- AstraZeneca has enlisted Catalent Cell & Gene Therapy to produce the drug substance for an experimental coronavirus vaccine it is developing with the University of Oxford.
- Catalent said it will have multiple production trains running in parallel to produce the substance at its plant in Harmans, Maryland, near the Baltimore-Washington International airport. The deal builds on an earlier contract under which Catalent will provide fill/finish services for the AstraZeneca vaccine at its site in Anagni, Italy.
- The Oxford vaccine is one of the most advanced in clinical development, and AstraZeneca has aggressively pursued manufacturing and supply deals across the globe ahead of its potential launch. The new agreement strengthens those efforts.
AstraZeneca is a leader on two fronts in the fight against COVID-19, advancing quickly in vaccine research and stringing together a series of manufacturing deals to allow production on a massive scale.
To effectively combat the pandemic, vaccines will be needed for most of the global population of almost 8 billion. That's prompting large drugmakers to seek out contract manufacturers and expand capacity well before any inoculation has proven effective.
After striking a series of manufacturing deals around the world, AstraZeneca now has the capacity to produce about 3 billion doses of its AZD1222 vaccine a year. It’s promised 300 million doses each to the U.S. and European Union, agreed to supply another 100 million doses to the U.K. and earmarked 1 billion for low- and middle-income nations under a license agreement with the Serum Institute of India.
In expanding its deal with Catalent, AstraZeneca is taking advantage of the contract manufacturer’s expertise in viral vector manufacturing, which is critical in making a vaccine that relies on modified viruses to help deliver genetic material into cells. Catalent is also working with other companies racing to develop a vaccine; the company signed a manufacturing deal with Johnson & Johnson in April and in June agreed to supply fill/finish services to Moderna.
AstraZeneca's vaccine is one of the furthest along in phase 3 testing, in addition to experimental shots from Moderna and a partnership of Pfizer and BioNTech. AstraZeneca has clinical studies underway in the U.K., Brazil and South Africa and plans another 30,000-patient study in the U.S. soon.
But the British pharmaceutical giant may not wait for the results from the U.S., signaling last month that the other trials could supply enough data for regulatory authorization of its vaccine. At the same time, AstraZeneca has since denied a Financial Times report that the U.S. government is considering pushing for an emergency use authorization of AZD1222 before the November election.
The Food and Drug Administration is under extraordinary pressure from the White House to quickly approve new treatments and vaccines, while insisting it’s maintaining strict standards for safety and efficacy. The agency has drawn criticism for misrepresenting the proven benefits of convalescent plasma upon its emergency approval as a COVID-19 treatment.