Aimed at hastening the pace and coverage of Vaccination across India, the government agreed to approve foreign produced COVID-19 Vaccines. The Centre agreed vaccines that got EUA in other countries.
EXPERT GROUP
The meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on April 11, 2021 discussed the matter of augmenting the “Basket of Vaccines” available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme. The Centre accepted the recommendation of NEGVAC.
WHO LISTED COVID VACCINE
The NEGVAC recommended that vaccines for COVID-19, developed and manufactured in foreign countries that got emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or WHO (Emergency Use Listing) listed vaccines may be granted emergency use. They mandated 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 and Clinical Trials Rules 2019.
Further, the first 150 beneficiaries of such foreign vaccines should be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country.
FACILITATE MORE COVID VACCINE
The decision will facilitate quicker access to foreign vaccines. It will also encourage imports including bulk drug material and optimise utilization of domestic fill. This will provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use. The government said that they followed a comprehensive approach to tackle COVID-19 pandemic in a proactive and pre-emptive manner. India constituted a Task Force headed by Principal Scientific Advisor to encourage R&D for vaccine manufacture in May 2020 itself. The government constituted an Expert Group headed by a member of NITI in August 2020 to assist in roll out of the Covid vaccination programme.
