By Joseph Walker and Jenny Strasburg
Among the front-runners racing to deliver a Covid-19 shot,
AstraZeneca PLC has the least vaccine experience. But it has
promised the world the most doses -- more than three billion.
The company has assembled an unprecedented network of
manufacturing and distribution partners spanning the globe,
complementing a series of deals with governments that have sought
to lock in vaccine supplies for their countries.
The British drugmaker this week said the results from late-stage
clinical trials in the U.K. and Brazil found its vaccine was as
much as 90% effective in preventing infections. Depending on the
dosage, the shot's efficacy ranged from 62% to 90%, with the higher
number applying to a limited subset of trial volunteers.
Still, even at an average efficacy of 70%, researchers called
the results a promising sign that the two-dose shot can help stem
the pandemic. AstraZeneca executives say they plan to supply every
region of the world by 2022 without profiting directly from the
vaccine during the pandemic. Working in partnership with the
University of Oxford, the company is pricing the vaccine at $3 to
$5 a dose.
That is a fraction of the price of each of the two leading
vaccines, which have shown to be more than 90% effective in
late-stage trials: one from Pfizer Inc. and Germany's BioNTech SE,
and the other from Moderna Inc. Their initial supply agreements are
with wealthier countries.
AstraZeneca executives said Monday they are poised, pending
regulators' signoff, to roll out hundreds of millions of doses in
the first quarter of 2021, ramping up production each month to meet
demand. That has positioned the drugmaker as the likely dominant
supplier to the developing world for vaccinating poor and
hard-to-reach populations where health-care services are sparse,
analysts say.
Oxford, using its own small manufacturing facility, was making
enough vaccine doses to support early clinical trials. The process
had to be reinvented for global production across some two dozen
contract manufacturers and partners, from Brazil to Japan and
Australia.
In June, the Serum Institute of India, the world's biggest
vaccine maker by volume, agreed to supply one billion doses for
low- to middle-income countries. The family-owned Indian drug
giant, located a couple of hours from Mumbai, previously partnered
with Oxford on a malaria drug. It has made 40 million doses of the
Oxford-AstraZeneca vaccine already, AstraZeneca Chief Executive
Pascal Soriot said Monday.
AstraZeneca also has an agreement with Mexico's Carlos Slim
Foundation to supply the vaccine to Latin America, starting with
150 million doses in the first half of 2021. The pact supplements
another between AstraZeneca and Brazil's government.
The drugmaker has also reached deals to partner with or sell its
vaccine to other countries, rich and poor, including the U.K., the
U.S., Russia, South Korea and China. Dr. Soriot said AstraZeneca's
Russian manufacturing partner has the capacity to make one billion
doses. That could be extended into 2022, boosting the
three-billion-dose count already announced for next year.
AstraZeneca's far-reaching pledge of low pricing and world-wide
distribution were hallmarks of the April deal it made with Oxford,
where scientists insisted on supplying the globe at a low cost.
AstraZeneca is tackling the task of rapidly developing and
deploying a pandemic vaccine after reinventing itself in recent
years as a cancer-drug powerhouse. It had suffered years of
shrinking revenue as blockbusters in its portfolio were hit by from
generic competition when patents expired.
The vaccine has raised AstraZeneca's profile with global leaders
and health organizations. It has also brought heavy risks. A long
pause in U.S. clinical trials caused delays and skepticism as rival
drugmakers' vaccines progressed. Monday's mixed efficacy data
fueled views among some investors and scientists that the
AstraZeneca shot could prove less effective but still provide a
crucial pandemic weapon with global reach.
In the spring, as AstraZeneca's medical team enrolled tens of
thousands of clinical-study volunteers globally, its manufacturing
side raced to secure materials made scarce by the pandemic. "How do
you get millions of vials in a hurry? How do you get resins for
your manufacturing?" Pam Cheng, AstraZeneca's head of global
operations and information technology, said in a recent
interview.
In early May, AstraZeneca signed on Jacobs Engineering Group
Inc. to retrofit a mothballed drug-production line in a plant the
drugmaker owns north of Cincinnati. Making a vaccine meant
introducing a live virus into the factory, requiring a new air
system. That is a normal job for big pharmaceutical companies, says
the Jacobs operations director who managed the job, Lindsay
Gerding. The timeline? "It was not normal." The 12-week job
normally would have taken closer to a year, she says.
AstraZeneca embedded scientists and engineers inside its
partners to troubleshoot production issues. Take Emergent
BioSolutions Inc. of Rockville, Md. In May, the U.S. agreed to
purchase 300 million doses with a contract now valued at $1.6
billion, a huge order. AstraZeneca enlisted Emergent and a rival to
manufacture bulk quantities of the vaccine.
Emergent, which is also manufacturing a Covid-19 vaccine in
development by Johnson & Johnson, produces mass batches that
are frozen and stored in large bags or containers. Eventually, the
frozen batches will be thawed and fed into vials at AstraZeneca's
Ohio plant and another similar "fill-finish" facility in
Albuquerque, N.M., run by Albany Molecular Research Inc. Emergent
received manufacturing equipment and vaccine ingredients shipped by
semitrailers multiple times a day for weeks.
Vaccines are grown in large bioreactor tanks that can produce
thousands of liters of liquid, which is then filtered of cell
debris and other waste. What is left is the finished product.
AstraZeneca and Emergent scientists and engineers hit technical
challenges creating a reliable, standardized process to maximize
the vaccine yield, Ms. Cheng says. "Every day we've got challenges
at this scale with this kind of complexity."
In July, Ms. Cheng, avoiding airplanes, drove 19 hours
round-trip to the Ohio plant from her home near Washington, D.C.
U.S. Army Gen. Gustave F. Perna and ex- GlaxoSmithKline PLC
executive Moncef Slaoui, officials overseeing U.S. Operation Warp
Speed, a $10 billion initiative aimed at speeding development of
Covid-19 vaccines and drugs, were there to tour the site.
"We were all nervous -- can we do this in such a short amount of
time?" Ms. Cheng says.
Back in the company's U.K. headquarters in Cambridge, Dr. Soriot
was dialing for equipment his procurement managers were struggling
to get. One target: filters that turn unpurified "drug substance"
into ready-to-use shots. Suppliers had their own constraints, Dr.
Soriot says.
It wasn't the only cajoling the CEO was doing. The
Oxford-AstraZeneca shot is the most widely preordered Covid-19
vaccine by governments globally, accounting for about 42% of doses
on order, according to Berenberg Bank research. But preordered
didn't always mean prepaid. AstraZeneca couldn't always offer the
typical upfront fees to reserve manufacturing capacity. It needed
governments and other funders to share the risks, Dr. Soriot
says.
--Eric Bellman contributed to this article.
Write to Joseph Walker at joseph.walker@wsj.com and Jenny
Strasburg at jenny.strasburg@wsj.com
(END) Dow Jones Newswires
November 24, 2020 08:54 ET (13:54 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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