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.
Also read: Pfizer says committed to supply COVID-19 vaccine across the globe
The development is significant since Prime Minister Narendra Modi, during an all-party meet on Friday, cited experts to say that India could have the first coronavirus vaccine in weeks and that eight vaccines will be manufactured in India.
The approval for Pfizer's vaccine candidate came in only 10 months since the company started developing it, which in itself was the fastest in the history of vaccines. Other countries like the US and the European Union are vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc.
Also read: Pfizer seeks approval for emergency use in India after nod in UK, Bahrain
Also Read: Common people have to wait until 2022 to get coronavirus vaccine shots, says AIIMS chief
Also read: Game of one-upmanship! Pfizer now says vaccine efficacy 95% - not 90%
Also read: What makes a good COVID-19 vaccine? Serum Institute's Adar Poonawalla explains
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.
Also read: Pfizer says committed to supply COVID-19 vaccine across the globe
The development is significant since Prime Minister Narendra Modi, during an all-party meet on Friday, cited experts to say that India could have the first coronavirus vaccine in weeks and that eight vaccines will be manufactured in India.
The approval for Pfizer's vaccine candidate came in only 10 months since the company started developing it, which in itself was the fastest in the history of vaccines. Other countries like the US and the European Union are vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc.
Also read: Pfizer seeks approval for emergency use in India after nod in UK, Bahrain
Also Read: Common people have to wait until 2022 to get coronavirus vaccine shots, says AIIMS chief
Also read: Game of one-upmanship! Pfizer now says vaccine efficacy 95% - not 90%
Also read: What makes a good COVID-19 vaccine? Serum Institute's Adar Poonawalla explains