Covid-19 vaccine: Pfizer India application for 'emergency use' to be considered this week
On December 2, the UK became the first nation to approve Pfizer-BioNTech vaccine against COVID-19 for emergency use; Bahrain has also approved vaccine candidate 'BNT162b2'. India decision on vaccine could come this week
- Dec 7, 2020,
- Updated Dec 7, 2020 12:38 PM IST
Authorities will consider Pfizer India's application for an emergency use authorisation of its Covid-19 candidate this week. The US pharma company has said it is dedicated to ensuring the availability of its COVID-19 vaccine for use by governments across the world.
On December 2, the UK became the first country to approve the Pfizer-BioNTech vaccine against COVID-19 for emergency supply. On December 5, Bahrain also approved Pfizer and BioNTech's vaccine candidate 'BNT162b2' for emergency use.
The company has now said Pfizer will be supplied only via government contracts based on agreements with respective govt authorities and following regulatory authorisation.
Pfizer has sought approval from the Drugs Controller General of India, and the matter has now reportedly been referred to the DCGI's Subject Expert Committee (SEC).
Pfizer, in its application submitted on December 4, has also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to get instant approval.
Authorities will consider Pfizer India's application for an emergency use authorisation of its Covid-19 candidate this week. The US pharma company has said it is dedicated to ensuring the availability of its COVID-19 vaccine for use by governments across the world.
On December 2, the UK became the first country to approve the Pfizer-BioNTech vaccine against COVID-19 for emergency supply. On December 5, Bahrain also approved Pfizer and BioNTech's vaccine candidate 'BNT162b2' for emergency use.
The company has now said Pfizer will be supplied only via government contracts based on agreements with respective govt authorities and following regulatory authorisation.
Pfizer has sought approval from the Drugs Controller General of India, and the matter has now reportedly been referred to the DCGI's Subject Expert Committee (SEC).
Pfizer, in its application submitted on December 4, has also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to get instant approval.