British drugmaker AstraZeneca has made clear its intent to rapidly scale production of the University of Oxford’s COVID-19 vaccine hopeful despite a dearth of clinical data to support its use. Now, with an eye-popping deal worth three-quarters of a billion dollars, AstraZeneca is putting its money where its mouth is.
The British pharma has inked a $750 million deal with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance to manufacture and distribute 300 million doses of Oxford’s adenovirus-based COVID-19 vaccine by the end of 2020, the drugmaker said Thursday.
AZ also agreed to a licensing deal with the Serum Institute of India to provide 1 billion doses of the vaccine to low- and middle-income countries, with the goal of 400 million produced by year’s end.
AstraZeneca’s enormous manufacturing and distribution layout represents the single largest effort so far to pump hundreds of millions of doses of a COVID-19 vaccine hopeful onto the market before the end of 2020.
AstraZeneca reached an agreement with Oxford in April to manufacture and commercialize hundreds of millions of doses of its COVID-19 vaccine as health regulators around the world scrambled to meet what will likely be global demand.
The vaccine, dubbed AZD1222, contains the genetic material of the SARS-CoV-2 spike protein. It isn’t replicating, so it can’t cause an ongoing infection in recipients, AZ says. The company hopes the vaccine can deliver a strong immune response from one dose by triggering the body to produce the spike protein and attack the novel coronavirus upon infection.
In late May, AstraZeneca scored a $1.2 billion contribution from the U.S. for development, production and delivery of its potential shot starting this fall.
The company has signed up to deliver 400 million doses through its initial supply agreements, including a 300-million-dose work order for the U.S. and 100 million doses for the U.K.
In a more minor move last week, AstraZeneca and Oxford BioMedica inked a one-year deal covering “multiple batches” of the vaccine.
As part of the agreement, AstraZeneca will have access to Oxford BioMedica’s 84,000-square-foot OxBox commercial manufacturing center in Oxford, England. The agreement will turn out most of the clinical and commercial supply in 2020 with the possibility of expansion in the future, Oxford BioMedica said in a release.
AstraZeneca’s massive supply commitments will depend on results from an ongoing phase 2/3 trial of the vaccine that hopes to enroll 10,260 people in the U.K. The study aims to generate results to support the first shipments to customers in September. A 1,000-patient phase 1 trial hasn’t yet turned out top-line data.
The phase 2 test will relax exclusion criteria used in phase 1, notably by enrolling a small number of children ages 5 to 12 and adults age 56 and older. One cohort will enroll adults over 70, a demographic that is particularly at risk from the coronavirus. By expanding the age range, the researchers aim to understand how immune response varies across demographic groups.
Once the vaccine moves into phase 3, the researchers will limit enrollment to people age 18 and older. Adult participants in the phase 2 and 3 trials will be randomized to receive one or two doses of AZD1222 or a vaccine against meningococcal bacteria that will serve as the control.