India
pti-Madhuri Adnal
New Delhi, Feb 24: An expert panel of India’s Central Drug Authority which reviewed the application of Dr Reddy’s Laboratories seeking emergency use authorisation for the COVID-19 vaccine Sputnik V on Wednesday recommended that the firm present immunogenicity and safety data, sources said.
Dr Reddy’s Laboratories on February 19 said it had approached drugs regulator DCGI for emergency use authorisation (EUA) for the Russian vaccine.
“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 as per the protocol approved by the CDSCO. Once it submits these data, its EUA application will be considered,” a source said.
The drug major on Wednesday presented the safety profile of phase 2…