• Kushal Kumar Jha

Pfizer becomes first company to seek emergency use authorisation for their COVID-19 vaccine in India


Pfizer India has raced ahead of Serum Institute of India (SII) and Bharat Biotech to seek emergency use authorisation for their mRNA based COVID-19 vaccine in India. Days after getting a nod from UK and Bahrain, Pfizer India has become the first pharmaceutical firm to seek emergency use authorisation from the Drugs Controller General of India (DCGI). Whereas, Oxford-AstraZeneca vaccine will take 2 more weeks to apply for the same.
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Pfizer India has raced ahead of Serum Institute of India (SII) and Bharat Biotech to seek emergency use authorisation for their mRNA based COVID-19 vaccine in India. Days after getting a nod from UK and Bahrain, Pfizer India has become the first pharmaceutical firm to seek emergency use authorisation from the Drugs Controller General of India (DCGI). Whereas, Oxford-AstraZeneca vaccine will take 2 more weeks to apply for the same. Reportedly, Pfizer India had submitted an application on December 4 to DCGI, seeking permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on the Indian population under the special provisions under the New Drugs and Clinical Trials Rules, 2019, news agency PTI quoted official sources as saying. "Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine in India," the source said. "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," the source said, citing the application. The United Kingdom (UK) on Wednesday became the first nation to approve the Pfizer/BioNTech vaccine against COVID-19. The UK drugs regulator, Medicines, and Healthcare products Regulatory Agency (MHRA) has granted a temporary authorisation for Pfizer's vaccine's emergency use. Whereas, Bahrain on Friday also announced that they have granted Pfizer-BioNtech's two-dose based vaccine emergency use authorisation in the country. The US-based Pfizer has also applied for FDA approval, seeking emergency use authorisation in the US. The key challenge with the Pfizer-BioNtech's vaccine is the storage requirements of the extremely low temperature of minus 70 degrees Celsius. So far in India, there are facilities to store drugs at -25° Celcius. The top government officials have time and again said that this is a big challenge for India, especially when it comes to smaller towns and rural areas where maintaining such cold chain facilities would be very difficult. "During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval," the pharmaceutical company said in a statement.

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