Fact Sheet on Vaccines and Child Health

Vaccines are critically important to child health – they protect and save lives.

• Vaccines play a critical role in our nation’s public health.
• Because of vaccines, we no longer see many of the diseases that disabled and killed children as recently as two decades ago.
  • Before polio vaccine was available, 13,000 to 20,000 cases of paralytic polio were reported each year in the U.S.
  • Before measles immunization was available, nearly everyone in the U.S. got measles. An average of 450 measles-associated deaths were reported each year between 1953-1963.
  • Before rubella immunization was routine in the U.S., an epidemic of rubella in 1964-1965 that resulted in an estimated 20,000 infants born with congenital rubella syndrome (CRS), with 2,100 neonatal deaths and 11,250 miscarriages. Of the 20,000 infants born with CRS, 11,600 were deaf, 3,580 were blind, and 1,800 were mentally retarded.
  • Immunizing children also helps to protect the health of our community and prevent disease outbreaks.
• In most cases, there are no effective medical treatments for vaccine-preventable diseases, so parents are urged to get their children the vaccines they need to stay healthy.

At HHS, we are committed to ensuring that vaccines are safe and effective.

• HHS is committed to protecting the nation’s health. We continually evaluate the safety of vaccines and are prepared to adjust our policies if allegations prove scientifically valid.
• As with all medical products, vaccines undergo extensive testing to document their efficacy and to explore potential harms. Before a potential vaccine is licensed for use, FDA scientists conduct a thorough and independent review of the testing data and often employ the help of an FDA public advisory review committee.
• In addition, FDA rigorously oversees the manufacturing process for vaccines used in this country – including approval of each step in the process and on site inspection.
• Following licensure, we continue to monitor the safety of the vaccines. Much of this information is learned through the information shared by parents, doctors, and other public health officials.

Thimerosal has been eliminated as a preservative from all childhood vaccines used in the U.S., with the exception of influenza.

• Since 2001, all vaccines recommended for children 6 years of age and younger have been manufactured in formulations that contain either no thimerosal or only trace amounts, with the exception of inactivated flu vaccine.
• Thimerosal-free influenza vaccine licensed for use in children six months to 35 months of age is available in limited supply. As additional manufacturing capability becomes available, inactivated flu vaccine is increasingly being produced in thimerosal preservative-free forms.

Current science shows no conclusive evidence that the preservative Thimerosal increases the risk of developing autism or any other behavior disorder.

• Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930s
• In 1999, even though there was no conclusive evidence of adverse health effects from thimerosal, the US Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a means of reducing an infant’s total exposure to mercury.
• In 2000, The Centers for Disease Control and Prevention and the National Institutes of Health asked the Institute of Medicine (IOM) to provide an independent and objective review of a series of vaccine safety concerns. This review resulted in 8 reports – two of which addressed thimerosal safety concerns. They are available to the public at www.iom.edu/imsafety.
• In 2001, the IOM committee concluded that there was not solid evidence linking thimerosal to brain disorders including autism, neither was the evidence sufficient to rule out a link. The committee supported the voluntary removal of thimerosal from vaccines.
• In 2004, the IOM issued another report Vaccines and Autism. It concluded that the totality of the evidence available indicated that neither thimerosal nor the MMR vaccine is associated with autism. The report recommended that research continue to seek the cause or causes of autism.

The IOM studies looked at the entire body of evidence, underwent peer-review, and met rigorous standards of objectivity, independence and openness.

• To reach its conclusions, the committee reviewed a large amount of literature on this topic – more than 215 references are cited in the 2004 report. The committee included experts in epidemiology, pediatrics, clinical medicine, statistics, and biological evidence pertaining to thimerosal and autism. The studies were peer-reviewed by a group of outside experts before being approved for publication.
• The IOM follows stringent policies for reviewing the potential conflicts of interest or biases of individuals who are chosen to serve on its study committees. The members selected for the committee that reviewed vaccine safety issues had no links to CDC, vaccine manufacturers, vaccine-related litigation or advocacy groups, and they had received no recent funding from the sponsors of the study.
• Committee members received no remuneration for their work on the committee.

Autism is an important public health concern, and we will continue to aggressively investigate information regarding the causes and possible treatments of autism.

• The Children's Health Act of 2000 required that a committee be formed to coordinate autism-related activities in the Department of Health and Human Services (HHS) and the Department of Education. The Interagency Autism Coordinating Committee (IACC) began in 2001. Its main role is to help agencies share information and to coordinate autism research and related activities in the agencies that are part of HHS.
• NIH’s specific role in the broader research agenda is to find the genetic causes, genetic susceptibility, environmental causes, improve diagnosis, and to find potential treatments and preventions for autism. In addition to individual grants for research projects, NIH sponsors training, small grants, career support, and program projects that involve autism research. Scientists and families are working together in a variety of ways through new programs, and collaboration with advocacy groups and families helps the NIH set research priorities.
• NIH recently developed a comprehensive plan known as the Autism Matrix. As one of its activities, the IACC convened a panel of outstanding scientists to assess the field of autism research and identify roadblocks that may be hindering progress in understanding the causes of autism and the best treatment options. As a result of this meeting, in November 2003, the IACC created the autism matrix that summarizes the state of science in autism as well as serves as a guide for future--both short and long term--research goals. The matrix is a living document, regularly reviewed by the IACC, as new discoveries emerge and research projects are launched.
• The Centers for Disease Control and Prevention is conducting a range of research on autism incidence and prevalence. CDC now supports five regional Centers of Excellence for Autism and Developmental Disabilities Research and Epidemiology as well as supporting 18 states involved in monitoring autism and other developmental disabilities.
• CDC has held listening sessions throughout the nation to hear directly from parents, health care providers, scientists, educators and other concerned citizens.
• In addition, in early 2005, CDC launched the “Learn the Signs. Act Early” campaign, designed to promote early identification and intervention for children with autism and other developmental disabilities.

The Bush Administration has increased funding for autism research.

• In Fiscal Year 2006, NIH and CDC expect to spend $117 million to better understand the causes and potential treatments of autism through surveillance and basic and clinical research that will provide answers to the key questions of what causes this complex neurological disorder and how best to treat and prevent it. This amount represents an increase of $56 million (a 91% increase) in investments since Fiscal Year 2001.

Finding cures for childhood diseases is an imperative for HHS scientists.

• Autism spectrum disorders are devastating and perplexing conditions that leave parents searching for answers to their child’s condition. As scientists and health professionals, we are dedicated to helping parents find those answers.
• HHS will continue to support research into the causes and treatments for autism spectrum disorders.
• HHS research and resources on autism can be found at www.hhs.gov/autism