AstraZeneca has received $1.2 billion from the Biomedical Advanced Research and Development Authority (BARDA) toward development, production, and delivery of AZD1222 (formerly ChAdOx1 nCoV-19), the COVID-19 vaccine it is co-developing with the University of Oxford and its spinout company.
The development and production work to be funded by BARDA will begin this fall, AstraZeneca said. It will include a Phase III trial designed to recruit 30,000 participants, as well as another trial to evaluate the vaccine in children.
On the production end, AstraZeneca has concluded its first manufacturing agreements to produce at least 400 million doses of the vaccine, as well as gain total manufacturing capacity for one billion doses so far.
AstraZeneca agreed to furnish BARDA with 300 million doses, the U.S. Department of Health and Human Services (HHS) said—four days after the U.K. government secured the other 100 million doses by agreeing to pay AstraZeneca £65.5 million ($80 million).
AstraZeneca said the U.K. will receive the first 30 million doses of AZD1222 in September. The United States is set to receive the vaccine in October, according to HHS’ announcement.
HHS and AstraZeneca said the manufacturing ramp-up, plus the planned Phase III trial, will enable the United States to achieve a few months early President Donald Trump’s call to develop 300 million doses of vaccine against SARS-CoV-2 by January 2021.
“We would like to thank the U.S. and U.K. governments for their substantial support to accelerate the development and production of the vaccine,” AstraZeneca CEO Pascal Soriot said in a statement. “We will do everything in our power to make this vaccine quickly and widely available.”
Also finalized, AstraZeneca added, was its license agreement with the University and its spinout company Vaccitech,which has joint rights to the platform technology behind AZD1222. Three weeks earlier on April 30, AstraZeneca said it would oversee global development, manufacturing, and distribution of the vaccine, establishing a partnership designed to enable rapid production and distribution of the vaccine should it prove effective in clinical studies.
AZD1222 has been developed by the University’s Jenner Institute, whose researchers last month partnered with colleagues from the University’s Oxford Vaccine Group to launch the COV001 Phase I/II trial (NCT04324606.)
The single-blinded, randomized, multi-center study is designed to determine the efficacy, safety, and immunogenicity of the vaccine candidate in healthy adult volunteers aged 18–55 years across five trial centers in southern England. Data from the Phase I trial is expected “shortly,” AstraZeneca said, to be followed by advancement to late-stage trials in several countries.
The trial began recruiting patients on April 23, after U.K. Health Secretary Matt Hancock pledged £20 million ($25 million) in government funding to support AZD1222 development.
At the time, AstraZeneca agreed to provide the U.K. with access to the vaccine as soon as possible should it succeed in clinical trials. AstraZeneca also agreed to work with global partners on the international distribution of the vaccine, with emphasis on making it available and accessible for low- and medium-income countries.
Also to that end, AstraZeneca said it is in talks with global organizations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance, and the World Health Organization (WHO) toward fair allocation and distribution of the vaccine worldwide.
Discussions are also in progress with numerous governments around the world to increase access, and with the Serum Institute of India and other potential partners to increase production and distribution, AstraZeneca added.
Oxford has also committed to reinvesting any royalties it receives from the vaccine once the pandemic ends directly back into medical research—including through the creation of a Pandemic Preparedness and Vaccine Research Centre to be developed in collaboration with AstraZeneca.
AZD1222 uses a replication-deficient simian viral vector based on a weakened version of the adenovirus containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body. The recombinant adenovirus vector (ChAdOx1) is designed to generate a strong immune response from a single dose and to not replicate, in order to preclude causing an ongoing infection in the vaccinated individual.
According to AstraZeneca, vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated—although they can cause temporary side effects such as a temperature, flu-like symptoms, headache, or sore arm, the company acknowledged.
AstraZeneca said the BARDA award is not expected to have any significant impact on the company’s financial guidance for 2020, since the government funding will offset company expenses in developing the vaccine.
In reporting first-quarter results on April 29, AstraZeneca left unchanged the 2020 guidance it gave investors three months earlier. The company said it expected total revenue to increase by “a high single-digit to a low double-digit” percentage, while core earnings per share was expected to increase by “a mid- to high-teens” percentage.
The company added: “AstraZeneca recognizes the heightened risks and uncertainties from the impact of COVID-19.”