By Bojan Pancevski
The maker of the West's first Covid-19 vaccine is building a new
manufacturing alliance that could throw Europe and the rest of the
world a lifeline amid a painful shortage of shots and a rebound in
BioNTech SE, a German company that joined with Pfizer Inc. to
manufacture and distribute its vaccine, has marshaled an alliance
of 13 companies, including Novartis AG, Merck KGaA and Sanofi SA,
in an effort to meet -- and perhaps exceed -- an ambitious target
of making two billion doses of vaccine this year.
The European Union has been struggling with a shortage of
vaccines as manufacturers, including British-Swedish pharmaceutical
firm AstraZeneca PLC, have fallen behind on their delivery pledges
to the bloc.
The shortage has largely been limited to the EU, which was
slower than its Western allies in ordering and approving the
vaccines, and it has raised tensions between the bloc and the U.K.
and the U.S.
This could pose a challenge to BioNTech's alliance. Its vaccine
uses sophisticated new techniques that require scarce ingredients
and expertise. This makes for a delicate supply chain that is
vulnerable to the type of export controls the EU, the U.K. and the
U.S. have imposed in recent months, company officials have
Pfizer and BioNTech developed the first Covid-19 vaccine
authorized in the West in record time, but its complex
manufacturing has left the U.S. giant struggling to meet production
BioNTech's response: An alliance designed to jolt production of
the vaccine and speed up vaccinations in Europe and elsewhere. The
negotiations for the new manufacturing alliance were coordinated
with Pfizer, according to a BioNTech spokeswoman.
The cancer-research firm, based in the small German town of
Mainz, came up with the vaccine based on the innovative messenger
RNA technology in February 2020, and then teamed up with Pfizer to
test, produce and market it around the globe.
The vaccine was authorized in Europe and the U.S. in December
after trials showed it was highly effective at preventing
infections in adults. On Thursday, a real-life study by Israel
showed that the shot was also 94% successful in stopping
Yet despite their successes, Pfizer and BioNTech have struggled
to make enough of the vaccine to satisfy demand, causing growing
frustration around the world at the pace of delivery -- a
bottleneck BioNTech's new manufacturing alliance now aims to
After months of negotiations, the company has now assembled a
web of companies, most of them in Europe and some key rivals to
Pfizer. BioNTech said it was confident the alliance would allow it
and Pfizer to meet their goal of producing two billion doses in
Under their original agreement, 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 U.S., 120 million to Japan, 110 million to China and its
territories, 40 million to the U.K. and 20 million to Canada.
Millions of doses have also been sold in undisclosed contracts
with Middle Eastern and other countries, and 40 million have been
sold to Covax, an international initiative to provide vaccines to
developing countries. Demand is set to keep growing.
Pfizer, a company going back nearly two centuries that employs
around 100,000 people, currently makes 50% of the active ingredient
for all doses, a spokeswoman said, with the other half produced by
medium-size BioNTech. A BioNTech spokeswoman said the company was
in fact producing 60% of the output.
BioNTech's co-founder and chief executive, Ugur Sahin, told The
Wall Street Journal he realized last fall that his partnership with
Pfizer wouldn't marshal 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 plants at its
sites in Kalamazoo, Mich., and Puurs, Belgium, according to the
A Pfizer spokeswoman blamed the delays on the need to put
together a supply chain for raw materials, adding that the company
had since scaled up production at an unprecedented pace.
In October, Dr. Sahin and other BioNTech executives opened
negotiations with other companies, weeks before Pfizer and BioNTech
released the final data from their final-stage trials showing that
the vaccine was more than 90% effective in preventing
Days later, the companies quietly notified authorities in the
U.S. and elsewhere that they would slash the delivery target for
2020 from 100 million to just 50 million. For the U.S., this meant
that Pfizer would deliver only 20 million instead of 40 million
doses by December.
The Kalamazoo factory was meant to supply the U.S. while the
Puurs site would cater to the rest of the world. Still, some of the
initial 20 million doses that the company supplied to the U.S. came
from Europe, according to the companies.
In January, Pfizer launched a major upgrade of its Puurs
facility. The upgrade paused production for two weeks, worsening
Europe's vaccine shortage and prompting some governments to
threaten Pfizer with legal action.
Sierk Poetting, BioNTech's chief operating officer, said the
experience had demonstrated to BioNTech the urgency of launching a
new manufacturing alliance, in order to live up to commitments in
Europe and other markets.
BioNTech is increasing its own production. Its German factory,
expected to come on line in April, should produce 750 million doses
a year. The facility will mainly supply the EU, but its output
won't be enough, so BioNTech had to enlist new partners across the
supply chain, said Mr. Poetting.
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 shots, but the process is
sophisticated, with new partners now involved at each step of the
The mRNA is first produced, then purified, concentrated and
filtered. BioNTech has brought in 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
In the next step, the mRNA is encased in its fatty envelope. The
lipids are supplied by the German firms Merck and Evonik Industries
AG, while Austria's Polymun Scientific Immunbiologische Forschung
GmbH, Canada's Acuitas Therapeutics Inc., and Germany's Dermapharm
Holding SE are helping with the formulation.
During the final step, the solution is filtered again and filled
into vials, a process known as finish and fill. 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 it
will cover around 20% of the finish and fill for each dose, Mr.
While BioNTech is confident the alliance will allow it to meet
demand, the number of partners, the complexity of the process, and
the raw materials required -- from DNA to enzymes, salts, sugars
and various lipids -- make the supply chain delicate, with many
opportunities for bottlenecks.
Right now, the scarcest ingredients are the lipids used to
deliver the vaccine's RNA. These are produced by a handful of
companies and the shortage is compounded by the fact that
vaccine-makers use a similar technology and rely on the same
"This is the ultimate bottleneck at the moment...the lipids are
the hand-to-mouth issue," Mr. Poetting said.
Write to Bojan Pancevski at firstname.lastname@example.org
(END) Dow Jones Newswires
March 13, 2021 10:01 ET (15:01 GMT)
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