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AstraZeneca Plc said Monday that it has begun enrolling adults for a 30,000-subject, late-stage, U.S.-funded study of its high-profile COVID-19 vaccine candidate.
Trial participants will receive two doses of the experimental vaccine, dubbed AZD1222, four weeks apart, or a placebo, the company said.
The trial is being conducted under the US government’s Operation Warp Speed program, which aims to accelerate the development, manufacturing, and distribution of vaccines and treatments for COVID-19.
US President Donald J. Trump has said that a vaccine for the new coronavirus could be available before the November 3 presidential election, much earlier than most experts anticipate.
AstraZeneca, which is developing its vaccine together with researchers at the University of Oxford, and Pfizer Inc. with its partner BioNTech SE have said they could have data in October to support the US emergency use authorization or approval of their respective vaccinations.
AZD1222 is already undergoing late-stage clinical trials in Britain, Brazil, and South Africa, with additional trials planned in Japan and Russia. The trials, along with the US phase III study, aim to enroll up to 50,000 participants worldwide.
The US trial will assess whether the vaccine can prevent COVID-19 infection or prevent the disease from worsening, the National Institutes of Health said in a statement.
It will also assess whether the vaccine can reduce the incidence of emergency department visits due to COVID-19. – Reuters
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