Expert panel recommended against granting EUA to Pfizer's vaccine: Officials
Just two days before pharma major Pfizer announced the withdrawal of its application for emergency use authorization 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. Pfizer on Friday said it has decided to withdraw its application for emergency use authorization of its vaccine in India.
SEC deliberated on Pfizer's application on February 3
Notably, it was the first pharmaceutical firm to seek such authorization 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 Organization (CDSCO) deliberated on Pfizer's application.
Serious adverse events were reported during postmarketing
The firm presented its proposal for emergency use authorization of COVID-19 mRNA vaccine BNT162b before the committee. But the committee noted that incidents of palsy, anaphylaxis, and other serious adverse events were reported during postmarketing, which is why the vaccine is being investigated. Further, the firm did not propose any plan to generate safety and immunogenicity data in the Indian population, the recommendations stated.
Which vaccines are currently in use in India?
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. Meanwhile, a Pfizer company spokesperson in a statement said that in pursuance of the emergency use authorization of its COVID-19 vaccine, the firm had participated in the SEC meeting.
Pfizer plans to resubmit its approval request with additional information
"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 in its application had sought clinical trial waiver
"Pfizer remains committed to making its vaccine available in India," the spokesperson added. Pfizer in its application submitted to the drug regulator in December 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 informed.