- AstraZeneca continued preparations to make and supply the experimental coronavirus vaccine it has licensed from the University of Oxford, signing deals with contract drug manufacturer Catalent Biologics and the Inclusive Vaccines Alliance, a consortium of four European countries.
- Catalent Biologics will help AstraZeneca supply hundreds of millions of doses of the vaccine, dubbed AZD1222, from a facility in Anagni, Italy. Though the deal with IVA, the British pharma company will supply 400 million of those doses, at no profit, to the European countries participating in the alliance.
- AstraZeneca is one of the frontrunners in the global race to develop a coronavirus vaccine. Like several of its drugmaker peers — among them Pfizer and Moderna — AstraZeneca is readying to distribute its vaccine worldwide without any surety that testing will show it can prevent coronavirus infections.
Any day now AstraZeneca could disclose preliminary study evidence in humans to support the coronavirus vaccine it recently licensed from the University of Oxford.
The expected data, from an early-stage study of more than 1,000 healthy volunteers aged 18 to 55, will give researchers a sense of whether AZD1222 is safe, and whether it can spur the body to produce antibodies against the virus. Longer studies — like an 10,000-participant trial that began in the U.K. last month and a larger U.S. study expected to start this summer — will be needed to show whether the vaccine can prevent disease.
Yet AstraZeneca is already agreeing to supply deals with governments and other groups before any of that evidence is available — part of a plan to set up global supply chains to make and distribute AZD1222 as quickly as possible, if it works.
The agreements reflect both the urgency of vaccine development, but also concern among governments that their citizens may not have access to any vaccine proven safe and effective.
The U.S. government, for instance, pledged up to $1.2 billion to AstraZeneca to help test its vaccine, claiming 300 million doses for U.S. citizens in the process.
The British drugmaker has cut similar deals with the U.K. government, the Coalition for Economic Preparedness Innovations and Gavi the Vaccine Alliance for access in the U.K. and other countries. A license agreement with the Serum Institute of India will provide for another 1 billion doses destined for low- and middle-income countries.
Friday's deal with the IVA pledges 400 million doses to the countries that participate in the alliance, which is currently led by Germany, France, Italy and the Netherlands but is open to other participants.
An agreement Monday with Catalent will provide help for filling vials and packaging doses of AstraZeneca's vaccine at the contract drug manufacturer's plant in Italy. On its own, the site would be able to make hundreds of millions of doses from August of this year to March 2022.
AstraZeneca's vaccine uses a genetically modified and weakened adenovirus, the type that causes colds, to send instructions into the body's cells. The cells then produce a key protein on the coronavirus' surface, which should train the immune system to respond to an actual infection. Researchers at the University of Oxford began work on the vaccine earlier than most groups, and had already started a clinical trial in England before they struck a deal with AstraZeneca in April.