Pfizer seeks EUA for its COVID-19 vaccine in India

In its EUA application submitted to the DCGI, Pfizer India has sought permission to import its vaccine for sale and distribution in the country.

By: Longjam Dineshwori | | Updated: December 6, 2020 11:19 am

The UK on Wednesday approved emergency use authorisation to the Pfizer/BioNTech’s COVID-19 vaccine.

Mass vaccination against COVID-19 may begin in India with the vaccine developed by US company Pfizer and its German partner BioNTech. Pfizer India has reportedly sought an emergency use authorisation (EUA) for its COVID-19 mRNA vaccine BNT162b2 in the country, becoming the first pharmaceutical firm to seek such request from the Drugs Controller General of India (DCGI). Also Read - Obesity, alcohol consumption can lower effectiveness of Covid-19 vaccines

In its application submitted to the DCGI, Pfizer India has sought permission to import the vaccine for sale and distribution in the country, and to waive of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, PTI reported quoting official sources. Also Read - Almost 30% of recovered COVID-19 patients develop complications within 5 months, over 12% die

Pfizer India submitted the EUA application in Form CT-18 on December 4, a source said. Also Read - COVID-19 vaccine side effects: Loss of sensation in arms and more reported by Pune health workers

Mention may be made that Pfizer and BioNTech had on Wednesday received approval from the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) for emergency use authorisation for its COVID-19 vaccine in the country. The vaccine is expected to be made available across the UK from next week. The UK is the first country to approve the Pfizer/BioNTech’s COVID-19 vaccine, which claims to offer up to 95 per cent protection against the deadly novel coronavirus.

The companies have also submitted a request to the US Food and Drug Administration (FDA) to secure EUA status for the vaccine. The vaccine is expected to be available for high-risk populations in the US by mid-December 2020.

Lack of storage facilities in India may cause problems

Top government officials are concerned that the extreme low temperature of minus 70 degrees Celsius required for storing the Pfizer/BioNTech’s COVID-19 vaccine may pose a big challenge for its delivery in India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult.

The UK government, however, is confident that the cold supply chain needed to distribute the Pfizer/BioNTech vaccine will not cause any problems or delays. When stored in a fridge, the vaccine has an effective life of up to five days at temperatures of 2 to 8 degrees, which will allow it to be easily stored at distribution centres, it had said.

Meanwhile, the cold chain points across India are being remodelled to support the storage of the upcoming COVID-19 vaccines. The Centre had recently asked the states and Union Territories to review cold storage and refrigerated vans used for the already existing universal immunisation programme.

Pfizer and BioNTech are reportedly charging $19.50 per dose for their vaccine, which is significantly lower than that of Moderna’s vaccine (that is expected to come around $25-$37 per dose).

Vaccines expected to reach Delhi by December end

Delhi is expected to receive its first batch of COVID-19 vaccines by the end of December. A building in the Rajiv Gandhi Super Speciality Hospital premises, has been selected by the Centre to be used as a COVID-19 vaccine storage facility, officials of the Hospital told IANS.

B.L. Sherwal, medical director of the hospital, informed the news agency that a separate facility in the hospital has been demarcated to store the vaccine doses which are expected to arrive by the month end.

The Centre will provide deep refrigerators with storage capacity ranging from -20 to -70-degree Celsius as well as regular refrigerators used to store medical drugs, he said.

Five vaccine candidates are in advanced phases of clinical trials in India including Russia’s Sputnik V, and four others developed by Oxford-AstraZeneca, Bharat Biotech, Zydus Cadila, and Biological E. Pune-based Serum Institute of India, which is conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, dubbed Covishield in India, has said that it will apply for emergency marketing authorisation of the vaccine in two weeks.

Published : December 6, 2020 10:59 am | Updated:December 6, 2020 11:19 am

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