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.
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.