Coronavirus

Govt’s Expert Group Recommends Emergency Approval for Restricted use of Foreign Covid-19 Vaccines

Foreign Covid-19 Vaccines

In a bid to augment the basket of vaccines available for fighting the Covid-19 pandemic and push the pace and coverage of domestic vaccination programme, the National Expert Group on Vaccine Administration for COVID-19 or NEGVAC has recommended the use of certain vaccines for Covid-19.

“The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, 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, 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,” a Union of Ministry of Health and Family Welfare (MoHFW) statement reads.

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 programme within the country, MoHFW added.

The Union Government, after due consideration, has accepted the recommendation of NEGVAC. This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports, including import of bulk drug material, optimal utilisation of domestic fill and finish capacity, etc, which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic, it also added.

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