Amid the rising number of coronavirus cases in the country, India on Tuesday fast-tracked approvals for foreign-produced COVID-19 vaccines that have been granted emergency use authorisation (EUA) in other countries.
The aim is to “accelerate the pace & coverage of domestic vaccination programme,” the ministry of health and family welfare mentioned in a release. This move will help in expanding “the basket of vaccines for domestic use and hasten the pace and coverage of vaccination”.
According to the statement issued by the Government of India, Vaccination is one of the critical pillars of COVID control and management strategy adopted by the Centre. Presently two vaccines i.e. Covaxin by Bharat Biotech International Limited (BBIL) and Covishield by Serum Institute of India (SII), have received Emergency Use Authorization (EUA) from the National Regulator (Drugs Controller General of India).
However, Govt made it specific that only those foreign vaccines 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.
A requirement for pre-approval clinical trials would be replaced by post-authorisation trials. 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, the health ministry added.