Washington: Multinational pharmaceutical company AstraZeneca announced it has started Phase III clinical trials in the United States of its COVID-19 candidate vaccine as the World Health Organization warned against prematurely approving drugs to fight the pandemic.
The company said in a statement Monday that it will enroll up to 30,000 adults in the United States to assess the safety, efficacy and immunogenicity of its candidate coronavirus prevention drug, AZD1222, which it co-invented with Britain’s Oxford University.
The U.S. trial centers are recruiting the tens of thousands of participants “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 SARS-CoV-2 virus,” AstraZeneca said, referring to COVID-19 by its technical name.
Participates in the trial will receive two doses of either the candidate vaccine or a placebo saline control separated by four weeks and while all will be assessed for the drug’s safety and efficacy a subset of 3,000 volunteers will be checked for local and systemic reactions and immune responses, it said.
