BioNTech recruits rivals to boost Covid-19 vaccine production

The European Union has been fighting the shortage of vaccines, as manufacturers, including Swedish-British pharmaceutical company AstraZeneca PLC, have not kept their promises to deliver to the bloc.

The scarcity has been largely limited to the EU, which has been slower than its western allies to request and approve vaccines, and has increased tensions between the bloc and the UK and the US

This can pose a challenge for the BioNTech alliance. Your vaccine uses sophisticated new techniques that require few ingredients and experience. This creates a delicate supply chain that is vulnerable to the kind of export controls that the EU, the UK and the United States have imposed in recent months, company officials warned.

Pfizer and BioNTech developed the first Covid-19 vaccine authorized in the West in record time, but its complex manufacturing left the U.S. giant struggling to meet production targets.

BioNTech’s response: An alliance designed to boost vaccine production and accelerate vaccinations in Europe and elsewhere. Negotiations for the new manufacturing alliance were coordinated with Pfizer, according to a BioNTech spokeswoman.

The cancer research company, based in the small German town of Mainz, created the vaccine based on innovative messenger RNA technology in February 2020 and then teamed up with Pfizer to test, produce and market it. all around the world.

The vaccine was authorized in Europe and the United States in December, after tests showed that it was highly effective in preventing infections in adults. On Thursday, a real study by Israel showed that the injection also had 94% success in stopping asymptomatic transmission.

However, despite their successes, Pfizer and BioNTech have struggled to make enough of the vaccine to meet demand, causing growing frustration worldwide with the pace of delivery – a bottleneck that BioNTech’s new manufacturing alliance now aims to relieve.

After months of negotiations, the company has now set up a network of companies, most of them in Europe and some important rivals to Pfizer. BioNTech said it is confident that the alliance will allow it and Pfizer to achieve their goal of producing two billion doses in 2021.

Under its original contract, BioNTech, which holds 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 USA, 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 undisclosed 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 is expected to continue growing.

Pfizer, a nearly two-century company that employs about 100,000 people, currently produces 50% of the active ingredient for all doses, said a spokeswoman, with the other half produced by medium-sized BioNTech. A spokeswoman for BioNTech said the company was in fact producing 60% of production.

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

Pfizer, which had no mRNA production capacity before its agreement with BioNTech, took longer than expected to set up factories in Kalamazoo, Michigan, and Puurs, Belgium, according to the companies.

A Pfizer spokeswoman attributed the delays to the need to set up a supply chain for raw materials, adding that the company has since increased production at an unprecedented pace.

In October, Dr. Sahin and other BioNTech executives began negotiations with other companies, weeks before Pfizer and BioNTech released final data from their final stage tests, showing that the vaccine was more than 90% effective in preventing infections.

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

The Kalamazoo plant was supposed to supply the United States, while the Puurs plant would serve the rest of the world. Even so, some of the 20 million starting doses the company supplied to the United States came from Europe, according to the companies.

In January, Pfizer launched a major update to its Puurs facility. The update halted production for two weeks, aggravating the vaccine shortage in Europe and prompting some governments to threaten Pfizer with legal action.

Sierk Poetting, director of operations at BioNTech, said that experience has shown BioNTech the urgency to launch a new manufacturing alliance in order to fulfill commitments in Europe and other markets.

BioNTech is increasing its own production. Its German factory, due to start operating in April, is expected to produce 750 million doses per year. The facility will mainly supply the EU, but its production will not be sufficient, so BioNTech had to recruit new partners across the supply chain, said Mr. Poetting.

The BioNTech-Pfizer vaccine uses mRNA packaged in a microscopic fat ball to induce an immune response. These vaccines can be produced more quickly than conventional vaccines, but the process is sophisticated, with new partners now involved in each 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. Swiss company Novartis is also negotiating a contract to produce DNA molecules used in the first stage.

In the next step, the mRNA is wrapped in its fatty envelope. Lipids are supplied by German companies Merck and Evonik Industries AG

, while Polymun Scientific Immunbiologische Forschung GmbH of Austria, Acuitas Therapeutics Inc. of Canada and Dermapharm Holding SE of Germany are helping with the formulation.

During the final step, the solution is filtered again and placed in flasks, 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.

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

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

At the moment, the most scarce ingredients are the lipids used to deliver the vaccine’s RNA. They are produced by a handful of companies and the shortage is compounded by the fact that vaccine manufacturers use similar technology and depend on the same suppliers.

“This is the biggest bottleneck at the moment … lipids are the problem we have,” said Poetting.

Write to Bojan Pancevski at [email protected]