India gets 3rd COVID-19 vaccine, DCGI approves Sputnik V for emergency use

Indias drug regulator has granted permission for the restricted emergency use of Russian COVID19 vaccine Sputnik V with certain conditions paving the way for a third vaccine to be available in the country sources said on MondayThe approval by the Drugs Controller General of India DCGI came after the Subject Expert Committee SEC on COVID19 of the Central Drugs Standard Control Organization CDSCO on Monday recommended granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditionsThe DCGI had in January given the emergency use authorisation for two COVID19 vaccines Covaxin of Bharat Biotech and Covishield of OxfordAstraZeneca manufactured by Serum Institute of India in PuneAccording to sources around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven monthsThe SEC on Monday deliberated upon the application of Dr Reddys Laboratories seeking emergency use authorisation for Sputnik VThe vaccine is indicated for active immunisation to prevent COVID19 in individuals aged 18 years and above and is to be administered intramuscularly in two doses of 05 ml each with an interval of 21 daysIt has to be stored at 18 degrees CelsiusAccording to recommendations by the SEC the firm has been asked to submit revised factsheets to CDSCO after incorporating the latest safety and efficacy data and other suggestions made during the meeting another source saidBesides the firm should submit the safety efficacy and immunogenicity data from the ongoing clinical trials in India and Russia for review as and when availableThe firm also has to submit safety data including the data on AEFI and AESI with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country as per the recommendationsThe SEC had reviewed the application by Dr Reddys in two meetings held on April 1 and February 24The health ministry earlier had said three more COVID19 vaccines by Zydus Cadila Biological E and Gennova are also in the pipeline and are in advanced clinical trials in IndiaGlobal healthcare major Johnson and Johnson is in discussions with the Indian government to begin a clinical trial of its singledose COVID19 vaccine in the country the company said on FridayIn light of the SEC meeting held on April 1 Dr Reddys on Monday presented the interim safety and immunogenicity data from phase 23 clinical trial including GMT titres for virus neutralising antibodies comparative phase 3 immunogenicity data generated in Indian and Russian studies and unblinded data of serious adverse events and RTPCR positive cases among othersIn September last year Dr Reddys partnered with the Russian Direct Investment Fund RDIF to conduct clinical trials of Sputnik V and for its distribution rights in IndiaSputnik V has demonstrated an efficacy rate of 916 per cent in the interim analysis of phase 3 clinical trial which included data on 19866 volunteers in RussiaThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever