India fast-tracks emergency approvals for foreign Covid-19 vaccines
14 April 2021
India has fast-tracked the process of granting emergency approvals to Covid-19 vaccines that have been granted EUA in other countries, in a bid to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination.
The union health ministry said it is following a comprehensive approach to tackle Covid-19 pandemic in a proactive and pre-emptive manner. India had, in May 2020, constituted a Task Force headed by Principal Scientific Advisor to encourage R&D for vaccine manufacture and constituted in August 2020 an Expert Group headed by Member, NITI to assist in roll-out of the Covid vaccination programme. These strategies helped India became the first country to have two “Made in India” Covid vaccines for domestic vaccination drive.
At present, two vaccines, ie, Covaxin produced by Bharat Biotech International Limited (BBIL) and Covishield from the Serum Institute of India (SII), are in use after receiving Emergency Use Authorization (EUA) from the Drugs Controller General of India.
But these two vaccines proved insufficient as India had to meet its international obligations of meeting requirements of the vaccine alliance anf the World Health Organisation.
Vaccination is one of the critical pillars of Covid control and management strategy and hence the urgency of augmenting vaccine supply by expanding the basket of vaccines available for fighting the pandemic.
The matter was discussed at the 23rd meeting of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) held on 11 April 2021.
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.
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.
The union government, after due consideration, has accepted the recommendation of NEGVAC.
The decision will facilitate quicker access to such foreign vaccines, which will provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use.