Regulators looking into emergency use authorization sought by Pfizer for Covid-19 vaccine

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DY365
Published: December 21,2020 08:29 AM
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December 21, 2020: Union Health Minister Dr Harsh Vardhan has said that regulators are examining the permission sought by Pfizer for emergency authorization of its Covid-19 vaccine.

December 21, 2020: Union Health Minister Dr Harsh Vardhan has said that regulators are examining the permission sought by the Indian arm of US pharmaceutical firm Pfizer for emergency authorization of its Covid-19 vaccine.



"I have heard that they have applied for emergency use permission from our regulators. According to my information, our regulators are examining it. If a politician speaks on the matter which is in the jurisdiction of experts, it will not be appropriate...perhaps they did not take part in the meeting," the Union Health Minister told ANI in an interview.



The Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) had earlier this month asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their Covid-19 vaccines.



The meeting was held to review the application submitted by the pharma majors for emergency use authorisation (EUA) for their vaccine candidates.



The application submitted by Pfizer was not discussed at the SEC meeting on December 9 as the company had requested more time for giving its presentation.



Harsh Vardhan indicated that India will focus on developing its own vaccine and said the country is not behind other countries in the development and research of vaccines against coronavirus. He said India is moving towards "atmanirbharta" (self-reliance).



"Our country is moving towards self-reliance and we are not less than any other country in the world in vaccine development and research," he said.



The minister also noted that India's vaccine manufacturing capacities are not less than anyone in the world.



There are six Covid-19 vaccines in different clinical trial stages in India. Besides, three vaccine candidates are in pre-clinical trial stages.



The United Kingdom became the first country in the world to administer the new coronavirus vaccine developed jointly by Pfizer and BioNTech. Canada, Mexico, the US are among the countries that later approved the Pfizer-BioNTech Covid-19 vaccine for their citizens.