BioNTech Recruits Competitors to Boost Covid-19 Vaccine Production

The European Union is grappling with a vaccine shortage as manufacturers, including Anglo-Swedish pharmaceutical company AstraZeneca PLC, have fallen behind in their block delivery pledges.

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

This could pose a challenge to BioNTech’s alliance. Its vaccine uses sophisticated new techniques that require rare ingredients and expertise. This creates a delicate supply chain that is vulnerable to the kind of export controls the EU, UK and US have imposed in recent months, company officials have warned.

Pfizer and BioNTech developed the first Covid-19 vaccine cleared in the West in record time, but its complex manufacture has left the American giant struggling to meet its production targets.

BioNTech’s response: An alliance designed to boost vaccine production and speed up vaccinations in Europe and beyond. Negotiations for the new manufacturing alliance have been coordinated with Pfizer, according to a spokesperson for BioNTech.

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

The vaccine was cleared in Europe and the United States in December after trials showed it was very effective in preventing infections in adults. On Thursday, a real-life study conducted by Israel showed that the shooting was also 94% successful in stopping asymptomatic transmission.

Yet despite their successes, Pfizer and BioNTech have struggled to manufacture enough vaccine to meet demand, causing growing frustration around the world with the pace of delivery – a bottleneck that BioNTech’s new manufacturing alliance is targeting. now to be mitigated.

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

As part of their initial deal, BioNTech, which owns the marketing rights for 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 the 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 provide vaccines to developing countries. Demand is expected to continue to grow.

Pfizer, a nearly two-hundred-year-old company that employs around 100,000 people, currently makes 50% of the active ingredient for all doses, a spokesperson said, with the other half produced by mid-sized BioNTech. A spokeswoman for BioNTech said the company actually produced 60% of the production.

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

Pfizer, which had no mRNA production capacity before its deal with BioNTech, took longer than expected to set up factories at its sites in Kalamazoo, Mich., 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 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 trials showing the vaccine was over 90% effective. in the prevention of infections.

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

The Kalamazoo plant was intended to supply the United States while the Puurs site would serve the rest of the world. Still, some of the initial 20 million doses the company supplied to the United States came from Europe, according to the companies.

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

Sierk Poetting, COO of BioNTech, said the experience demonstrated to BioNTech the urgency to launch a new manufacturing alliance, in order to meet commitments in Europe and other markets.

BioNTech is increasing its own production. Its German plant, which is scheduled to start up in April, is expected to produce 750 million doses per year. The facility will primarily supply the EU, but its production will not be sufficient, which is why BioNTech had to recruit new partners along the supply chain, Poetting said.

The BioNTech-Pfizer vaccine uses mRNA packaged in a microscopic ball of fat to trigger an immune response. These vaccines can be produced faster than conventional vaccines, but the process is sophisticated, with new partners now involved every step of the way.

MRNA is first produced, then purified, concentrated and filtered. BioNTech called on the German company Rentschler Biopharma SE to help it with these steps. The Swiss company Novartis is also negotiating a contract to produce DNA molecules used in the first stage.

In the next step, the mRNA is locked in its fatty envelope. The lipids are supplied by the German firms Merck and Evonik Industries AG

, while Polymun Scientific Immunbiologische Forschung GmbH in Austria, Acuitas Therapeutics Inc. in Canada and Dermapharm Holding SE in Germany contribute formulation.

In the last step, the solution is filtered again and filled into vials, a process known as finishing and filling. This will be carried out by Delpharm SAS, a French company; Siegfried AG

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

BioNTech’s European alliance will produce around half of the global supply of active ingredients for the Covid-19 vaccine, and cover around 20% of the finishing and filling for each dose, Mr 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 raw materials needed – from DNA to enzymes, salts, sugars and various lipids. – make the supply chain delicate, with many bottleneck opportunities.

Currently, the rarest ingredients are the lipids used to deliver vaccine RNA. These are produced by a handful of companies and the shortage is compounded by the fact that vaccine makers use similar technology and rely on the same suppliers.

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

Write to Bojan Pancevski at [email protected]