Pharma major Pfizer on Friday said it has decided to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India.
However, an expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
Pfizer was the first pharmaceutical firm to seek an emergency use authorisation from the Drugs Controller General of India for its COVID-19 vaccine in the country, after it secured such clearance in the UK and
Bahrain.
"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.
On February 3, the Subject Expert Committee of the Central Drugs Standard Control Organisation deliberated on Pfizer's application.
The firm presented its proposal for emergency use authorisation of COVID-19 mRNA Vaccine BNT162b before the committee, an official said.
"The committee noted that incidents of palsy, anaphylaxis and other SAE's have been reported during post marketing and the causality of the events with the vaccine is being investigated.
"Further, the firm has not proposed any plan to generate safety and immunogenicity data in Indian population. After detailed deliberation, the committee has not recommended for grant of permission for
emergency use in the country at this stage," the recommendations of the SEC stated.
As of now, two vaccines -- Covishield, manufactured by Serum Institute of India, and Bharat Biotech's Covaxin -- have been approved for restricted emergency use in India.
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 Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources had said.
