As India battles a surge in the number of Coronavirus infections, the central government has said it is expediting emergency approvals for foreign vaccines that have been granted emergency use authorisation (EUA) in other countries.
Currently, India is using two vaccines—Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII)—for inoculating those aged over 45 years. India’s drug regulator has granted permission for restricted emergency use of the Russian Covid-19 vaccine Sputnik V with certain conditions, the health ministry announced on Tuesday.
Augmenting the basket of vaccines as well as accelerating the pace and coverage of vaccination was discussed at a meeting of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) held a couple of days ago.
It was recommended that vaccines developed and 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.
“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 programme within the country,” the health ministry said.
