sputnik V in mid-April this year.
The company has launched a soft pilot for two doses in several cities in 26 cities throughout the country but the full commercial launch is still awaited.