AstraZeneca Starts 30,000-subject U.S. Phase 3 COVID-19 Vaccine Trial - COVID-19 Clinical Trial
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AstraZeneca Starts 30,000-subject U.S. Phase 3 COVID-19 Vaccine Trial

AstraZeneca has begun a U.S. phase 3 clinical trial of its COVID-19 vaccine candidate AZD1222. The Biomedical Advanced Research and Development Authority-funded study will enroll 30,000 adults at sites in the U.S. and some other countries in which the virus is prevalent. 

AZD1222 began phase 2/3 testing in Brazil, South Africa and the U.K. earlier in the summer, putting AstraZeneca toward the front of the race to bring a COVID-19 vaccine to market. Those clinical trials are set to enroll around 17,000 people, potentially giving AstraZeneca a big enough sample to show whether AZD1222 works, but won’t shed any light on how people in the U.S. react to the vaccine.

The new phase 3 trial will provide AstraZeneca with those data and, in doing so, could boost its effort to bring the chimpanzee adenovirus-vectored vaccine to market in the U.S. The FDA accepts foreign clinical trial data, but filings for approval typically include results from U.S. study centers.


GSK, Vir Bio Start Study of COVID-19 Antibody Therapy

The first patient has been dosed in a new Phase II/III study assessing the safety and efficacy of an antibody treatment for COVID-19 being developed by GlaxoSmithKline and Vir Biotechnology. VIR-7831 (also known as GSK4182136), is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, designed for early treatment of COVID-19 in patients at high risk of hospitalisation. The COMET-ICE study, which will enrol around 1,300 patients worldwide who have early symptomatic infection, will assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalisation due to COVID-19.

Initial read-outs may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021, the firms noted. “Treating those with early COVID-19 disease so that it doesn’t become worse is critical both for the patients and for society. Hospital systems are overwhelmed worldwide, with new infections continuing to strain already limited resources,” said George Scangos, Vir’s chief executive.

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