BioNTech recruits competitors to increase Covid-19 vaccine production

The European Union is struggling with a shortage of vaccines, as manufacturers, including the British-Swedish pharmaceutical firm AstraZeneca PLC, have fallen behind on their delivery promises to the block.

The shortfall was largely limited to the EU, which was slower than its Western allies in ordering and approving the vaccines, and this created tensions between the bloc and the UK and US.

This could be a challenge for BioNTech’s alliance. The vaccine uses sophisticated new techniques that require scarce ingredients and expertise. It creates a delicate supply chain that is vulnerable to the kind of export controls that the EU, the UK and the US have introduced in recent months.

Pfizer and BioNTech developed the first Covid-19 vaccine in the West in record time, but its intricate manufacturing has made the American giant struggle to reach production targets.

BioNTech’s Response: An alliance designed to accelerate vaccine production and accelerate vaccinations in Europe and elsewhere. According to a BioNTech spokesperson, negotiations for the new manufacturing alliance have been coordinated with Pfizer.

The cancer research firm, based in the small German town of Mainz, came up with the vaccine in February 2020 based on the innovative messenger RNA technology, and partnered with Pfizer to test, manufacture and market it worldwide.

The vaccine was approved in Europe and the United States in December after trials showed it to be very effective in preventing infections in adults. On Thursday, an actual study by Israel showed that the shot was also 94% successful in stopping the asymptomatic transmission.

Despite their successes, however, Pfizer and BioNTech have struggled to make enough of the vaccine to meet demand, causing increasing frustration worldwide with the delivery rate – a bottleneck of BioNTech’s new manufacturing alliance now wants to ease.

After months of negotiations, the company has now put together a web of companies, most of which are in Europe and some key competitors for Pfizer. BioNTech said it was confident the alliance would allow Pfizer to reach its target of producing two billion doses by 2021.

Under their original agreement, BioNTech, which has the marketing rights for the vaccine, supplies Germany, China and Turkey, while Pfizer covers the rest of the world. To date, BioNTech and Pfizer have sold 500 million doses to the EU, 300 million to the US, 120 million to Japan, 110 million to China and its territories, 40 million to the United Kingdom and 20 million to Canada.

Millions of doses have also been sold in unknown contracts with the Middle East and other countries, and 40 million have been sold to Covax, an international initiative to supply vaccines to developing countries. Demand will continue to grow.

Pfizer, a company that dates back nearly two centuries and employs about 100,000 people, currently makes up 50% of the active ingredient for all doses, a spokesman said. The other half is manufactured by medium-sized BioNTech. A spokesman for BioNTech said the company produces 60% of the production.

Ugur Sahin, co-founder and CEO of BioNTech, told The Wall Street Journal he realized last fall that his partnership with Pfizer would not have enough capacity to meet global demand.

Pfizer, which had no mRNA production capability prior to its agreement with BioNTech, said the companies had expected longer than expected to set up plants in Kalamazoo, Mich., And Puurs, Belgium.

A Pfizer spokesman blamed the delays for the need to put together a supply chain for raw materials, adding that the company has since increased production at an unprecedented rate.

In October, dr. Sahin and other executives of BioNTech began negotiations with other companies, just weeks before Pfizer and BioNTech released the final details of their final phase trials, which showed that the vaccine was more than 90% effective in preventing infections.

Days later, the companies quietly informed authorities in the US and elsewhere that they would reduce the delivery target for 2020 from 100 million to just 50 million. For the US, this meant that by December, Pfizer would deliver only 20 million doses instead of 40 million doses.

The Kalamazoo factory was intended to supply in the US, while the Puurs site would supply for the rest of the world. According to the companies, some of the initial 20 million doses the company delivered to the US come from Europe.

In January, Pfizer launched a major upgrade of its Puurs plant. The upgrade disrupted production for two weeks, exacerbating vaccine shortages in Europe and prompting some governments to threaten Pfizer with legal action.

Sierk Poetting, Chief Operating Officer of BioNTech, said that experience has shown BioNTech that it is urgently necessary to launch a new manufacturing alliance to meet its commitments in Europe and other markets.

BioNTech increases its own production. The German plant, which is expected to start up in April, should deliver 750 million doses a year. The factory will mainly supply to the EU, but its production will not be enough, and therefore BioNTech had to recruit new partners in the supply chain, said Mr. Poetting said.

The BioNTech-Pfizer vaccine uses mRNA packaged in a microscopic ball of fat to elicit an immune response. Such vaccines can be produced faster than ordinary shots, but the process is advanced, and new partners are now involved in every step of the process.

The mRNA is first produced, then purified, concentrated and filtered. BioNTech brought the German company Rentschler Biopharma SE to help with these steps. The Swiss company Novartis is also negotiating a contract to manufacture DNA molecules used in the first step.

In the next step, the mRNA is encapsulated in its fatty shell. The lipids are supplied by the German companies Merck and Evonik Industries AG

, while the Austrian Polymun Scientific Immunbiologische Forschung GmbH, Canada’s Acuitas Therapeutics Inc., and the German Dermapharm Holding SE assist with the formulation.

During the last step, the solution is filtered again and filled into vials, a process known as finishing and filling. This will be done by Delpharm SAS, a French company; Siegfried AG

; Baxter Oncology GmbH from Germany; Novartis, Dermapharm and Sanofi.

Poetting says the European alliance of BioNTech will produce about half of the global inventory of active ingredients for the Covid-19 vaccine, and it will contain about 20% of the finish and filling.

BioNTech is confident that the alliance can meet demand, the number of partners, the complexity of the process and the raw materials needed – from DNA to enzymes, salts, sugars and various lipids – are fine-tuning the supply chain, with many opportunities for bottlenecks.

Currently, the rarest ingredients are the lipids used to deliver the vaccine’s RNA. It is manufactured by a handful of companies and the shortage is exacerbated by the fact that vaccine manufacturers use a similar technology and rely on the same suppliers.

“This is the ultimate bottleneck at the moment … the lipids are the hand-to-mouth issue,” Poetting said.

Write to Bojan Pancevski by [email protected]