BioNTech is recruiting rivals to boost production of Covid-19 vaccines

The European Union is struggling with a vaccine shortage as manufacturers, including the British-Swedish pharmaceutical firm AstraZeneca PLC, have fallen behind in their pledges to the bloc.

The deficit has been largely confined to the EU, which has been slower than its Western allies in ordering and approving the vaccines, and it has increased tensions between the bloc and the UK and US.

This could pose a challenge to the BioNTech alliance. The vaccine uses advanced new techniques that require scarce ingredients and expertise. This makes for a delicate supply chain that is vulnerable to the kind of export controls the EU, UK and US have imposed in recent months, business officials have warned.

Pfizer and BioNTech have developed the first Covid-19 vaccine to be approved in the West in record time, but complex manufacturing means the American giant is struggling to meet production targets.

BioNTech Response: An alliance designed to accelerate vaccine production and accelerate vaccinations in Europe and elsewhere. Negotiations for the new manufacturing alliance were coordinated with Pfizer, a BioNTech spokeswoman said.

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

The vaccine was approved in Europe and the US in December after studies showed it to be very effective in preventing infections in adults. On Thursday, a real-life study by Israel showed that the shot was also 94% successful in stopping asymptomatic transmission.

But despite their successes, Pfizer and BioNTech are struggling to make enough of the vaccine to meet demand, increasing frustration around the world at the pace of delivery – a bottleneck BioNTech’s new manufacturing alliance now wants to provide relief.

After months of negotiation, the company has now built a network of companies, most of them in Europe and some of Pfizer’s major rivals. BioNTech said it was confident the alliance would allow it and Pfizer to meet their goal of producing two billion doses by 2021.

Under their original agreement, BioNTech, which owns the marketing rights to the vaccine, supplies Germany, China and Turkey, while Pfizer covers the rest of the world. So far, 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 UK and 20 million to Canada.

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

Pfizer, a company that dates back nearly two centuries and employs approximately 100,000 people, currently makes 50% of the active ingredient for all doses, a spokeswoman said, while the other half is produced by medium-sized BioNTech. A BioNTech spokeswoman said the company actually produced 60% of its output.

BioNTech’s co-founder and chief executive, Ugur Sahin, told The Wall Street Journal that he realized last fall that his partnership with Pfizer wouldn’t accumulate enough capacity to meet global demand.

Pfizer, which had no mRNA manufacturing capacity prior to the BioNTech deal, took longer than expected to set up factories at its locations in Kalamazoo, Mich., En Puurs, Belgium, the companies said.

A Pfizer spokeswoman blamed the delays in establishing a raw materials supply chain, adding that the company had since scaled production at an unprecedented pace.

In October, Dr. Sahin and other BioNTech executives opened negotiations with other companies, weeks before Pfizer and BioNTech released final data from their final phase of trials, showing that the vaccine was more than 90% effective at preventing infections.

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

The Kalamazoo plant was intended to supply the US, while the Puurs facility would serve the rest of the world. Still, according to the companies, some of the first 20 million doses the company delivered to the US came from Europe.

In January, Pfizer launched a major upgrade to its Puurs plant. The upgrade halted production for two weeks, exacerbating the European vaccine shortage and prompting some governments to threaten Pfizer with legal action.

Sierk Poetting, BioNTech’s Chief Operating Officer, said the experience for BioNTech had demonstrated the urgency to launch a new manufacturing alliance to meet commitments in Europe and other markets.

BioNTech increases its own production. The German plant, expected to be operational in April, is expected to produce 750 million doses per year. The facility will primarily supply the EU, but the output will not be sufficient, so BioNTech had to attract new partners in the supply chain, said Mr. Poetting.

The BioNTech-Pfizer vaccine uses mRNA wrapped in a microscopic ball of fat to trigger an immune response. Such vaccines can be produced more quickly than conventional injections, but the process is advanced and new partners are now involved at every step of the process.

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

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

, while the Austrian Polymun Scientific Immunbiologisch Forschung GmbH, the Canadian Acuitas Therapeutics Inc. and the German Dermapharm Holding SE assist with the formulation.

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

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

BioNTech’s European alliance will produce approximately half of the global active ingredient supply for the Covid-19 vaccine and approximately 20% of the finish and fill for each dose, said Mr Poetting.

While BioNTech is confident that the alliance will be able to meet the demand, number of partners, process complexity and raw materials required – from DNA to enzymes, salts, sugars and various lipids – make the supply chain delicate, with many opportunities for bottlenecks.

Currently, the most scarce ingredients are the lipids used to deliver the vaccine RNA. These are produced by a handful of companies and the shortage is exacerbated by the fact that vaccine manufacturers use similar technology and depend on the same suppliers.

“This is the ultimate sticking point right now… the lipids are the hand-to-mouth problem,” said Mr Poetting.

Write to Bojan Pancevski at [email protected]