An expert panel of DCGI, India’s apex drug regulator, has recommended permission for conducting phase-3 clinical trial of Russia’s single-dose COVID-19 vaccine ‘Sputnik Light’ as a booster dose, official sources said on Saturday.
The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
Hyderabad-based Dr Reddy’s Laboratories had sent its proposal to DCGI for conducting the phase-3 trial of Sputnik Light vaccine as booster dose.
“The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, which reviewed the application on Friday after detailed deliberation, recommended granting permission for the phase-3 clinical trial with condition to initiate the trial with Sputnik Light vaccine for which the firm is holding emergency use authorisation permission in the country subject to certain regulatory provisions,” an official source said, PTI reported.
Last month, the DCGI had granted emergency use authoristaion (EUA) to Sputnik Light vaccine in India, subject to certain regulatory provisions. With this, Sputnik Light has become the ninth COVID-19 vaccine that has been granted EUA in the country.
Sputnik Light is equivalent to the first component of two-dose Sputnik V COVID-19 vaccine. Dr Reddy’s Laboratories has claimed that the vaccine is approved in 29 countries, including Argentina and Russia.
An independent comparative study conducted by the Spallanzani Institute in Italy earlier this year showed that Sputnik V demonstrates strong protection against the Omicron variant, with over two times higher virus neutralising activity compared to the Pfizer vaccine.
The data supports the results of the recent laboratory study by the Gamaleya Center demonstrating that Sputnik V induces robust neutralising antibody response to the Omicron variant, further strengthened by Sputnik Light as a booster.
