British drugmaker AstraZeneca announced Monday it has started Phase 3 trials of its coronavirus vaccine candidate in the United States.
AZD 1222 becomes the third vaccine to enter large-scale trials in the United States, after vaccines made by Moderna and Pfizer/BioNTech.
For the US trial, AstraZeneca said in a statement that it is “recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.”
Participants will receive two active or placebo doses, spaced two weeks apart.
The trial will assess safety and efficacy in all participants – a subset of 3,000 participants will be assessed for local and systemic reactions and immune responses.
Currently, Phase 3 trials of AZD1222 are going on in the UK, Brazil and South Africa. Trials are also planned for Japan and Russia.
In total, Phase 3 clinical trial for AZD 1222 will enroll up to 50,000 participants globally. Results from the late-stage trials are anticipated later this year.
The trial is funded by the Biomedical Advanced Development Authority, which is run by the US Department of Health and Human Services and the National Institute of Allergy and Infectious Diseases.