Sunday, December 6, 2020
Pfizer seeks Emergency authorization use of Covid-19 Vaccine in India
Pfizer has applied for emergency use authorization of its corona virus vaccine in India, the first pharmaceutical company to seek from the Drugs Controller General of India (DGCI) after getting clearance from UK and Bahrain.
The US company Pfizer, in its application submitted to drug regulator on 4th December, has seek permission to import the vaccine for sale and distribution in India, including waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules.
- The United Kingdom became the first country to approve Pfizer vaccine against Corona virus, with UK regulator Medicines and Healthcare products Regulatory Agency, granting authorization for its emergency use. Trending : Health Council clarifies on fate of Insurance if the worker changed the job
- Bahrain also announced that it has granted authorization to Pfizer two dose vaccine.
- Indian officials have said they are focusing mainly on local tested vaccines instead of Pfizer and Moderna. As Pfizer shot needs to be stored at -70 degree Celsius or below temperatures that most Indian cold storages cannot reach.
- Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase 3 trial of Oxfor Astrazenca Corona vaccine, while the local developed vaccine by Bharat Biotech in collaboration with ICMR is in phase 3 clinical trial.
- Drug from Zydus Cadila has received the approval from India to start its phase-3 trials of the locally developed anti corona vaccine. Read : Saudi banks warned against Transferring money to unknown persons
- Dr Reddy's laboratories and the Russian Direct Investment Fund (RDIF) have said they started adaptive phase 2 and phase 3 clinical trials for Sputnik-V vaccine in India, Also Biological E.ltd has started its phase 1 and 2 human trials of its Corona vaccine.
