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299 Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years

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Premarket FDA review of modified risk products is critical for the agency to determine whether the product, as used by consumers, will significantly reduce the risk of disease to individual users and to assess whether its marketing, with the claim of reduced risk, will benefit the health of the population as a whole