Govt Hits On Quick Approval Strategy To Boost Vaccine Arsenal
New Delhi: With Odisha and several other states complaining of acute shortage of COVID-19 vaccines, the Centre has decided to fast-track emergency use approvals for foreign doses.
This will augment the country’s “basket of vaccines” and also accelerate the pace and coverage of the domestic vaccination programme, according to a release by the Union Health and Family Welfare Ministry on Tuesday.
The government decision came following a recommendation by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
The NEGVAC recommended that COVID-19 vaccines, which have been developed and 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. At the same time, the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the law must be madew mandatory for these vaccines, it added.
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 immunization programme within the country.
This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc. This will in turn boost vaccine manufacturing capacity and total vaccine availability for domestic use, the release said.