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Letter to the Secretary of Health and Human Services, FDA Commissioner and NIH Director Regarding Coronavirus Human Challenge Studies

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Public Citizen requested that the Department of Health and Human Services publicly announce that the Food and Drug Administration (FDA) will not permit and the National Institutes of Health (NIH) will not support any clinical trials during which human subjects — after immunization with an investigational severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine — would be intentionally infected with the novel coronavirus causing the coronavirus disease 2019 (COVID-19) pandemic.

July 23, 2020, FDA response letter.

July 30, 2020, NIH response letter.

See Public Citizen’s other work on the coronavirus pandemic.

See Public Citizen’s other work on ethics and clinical trials.