Drug maker Hetero on Monday said its biologics arm Hetero Biopharma has received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell Sputnik Lite with restricted emergency use in India.
Hetero is the first biopharmaceutical company in India to receive Manufacturing and Marketing (M&M) approval for a locally manufactured product for the prevention of COVID-19 in adults above 18 years of age, administered in a single dose of 0.5ml Has been done. With the approval, Hetero will be able to sell the vaccine directly in the domestic market.
All other vaccines currently approved in India require two doses of administration.
Sputnik Lite is the first component of Sputnik V (recombinant human adenovirus serotype number 26 (RAD 26)) – the world’s first registered vaccine against the coronavirus disease, COVID-19.
In February 2022, Dr Reddy’s said it has received emergency use approval for a single-dose Sputnik Lite COVID-19 vaccine in India from the Drug Controller General of India (DCGI).
“Clinical data from Sputnik Lite (component I of Sputnik V) showed high titers of antibodies against COVID-19, both glycoprotein specific and virus-neutralizing antibodies, along with increased CD4 and IFN-γ levels.” showed,” Dr. Shubhdeep Sinha, Senior Vice President and Head of Clinical Development and Medical Affairs (CDMA) at Hetero.
Sinha said, “Sputnik Lite has also shown its inactive activity against the Omicron version of the SARS-CoV-2 virus. Earlier Sputnik V clinical trials have shown significant protection against COVID-19, including other subtypes.” was shown.”
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