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 

Vaccine Safety

"In the United States, a number of safeguards are required by law to help ensure that the vaccines we receive are safe.

The safety of vaccines is often a topic of media stories and blog postings. This attention may make you wonder, “How do we know our vaccines are safe?” Here are some important things to know about vaccine safety.

1. The safety of vaccines is thoroughly studied before they are licensed for public use.

Clinical trials are conducted to evaluate the safety and effectiveness of a vaccine before it can be brought to market. Vaccines are first tested in laboratory studies and animal studies. If the results indicate the vaccine is safe, additional testing in people must be done before the vaccine can be approved by the Food and Drug Administration (FDA). Learn more about vaccine clinical trialsexternal icon.

2. There is a strong system in place to help scientists monitor the safety of vaccines.

Multiple systems are used to monitor the safety of vaccines after they have been licensed for public use. These systems, such as the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), and the Clinical Immunization Assessment (CISA) project, complement each other and help scientists monitor the safety of vaccines and conduct vaccine safety research. Learn more about how vaccines are monitored for safety.

3. Like any medicine, vaccines can cause side effects. However, serious adverse events from vaccines are rare.

Most side effects from vaccines, such as pain and redness at the injection site, are mild and go away quickly on their own. Serious adverse events are rare. If you have questions or concerns about a vaccine, talk with your healthcare provider. Learn more about the safety of recommended vaccines.

4. Receiving combination vaccines or several different vaccines during one visit is safe and offers the quickest protection again multiple diseases.

It is safe to receive several different vaccines during one visit. Also, combination vaccines are as effective as individual vaccines. Learn more about multiple vaccines and the immune system..."
Vaccines