Pfizer defers India release of Covid-19 vaccine for want of clinical data
08 February 2021
US pharma giant Pfizer on Friday said it has decided to withdraw its application seeking emergency use authorisation (EUA) of its Covd-19 vaccine in India as it failed to conduct clinical trials in India.
Pfizer was the first pharmaceutical firm to seek an emergency use authorisation from the Drugs Controller General of India (DCGI) for its Covid-19 vaccine in the country, but it had come with insufficient clinical trial data needed for such an authorisation in India.
Pfizer wanted India to authorise use of its Covd-19 vaccine in India on the strength of such permission granted in the US and UK.
Pfizer in its application submitted to the drug regulator in December 2020, had sought waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019 besides permission to import the vaccine for sale and distribution in India, according to official sources.
"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 company spokesperson said in a statement.
Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement said.
"Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," the spokesperson said.