Pfizer Seeks Emergency Authorisation For Its Covid-19 Vaccine In India

Pfizer India has become the first pharmaceutical firm in the country to seek emergency authorisation for its Covid-19 vaccine, after its parent company secured similar clearance in the UK and Bahrain.

The firm, in its application submitted to the Drugs Controller General of India (DCGI), has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official 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," a source said. "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," the source added, citing the application.

The UK on Wednesday became the first country to approve the Pfizer/BioNTech Covid-19 vaccine, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use. The British regulator said the jab, which claims to offer up to 95 per cent 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 already applied to the US FDA seeking EUA for the vaccine.

The outrageous



low temperature of short 70 degrees Celsius needed for putting away the antibody represents a major test for its conveyance in a nation like India, particularly in more modest towns and provincial regions where keeping up such virus chain offices would be troublesome, top government authorities said. 

When reached, Pfizer said it stays focused on drawing in with the Indian government to investigate occasions to make this antibody accessible for use in the nation. "During this pandemic stage, Pfizer will gracefully this antibody just through government contracts dependent on concurrences with separate government specialists and following administrative authorisation or endorsement," the worldwide pharma major said in an articulation. 

Five immunizations are in cutting edge periods of clinical preliminaries in India with the Serum Institute of India leading stage 3 preliminaries of the Oxford-Astrazeneca Covid-19 antibody, while the indigenously evolved antibody by Bharat Biotech as a team with the Indian Council Of Medical Research (ICMR) has likewise begun the stage 3 clinical preliminary.

Drug firm Zydus Cadila has also received approval from the DCGI to start phase-3 clinical trials for its vaccine candidate.

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 phase 1 and 2 human trials of its Covid-19 vaccine candidate.