{"id":10176,"date":"2021-02-24T23:35:34","date_gmt":"2021-02-25T06:35:34","guid":{"rendered":"https:\/\/sanjhisoch.com\/english\/?p=10176"},"modified":"2021-02-24T23:35:34","modified_gmt":"2021-02-25T06:35:34","slug":"expert-panel-reviews-emergency-use-authorisation-for-sputnik-v-vaccine-seeks-safety-data","status":"publish","type":"post","link":"https:\/\/sanjhisoch.com\/english\/expert-panel-reviews-emergency-use-authorisation-for-sputnik-v-vaccine-seeks-safety-data\/","title":{"rendered":"Expert Panel Reviews Emergency Use Authorisation for Sputnik V Vaccine; Seeks Safety Data"},"content":{"rendered":"
Sputnik V has already received approval in 26 countries and has been administered to more than 2 million people.<\/strong><\/h6>\n

Sanjhi Soch buero :<\/strong>An expert panel of India\u2019s Central Drug Authority which reviewed the application of Dr Reddy\u2019s Laboratories seeking emergency use authorisation for the\u00a0COVID-19\u00a0vaccine Sputnik V on Wednesday recommended that the firm present immunogenicity and safety data, sources said. Dr Reddy\u2019s Laboratories on February 19 said it had approached drugs regulator DCGI for emergency use authorisation (EUA) for the Russian vaccine.<\/p>\n

\u201dThe Subject Expert Committee (SEC) on COVID-19 of the CDSCO which discussed the application by Dr Reddy\u2019s 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,\u201d a source said. The drug major on Wednesday presented the safety profile of phase 2 study, and interim data of phase 3 trial, the source said.<\/p>\n

Meanwhile, the SEC also asked Hyderabad-based Bharat Biotech to submit efficacy data of Covaxin on adults before seeking permission to conduct phase-3 clinical trial on children aged 5-18 years. In September last year, the Hyderabad-based firm Dr Reddy\u2019s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India.<\/p>\n

The vaccine is undergoing phase 3 clinical trial in India. The Drugs Controller General of India (DCGI) has already given the EUA nod for two\u00a0COVID-19\u00a0vaccines \u2014 Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune.The vaccines are being administered to healthcare and frontline workers across the country. Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia, the statement said.<\/p>\n

The vaccine also maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old. \u201dThe efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the fight against COVID-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India,\u2019 Dr Reddy\u2019s Laboratories co-chairman and managing director G V Prasad said.<\/p>\n

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020 and became the world\u2019s first registered vaccine against COVID-19 based on the human adenoviral vector platform. Sputnik V has already received approval in 26 countries and has been administered to more than 2 million people worldwide.<\/p>\n","protected":false},"excerpt":{"rendered":"

Sputnik V has already received approval in 26 countries and has been administered to more than 2 million people. Sanjhi Soch buero :An expert panel of India\u2019s Central Drug Authority which reviewed the application of Dr Reddy\u2019s Laboratories seeking emergency use authorisation for the\u00a0COVID-19\u00a0vaccine Sputnik V on Wednesday recommended that the firm present immunogenicity and […]<\/p>\n","protected":false},"author":2,"featured_media":10181,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[3],"tags":[],"yoast_head":"\n\n\n\n\n\n\n\n\n\n\n\n\t\n\t\n\n\n\n\n\t\n