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Novavax lays out specific minority targets for U.S. COVID-19 vaccine trial

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By Julie Steenhuysen

CHICAGO, Oct 30 (Reuters) - Novavax Inc on Friday outlined specific diversity targets for its large-scale COVID-19 vaccine study expected to begin in the United States and Mexico next month.

The company, which is already testing its vaccine in a Phase III trial in Britain, aims to include at least 15% Black or African Americans, 10% to 20% Latinos and 1% to 2% Native Americans, the company said at a meeting of advisors to the U.S. Centers for Disease Control and Prevention.

The group, known as Advisory Committee on Immunization Practices, is charged with making recommendations for how vaccines should be used and tracked once they are deemed safe and effective by the U.S. Food and Drug Administration.

Diversity has become an important consideration in the testing of vaccines to prevent infection by the coronavirus because of the outsize toll the pandemic has taken on minorities. Blacks have been three times as likely to contract COVID-19 as white Americans and twice as likely to die from the disease.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a Twitter and Facebook event on Thursday that having adequate representation from minorities is key to building confidence in those communities that the vaccine is safe.

Pfizer Inc and Moderna Inc, which began their Phase III vaccine trials in late July, initially struggled to reach adequate minority enrollment, especially of Black Americans.

Pfizer expanded its trial to 44,000 subjects, in part to increase minority enrollment. Moderna slowed its trial to increase minority participation, which last week completed enrollment with Black Americans making up 10% of the study population.

Novavax said the earliest it could determine if its vaccine works will come after 72 participants in the Phase III trial become infected with COVID-19. That is more cases than needed for the first interim look under protocols for the Phase III vaccine trials being conducted by Pfizer and Moderna. (Reporting by Julie Steenhuysen and Michael Erman; Editing by Bill Berkrot)