Pfizer withdrew the emergency use request of its Covid-19 vaccine in India after an expert panel under India’s drug regulator recommended against approving its vaccine.
On Friday, pharma major Pfizer Inc announced the withdrawal of its application for emergency-use authorization (EUA) of its Covid-19 vaccine in India, which it has developed with Germany’s BioNTech.
On Wednesday, the company had a meeting with Indian drug regulators, and after that, the decision of withdrawal was made. In a statement to Reuters, a Pfizer spokesperson said: “In pursuance of the emergency-use authorization 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.”
According to media reports, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended the Drug Controller General of India (DCGI) against approval of Pfizer’s vaccine under emergency circumstances due to Serious Adverse Events (SAEs). The committee also highlighted that additional safety information had not been produced from local trials of the vaccine developed with German biotech firm BioNTech.
However, Pfizer has stated that it will continue to engage with the authority to resubmit the approval request with additional information. 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 authorization that enables the availability of this vaccine for any future deployment.”
In India, Pfizer was the first pharmaceutical company to request EUA from the DCGI for its Covid-19 vaccine, after it acquired clearance in the UK and Bahrain. In its application submitted to the drug regulator in December, the firm had sought permission to import the vaccine for sale and distribution in India and to conduct clinical trials on the country’s population following the special provisions under the New Drugs and Clinical Trials Rules, 2019.
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