Technical bulletin provides details on authorization and administration of vaccine On Monday, the U.S. Food and Drug Administration (FDA) issued full approval to the Pfizer-BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty, for use as a two-dose series indicated for individuals 16 years of age and older. Comirnaty will remain available under the existing Emergency Use Authorization (EUA) to prevent COVID-19 in individuals ages 12 through 15 years and to provide a third dose to individuals 12 years of age and older who have been determined to be moderately to severely immunocompromised.
FDA’s full approval of the first COVID-19 vaccine, which required additional safety and efficacy data beyond what was provided for the EUA, is an important milestone that should reassure anyone who has concerns about getting vaccinated. On top of the rigorous testing and trials that went into Emergency Use Authorization of the Pfizer vaccine, the FDA has now completed additional analysis of the effectiveness and safety data from tens of thousands of clinical trial participants ages 16 years and older, as well as the analysis of real-world safety data. A technical bulletin on the Division of Public and Behavioral Health’s website outlines details on these related topics:
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AuthorThe Bureau of Health Care Quality and Compliance (HCQC) licenses medical and other health facilities, child care facilities and personnel, and medical laboratories and personnel in Nevada. HCQC also conducts compliance surveys and takes complaints. Archives
October 2023
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