India is in a position to not only augment and strengthen, but also add to its cold chain capabilities, health secretary Rajesh Bhushan said on Tuesday in response to a query on the country’s cold storage capacity for vaccines such as Pfizer’s that need to be kept in minus 70 degrees Celsius temperature.
The government has been in talks with US drug-maker Pfizer which has reported that its vaccine BNT162b2, has been more than 90 per cent effective in late-stage trials. The vaccine developed with German biotech firm BioNTech will be reviewed by the US Food and Drug Administration this month.
“We cannot reveal the specifics of our conversations with Pfizer...when it reaches finality we will share with you,” Bhushan told reporters.
He however, said that the national expert group on vaccine administration is in dialogue with all vaccine manufacturers both domestic and international and is looking at not just their status of development but also the progress of regulatory approval. “We also engage in a dialogue about the logistical requirements if such vaccines have to be stored at temperature which may range from 2 to 8 degrees or -50 to -70 or -90 degree as well as the doses. It is a dynamic situation,” Bhushan added.
According to reports, Pfizer’s vaccine requires an ultra cold chain system with storage at temperatures below -90 degree Fahrenheit (-70 degree celsius).
In 2019 the overall cold storage capacity in India stood at around 37-39 million tonnes — one of the largest in the world, according to CBRE South Asia data. A vast portion of the cold storage available in India is used for agricultural produce and very few are pharma compliant as per the guidelines of the World Health Organisation.
B Thiagarajan, managing director, Blue Star, which has a 70 per cent market share in pharma cold chain products in India, said that India has got cold chain infrastructure to handle vaccines in 2/8 degrees Celsius and minor improvements would be required to improve the last mile. “To manage vaccines -40 ,-70 degrees Celsius, the country definitely needs to invest a large sum to develop the infrastructure.”
The health ministry has also acknowledged that large-scale immunisation will not only require a substantial increase in the number of cold chain points but also equipment such as reefer vans, walk in coolers, deep freezers.
Pfizer will have to take the approval of the Central Drugs Standard Control Organisation to conduct human trials of the vaccine in India in order to launch its candidate here.
Five other vaccine candidates are under development by Serum Institute of India, Bharat Biotech, Zydus Cadila, Dr Reddy’s Laboratories and Biological E in India.
Roughly estimated, nearly 3 billion people in developing countries will miss out on the Covid-19 vaccine as they live in locations which lack adequate temperature-controlled storage for a mass vaccination campaign.
Health secretary however assured that the government has a plan to make the vaccine available to all priority groups irrespective of the regions where they reside.
Ketan Kulkarni, CMO and Head – Business Development, Blue Dart said that a significant number of vaccines provided by the government fall under the traditional cold chain temperature range, stored between 2 degress Celsius to 8 degrees Celsius in the cold chain. The company has the required infrastructure to store at temperatures -80 degrees Celsius to -20 degrees Celsius as part of it our temperature controlled logistics division. ““We use both single use packaging which provides temperature stability for 48-72 hours and multi-use boxes which provides temperature stability for 96 hours.”
–With Inputs from T E Narasimhan in Chennai