Covid-19: Pfizer seeks permission for emergency vaccine use in India

Pfizer India has become the first pharmaceutical company to seek permission from the Drugs Controller General of India (DCGI) for emergency use of its Covid-19 vaccine in the country, after its parent company secured the clearance for the same in the UK and Bahrain.

The global pharma major, in its application submitted to the DCGI, has sought permission to import the vaccine, which Pfizer claims offers 95 percent efficacy, for sale and distribution in India, official sources said.

The company has also sought waiver of clinical trials of the vaccine on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, our New Delhi correspondent reports quoting the sources.

"Pfizer India has submitted an application on December 4 to the DCGI, seeking emergency use authorization (EUA) for its COVID-19 vaccine in India," the sources said.

"The firm has submitted the Emergency Use Authorization (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 sources said, citing the application.

US drug-maker Pfizer has partnered with Germany company BioNTech for developing and manufacturing the vaccine.

However, the Pfizer vaccine needs a temperature of minus 70 degrees Celsius for storage, which is a major challenge for its distribution in a country like India, especially in small towns and villages where maintaining and creation of such cold chain facilities would be very difficult, Health Ministry officials have said.

On Wednesday, Britain became the first country to approve the Pfizer/BioNTech 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 Pfizer vaccine 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.

Pfizer said it remains committed to engaging with the government of India and explore opportunities to make this 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 authorization or approval," the pharma company said in a statement on Saturday night.

Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 human trial of the Oxford-AstraZeneca vaccine while the indigenously-developed vaccine by Bharat Biotech in collaboration with Indian Council of Medical Research has already started the phase-3 clinical trial.

Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed DNA-based vaccine.

Another Indian pharma major 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.