Hetero Biopharma, the biologics arm of drugmaker Hetero, has received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell Sputnik Light, Russia’s single-dose vaccine against COVID-19, in India.
It is the first biopharmaceutical company in the country to receive manufacturing and marketing authorization for the locally manufactured product. “All other vaccines currently approved in India require two doses of administration,” Hetero said in a press release on Monday.
Sputnik Light is the first component of Russia’s two-dose COVID-19 vaccine Sputnik V, which has been approved by India and used as part of the vaccination program. In February, the Drugs Controller General of India had granted emergency use authorization to the single-dose Sputnik Light.
“Sputnik Light clinical data had shown significantly high titers of antibodies to COVID-19, both glycoprotein specific and virus neutralizing antibodies, along with CD4 and IFN-γ levels. Sputnik Light has also demonstrated its neutralizing activity against the Omicron variant of the SARS-CoV-2 virus,” said Shubhadeep Sinha, Senior VP and Head – Clinical Development and Medical Affairs at Hetero.