India's central drug authority's expert panel on Friday recommended granting restricted emergency use authorisation (EUA) to single-dose Covid-19 vaccine Sputnik Light subject to various regulatory provisions, according to official sources.
Sputnik Light is equivalent to the component-1 of Sputnik V.
According to an official source, in light of the recommendations made during an SEC meeting on January 31, Dr Reddy's Laboratories presented its proposal for grant of permission to import Sputnik Light for a restricted use in an emergency situation and booster-dose vaccination, along with the analysis of the latest safety and efficacy data, including its benefits against the Omicron variant of the coronavirus.
The firm said the Sputnik Light vaccine is approved in 29 countries, including Argentina, Russia etc.
"The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application by Dr Reddy's Laboratories, noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the ongoing phase-3 clinical trial interim data from Russia," the source said.
The interim data of the efficacy trial from Russia has shown an efficacy of 65.4 per cent against COVID-19, 21 days after immunisation.
"After detailed deliberations, the SEC recommended for grant of permission for a restricted use in an emergency situation, subject to various regulatory provisions," the source said.
The recommendations have been sent to the Drugs Controller General of India (DCGI) for the final approval.
"With regard to the use of the Sputnik Light vaccine as a booster dose, the applicant may provide clinical data, including immunogenicity data in the Indian population, for further evaluation," the source said.
According to some of the conditions for granting EUA, the vaccine is indicated for active immunisation to prevent Covid-19 in individuals aged above 18 years and the firm should submit the safety, efficacy and immunogenicity data from the ongoing clinical trials in India and Russia for a review as and when available.
The firm should submit the safety data, including the data on AEFI and AESI, with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country. Thereafter, the firm should submit the safety data in accordance with the provisions and standard procedures.
On July 1 last year, India's drug regulator had refused to grant EUA to Sputnik Light.