Days after its parent company secured clearance in the UK and Bahrain for mass use, 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.
The firm, in its application submitted to DGCI, has sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, news agency PTI reported official sources as saying.
“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 told PTI.
“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 said, citing the application.
On Wednesday, the United Kingdom (UK) became the first country in the world to approve the Pfizer-BioNTech coronavirus vaccine for use and said that it will be rolled out from early next week.
The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out.
Two days later, Bahrain became the second country in the world to grant EUA for Pfizer’s vaccine.
Minus 70 degrees Celsius storage
The extreme low temperature of minus 70 degrees Celsius required for storing the Pfizer vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said.
According to PTI, when contacted, 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 authorisation or approval,” the global pharma major said in a statement.
Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca Covid-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR 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 anti-coronavirus vaccine.
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.
(With PTI inputs)