Covid vaccine: Pfizer seeks emergency use authorization in India

Pfizer has become the first company to seek emergency use authorization of its coravirus vaccine in India. According to reports, the company has sought the permission from Drugs Controller General of India for emergency use of its vaccine named BNT 162b2 which has shown 95 per cent efficacy against coronavirus during a preliminary clinical trial data analysis. Earlier Pfizer and BioNTech SE had received authorization from UK and Bahrain.

Pfizer, in its application submitted on December 4, has sought permission to import the vaccine for sale and distribution in India. It also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to get instant approval for emergency use, a PTI report said.

“Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India,” an official source told the news agency.

AIIMS Delhi Director Dr Randeep Guleria had earlier said that India was in talks with Pfizer-BioNTech regarding its COVID-19 vaccine candidate. He said no such communication had been initiated with Moderna for its experimental COVID-19 vaccine.

Last week, the U.K became the first country to give clearance for the vaccine after the Medicines and Healthcare Products Regulatory Agency (MHRA) found the vaccine safe. The country has announced that it will start vaccination in the next week and has already ordered 40 million doses aiming at vaccinating 20 million population. The pfizer has also received permission from Bahrain for ’emergency use’ of its vaccine.