The Drug Controller General of India (DCGI) on February 6 granted emergency use authorisation to Sputnik Light in India, making it the first single-dose COVID-19 vaccine to be approved for use in the country.
This is the 9th Covid vaccine to be receive regulatory approvals in the country.
Sources in the Central Drug Standards Control Organisation (CDSCO) told Moneycontrol that the permission has been issued based on the basis of data from the phase 1 and 2 clinical trials of Sputnik Light in Russia, along with data from its phase 3 clinical trial in Russia, along with few other countries.
They also said that this vaccine may be used as booster dose against COVID-19 for the eligible population groups.
Also read: Omicron India Live Updates
Sputnik Light is a component of Sputnik V vaccine, which is given in two doses—but both the doses are different from each other. Sputnik Light comprises of the component used in the first dose.
In India, Sputnik V is being imported and also manufactured by the Hyderabad based vaccine maker Dr Reddy’s.
The company had applied for the restricted use permission of Sputnik Light vaccine in India in last June only, but the approval has come nearly eight months later.
Earlier, the firm had said that Dr Reddy’s has already generated safety and immunogenicity data on the first dose component in India through its clinical trial and while a phase 3 efficacy trial is currently underway in Russia on Sputnik Light.
However, Sputnik V, which started arriving in India during the massive second wave of the pandemic itself and has remained available in only private hospitals so far, has been the least administered Covid19 vaccine in the country.
Of over 169 crore COVID vaccine doses administered in the country so far, just about 12 lakh doses have been that of Sputnik V.
Meanwhile RDIF, Russia's sovereign wealth fund that promotes the vaccine globally, said in a statement that clinical studies and the real-world data in many countries have demonstrated Sputnik Light is a safe and effective vaccine when used both on a standalone basis and as a booster.
“.. Sputnik Light has been registered in more than 30 countries with total population of over 2.5 billion people. A number of countries, including Argentina, Bahrain, UAE, San Marino and Philippines, have already authorized Sputnik Light as a universal booster,” it said.
RDIF also said that a recent comparative study had shown that Sputnik V demonstrates more than 2 times higher titers of virus neutralizing antibodies to Omicron variant than 2 doses of Pfizer vaccine (2.1 times higher in total and 2.6 times higher 3 months after vaccination).
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