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Expert panel recommended not granting emergency use authorization to Pfizer’s Covid vaccine: Officials | India News


NEW DELHI: Just two days before major pharmaceutical company Pfizer announced the withdrawal of its request for authorization for the emergency use of its Covid-19 vaccine in India, a panel of experts from the country’s drug regulatory authority recommended against granting such approval to the company at this stage. officials said Friday.
Pfizer said on Friday that it decided to withdraw its request for authorization of emergency use of its Covid-19 vaccine in India.
It was the first pharmaceutical company to apply for such authorization from the Controller General of Drugs of India (DCGI) on December 5 for its Covid-19 vaccine, after obtaining such authorization in the UK and Bahrain.
On February 3, the Subject Matter Expert Committee (SEC) of the Central Drug Standards Control Organization (CDSCO) deliberated on Pfizer’s application.
The firm presented its proposal for the authorization of emergency use of the Covid-19 BNT162b mRNA vaccine to the committee, an official said.
“The committee noted that incidents of paralysis, anaphylaxis and other SAEs have been reported during the post-marketing phase and the causality of the events with the vaccine is being investigated.
“Furthermore, the firm has not proposed any plans to generate safety and immunogenicity data in the Indian population. After detailed deliberation, the committee did not recommend the granting of the permit for emergency use in the country at this stage,” said the SEC recommendations. .
So far, two vaccines, Covishield, manufactured by the Serum Institute of India, and Covaxin from Bharat Biotech, have been approved for restricted emergency use in India.
A spokesperson for the Pfizer company in a statement said that in compliance with the authorization of emergency use of its Covid-19 vaccine, the firm participated in the SEC meeting.
“Based on the deliberations of the meeting and our understanding of additional information that the regulator may need, the company decided to withdraw its request at this time,” the spokesperson said.
Pfizer will continue to interact with the authority and will resubmit its request for approval with additional information as it becomes available in the near future, according to the statement.
“Pfizer remains committed to making its vaccine available for government use in India and to following the required pathway for emergency use authorization that allows for the availability of this vaccine for any future deployment,” the spokesperson said. .
Pfizer, in its application submitted to the drug regulator in December 2020, had requested permission to import the vaccine for sale and distribution in India, in addition to exemption from clinical trials in the Indian population in accordance with the special provisions of the Rules on New Drugs and Clinical Trials. 2019, according to official sources.

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