Vaccine Safety in the United States: Overview and Considerations for COVID-19 Vaccines

"Widespread immunization efforts have been linked to increased life expectancy and reduced illness. U.S. vaccination programs, headed by the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), have helped eradicate smallpox and nearly eradicate polio globally, and eliminate several infectious diseases domestically. With the Coronavirus Disease 2019 (COVID-19) pandemic now causing major health and economic impacts across the world, efforts are underway to make safe and effective vaccines available quickly to help curb spread of the virus.

Background

Federal regulation of vaccine safety began with the Biologics Control Act of 1902, which was the first federal law to require premarket review of pharmaceutical products. Since the 1902 law was enacted, federal vaccine safety activities have expanded, with the aim of minimizing the possibility of adverse events following vaccination and detecting new adverse events as quickly as possible. Today, as covered in this report, federal efforts to ensure vaccine safety include the following activities:

 Premarket requirements: Clinical trials, or testing of investigational vaccines in human subjects, and U.S. Food and Drug Administration (FDA) licensure or authorization.

 Clinical recommendations: Recommendations for the clinical use of vaccines by the Advisory Committee on Immunization Practices (ACIP), and CDC clinical guidance and resources.

  Postmarket safety: Manufacturing requirements and ongoing safety monitoring of vaccines administered to patients.  Federal research on vaccine safety: Ongoing research to inform a better scientific understanding of vaccine safety and comprehensive scientific reviews on the safety of vaccines in use.

 Vaccine injury compensation: In nonemergency circumstances, the National Vaccine Injury Compensation Program (VICP) provides compensation to eligible individuals found to have been injured by a covered vaccine. In emergency circumstances, like COVID-19, a separate Countermeasures Injury Compensation Program (CICP) may be used.

 Vaccine distribution: Programs and requirements to ensure safety controls in vaccine distribution programs, led by CDC..."
Vaccine safety