Pfizer India becomes first pharma to apply for COVID-19 vaccine use in India

Pharmaceutical giant seeks DGCI’s permission to import and market vaccine, which showed 95% efficacy in Phase 3 trials

On Wednesday (April 21), the US-based vaccine manufacturer said it is exploring opportunities to make the COVID-19 vaccine available in India instead of manufacture it here.

In a first, the Indian arm of American pharmaceutical major Pfizer has sought the nod of the Drugs Controller General of India (DGCI) for the emergency use authorisation of its COVID-19 vaccine in the country.

“Pfizer India has sought permission for emergency usage authorisation of its COVID-19 from DGCI to import and market,” a source was quoted by various news reports.

The vaccine developed by the company in collaboration with its German biotechnology partner BioNTech displayed an efficiency of 95 per cent in the third stage of trials and has already been approved for use in the United Kingdom and Bahrain.

Pfizer India on December 4 had sought permission to import and market the vaccine for sale and distribution in India, as well as for the “waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.”

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The CT-18 application for the grant of permission to import the vaccine, is reportedly under process and has a window of 90 days before a decision is taken.

The United Kingdom on Wednesday (December 2) became the first country to green-light the Pfizer vaccine. On Friday (December 4), Bahrain cleared the two-dose vaccine for use.

At a recent meeting, Prime Minister Narendra Modi hinted that a vaccine will be ready for use within a few weeks.

India on Sunday reported 36,011 new infections pushing its COVID-19 tally to 96,44,222. While 1.40 lakh people have died of the disease so far, 91 lakh have recovered.

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