Govt fast-tracks emergency approvals for foreign-made COVID-19 vaccines

The matter of augmenting the basket of vaccines available for fighting the pandemic as well as accelerating the pace and coverage of domestic vaccination programmes was discussed recently at the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019. Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programmes within the country. The Union Government, after due consideration, has accepted the recommendation of NEGVAC.