MOSCOW (Sputnik) – India’s Central Drugs Standard Control Organisation, which is reviewing an emergency use authorization application for the Russian vaccine Sputnik V, has requested Dr. Reddy’s Laboratories, the Indian manufacturer of the shots, to provide additional immunogenicity and safety data, the PTI news agency reported, citing a source.
“The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, which discussed the application by Dr Reddy’s Laboratories seeking emergency use authorisation for COVID-19 vaccine Sputnik V, on Wednesday asked the firm to submit immunogenicity and safety data in accordance with the protocol approved by the CDSCO. Once it submits the data, its EUA application will be considered,” the source said.
Dr. Reddy’s applied for an emergency use authorization for the Russian vaccine last week.
India has so far approved the use of only two coronavirus vaccines: AstraZeneca’s domestically-produced Covishield shots, and indigenous Covaxin.
Sputnik V was developed by the Moscow-based Gamaleya Institute and officially registered for emergency use in Russia on 11 August. The vaccine efficacy was confirmed at 91.6 percent, according to an interim analysis from phase 3 trial, published in The Lancet.
Sourse: sputniknews.com
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