COVID-19: Pfizer seeks emergency use authorisation for its 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.

In its application to DCGI, the company has requested approval for the import and distribution of vaccines in India.

The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, 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% protection against COVID-19, is safe for roll-out. Britain has ordered 40 million doses - enough to vaccinate 20 million people in the country of 67 million.

Following in the UK's footsteps, Bahrain on Friday also announced that it has granted a 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 Pfizer shot needs to be stored at minus 70 degrees Celsius (-94 F) or below, which will pose a big challenge for India, especially in small towns or rural areas, where maintaining such cold chain facilities would prove to be difficult.

For its part, Pfizer has said it remains committed to engaging with the Indian government in order to explore opportunities to make its vaccine available for use in the country.

"During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval," the global pharma major said in a statement.