All globally approved vaccines may get emergency use approval in India

This is being done to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination, the government has said.
Person administering vaccine, representative image
Person administering vaccine, representative image
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In a major move to speed up the vaccination drive in India, the Union government has fast-tracked emergency approvals for foreign-produced COVID-19 vaccines that have been granted emergency use authorisation in other countries. This is being done to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination, the government has said. 

The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) had recommended that all those vaccines which have been granted emergency approval for restricted use in the United States, Europe, United Kingdom and Japan, or those which have been listed under the World Health Organisation’s Emergency Use Listing, may be granted emergency use approval in India. The Union government has accepted this recommendation, an official release said. This means that mRNA vaccines like Pfizer-BioNTech and Moderna as well as Johnson & Johnson, an adenovirus vaccine, could soon be available in India.

The government has said that 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 programmes within the country.

This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc, which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for the country, the release said.  

The aim of fast tracking the process was to ensure that a basket of vaccines is available for fighting the pandemic as well as to accelerate the pace and the coverage of the domestic vaccination programme, the government has said. 

This comes shortly after the Drugs Controller General of India on Tuesday approved the Russian vaccine Sputnik V for emergency use in India. The development came a day after the DCGI’s subject expert committee recommended that there was data to support that the vaccine was fit for use. Interim results of a phase 3 trial published in the Lancet journal showed “a consistent strong protective effect across all participant age groups.” This is the third vaccine approved by the Union government after Covishield and Covaxin. 

 

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