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Pfizer India has submitted an application on December 4 to the DCGI hunting emergency use authorization (EUA) for its COVID-19 vaccine in India. The firm has filed the EUA program in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s COVID-19 mRNA vaccine BNT162b2 in the nation,” the source said, citing the program.
The British regulator said the jab, which claims to offer up to 95 percent protection against COVID-19, is safe for roll-out.
Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has applied to the US FDA seeking EUA for the vaccine.
The extreme low temperatures of minus 70 degrees Celsius required for storing the vaccine poses a large challenge for its delivery in a country like India, particularly in its smaller cities and rural areas where maintaining these cold chain facilities would be extremely tough, leading government officials have stated.
“Through this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or consent,” the global pharma major said in a statement.
Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.
Drug firm Zydus Cadila has obtained the approval from the DCGI to begin the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine.
Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early stage 1 and 2 human trials of its COVID-19 vaccine candidate.
