Pfizer India seeks emergency use authorisation for its COVID-19 vaccine in India, after the parent company Pfizer secured clearance for a similar use in the UK and Bahrain.
Approval was requested from the drug regulator - the Drugs Controller General of India (DCGI). Pfizer India is also seeking permission to import the vaccine into the country for sale and distribution.
According to reports, under the New Drugs and Clinical Trials Regulations, 2019, Pfizer has also requested the waiver of clinical trials in India as per the special provisions.
The US pharma major earlier released a statement saying, “Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval."
As Pfizer India seeks emergency use authorisation for its COVID-19 vaccine in India, there have been discussions about the challenges in terms of availability, storage, distribution and cost.
No clinical trials in India for Pfizer's candidate vaccine
Following a peer review and the vaccine candidate passing the efficacy test, which stated 95 per cent safety, an emergency use authorization was given in the UK and Bahrain. If an emergency authorisation for Pfizer in India is to be granted, the clinical evidence for a candidate vaccine abroad should be taken into account for approval.
Cold chain network challenge
The vaccine Pfizer-BioNTech must be kept at a temperature of -70°C. Currently, this temperature range is not supported by the cold chain capability in India. This presents a major challenge to its distribution in India especially in its smaller towns and rural areas.
Pfizer assures solutions to make storage easy in countries like India:
Pfizer offers the following options for storage
Commercially available ultra-low-temperature freezers can extend up to six months of shelf life.
Thermal shippers are specially built and temperature-controlled. Doses arrive in these and can be used as temporary storage units. The shipper can remain unopened for 10 days at -70 degrees Celsius. When opened, by re-icing every five days, it can be used for 30 days.
The vaccine can be kept under conditions of 2-8 °C for five days.
In every thermal shipper, GPS-enabled thermal sensors monitor their quality, temperature across their pre-set routes.
Given that Pfizer is also supplying the US, UK and Japan with its Covid-19 vaccine candidate and has committed 200 million doses to them,
its availability in India will be a challenge from January to September 2021, when India intends to cover the priority population group during this period.
High cost of vaccine Pfizer's costs depend on the quantity requested and on its obligations to countries.
For a double-dose, the cost of Pfizer in the US is $39. It is supposed to be a little smaller in India, but it may still be costly.