Pfizer Withdraws Emergency Use Request: Pharma major Pfizer Inc on Friday has decided to withdraw a request for emergency approval of its COVID-19 vaccine in India.
The announcement came after the US-based drug major company met the Subject Expert Committee (SEC) on February 3 and decided to retract the application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine.
Pfizer Withdraws Emergency Use Request:
The company said they will "continue to engage" with the authority for this permission and would submit its approval request again with additional information "as it becomes available in the near future."
"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," stated a Pfizer spokesperson.
Developed with BioNTech, Pfizer vaccine was termed “safe” to use in countries like the UK and Bahrain. The company became the first pharmaceutical firm to seek an EUA from the Drugs Controller General of India (DCGI) for its coronavirus vaccine in India in December 2020. The request for approval was declined citing a necessary small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters reported. The trials for its mRNA vaccine never happened and subsequently, the applications of Serum Institute of India's (SII) Covishield and Bharat Biotech's Covaxin were approved for mass use.
"Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," the spokesperson said.
So far, India has witnessed the vaccination drive on more than 49 lakh people in the first phase.
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