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

Aditi Tandon
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. ....

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More COVID-19 vaccines coming! Centre fast-tracks emergency use approvals for foreign-produced jabs

India on Monday approved Russia s Sputnik V COVID-19 vaccine for emergency use in the country. ....

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First 100 beneficiaries of foreign vaccines to be assessed for a week before vaccine rollout for public: MOHFW

The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country. ....

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Govt fast-tracks nod for Covid vaccination cleared in other countries | India News

India News: With surging Covid-19 cases fuelling calls for faster vaccination, the Centre on Tuesday enabled faster access to foreign-made vaccines by doing away ....

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Govt Fast-Tracks Emergency Use Approvals For Foreign-Produced COVID-19 Vaccines

Govt Fast-Tracks Emergency Use Approvals For Foreign-Produced COVID-19 Vaccines
by Swarajya Staff - Apr 13, 2021 08:27 AM
Covid-19 vaccine - representative image (Twitter)
In a bid to boost the nationwide Covid vaccination drive, the Centre on Tuesday (13 April) fast-tracked the emergency use approvals for foreign-manufactured Covid-19 vaccines in a move that is expected to increase the availabilty of the jabs in the country.
However, only those foreign firms that had received Emergency Use Authorisation (EUA) for their jabs from US Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK s Medicines and Healthcare products Regulatory Agency (MHRA), Japan s Pharmaceuticals and Medical Devices Agency (PMDA) or are listed in WHO emergency use listing will be eligible for the fast-tracking of approvals. ....

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