Expert Committee had recommended against approval
Those looking for Pfizer developed mRNA-based vaccine against Covid-19 will have to wait. Just two days before the pharma major announced the withdrawal of its application for the emergency use authorisation of its Covid-19 vaccine in India, an expert panel of the country’s drugs regulatory authority recommended against granting such approval to the firm at this stage.
Pfizer had said it has decided to withdraw its application for emergency use authorisation of its Covid-19 vaccine in India.
The first pharmaceutical firm to seek such authorisation from the Drugs Controller General of India (DCGI), Pfizer on December 5 approached the Indian authorities for its Covid-19 vaccine, after it secured such clearance in the UK and Bahrain.
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.
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 the Indian population. After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,†states the recommendations of the SEC.
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.
