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AstraZeneca Begins Coronavirus Vaccine US Phase III Study

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AstraZeneca plc (AZN - Free Report) announced the start of a late-stage study in the United States on its COVID-19 vaccine candidate, AZD1222, which it is developing in partnership with Oxford University. The phase III study (D8110C00001) will include 30,000 adult participants and will assess the safety, efficacy and immunogenicity of AZD1222 across all adult age groups and various racial, ethnic and geographic populations. The study is funded by Biomedical Advanced Development Authority (BARDA) and National Institute of Allergy and Infectious Diseases (NIAID).

The study participants will be administered two doses of either AZD1222 or a saline control, four weeks apart

AstraZeneca shares have risen 12.3% so far this year compared with the industry’s increase of 1.4%.

 

 

AZD1222 is also being evaluated in late-stage studies in the UK, Brazil and South Africa with studies due to start in Japan and Russia shortly. Data from the late-stage studies are expected later this year. Data from the phase I/II study on AZD1222 announced in July showed that the vaccine candidate generated strong antibody and T-cell responses in the majority of patients.

Moreover, the company has signed supply deals with several countries under which it has committed to supply almost 3 billion doses of the vaccine, if it is successfully developed. Meanwhile, it has received more than $1 billion in funding from BARDA for the development, production and delivery of the AZD1222 vaccine. The company targets to file a regulatory application with the FDA later this year. Last week, a Financial Times report stated that the FDA may grant emergency use authorization (EUA) to AZD1222. The EUA is not a full approval and is granted when the FDA believes that the known and potential benefits of the treatment outweigh its risks.

AstraZeneca is one of the dozen companies developing a vaccine for the deadly coronavirus disease. Of these, other than AstraZeneca/Oxford University, Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) and its Germany-based partner, BioNTech have initiated phase III studies on a coronavirus vaccine. J&J (JNJ - Free Report) expects to initiate a pivotal phase III study this month.

Last week, AstraZeneca also initiated a phase I study on AZD7442, a monoclonal-antibody combination for the prevention and treatment of COVID-19. AZD7442 is a combination of two monoclonal antibodies, AZD8895 and AZD1061, which were derived from convalescent patients with SARS-CoV-2 infection, which AstraZeneca licensed from Vanderbilt University, in the United States in June 2020.

AstraZeneca currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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