Pfizer seeks emergency approval for COVID-19 vaccine in India, media say

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Intl desk, Dec 06: Pfizer Inc has applied for emergency use authorization of its coronavirus vaccine in India, media said on Sunday, the first to do so in a country with the world’s second highest number of infections.

FILE PHOTO: Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration taken November 10, 2020. REUTERS/Dado Ruvic

The vaccine is ready to be rolled out in the United Kingdom and Bahrain. This is the first such request received by the DCGI amid the race to find a vaccine for the deadly virus, which has affected over 96 lakh people in India.

In its application submitted on December 4, Pfizer India has sought approval to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019,” sources have been quoted as saying by news agency PTI.

On Wednesday, the United Kingdom became the first western country to clear the Covid-19 shot developed jointly by Pfizer and German biotechnology partner BioNTech, which has reported an efficiency of over 90 per cent.

For a vaccine to be allowed in India it must clear clinical trials here, and sources had earlier told NDTV neither Pfizer nor its partner companies had asked to hold such trials. However, the Drugs Controller General of India has “discretionary power to waive localised clinical trials for a vaccine”, officials added.

A day after UK’s go-ahead marked a “historic” moment, Pfizer said it remains “committed to engaging with the Government of India and explore opportunities” to make its vaccine against coronavirus available in the country.

India’s daily coronavirus cases rose by less than 40,000 for the fifth straight day, health ministry data showed on Friday, with 36,595 new infections reported in the last 24 hours.

India’s daily rate has fallen since the south Asian nation reported the world’s highest such tallies through most of August and September, despite a busy festival season last month that experts had warned could trigger a spike in infections.

Its tally is now at 9.57 million and remains the world’s second-highest after the United States, where there have been nearly 14 million infections.

Deaths in India rose by 540, the ministry said, with the total now at 139,188.

Source: News Agencies