Pfizer seeks emergency authorisation for Covid vaccine in India
Pfizer India has sought emergency use authorisation for its Covid-19 vaccine from the Drugs Controller General of India, become the first pharmaceutical firm in the country to do so.
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FollowPfizer India has sought emergency use authorisation for its Covid-19 vaccine from the Drugs Controller General of India, become the first pharmaceutical firm in the country to do so.
Sources said Pfizer India submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its Covid-19 vaccine in India.
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.
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On Friday, Bahrain had granted an emergency use authorisation for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine.
According to India government sources, the extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in smaller towns and rural areas where maintaining such cold chain facilities would be very difficult.
Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trials of the Oxford-Astrazeneca Covid-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with the Indian Council Of Medical Research has also started the phase-3 clinical trial.
Drug firm Zydus Cadila has also received approval from the DCGI to start phase-3 clinical trials for its vaccine candidate.
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