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https://www.fda.gov/media/151710/download "We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion." https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee "The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs." Also from FDA approval letter see: The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT04368728 and NCT04380701. https://clinicaltrials.gov/ct2/show/NCT04368728 Recruitment Status : Recruiting Estimated Primary Completion Date : May 2, 2023 Estimated Study Completion Date : May 2, 2023 https://clinicaltrials.gov/ct2/show/study/NCT04380701 Actual Study Start Date : April 23, 2020 Estimated Primary Completion Date : April 2023 Estimated Study Completion Date : April 2023