Pfizer seeks emergency use authorisation for COVID-19 vaccine in India after UK clearance

Pfizer India has become first pharmaceutical firm to seek from Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in country. development comes days after its parent company secured such clearance in UK and Bahrain.

'Pfizer India submitted an application on December 4'

firm, in its application submitted to drug regulator, has sought permission to import vaccine for sale and distribution in country, besides waiver of clinical trials on Indian population in accordance with special provisions under New Drugs and Clinical Trials Rules, 2019, news ncy PTI quoted official sources as saying.

"Pfizer India has submitted an application on December 4 to DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine in India,"  source said. " firm has submitted EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's COVID-19 mRNA vaccine BNT162b2 in country," source said, citing application.

UK, Bahrain give d to Pfizer

United Kingdom on Wednesday became first country to approve Pfizer/BioNTech vaccine against COVID-19, with UK regulator Medicines and Healthcare products Regulatory ncy (MHRA) granting a temporary authorisation for its emergency use. British regulator said jab, which claims to offer up to 95% protection against COVID-19, is safe for roll-out.

Meanwhile, Bahrain on Friday also anunced that it has granted an EUA for two-dose vaccine made by Pfizer and its German partner BioNTech. pharma company has already applied to US FDA seeking EUA for vaccine.

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extreme low temperature of minus 70 degrees Celsius required for storing vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said.

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When contacted, Pfizer said it remains committed to engaging with Government of India and explore opportunities to make this vaccine available for use in country. "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," global pharma major said in a statement.

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According to reports, Indian Government didn't hold talks with Pfizer in August and re has been development since n as country focuses on five or candidates, including one developed by AstraZeneca and Oxford University and produced by Pune's Serum Institute of India.

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