BioNTech recruits rivals to increase Covid-19 vaccine production

The European Union has struggled with the shortage of vaccines as manufacturers, including the British-Swedish pharmaceutical company AstraZeneca PLC, have lagged behind in their promises of delivery to the block.

The shortage has largely been limited to the EU, which has been slower than its Western allies in ordering and approving vaccines, and has raised tensions between the bloc and the UK and United States.

This could pose a challenge to the BioNTech alliance. Their vaccine uses sophisticated new techniques that require few ingredients and experience. This results in a delicate supply chain vulnerable to the type of export controls that the EU, the UK and the US have imposed in recent months, company officials have warned.

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

BioNTech Response: An alliance designed to boost vaccine production and accelerate vaccination 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 city of Mainz, developed the vaccine based on the innovative messenger RNA technology in February 2020 and then partnered with Pfizer to test, produce and market it worldwide.

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

Despite their successes, Pfizer and BioNTech have struggled to get enough vaccine to meet demand, causing growing frustration around the world at the pace of delivery – a new bottleneck that BioNTech’s new manufacturing alliance aims to alleviate.

After months of negotiations, the company has now assembled a network of companies, most of them in Europe and some key rivals of Pfizer. BioNTech said it was confident the alliance would allow Pfizer and it to meet its goal of producing two billion doses by 2021.

Under its original agreement, BioNTech, which owns the vaccine marketing rights, supplies Germany, China and Turkey, while Pfizer covers the rest of the world. To date, BioNTech and Pfizer have sold 500 million doses in the EU, 300 million in the US, 120 million in Japan, 110 million in China and its territories, 40 million in the UK and 20 million in 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 provide vaccines to developing countries. Demand continues to grow.

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

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

Pfizer, which had no mRNA production capacity prior to its agreement with BioNTech, took longer than expected to install plants at its sites in Kalamazoo, Michigan, and Puurs, Belgium, according to the companies.

A Pfizer spokeswoman blamed the delays on the need to create a raw material supply chain, adding that since then the company had expanded production at an unprecedented rate.

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 trials showing that the vaccine was more than 90% effective in prevention. of infections.

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

The Kalamazoo plant was intended to supply the US, while the Puurs site would be destined for the rest of the world. Still, some of the 20 million initial doses the company supplied to the U.S. came from Europe, according to the companies.

In January, Pfizer released a major upgrade to its Puurs facility. The upgrade halted production for two weeks, worsening Europe’s vaccine shortage and causing some governments to threaten Pfizer with legal action.

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

BioNTech increases its own production. Its German factory, which is expected to be online 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 throughout the supply chain, Poetting said.

The BioNTech-Pfizer vaccine uses mRNA packaged in a microscopic ball of fat to elicit an immune response. These vaccines can be produced faster than conventional vaccines, but the process is sophisticated as there are new partners involved in each step of the process.

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

In the next step, the mRNA is inside the fatty envelope. The lipids are supplied by the 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 help with the formulation.

During the final step, the solution is re-filtered 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 of Germany; Novartis, Dermapharm and Sanofi.

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

Although 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 chain supply is delicate, with many opportunities for bottlenecks.

Right now, the rarest ingredients are the lipids used to administer the vaccine RNA. These are produced by a handful of companies and the shortage adds to the fact that vaccine manufacturers use similar technology and rely on the same suppliers.

“This is the last bottleneck right now … lipids are the melee problem,” Poetting said.

Write to Bojan Pancevski to [email protected]