AstraZeneca is on the hook for millions of doses of the University of Oxford's front-runner COVID-19 vaccine candidate, assuming it proves effective. To fill those orders, the British drugmaker has agreed to a short-term manufacturing deal that will help it bridge the gap.
AstraZeneca and Oxford BioMedica inked a one-year deal covering "multiple batches" of the University of Oxford's adenovirus-based COVID-19 vaccine candidate, AZD1222, as part of a consortium aimed at speeding production of the shot.
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.
So far, it's a small-scale tie-up for AstraZeneca, which agreed in April to handle commercialization and manufacturing of Oxford's vaccine candidate.
Last week, AstraZeneca scored a $1.2 billion contribution from the U.S. for development, production and delivery of its potential shot starting this fall.
The vaccine, developed by the University of Oxford’s Jenner Institute, 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.
AstraZeneca has signed up to deliver 400 million doses through its initial supply agreements. A Biomedical Advanced Research and Development Authority-funded deal with the U.S. follows a U.K. pact unveiled early last week for 100 million total doses. That would give the U.S. delivery of about 300 million vaccine doses starting this fall.
Those massive contracts will have to wait on the hotly anticipated results of a phase 2/3 clinical trial of the vaccine that launched late last week.
Oxford researchers hope to enroll 10,260 people in the U.K. to generate results to support the first shipments to customers in September. The study follows a 1,000-patient phase 1 trial that still hasn't 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 aged 5 to 12 years and adults aged 56 years and older. One cohort will enroll adults aged over 70 years, 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 years 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.