According to the U.S. Centers for Disease Control and Prevention (CDC), the United States currently has “the safest, most effective vaccine supply in its history.” Vaccine safety is a top national health priority and the CDC shares responsibility with the U.S. Food and Drug Administration (FDA) for ensuring that all vaccines are as safe as possible. In this article, vaccine lawyer Leah V. Durant discusses some of the CDC’s and FDA’s key measures for ensuring vaccine safety.
7 Key Measures for Ensuring Vaccine Safety
The CDC and FDA rely on seven key measures to ensure the safety of all vaccines approved for use in the United States. These measures are:
1. Testing During Vaccine Development
Federal laws require vaccine manufacturers to conduct extensive testing during the development phase. This begins with testing in a laboratory. If a potential vaccine appears to present health risks based on this initial testing in the lab environment, it will not move forward to clinical trials.
2. Clinical Trials
After laboratory testing, the next major phase is clinical evaluation. Vaccine manufacturers must conduct clinical trials in three phases according to FDA guidelines.
3. FDA Approval
Once a vaccine passes the clinical trial phase, the manufacturer must seek FDA approval. As the FDA explains, “FDA scientists and medical professionals carefully evaluate all the available information about the vaccine to determine its safety and effectiveness.” Vaccine manufacturers have various paths to FDA approval, some of which are faster than others (i.e., emergency use authorization).
4. Vaccine Safety Monitoring
Efforts to ensure vaccine safety do not end when the FDA approves a vaccine for administration in the United States. The FDA, CDC and vaccine manufacturers all monitor vaccines’ safety on an ongoing basis.
5. Vaccine Manufacturing Facility Inspections
The FDA also conducts regular inspections of vaccine manufacturing facilities. Among other purposes, these inspections serve to confirm that manufacturers are following all federal vaccine manufacturing regulations and that they are submitting all vaccine “lots” to the FDA for review prior to distribution.
6. Vaccine Adverse Event Reporting System (VAERS)
The Vaccine Adverse Event Reporting System (VAERS) is a monitoring system that allows healthcare providers and vaccine recipients to report vaccine-related complications to the CDC and FDA. According to the FDA, “[r]eports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies.”
7. National Vaccine Injury Compensation Program (VICP)
Individuals who are diagnosed with vaccine-related injuries and illnesses can also file claims under the National Vaccine Injury Compensation Program (VICP). In addition to notifying the federal government of these injuries and illnesses, filing claims under the VICP also provides vaccine recipients and families with a source of financial recovery.
Request an Appointment with Vaccine Lawyer Leah V. Durant
Vaccine lawyer Leah V. Durant represents vaccine recipients and families nationwide in claims under the National Vaccine Injury Compensation Program. If you have questions about filing a VICP claim, you can call 202-800-1711 or contact us online to arrange a free consultation.
Leah Durant Bio
Experienced litigation attorney Leah Durant focuses on representing clients in complex vaccine litigation matters. Leah Durant is the owner and principal attorney of the Law Offices of Leah V. Durant, PLLC, a litigation firm based in Washington, DC. Leah Durant and her staff represent clients and their families who suffer from vaccine-related injuries, adverse vaccine reactions and vaccine-related deaths. The Law Offices of Leah V. Durant, PLLC is dedicated to assisting individuals in recovering the highest level of compensation as quickly and efficiently as possible. To learn more, contact vaccine attorney Leah Durant today.