Pfizer seeks emergency use authorisation of its COVID-19 vaccine in India 

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.

According to a report in PTI, the firm, in its application submitted to the drug regulator, 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 has 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 approval for Pfizer's vaccine candidate came in only 10 months since it started developing it, which is the fastest in the history of vaccines. Other countries like the US and the European Union are also vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc. 

Notably, Pfizer, BioNTech, Moderna, and Russia's Sputnik V are the only vaccines that have claimed over 90 per cent efficacy of their respective candidates so far.

While Russia had already rolled out Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, Pfizer, and BioNTech's vaccines have also raised high hopes.

Besides, Swedish drugmaker AstraZeneca and the University of Oxford's vaccine candidate, being developed along with India's Serum Institute, has also achieved 70 per cent efficacy during the preliminary analysis of its Covid-19 trial participants.

On Wednesday, the United Kingdom became the first western country to clear the Covid-19 shot developed jointly by Pfizer and German biotechnology partner BioNTech, which has reported an efficiency of over 90 per cent.

For a vaccine to be allowed in India it must clear clinical trials here, and sources had earlier told NDTV neither Pfizer nor its partner companies had asked to hold such trials. However, the Drugs Controller General of India has "discretionary power to waive localised clinical trials for a vaccine", officials added.