AstraZeneca has nabbed an HHS contract worth up to $1.2 billion to speed development and production of the University of Oxford’s promising COVID-19 vaccine candidate. The deal also would lock in the distribution of 300 million doses of the vaccine for the U.S.
The Operation Warp Speed funding, which will come from HHS’ Biomedical Advanced Research and Development Authority (BARDA), ensures that the U.S. would receive priority for the distribution of the vaccine, though the UK is first in line for 100 million doses (DID, May 19).
The first shipments to the U.S. could be delivered as early as October, HHS said.
While AstraZeneca’s BARDA contract is hefty, the office has previously granted larger ones, including a next-generation anthrax vaccine contract in 2016 for up to $1.6 billion with Emergent BioSolutions.
The contract will help finance a large phase 3 U.S. clinical trial this summer that will enroll an estimated 30,000 participants.
AstraZeneca also announced it has reached a deal to license the vaccine with the university, renaming it AZD1222. The UK-based drugmaker, which has so far finalized agreements to supply at least 400 million doses, says it has the capacity to manufacture 1 billion doses and will continue to increase its capabilities.
AstraZeneca is also working with international organizations, including the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the World Health Organization to make sure the vaccine is made available to lower-income nations. It’s also in talks with the Serum Institute of India and others about increasing production and distribution.
The vaccine is currently being studied in humans in the UK in a phase 1/2 trial, and positive results will clear the way for late-stage trials in other countries.
Researchers at the National Institutes of Health and Oxford recently announced that the vaccine protected six rhesus monkeys against COVID-19-induced pneumonia. The vaccinated animals showed no signs of virus replication in the lungs or lung damage and much lower levels of respiratory disease. — James Miessler