ダウンロード Vaccine Safety in the United States: Overview and Considerations for COVID-19 Vaccines pdf 本

Updated 11/4/2020: Widespread immunization efforts have been linked to increased life expectancyand reduced illness. U.S. vaccination programs, headed by the Centers for Disease Control andPrevention (CDC) within the Department of Health and Human Services (HHS), have helpederadicate smallpox and nearly eradicate polio globally, and eliminate several infectious diseasesdomestically. With the Coronavirus Disease 2019 (COVID-19) pandemic now causing major healthand economic impacts across the world, efforts are underway to make safe and effective vaccinesavailable quickly to help curb spread of the virus.Federal regulation of vaccine safety began with the Biologics Control Act of 1902, whichwas the first federal law to require premarket review of pharmaceutical products. Since the 1902law was enacted, federal vaccine safety activities have expanded, with the aim of minimizing thepossibility of adverse events following vaccination and detecting new adverse events as quicklyas possible. Today, as covered in this report, federal efforts to ensure vaccine safety include thefollowing activities: Clinical trials, or testing of investigational vaccines in human subjects, andU.S. Food and Drug Administration (FDA) licensure or authorization. Recommendations for theclinical use of vaccines by the Advisory Committee on Immunization Practices (ACIP), and CDCclinical guidance and resources. Manufacturing requirements and ongoing safety monitoring ofvaccines administered to patients. Ongoing research to inform a better scientific understandingof vaccine safety and comprehensive scientific reviews on the safety of vaccines in use. Innonemergency circumstances, the National Vaccine Injury Compensation Program (VICP) providescompensation to eligible individuals found to have been injured by a covered vaccine. In emergencycircumstances, like COVID-19, a separate Countermeasures Injury Compensation Program(CICP) may be used. Programs and requirements to ensure safety controls in vaccine distributionprograms, led by CDC.Safety considerations for COVID-19 vaccines in development are unique in many ways. FDA hasnever licensed a vaccine for a coronavirus, and much remains unknown about potential safety issuesrelated to COVID-19 vaccines. Under Operation Warp Speed (OWS)—the Trump Administration’smajor medical countermeasure development initiative—COVID-19 vaccines are under an expediteddevelopment timeline. FDA may initially make the vaccine available under an Emergency UseAuthorization (EUA) instead of its standard biologics licensing process—a first for the agency fora previously unapproved vaccine. In light of reported concerns from the public surrounding thesafety and effectiveness of COVID-19 vaccines developed on an expedited timeline, FDA officialshave sought to clarify that any vaccine candidate “will be reviewed according to the establishedlegal and regulatory standards for medical products.” If made available within the next severalmonths, available safety and effectiveness data would be based on months of data collection ratherthan on years of data collection typically used in vaccine development. In addition, efforts areunderway with regard to (1) clinical guidance and prioritization of individuals to receive the likelylimited initial supply of COVID-19 vaccines; (2) strengthening safety monitoring systems to collectongoing safety surveillance data on vaccines administered to the population; and (3) preparing forsafety controls in vaccine distribution and patient administration, in addition to other activities.