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

India’s CDSCO’s expert committee stressed that ‘at this stage’ they would not recommend granting permission for emergency use authorization of Pfizer’s Covid-19 vaccine
Covid-19 vaccine: Pfizer withdraws application for emergency use authorisation in India

US-based pharma company Pfizer has withdrawn their application for emergency use authorisation of its Covid-19 vaccine that it has developed with Germany’s BioNTech in India. The decision follows the company’s meeting with India’s drug regulators on Wednesday. In India, Pfizer was the first pharma company to apply for emergency use authorisation of its Covid19 vaccine.

According to reports, the company has decided to withdraw as the regulator required additional information. The statement released by the company further added that the company seeks to resubmit the application with the additional information that regulators requested. It said, “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.”

Meanwhile, India’s Central Drugs Standard Control Organisation (CDSCO)’s expert committee stressed that ‘at this stage’ they would not recommend granting permission for emergency use authorisation of Pfizer’s Covid-19 vaccine. According to reports, the committee said that “incidents of palsy, anaphylaxis and other SAE’s have been reported and the causality of the events with the vaccine is increasing”.

On the other hand, the Bihar government has decided to reopen the school for students of classes VI to VIII from February 8. In addition, India’s Covid-19 tally reached 10,802,591 with 12,408 new confirmed infections on Friday.

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