BioNTech is recruiting rivals to boost Covid-19 vaccine production

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

The shortage was largely limited to the EU, which was slower than its Western allies in commanding and approving vaccines and raised tensions between the bloc and Britain and the United States.

This could be a challenge for the BioNTech alliance. His vaccine uses new sophisticated techniques that require rare ingredients and expertise. This makes a delicate supply chain vulnerable to the type of export controls that the EU, UK and US have imposed in recent months, company officials have warned.

Pfizer and BioNTech have developed the first Covid-19 vaccine licensed in the West in record time, but its complex production has left the American giant struggling to achieve production goals.

BioNTech’s response: an alliance designed to produce the vaccine and accelerate vaccination in Europe and elsewhere. Negotiations for the new production alliance have been coordinated with Pfizer, according to a BioNTech spokeswoman.

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

The vaccine was approved in Europe and the United States in December, after studies showed that it is very effective in preventing infections in adults. On Thursday, a real Israeli study showed that the shooting was also 94% successful in stopping asymptomatic transmission.

However, despite their successes, Pfizer and BioNTech have worked hard to make enough vaccine to meet demand, causing growing frustration around the world with the pace of delivery – a new bloc of the new production alliance. of BioNTech now aims to mitigate.

After months of negotiations, the company has now assembled a network of companies, mostly from Europe and a few key rivals of Pfizer. BioNTech said it is confident the alliance will allow it and Pfizer to meet its goal of producing two billion doses by 2021.

Under their initial agreement, BioNTech, which owns the rights to market 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 UK and 20 million to Canada. .

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

Pfizer, a company that returns almost two centuries ago and has about 100,000 employees, currently produces 50 percent of the active ingredient for all doses, a spokeswoman said, with the other half being produced by medium-sized BioNTech. A BioNTech spokeswoman said the company actually produces 60% of its production.

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

Pfizer, which did not have mRNA production capacity before the deal with BioNTech, took longer than expected to set up plants at its headquarters in Kalamazoo, Michigan and Puurs, Belgium, according to the companies.

A Pfizer spokeswoman blamed the delays on the need to set up a supply chain with raw materials, adding that since then the company has increased production at an unprecedented rate.

In October, Dr. Sahin and other BioNTech executives opened talks with other companies a few weeks before Pfizer and BioNTech released final data from their final phase studies showing that the vaccine was more than 90% effective in preventing infections. .

Days later, companies quietly notified authorities in the US 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 designed to supply the US, while the Puurs site will serve the rest of the world. However, some of the 20 million initial doses that the company provided to the US came from Europe, according to the companies.

In January, Pfizer launched a major upgrade to the Puurs facility. The update cut off production for two weeks, exacerbating the lack of vaccines in Europe and prompting some governments to threaten Pfizer with legal action.

Sierk Poetting, BioNTech’s chief operating officer, said experience had shown BioNTech the urgency of launching a new production alliance to meet commitments in Europe and other markets.

BioNTech is increasing its own production. Its German plant, expected to be launched in April, is expected to produce 750 million doses a year. The facility will mainly supply the EU, but its production will not be enough, so BioNTech had to hire new partners along the supply chain, 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 conventional photographs, but the process is sophisticated, with new partners now involved at every stage 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 produce the DNA molecules used in the first step.

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

, while Austria Polymun Scientific Immunbiologische Forschung GmbH, Canada Acuitas Therapeutics Inc. and Germany Dermapharm Holding SE help with forms.

In the final stage, 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.

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

While BioNTech is confident that the alliance will enable it to 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 – make the supply chain delicate, with many opportunities for blockages.

At this time, the rarest ingredients are the lipids used to administer the vaccine RNA. They are produced by a handful of companies, and the lack is exacerbated by the fact that vaccine manufacturers use a similar technology and rely on the same suppliers.

“This is the last block at the moment … lipids are a hand-to-mouth problem,” Mr Poetting said.

Write to Bojan Pancevski at [email protected]