Pfizer seeks authorisation for its COVID-19 vaccine emergency use in India
Pfizer, one of the world’s premier biopharmaceutical companies, has sought emergency use authorisation for its COVID-19 vaccine in India. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country.
Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain.
Our correspondent reports, the firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country.
Five vaccine candidates are in advanced phases of clinical trials in the country. The Serum Institute of India is conducting a phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine. Indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trials.
Drug firm Zydus Cadila has received approval from the DCGI to start the phase-three clinical trials of the indigenously-developed coronavirus vaccine candidate.
Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase two and three clinical trials for COVID-19 vaccine candidate Sputnik V in the country. Biological E. Ltd has also started early phase 1 and 2 human trials of its COVID-19 vaccine candidate.