Just two days before pharma major Pfizer announced withdrawal of its application for emergency use authorisation of its COVID-19 vaccine in India, an expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage, officials said on Friday.
Pfizer on Friday said it has decided to withdraw its application for emergency use authorisation of its COVID-19 vaccine in India. It was the first pharmaceutical firm to seek such an authorisation from the Drugs Controller General of India (DCGI) on December 5 for its COVID-19 vaccine, after it secured such clearance in the UK and Bahrain.
On February 3, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) 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.
A Pfizer company spokesperson in a statement said that in pursuance of the emergency use authorisation of its COVID-19 vaccine, the firm participated in the SEC meeting. "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," the 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, 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.
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, according to official sources.