Written By: Satata Karmakar | Published : February 5, 2021 12:25 PM IST
Pfizer withdraws application for Covid-19 vaccine in India
Pfizer has decided to withdraw its application for Emergency Use Authorisation of its Covid-19 vaccine in India. Pfizer has developed the vaccine with Germany's BioNTech.
"In pursuance of the Emergency Use Authorisation of its Covid-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time," a Pfizer spokesperson said.
"Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future. Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorization that enables the availability of this vaccine for any future deployment," the spokesperson said.
Pfizer was the first pharmaceutical firm to seek an emergency use authorization from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country after it secured such clearance in the UK and Bahrain.
Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on the Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources had said.
This comes months after Pfizer and its German partner BioNTech had released the second batch of interim results saying their COVID-19 vaccine candidate is 95 per cent effective and also protects the most vulnerable people in older age groups from the risk of falling prey to the virus.
So far, the Indian government has already distributed over 16.5 million doses of the two approved Covid-19 vaccines to states, with a plan to deliver over 600 million vaccine shots to the most vulnerable people of the society (which include healthcare workers, frontiers, etc) in the next six to eight months.
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