‘Experts recommended against granting approval’: India on Pfizer’s Covid-19 vaccine withdrawal

The statement came after Pfizer said that it has decided to withdraw its application for emergency use authorisation of its COVID-19 vaccine in India.

By: Satata Karmakar | | Published: February 5, 2021 5:05 pm

अध्‍ययन में फाइजर वैक्‍सीन लगने के बाद लोगों में गंभीर प्रभाव नहीं दिखे।

Just two days before pharma major Pfizer announced the withdrawal of its application for emergency use authorization of its COVID-19 vaccine in India, an expert panel of the country’s drugs regulatory authority had recommended against granting such approval to the firm at this stage, officials said on Friday. Also Read - New highly contagious COVID-19 variant spreading rapidly across New York

The statement from the officials came after Pfizer on Friday said that it has decided to withdraw its application for emergency use authorisation of its COVID-19 vaccine in India. Also Read - COVID-19 cases rising in schools across India, over 220 students test positive in 24 hrs

Pfizer Was First To Seek An Emergency Use Authorization

Pfizer was the first pharmaceutical firm to seek such authorization from the Drugs Controller General of India (DCGI) on December 5 for its COVID-19 vaccine, after it secured such clearance in the UK and Bahrain. Also Read - Is it safe to travel if you have got the COVID-19 vaccine? Here's what experts say

On February 3, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) deliberated on Pfizer’s application.

The firm presented its proposal for emergency use authorization of COVID-19 mRNA Vaccine BNT162b before the committee, an official said.

“The committee noted that incidents of palsy, anaphylaxis, and other SAE’s have been reported during post-marketing and the causality of the events with the vaccine is being investigated.

“Further, the firm has not proposed any plan to generate safety and immunogenicity data in the Indian population. After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” the recommendations of the SEC stated.

Covid-19 Vaccine – Where Is India Standing Today?

As of now, two vaccines — Covishield, manufactured by Serum Institute of India, and Bharat Biotech’s Covaxin — have been approved for restricted emergency use in India.

A Pfizer company spokesperson in a statement said that in pursuance of the emergency use authorisation of its COVID-19 vaccine, the firm participated in the SEC meeting.

“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,” the spokesperson said.

Pfizer Withdraws Application For Emergency Use Of Its Covid-19 Vaccine In India

Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement said.

“Pfizer remains committed to making its vaccine available for use by the government in India and to pursuing the requisite pathway for emergency use authorisation that enables 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 sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on the Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, according to official sources.

India Continues To Fight Against Covid-19

India’s COVID-19 tally of cases went past 1.08 crore with 12,408 people testing positive for coronavirus infection in a day, while the recoveries surged to 1,04,96,308, according to the Union Health Ministry data updated on Friday.

With the new figures, the total cases mounted to 1,08,02,591, while the death toll increased to 1,54,823 with 120 daily new fatalities, the data updated at 8 am showed.

According to the latest reports, the number of people who have recuperated from the disease surged to 1,04,96,308 pushing the national COVID-19 recovery rate to 97.16 per cent, while the COVID-19 case fatality rate stands at 1.43 per cent.

(With inputs from IANS)

Published : February 5, 2021 5:05 pm

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