US Pharma major Pfizer Inc, which was the first Pharma company to seek authorization from DCGI (Drugs Controller General of India) said on Friday that it has decided to withdraw its application for Emergency Use Authorization (EUA) of its COVID-19 vaccine in India. Pfizer had earlier secured clearance for its covid-19 vaccine in the UK and Bahrain.
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Pfizer had participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India in pursuance of the Emergency Use Authorization of its COVID-19 vaccine. In its statement, Pfizer said that based on deliberations in the meeting and understanding of the additional information that the Indian regulator needs, the company has decided to withdraw its application at the moment.
Further, the company said that it will continue to engage with the authority and resubmit its application for approval with additional information as it becomes available in the near future. The company spokesperson said that Pfizer remains committed to making its vaccine available for use by the Indian government and to pursuing the requisite pathway for emergency use authorization to enable the availability of this vaccine for future deployment.
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Pfizer had sought permission to import the vaccine for sale and distribution in India vide its application submitted to the drug regulator in December 2020. However, the Indian government had approved two cheaper vaccines – Covaxin by Bharat Biotech and Covishield by Oxford, AstraZeneca in association with Serum Institute of India.
As per official sources, Pfizer had sought permission for waiver of clinical trials on the Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019.
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The Indian drug regulator committee said that Pfizer did not offer any plan to generate safety and immunogenicity in the Indian population and also noted the side effects reported abroad from the Pfizer vaccine. The UK was the first country to approve the Pfizer vaccine which needs to be stored in extremely low temperatures of minus 70 degrees.
