JOIN USWhy the Pfizer-BioNTech Covid-19 vaccine is not coming to India any time soon
As countries to race to develop and get their hands on a Covid-19 vaccine, all eyes are now on the Pfizer-BioNTech mRNA vaccine after the UK gave its nod on Wednesday, becoming the first country in the West to approve mass rollout. However, it is unlikely to be available in India any time soon.
This is mainly because the pharma major has not held any clinical trials of its vaccine in India and the extremely cold temperatures required to store the vaccines pose a logistical challenge not just for India, but for most countries in the world.
Clinical trials
For any vaccine or drug to get authorisation for usage by regulators in India, it needs to undergo clinical trials locally first. So far, Pfizer has not applied for conducting these trials in India yet, Business Standard reported.
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Pfizer reportedly held talks with the government for the vaccine requirements of India. But the NITI Aayog has indicated that Pfizer’s limited doses may not be enough for India.
A Pfizer spokesperson told BS that once the company gets the government’s approval, it will work with authorities to determine a safe deployment of the vaccine.
Cold-chain storage
India also does not have the cold chain infrastructure for this vaccine, which requires a storage temperature of -75 degrees Celsius. However, India does have the required cold chain for the Moderna vaccine, which showed similar efficacy results as Pfizer in its trials. Required equipment to store the Sputnik and AstraZeneca-Oxford are also available in India, even though they are limited.
Currently there are 28,000 cold chain points and 700 plus refrigeration vans. The government is in talks with the private sector for additional cold chain facilities. State governments have also been asked to prep up their cold chain network. Also, there are 70,000 plus trained vaccine-givers but efforts are underway to find out more people to administer the two-dose vaccine.
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Apart from this, the high cost and pre-booking of entire stock by rich nations will also pose issues.
High costs
Until last week, Pfizer had said its vaccine would cost $39.
For a two-dose regimen, the AstraZeneca vaccine would cost $8, which makes the price extremely competitive for Indians. Poonawalla said he would sell the vaccine at Rs 1,000 while talks are on with the health ministry to fix a procurement rate for the government. Sputnik-V will cost less than $20 for two doses while Moderna's vaccine will cost $30.
The AstraZeneca vaccine being developed in collaboration with Oxford is in phase-3 trials in India, being tested on 1,600 Indian candidates. Russia’s vaccine candidate Sputnik V is also undergoing tests on Indians with Dr Reddy’s Laboratories.
“Pfizer’s phase-3 study has enrolled 43,358 participants with 42% having diverse backgrounds. It will be making this data available to governments across the world to seek regulatory approvals,” a Pfizer spokesperson said.