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 Gaithersburg, 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 email@example.com and Jenny Strasburg at firstname.lastname@example.org
Corrections & Amplifications
This article was corrected at 1:48 p.m. ET because it incorrectly stated that Emergent BioSolutions Inc. is based in Rockville, Md.
(END) Dow Jones Newswires