TV Jayan The Covid-19 vaccine developed by US pharma giant Pfizer along with its German collaborator BioNTech is very unlikely to be available in India, though its limited availability in private markets cannot be ruled out completely, according to an Indian vaccine expert.

The Pfizer-BioNTech vaccine, which has shown over 90 per cent efficacy in preliminary tests, is expected to be considered for Emergency Use Authorisation by the US Food and Drug Administration, if the data the firms are expected to submit later this month are found satisfactory.

Renowned microbiologist Nirmal Kumar Ganguly, former Director General of the Indian Council of Medical Research (ICMR), said it is not sure India will manage to get sufficient quantities of the Pfizer vaccine, which will not only be prohibitively expensive but also difficult to store and transport because of its ultra-cold temperature requirements.

Production constraints

“The developers have already produced 100 million doses of the two-shot vaccine even though they are yet to get the approvals. But they will also be able to produce only 1.3 billion doses of the vaccine by the end of 2021, which is sufficient only for 650 million people. The actual numbers may go further down as there could be 20-25 per cent vaccine wastage,” Ganguly told BusinessLine .

The vaccine is yet to undergo trials in India.

The potential availability of the Pfizer vaccine in India is impeded by two major factors. Firstly, the firm will not be able to set aside sufficient supplies for India. It already has huge supply commitments for the EU, the UK and the US among others, Ganguly said.

Deployment issues

Secondly, it faces major deployment issues. The world’s first messenger RNA vaccine needs to be stored at extremely low temperatures (in the range of -70°C to -80°C). Pfizer, in partnership with other entities, is already producing such -80°C storage refrigerators at breakneck speed.

“They have mapped country-wise supply chains. For main depots and sub-depots, they are creating these -80°C deep freezer storages. The vaccine will be manufactured in Germany and shipped in drums once it gets Emergency Use Authorisation,” said Ganguly.

The stored vaccine will need to maintained at -80°C throughout the shipment and tested for stability at regular intervals till it reaches the depots and sub-depots, where it can be stored at -20°C for a brief period. It then needs to be used in less than a week, he added.

Vaccine wastage (caused mainly by loss of potency) is going to be very high when the storage temperature increases, and is estimated at 25 per cent, he observed.

The Pfizer vaccine will, in all likelihood, be available to people who can afford it, said Ganguly. “People driving around in Mercedes may be able to get it, but not those with Maruti Swift. This could lead to major public disenchantment,” Ganguly warned.