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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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Govt to waive India bridging study rule to allow foreign-approved vaccines for emergency use at home

Govt to waive India bridging study rule to allow foreign-approved vaccines for emergency use at home
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