BackPfizer withdraws application for covid-19 vaccine in India for now
Pfizer had approached the DCGI V.G. Somani for emergency authorisation of its messenger RNA vaccine in December along with Bharat Biotech International and Serum Institute for India, but had so far not made its presentation to the SEC--from whom a crucial recommendation is needed for EUA.
PremiumNEW DELHI : Pfizer Inc has withdrawn its application for emergency licensure in India for now after a subject expert committee of the Indian regulator sought additional information from the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.
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While the nature of the information sought by the SEC is not yet known, the company said that it remains committed to making its vaccine, which Pfizer developed with German ferm BioNTech, available for use by the Government in India.
The company will pursue emergency licensure so as market its vaccine in India, the spokesperson said.
Pfizer had approached the Drugs Controller General of India V.G. Somani for emergency authorisation of its messenger RNA vaccine in December along with Bharat Biotech International and Serum Institute for India, but had so far not made its presentation to the SEC--from whom a crucial recommendation is needed for EUA.
On the other hand, Bharat Biotech and Serum Institute had recieved the nod for Covaxin and Covishield from Somani on 3 January, following which the vaccination process began 13 days later.
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, 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.
Ethinicity and regional variations have an impact on vaccine efficacy.
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