Pfizer Seeks India Approval for COVID-19 Vaccine

American pharma giant Pfizer becomes the first pharmaceutical firm to approach the Drugs Controller General of India (DCGI) seeking an emergency use authorization for its COVID-19 vaccine in the country. 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 9.6 million people in India. It is to be noted that Pfizer India’s parent company Pfizer has already got emergency-use clearance in the United Kingdom and Bahrain.

According to an official source, “Pfizer India has sought permission for emergency usage authorization of its COVID-19 from DGCI to import and market”. The application was submitted by Pfizer India on December 4 to the DCGI seeking emergency use authorization (EUA) for its vaccine in India.

A spokesperson from the pharma firm said: “Pfizer is dedicated to ensure the availability of this vaccine for use by governments across the world. During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval. We remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.”

Pfizer India has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s COVID-19 vaccine in India. The extremely low temperature of minus 70 degrees Celsius, required for storing the vaccine poses a big challenge for its delivery in a country like India.

On December 2, the UK became the first country to approve the Pfizer/BioNTech coronavirus vaccine. The UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) has granted a temporary authorization for the emergency use of coronavirus vaccine developed by Pfizer. Bahrain on Friday also granted permission for the two-dose vaccine made by Pfizer and its German partner BioNTech.

At an all-party meeting recently, Prime Minister Narendra Modi said a COVID-19 vaccine is expected to be ready in the next few weeks, and as soon as scientists give a green signal, vaccination will start in India.

Meanwhile, India recorded 36,011 new COVID-19 infections in the last 24 hours, the Union Ministry of Health and Family Welfare said on Sunday. The overall COVID-19 cases in India reached 9.67 million including 0.39 million active cases and 9.1 million recoveries.