Central Govt. fast-tracks approvals for foreign-produced Covid-19 vaccines
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Central Govt. fast-tracks approvals for foreign-produced Covid-19 vaccines

April 14, 2021

New Delhi: The Central Government has fast-tracked approvals for foreign-produced Covid-19 vaccines that have been granted emergency use authorisation in other countries. 

This has been done to expedite the pace and coverage of ongoing vaccination drive in India. 

Calling vaccination as one of the critical pillars of Covid-19 control and management, the Government said that fast-tracking of approvals will facilitate easier access to foreign Covid-19 vaccines approved by credible foreign regulators. 

The decision will pave the way for imports, fill and finish as well as production in India of those vaccines which have already been received such authorisation in other countries, the Centre said. 

A meeting of National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) was held on Apr. 11, where the issue was discussed. 

“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,” the Government said in a release. 

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

The Government also said that first 100 beneficiaries of such foreign vaccines will be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country. 

This comes shortly after Russia’s Sputnik V was approved by India’s drug regulator Drugs Controller General of India (DCGI) for emergency use. The regulator’s subject expert committee on Monday recommended that there was enough data to support that the vaccine was fit to be used. 

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Presently, two Covid-19 vaccines — Covaxin by Bharat Biotech International Limited and AstraZeneca-Oxford University’s Covishield by Serum Institute of India (SII) — have received emergency use authorisation (EUA) from the DCGI. 

Meanwhile, the cumulative number of Covid-19 vaccine doses administered in the country has crossed 10.85 crore, the Union Health Ministry said on Tuesday. 

A total of 10,85,33,085 vaccine doses have been administered through 16,08,448 sessions, as per the provisional report till 7 am on Tuesday.

The nationwide inoculation drive began on Jan. 16 this year, with healthcare and frontline workers getting the vaccine shot in the first phase. The drive was later expanded to include those above the age of 60 and 45+ with comorbidities. 

From Apr. 1, the Government opened the drive for everyone above the age of 45.

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