BioNTech Plans Vaccine Scale-up to 2 Billion Doses

13.01.2021 - Germany’s BioNTech has scaled up its projections for the number of doses of its Covid-19 vaccine it will make this year from 1.3 billion to 2 billion, as it seeks approvals from regulatory agencies outside the US, UK and the EU, where its Comirnaty-branded product is already on the market.

At the same time, the Mainz-based biotech partnered with US drugmaker Pfizer hopes to roll out a temperature-stable formulation of the shot, as CEO Ugur Sahin told this week’s virtual J.P. Morgan Healthcare Conference. The company also hopes to deliver a new formula free of polyethylene glycol, Sahin said, without revealing a timetable for either action.

Distribution of the Pfizer-BioNTech vaccine, which must be stored at a consistent  low temperature of minus 70°C, is costly and requires large amounts of dry ice, which, to meet the current rollout, have been commandeered at the expense of other applications. Ethylene glycol is suspected of being responsible for some of the side effect seen with this and other vaccines.

Another part of the output boost is expected to result from the creation of special syringes, which allow the extraction of six doses from a standard vial, instead of the usual five.

BioNTech has already been recommending that physicians try to get a sixth dose out of the vials. It said the labeling of the vials as yielding five doses allowed for the use of syringes that did not extract maximum yield or for less experienced practitioners.

The CEO said the increased output will come from six global manufacturing sites it operates as part of the alliance with Pfizer, starting next month with the facility in Marburg, Germany acquired from Novartis last year. This will have output capability of 75 million doses per year. The vaccine maker is also scouting for new CDMO partners.

In November last year, Pfizer's chief scientist, Mikael Dolsten, told the US journal Business Insider that there were also plans to produce a powder form of the vaccine to circumvent the cold chain problems.

Pfizer and BioNTech have already revealed that lab tests with their vaccine have shown it to be effective against 16 Covid variants, including a key mutation of the coronavirus found in South Africa and the UK, which has begun to spread across the globe.

Author: Dede Williams, Freelance Journalist