FAQ: Pfizer COVID Vaccine in India, What We Know So Far

FAQ: Pfizer COVID Vaccine in India, What We Know So Far

After the United Kingdom became the first country to approve the Pfizer-BioNTech vaccine for rollout, Pfizer Inc became the first to seek emergency use approval in India from the Drugs Controller General of India (DCGI) on 4 December. The US’s FDA has given emergency approval to the vaccine as well.

But as FIT as explained before, experts are not too excited about Pfizer with its many logistical and storage issues.

What Approval Has Pfizer Sought?

Pfizer Inc has sought an emergency use authorization (EUA) for their COVID vaccine in India from the DCGI. The Drugs Controller General of India (DCGI) is an official body of the Central Drugs Standard Control Organization (CDSCO). The DCGI is the final regulatory authority for the approval of clinical trials in the country.

The firm has sought permission to import the vaccine for sale and distribution in the country, and a waiver for clinical trials on Indian population. This is in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.

“During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval.”
Spokesperson from Pfizer Inc.

How Will The Vaccine Be Distributed in India?

FIT earlier spoke with Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University to understand what the news meant for us - will the vaccine reach India? To put it bluntly, Dr Jameel says,

“Don’t get too happy that this vaccine will reach us In India in the near future. It won’t.”
Dr Shahid Jameel, Virologist

He added that the cold chain challenges and the need for the vaccine to be stored at near -94 degrees Fahrenheit pose a huge problem for India.

He said, “A word of caution here. This vaccine requires ultra-cold temperatures to be stored in - near -94 degree F in supercooled containers. This creates immense challenges as far as the distribution and cold chain for the vaccine is concerned. Therefore, it is certainly not a vaccine with which you can think of immunising a lot of people in India because India just doesn’t have the infrastructure for this kind of a cold chain. Perhaps, some very rich people who can afford to pay a lot of money may be able to afford it, that too if the vaccine finally becomes available in India.”

Read more about India’s vaccine distribution plans here.

How Much of the Vaccine Will be Available to India?

As per reports, India has not yet officially booked orders of Pzifer to determine timelines, so we don’t know how much can and will be available to us.

By contrast, the UK government has ordered 40 million doses and the EU has ordered the most at 300 million. Pfizer Inc experts to make 50 million doses this year and up to 1.3 billion does in 2021.

Will Pfizer Vaccine be Distributed Only Through Government Contracts?

Pfizer has made clear that during the pandemic phase, the vaccine will only be distributed through the government of India.

India may possibly get access to the Pfizer vaccine from the Covax facility which is co-led by the World Health Organisation, GAVI, and Coalition for Epidemic Preparedness Innovations (CEPI) to help fair and equitable access for vaccines for every country, especially developing countries like ours.

Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility.

However, this also needs emergency authorization first.

How Much Will it Cost?

For the US, Pfizer is charging 20 dollars per dose for its two-dose vaccine. In India, the price has not been set yet but would be done keeping in mind access and affordability.

(With inputs from the Economic Times)

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