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Covid-19: Pfizer withdraws application for emergency use of its vaccine in India

Pfizer withdraws COVID vaccine emergency use bid in India

Pfizer withdraws COVID-19 vaccine emergency use bid in India Celine Castronuovo © Getty Images Pfizer withdraws COVID-19 vaccine emergency use bid in India Pfizer has removed its bid for emergency approval of its coronavirus vaccine in India, citing additional information needed by the country s drug regulator, the pharmaceutical company confirmed to The Hill. The decision, first reported by Reuters on Friday, came after a Wednesday meeting with India s Central Drugs Standard Control Organization. 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 said in a statement shared with The Hill.

Pfizer withdraws emergency use bid of its COVID vaccine in India

Pfizer to submit emergency use approval request for Covid-19 vaccine again: Spokesperson

updated: Feb 05 2021, 14:59 ist Pfizer Inc said on Friday it had withdrawn an application for emergency-use authorisation of its Covid-19 vaccine in India, after failing to meet the drug regulator s demand for a local safety and immunogenicity study. The decision means the vaccine will not be available for sale in the world s two most populous countries, India and China, in the near future. Both countries are running their immunisation campaigns using other products. Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany.

Pfizer Drops India Vaccine Application after Regulator Seeks Local Trial - Novinite com

Send to Kindle Pfizer Inc said on Friday it had withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study. The decision means the vaccine will not be available for sale in the world’s two most populous countries, India and China, in the near future. Both countries are running their immunisation campaigns using other products. Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany.

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