US pharma giant Pfizer has withdrawn its application for emergency use authorization of its COVID-19 vaccine in India. The decision came after the company participated in a subject expert committee meeting of the Drug Regulatory Authority of India (DGCI) on February 3, 2021.
Pfizer withdraws application for emergency use of its COVID-19 vaccine in India, reports Reuters
— ANI (@ANI) February 5, 2021
Pfizer's spokesperson said that the company will continue to engage with the DGCI and resubmit its approval request with additional information as it becomes available in the near future.
The company had applied for emergency use authorisation to the Drug Regulatory Authority of India on December 6, 2020.
Key Details
•The Pfizer company spokesperson said that the company has decided to withdraw its application at this time based on the deliberations at the subject expert committee meeting and their understanding of additional information that the regulator may need.
•Pfizer had participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India in pursuance of Emergency Use Authorisation of its Covid-19 vaccine.
In pursuance of the Emergency Use Authorisation of its Covid-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3: Pfizer, Spokesperson https://t.co/eoqJWevQem
— ANI (@ANI) February 5, 2021
•The company spokesperson assured that Pfizer will resubmit its approval request with additional information as it becomes available in the near future.
•The spokesperson added saying that Pfizer remains committed to making its vaccine available for use by the Indian Government.
Pfizer will continue to engage with authority & resubmit its approval request with additional information as it becomes available in the near future: Pfizer, Spokesperson
— ANI (@ANI) February 5, 2021
•The drug manufacturer will pursue the required path for emergency use authorisation that enables the availability of this vaccine for any future deployment.
Background
The United Kingdom became the first country in the world on December 2, 2020 to approve emergency use authorisation of the COVID-19 vaccine developed jointly by US-based Pfizer and Germany's BioNTech.
Bahrain became the second country to give a go-ahead to the emergency use of Pfizer's COVID-19 vaccine, followed by Canada.
Pfizer's coronavirus vaccine was later approved for emergency use in several other nations including the United States, Mexico, Costa Rica and European nations like Belgium, Hungary and Greece.
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