The maker of the West’s first Covid-19 vaccine is building a new manufacturing alliance that could put Europe and the rest of the world on a lifeline amid a painful injection shortage and a spike in infections.
BioNTech SE, a German company that joined Pfizer Inc.
To manufacture and distribute its vaccine, it has assembled an alliance of 13 companies, including Novartis AG
, Merck KGaA and Sanofi SA,
in an effort to meet, and perhaps exceed, the ambitious goal of producing two billion doses of vaccines this year.
The European Union has been battling vaccine shortages as manufacturers, including British-Swedish drugmaker AstraZeneca PLC, have fallen behind on their promises to deliver to the bloc.
The shortage has largely been confined to the EU, which was slower than its Western allies in ordering and approving the vaccines, and has increased tensions between the bloc and the UK and US.
This could represent a challenge for the BioNTech alliance. Their vaccine uses sophisticated new techniques that require few ingredients and expertise. This creates a delicate supply chain that is vulnerable to the kinds of export controls that the EU, the UK and the US have imposed in recent months, company officials warned.
Pfizer and BioNTech developed the first Covid-19 vaccine licensed in the West in record time, but its complex manufacture has left the US giant struggling to meet production targets.
BioNTech’s answer: an alliance designed to boost vaccine production and accelerate vaccines 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, devised the vaccine based on innovative messenger RNA technology in February 2020 and then partnered with Pfizer to test, produce and market it around the world.
The vaccine was licensed in Europe and the US in December after trials showed it to be very effective in preventing infections in adults. On Thursday, a real-life study by Israel showed that the injection was also 94% successful in stopping asymptomatic transmission.
However, despite their successes, Pfizer and BioNTech have struggled to produce enough vaccine to meet demand, leading to growing frustration around the world over the pace of delivery, a bottleneck that the new manufacturing alliance BioNTech now claims to alleviate.
After months of negotiations, the company has assembled a network of companies, most of them in Europe and some key rivals from Pfizer. BioNTech said it was confident the alliance would allow it and Pfizer to reach 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 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. The demand will continue to grow.
Pfizer, a company that dates back nearly two centuries and employs around 100,000 people, currently produces 50% of the active ingredient for all doses, a spokeswoman said, with the other half produced by mid-size BioNTech. A BioNTech spokeswoman said the company was in fact producing 60% of the production.
SHARE YOUR THOUGHTS
How do you think cooperation in the distribution of vaccines will change the trajectory of the pandemic in Europe? Join the conversation below.
BioNTech co-founder and CEO Ugur Sahin told The Wall Street Journal that he realized last fall that his partnership with Pfizer would not muster enough capacity to meet global demand.
Pfizer, which had no mRNA production capacity prior to its deal 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 need to put together a supply chain for raw materials for the delays, adding that the company had since increased 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 end-stage trials showing the vaccine was more than 90% effective in preventing infections.
Days later, companies quietly notified 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 administer just 20 million instead of 40 million doses by December.
The Kalamazoo factory was intended to supply the US, while the Puurs site would supply the rest of the world. Still, part of the initial 20 million doses the company supplied to the United States came from Europe, according to the companies.
In January, Pfizer released a major upgrade to its Puurs facility. The update halted production for two weeks, exacerbating the vaccine shortage 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 manufacturing alliance, to meet commitments in Europe and other markets.
BioNTech is increasing its own production. Its German factory, which is expected to come online in April, should produce 750 million doses a year. The facility will primarily supply the EU, but its production will not be sufficient, so BioNTech had to recruit 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 injections, but the process is sophisticated, and new partners are now involved in every step of the way.
The mRNA is produced first, then purified, concentrated, and filtered. BioNTech has contracted with the 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 encased in its 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 are assisting with the formulation.
During the final 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 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% of the finishing and filling of each dose, Poetting said.
While BioNTech is confident that the alliance will allow it to meet the 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 this time, the scarcest ingredients are the lipids that are used to deliver the RNA in the vaccine. These are produced by a handful of companies, and the shortage is compounded by the fact that vaccine manufacturers use similar technology and rely on the same suppliers.
“This is the last bottleneck right now … lipids are the hand-to-mouth problem,” Poetting said.
Write to Bojan Pancevski at [email protected]
Copyright © 2020 Dow Jones & Company, Inc. All rights reserved. 87990cbe856818d5eddac44c7b1cdeb8