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AstraZeneca COVID-19 Vaccine Candidate Moves Into Late-Stage US Clinical Trials With 30,000 Participants

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AstraZeneca COVID-19 Vaccine Candidate Moves Into Late-Stage US Clinical Trials With 30,000 Participants

AstraZeneca Plc (NYSE: AZN) announced Monday that its COVID-19 vaccine candidate is moving into phase three clinical trials for all adult age groups in the United States.

What Happened:  The development of AZD1222 is already in the late stages of testing in the United Kingdom, Brazil, and South Africa, with upcoming trials planned in Japan and Russia.

The company is enlisting up to 30,000 people in the United States, aged 18 and above, to test the safety, efficacy, and immunogenicity of the vaccine in COVID-19 prevention. Collectively, the company anticipates over 50,000 participants globally.

Additionally, the British biopharma company estimates a global supply capacity close to 3 billion doses of vaccine.

Why It Matters: The trial in the US is backed by the Biomedical Advanced Development Authority (BARDA), a section of the Assistant Secretary for Preparedness and Response (ASPR) office at the US Department of Health and Human Services (HHS), and National Institute of Allergy and Infectious Diseases (NIAID), a part of US National Institute of Health.

BARDA offered a $1 billion support to the company in May 2020 for the vaccine.

The FDA Chairman Stephen Hahn told the Financial Times that the regulator is prepared to grant emergency use authorization to a vaccine candidate before third-phase clinical trial results become available.

AstraZeneca's COVID-19 vaccine could receive such an approval by October, according to FT.

Coronavirus vaccine candidates of Moderna Inc. (NASDAQ: MRNA) and Pfizer Inc. (NYSE: PFE) are also undergoing late-stage clinical trials in the U.S.

Price Action: At the end of the extended market hours, AZN shares were up 0.89% at $56.50.

 

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