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Pfizer Applies For Emergency Use Authorization Of Its COVID Vaccine In India
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India, 6 Dec 2020 6:13 AM GMT | Updated 6 Dec 2020 10:02 AM GMT
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The vaccine has been jointly developed by Pfizer and German biotechnology partner BioNTech and has reported efficiency of over 90 per cent.
American Pharma major, Pfizer, has sought approval from Drug Controller General of India (DCGI), for the emergency use authorisation (EUA) of its COVID-19 vaccine, after securing clearance in the United Kingdom and Bahrain.
It is the first such request received by DCGI amid the race to find a vaccine for the coronavirus, which has affected over 96 lakh people in India, and crores globally. The vaccine has been jointly developed by Pfizer and German biotechnology partner BioNTech and has reported efficiency of over 90 per cent.
"The company is seeking permission to import the vaccine for sale and distribution in India, in addition to the waiver of clinical trials on Indian population by the special provisions under the New Drugs and Clinical Trials Rules, 2019," NDTV quoted the officials.
"The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's COVID-19 mRNA vaccine BNT162b2 in the country," officials said in the application. DCGI will take a call on the application in 90 days.
The United Kingdom became the first country to roll out the Pfizer/BioNTech COVID-19 vaccine on Wednesday. Bahrain, on Friday, announced that it had granted a EUA for the two-dose vaccine made by the pharma company and its partners.
For clearance in India, the company is required to clear clinical trials in the country, which neither Pfizer nor its partner companies have asked for, officials told the media. However, the DCGI has 'discretionary power to waive localised clinical trials for a vaccine', officials added.
Pfizer, in its official statement, said it 'remains committed to engaging with the Government of India and exploring opportunities to make this vaccine available for use in the country.'
Currently, five vaccines have reached the advanced phases of clinical trials in India:
- Serum Institute of India, conducting Phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine.
- Vaccine by Bharat Biotech, in collaboration with ICMR, has started with its Phase-3 clinical trial.
- Pharmaceutical company Zydus Cadila has received the approval from the DCGI to start the Phase-3 clinical trials of their anti-coronavirus vaccine.
- Dr Reddy's Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they started with Phase 2 and 3 clinical trials for coronavirus vaccine Sputnik V.
- Hyderabad-based pharmaceutical company Biological E. Ltd has started early Phase 1 and 2 human trials of its COVID-19 vaccine.
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