April 29, 2019
“As we head into National Infant Immunization week, I want to take the opportunity to underscore the public health importance of immunizations. One of my priorities at FDA is to continue to support the agency’s efforts to reinforce the rigorous and robust process we use to ensure the safety and effectiveness of vaccines that prevent infectious diseases like influenza and measles," said Ned Sharpless, M.D., FDA Acting Commissioner. "I’m horrified by the current outbreaks of measles – a disease we thought we had eliminated in the United States in 2000. With a vaccine that is highly effective, this life-threatening infection is now making a tragic comeback, in part because of vaccine avoidance. And, unfortunately, measles is not the only disease that is threatening to make a resurgence. The best way to prevent such diseases is to vaccinate against them. I want to reassure the American public that these vaccines have been determined to be safe and effective and dispel the continued misconception that they are associated with the development of autism. We remain dedicated to continuing our important work alongside our federal, state, and local partners to monitor the safety and effectiveness of our current vaccines, encourage vaccinations against preventable diseases, and support the development of novel vaccines to address emerging threats to public health.”
The FDA ensures that all vaccines used in the U.S. go through a rigorous and extensive development program. The development program for vaccines includes studies conducted by the manufacturers according to FDA standards to evaluate safety and effectiveness. FDA then undertakes its own examination and analysis of the data submitted by manufacturers. FDA licenses a vaccine only if it determines that a vaccine is safe and effective. Additionally, the FDA partners with the U.S. Centers for Disease Control and Prevention (CDC) to monitor the use and safety of vaccines on an ongoing basis after they are approved.
During National Infant Immunization week, the U.S. Department of Health and Human Services and its agencies, including the FDA, are sharing information on the importance of vaccination. Like many medical products, the vaccines can have known potential side effects that are generally mild and short-lived, such as rash and fever. However, there is no credible evidence linking vaccination -- and in particular, the MMR vaccine -- and autism.
The overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect public health.
- CDC: National Infant Immunization Week
- FDA: Vaccines for Children - A Guide for Parents and Caregivers
- Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.