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ACIP evidence to recommendations for use of Novavax COVID-19 vaccine, adjuvanted in adults ages 18 years and older under an emergency use authorization

Ano de publicação: 2022

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), in late 2019 has led to a global pandemic with dramatic societal and economic impact on individual persons and communities. In the United States, more than 89 million cases and more than 1 million COVID-19-associated deaths have been reported as of July 14, 2022. Persons of all ages are at risk for infection and severe disease. However, the risk for severe illness from COVID-19 is higher in people aged ≥65 years, those living in long-term care facilities, and those with chronic medical conditions. Additionally, there is a disproportionate burden of COVID-19 infections and deaths among racial and ethnic minority communities. Non-Hispanic Black, Hispanic/Latino (Hispanic) and American Indian/Alaska Native persons have experienced higher rates of disease, hospitalization and death compared with non-Hispanic White persons. This is likely related to inequities in social determinants of health that put racial and ethnic minority groups at increased risk for COVID-19, including overrepresentation among essential workers who have higher risk of exposure to COVID-19, lower incomes, reduced access to healthcare, or higher rates of comorbid conditions. In the United States, the first vaccines to prevent COVID-19 received Food and Drug Administration (FDA) Emergency Use Authorizations (EUA): Pfizer-BioNTech on December 11, 2020, for persons aged 16 years and older, Moderna on December 18, 2020, for adults aged 18 years and older, and Janssen on February 27, 2021, for adults aged 18 years and older. On July 13, 2022, the FDA issued an EUA for the Novavax COVID-19 vaccine, Adjuvanted for the prevention of COVID-19 in persons ages 18 years and older. Additional background information supporting the interim ACIP recommendation on the use of Novavax COVID-19 vaccine can be found in the relevant publication of the recommendation referenced on the ACIP website.