Govt to waive 'bridging study' to allow foreign-approved vaccines for emergency use

This could mean early India approvals for Pfizer, Moderna and Johnson and Johnson vaccines which have not done India-specific studies but have proven strong safety profiles in clinical trials abroad

Govt to waive 'bridging study' to allow foreign-approved vaccines for emergency use

Photo for representation only. Tribune file

Aditi Tandon

Tribune News Service

New Delhi, April 13

Faced with growing pressures to hasten the delivery of COVID vaccines at home, the government on Tuesday agreed to waive the requirement of prior India bridging study to grant emergency use authorisation approval to foreign-made and -approved vaccines.

This could mean early India approvals for Pfizer, Moderna and Johnson and Johnson vaccines which have not done India-specific studies but have proven strong safety profiles in clinical trials abroad.

The decision had been taken to allow for emergency use in India COVID vaccines approved by the drug regulators of the US, the EU, Japan and the UK.

The government accepted a recommendation in this respect by the National Expert Group on Vaccine Administration headed by Member Health NITI Aayog VK Paul.

The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID, which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA (European Medicines Agency), 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 and Clinical Trials Rules, 2019.

NEGVAC said the first 100 beneficiaries of such foreign vaccines would be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.

The Centre, after due consideration, has accepted the recommendation of NEGVAC.

This decision, government said, would 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 which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic beneficiaries.

India is following a comprehensive approach to tackling COVID-19 pandemic in a proactive and pre-emptive manner. In this context, as early as May 2020, India constituted a Task Force headed by the Principal Scientific Advisor to encourage research and development for vaccine manufacture and constituted in August 2020 an Expert Group headed by member, NITI, to assist in rollout of the Covid vaccination programme. It was because of these strategies that India became the first country to have two ‘Made in India’ Covid vaccines for domestic vaccination drive.

Vaccination is one of the critical pillars of COVID control and management strategy adopted by the Centre. At present, two vaccines, that is, Covaxin by Bharat Biotech International Limited (BBIL) and Covishield by Serum Institute of India (SII), have received Emergency Use Authorisation (EUA) from the National Regulator (Drugs Controller General of India).

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 was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on April 11 , chaired by VK Paul, Member (Health), Niti Aayog.

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