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Pfizer withdraws application for emergency use authorization of its COVID-19 vaccine in India

“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,” it said in a statement to Reuters.

Pfizer withdraws application for emergency use authorization of its COVID-19 vaccine in India-dnm
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New Delhi, First Published Feb 5, 2021, 3:42 PM IST
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New Delhi: Pfizer Inc has withdrawn an application for emergency use authorization of its Covid-19 vaccine in India that it has developed with Germany's BioNTech, the company spokesperson told Reuters on Friday.

The US company was the first pharmaceutical firm to seek an emergency use authorisation from the Drugs Controller General of India (DCGI) for its Covid-19 vaccine in the country, after it secured such clearance in the UK and Bahrain. The company had a meeting with the country’s drugs regulator on Wednesday and the decision was made after that, the company said.

“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,” it said in a statement to Reuters.

“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”

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.

In response, the Indian drug regulator committee said not recommended granting permission for emergency use for Pfizer's Covid-19 vaccine.

In a statement, the CDSCO's expert committee said, "Pfizer did not propose any plan to generate safety and immunogenicity data in Indian population."

The committee also said that it noted side effects reported abroad, causality of events being investigated.

Pfizer's Covid-19 vaccine needs to be stored in an extremely low temperature of minus 70 degrees Celsius since the vaccine uses synthetic messenger RNA (mRNA) to prompt an immune response against the virus.

Pfizer aims to make two billion doses of the Covid-19 vaccine in 2021.

(With inputs from agency)

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