Sputnik Light: DCGI nod to emergency use of single-dose Covid vaccine
Sputnik Light is the 9th COVID-19 vaccine in the country, says Dr Mansukh Mandaviya
The drug regulator DCGI (Drugs Controller General of India) has granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India, Union health minister Dr Mansukh Mandaviya said today.
An expert panel of India's central drug authority had this week recommended granting restricted emergency use authorisation (EUA) to single-dose COVID-19 vaccine Sputnik Light. Notably, on July 1 last year, India's drug regulator had refused to grant EUA to Sputnik Light.
Sputnik Light is based on recombinant human adenovirus serotype number 26 (the first component of Sputnik V).
Health officials in Russia had authorised the one-shot Sputnik Light version of its coronavirus vaccine for use in May last year.
As per the vaccine developer Russian Direct Investment Fund (RDIF), a one-shot vaccination regimen of Sputnik Light provides for ease of administration and helps to increase the efficacy and duration of other vaccines when used as a booster shot. “Sputnik Light has already been authorised in more than 30 countries," it said.
The RDIF has said that the real-world data in many countries have shown that Sputnik Light is a safe and effective vaccine when used both on a standalone basis and as a booster.
What studies show
A preliminary study of the Gamaleya Center has found Sputnik Light significantly increases virus-neutralising activity against Omicron. “Sputnik Light booster is recommended to strengthen the efficacy of vaccines against Omicron," the company said, adding that the boosting by Sputnik Light can strengthen and lengthen the quickly waning efficacy of many vaccines in light of combined Delta and Omicron challenge.
A study in Argentina on heterogeneous regimens combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino has demonstrated that Sputnik Light is an effective universal booster, RDIF said.
Sputnik Light efficacy data
Sputnik V and Sputnik Light are based on human adenoviral vector platform and have not been associated with rare serious adverse events following vaccination.
Findings by the Gamaleya Center based on data collected in Moscow have demonstrated Sputnik Light vaccine administered standalone has 70 per cent efficacy against infection from the Delta variant of coronavirus during the first three months after vaccination.
"The vaccine is 75 per cent effective among subjects under the age of 60.
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