LONDON – Biontech SE is looking ahead from the announcement on Nov. 9 of 90% efficacy in the interim analysis of the phase III trial of its COVID-19 vaccine, BNT-162b2, to outline shipping and distribution plans for a product that has the exacting requirement of needing to be kept at minus 70 degrees Celsius.

That is beyond the capability of cold chains, even in developed countries, and to satisfy that requirement, partner Pfizer Inc. has developed a “thermal shipper” to encase the vaccine, keeping it at this ultralow temperature for up to 10 days. The shipper itself can be stored at the benign temperature of +15 to +25 degrees C. Once taken out of the shipper, the vaccine will remain stable for up to five days at the more regular vaccine storage temperature of +2 to -8 degrees C.

Sean Marett, chief business officer, Biontech

“So we have the ability for five days storage in a refrigerator,” said Sean Marett, chief business officer of Biontech. “We’ve got flexibility with respect to storage and distribution.”

Marett noted that ultralow temperature freezers are commercially available. Stability testing is ongoing, but BNT-162b2 can be stored in those freezers at minus 70 degrees centigrade for up to six months.

The global positioning system-tracked specialist shipper appears to address concerns that in addition to requiring two injections, BNT-162b2, an mRNA vaccine, must be stored at such a low temperature.

“Both properties will severely complicate administering the vaccine, particularly in countries which are warm and have less developed cold chains,” said Johnathan Stoye, group leader at the Retrovirus-Host Interactions Laboratory at the Francis Crick Institute, London.

Toby Peters, professor of Cold Economy at Birmingham University echoed that. “Nowhere on the planet does the logistical capacity exist to distribute vaccines at this temperature and volume without massive investment.” The problem is particularly acute in the global south, where many rural villages don’t even have a working fridge, he said.

Laboratory equipment supplier Fisher Scientific offers ultralow temperature freezers for between £13,000 and £18,000 (US$17,000 and US$24,000) on its U.K. website.

Biontech is working on improving the stability of BNT-162b2, to optimize the supply chain requirements. “We are looking at formulations that are more stable,” said Marett. “We have a project running to do that.” The aim is to come up with a version “you can stick in the fridge for longer periods of time,” he said. If successful, Biontech and Pfizer will launch a line extension.

Speaking at Mainz, Germany-based Biontech’s third-quarter results meeting, Marett said the shipping and distribution model for BNT-162b2 will depend on the region, with some being serviced from centralized hubs and others from distributed networks.

Biontech will distribute the vaccine in Germany and leverage Pfizer’s distribution infrastructure elsewhere. The two will have a 50-50 share of the profits, apart from in China, where Biontech has a partnership with Fosun Pharmaceutical Co. Ltd.

“The economies for Biontech are the same, regardless of who distributes,” said Marett.

Demand for BNT-162b2 is “strong around the world,” with firm commitments to purchase 570 million doses in 2020 – 2021, from 13 countries and the EU on behalf of 27 member states. Biontech said there will be capacity to manufacture 1.3 billion doses in 2021.

The U.S. has committed to buy 100 million doses, with an option for a further 500 million; the EU 200 million doses with an option for 100 million more; the U.K. 30 million; Japan 120 million. The volume of agreements with other countries, including with Canada, has not been disclosed.

“We continue to work diligently with Pfizer to complete additional agreements,” Marett said. That includes sealing an agreement with COVAX, the global procurement mechanism that is pooling the purchasing power of all countries that participate, and supporting equitable access to COVID-19 vaccines for 92 low- and middle-income countries.

Ugur Sahin, co-founder and CEO, Biontech

The order value for the commercial supply agreements has not been disclosed, apart from that with the U.S. government for an initial 100 million doses, which is priced at $1.95 billion.

The cost of $19.50 per dose is a benchmark for the developed world, though it will vary from country to country, said Ugur Sahin, co-founder and CEO of Biontech. “The committed orders are in the developed world, but we are committed to supply the developing world,” he said.

Sahin was unable to satisfy the clamor for more information on the data released on Monday, following the planned interim analysis by the independent board monitoring the trial. Important issues, such as if efficacy spans different age groups in the study, if protection against the virus also stops it from being transmitted, durability of protection, and if one dose rather than two might be effective, cannot be addressed at this time.

As yet, correlates of protection for a successful COVID-19 vaccine are unknown and the monitoring committee released the minimum of data, in order not to compromise the integrity of the trial, Sahin said.