Pfizer Inc has withdrawn its application for emergency licensure in India for now after a subject expert committee of the Indian regulator sought additional information from the company on Wednesday, a spokesperson for the company said on Friday.
“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. 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 spokesperson said.
Pfizer had sought authorisation for its vaccine in India late last year, but the government in January approved two much cheaper shots – one from Oxford University/AstraZeneca and another developed at home by Bharat Biotech with the Indian Council of Medical Research. Both companies had applied for approval of their vaccines after Pfizer.
Bharat Biotech and Serum Institute had received the nod for Covaxin and Covishield from Somani on 3 January, following which the vaccination process began 13 days later.
Reason for Denial of Vaccine made by Pfizer
India’s Central Drugs Standard Control Organisation had declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported.
To be sure, the government also has not shown much interest in using the Pfizer vaccine in India due to its high cost and requirement of -70-degree Celsius ultra-low temperature freezers.
Pfizer’s mRNA vaccine costs $19.5 per dose in the US. While it has said it will provide the vaccine at a lower cost in India, the expectation is it will still be more expensive than Serum Institute’s Covishield that costs ₹200 per dose, a little less $3, for the Indian government. Bharat Biotech has priced Covaxin at ₹295 ($4 per dose).
Further, Pfizer’s trial in the US and other countries had a very low representation of Asians.
Only 4.3% of the 40,000-odd participants in its global phase 3 trial were Asian, while the efficacy rate for the diverse ethnic group was 74.4%. In contrast, the company’s overall efficacy was 95% for a cohort, which comprised 83% whites, according to the documents published by the US FDA.
Ethnicity and regional variations have an impact on vaccine efficacy.