Advisory Committee on Immunization Practices

The Advisory Committee on Immunization Practices (ACIP) consists of fifteen advisors to the Centers for Disease Control and Prevention (CDC), selected by the Secretary of the United States Department of Health and Human Services, to provide advice and guidance on the most effective means to prevent diseases through nation-wide vaccination campaigns.

The Committee develops written recommendations for routine administration of vaccines to the pediatric and adult populations, along with vaccination schedules regarding appropriate periodicity, dosage, and contraindications. ACIP statements are official federal recommendations for the use of vaccines and immune globulins in the US, and are published by the CDC. ACIP is the only entity in the federal government which makes such recommendations.

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Objectives

The overall goals of the ACIP are to provide advice to government agencies for reducing the incidence of vaccine preventable diseases and to increase the safe usage of vaccines and related biological products. According to government agencies, immunizations have resulted in the eradication of smallpox and poliomyelitis, and control of measles, rubella, tetanus, diphtheria, Haemophilus influenzae type b, and other infectious diseases in the United States and other parts of the world.

Recommendation process

Regularly scheduled ACIP meetings are held three times a year. Notices of each meeting, along with agenda items, are published in the Federal Register in accordance with the requirements of the Federal Advisory Committee Act (FACA). A vote on vaccine recommendations may be taken when a quorum of at least seven eligible ACIP members are present. Eligible voters are those members who do not have a conflict of interest. If there are not seven eligible voting members present, the ACIP executive secretary can appoint ex officio members as voting members, as provided in the committee charter.

Their process includes review of labeling and package inserts; review of the scientific literature on the safety and efficacy; assessment of cost effectiveness; review of the morbidity and mortality associated with the disease; review of the recommendations of other groups; and consideration of the feasibility of vaccine use in existing programs.

Working groups

To ensure thorough review of available information, ACIP often appoints working groups to assist drafting its recommendations, comprised of ACIP members, CDC staff and others with immunization expertise.

Recent additions to recommended vaccination schedules

In recent years, new guidelines from ACIP have expanded the eligibility for influenza vaccination among children under the Vaccines for Children (VFC) program. The influenza vaccine is now strongly recommended by ACIP for all children six to 23 months old.

Young adolescents should be routinely vaccinated with tetravalent meningococcal polysaccharide-protein conjugate vaccine, or MCV4, which was approved by the FDA in January, 2005, for persons ages 11 to 55. The vaccine, called Menactra, was added to the CDC's recommendations that May. In October, 2005, the FDA, the CDC, and Menactra's maker, Sanofi Pasteur, warned that five US teens developed a serious neurological condition called Guillain-Barré syndrome after being vaccinated with Menactra.

In January of 2006, a new booster vaccine for pertussis, tetanus, and diphtheria was recommended for children.

In February, 2006, the rotavirus vaccine was reintroduced by ACIP to its list of recommendations. An earlier version of the rotavirus vaccine was pulled off the US market in the late 1990s, after serious vaccine injury problems arose; the problems were initially identified during clinical trials. Dr. Paul Offit, who shares the rotavirus vaccine patent with Merck & Co., began his tenure on ACIP in October of 1998 and shortly thereafter voted three times in favor of inclusion of the original rotavirus vaccine in the VFC program.

In June of 2006, ACIP recommended that Gardasil®, an experimental HPV vaccine which prevents some types of the Human Papillomavirus Virus (HPV), be routinely given to girls when they are 11-12 years old. The ACIP recommendation also allows for vaccination of girls beginning at nine years old as well as vaccination of girls and women 13-26 years old. The vaccine is most effective when given to females before onset of sexual activity. HPV is the leading cause of cervical cancer in women. Cervical Cancer is listed as a rare disease by the Office of Rare Diseases (ORD) of the National Institutes of Health (NIH).

Compulsory immunizations

Individual states adopt ACIP vaccine recommendations as compulsory for students before admission to schools. Parents can refuse vaccinations for their children, but for enrollment in public school, an exemption is necessary to avoid compulsory vaccination requirements. In order to shield themselves from liability for compulsory vaccinations, all states provide for medical exemptions. All but three states offer a religious exemption, and nineteen states allow a philosophical exemption. Some require only a letter from a parent, whereas other states require exemptions from physicians or church leaders.[1]

Vaccine safety

Autism

The CDC, Food and Drug Administration (FDA) and ACIP have all taken the position that recent increases in the number of reported autism cases are attributable to improved diagnoses and a purely coincidental temporal connection between the vaccine schedule given to most American children, and the diagnosis of late onset autism and other learning disabilities such as ADHD. Representatives of the CDC, FDA and American Academy of Pediatrics have all gone on record as stating there is no connection between vaccinations, particularly thimerosal containing vaccines and the MMR vaccine, and autism.

Nevertheless, the CDC has issued an “Autism Alarm”, warning of an impending crisis due to concerns over the fact that one in six children are now being diagnosed with a behavioral or pervasive developmental disorder, and that one in 166 children are currently diagnosed with an autism spectrum disorder.

Simpsonwood

Main article: 2000 Simpsonwood CDC conference

In June of 2000, 53 scientists from the CDC, FDA, ACIP and industry met at the Simpsonwood conference center, in Norcross, Georgia, to review the findings of Dr. Thomas Verstraeten, an epidemiologist hired by CDC to review data from the Vaccine Safety Datalink. Verstraten reported a "statistically significant connection" between thimerosal and tics, verbal delays and ADHD and autism, and that "...we have found statistically significant relationships between the exposures and outcomes for these different exposures and outcomes. First, for two months of age, an unspecified developmental delay, which has its own specific ICD9 code. Exposure at three months of age, Tics. Exposure at six months of age, an attention deficit disorder. Exposure at one, three and six months of age, language and speech delays which are two separate ICD9 codes. Exposure at one, three and six months of age, the entire category of neurodevelopmental delays, which includes all of these plus a number of other disorders."

Members

In addition to its fifteen regular members, ACIP includes ex-officio members from other Federal agencies involved with vaccine issues, and non-voting liaison representatives from professional societies and organizations responsible for immunization campaigns. ACIP membership, as of October, 2005:

• Chairman, Jon S. Abramson, MD, Wake Forest University School of Medicine
• Executive Secretary, Larry K. Pickering, MD, Senior Advisor to the Director of the CDC's National Immunization Program
• Ban Mishu Allos, MD, Assistant Professor, Division of Infectious Diseases, Vanderbilt University
• Robert L. Beck, Consumer Representative
• Judith Campbell, MD, Associate Professor of Pediatrics, Baylor College of Medicine
• Reginald Finger, MD, MPH, former medical adviser to Focus on the Family
• Janet R. Gilsdorf, MD, Director, Pediatric Infectious Diseases, Department of Pediatrics and Communicable Diseases, University of Michigan
• Harry Hull, MD, State Epidemiologist and Director Minnesota Department of Health
• Tracy Lieu, MD, Associate Professor of Ambulatory Care and Prevention, Harvard Medical School
• Edgar K. Marcuse, MD, MPH, Associate Medical Director, Seattle Children’s Hospital
• Dale L. Morse, MD, Director, Office of Science and Public Health, New York State Department of Health
• Julia Morita, MD, Immunization Program Medical Director, Chicago Department of Public Health
• Gregory A. Poland, MD, Professor of Medicine, Mayo Medical School
• Patricia Stinchfield, NP, St. Paul Children’s Hospitals and Clinics
• John J. Treanor, MD, Associate Professor of Medicine, University of Rochester
• Robin J. Womeodu, MD, Medical Director, Center on Health Disparities, University of Tennessee Health Science Center
• Ex officio members: James E. Cheek, MD, MPH; Wayne Hachey, DO, MPH, LTC; Geoffrey S. Evans, MD; Bruce Gellin, MD; Linda Murphy; George T. Curlin, MD; Norman Baylor, PhD; Kristin Lee Nichol, MD

Conflict of interest waivers

Most ACIP members, if not all, have ties to vaccine makers, such that the CDC must grant them waivers from statutory conflict of interest rules. This professional experience contributes toward the development of their immunization expertise, and is the rationale offered by the CDC to justify waivers. The United States Congress has accepted this justification for service on federal advisory committees by experts with conflicts, and has provided for waivers from such prohibitions, under 18 USC § 208, when the need for the individual's service outweighs the potential for a conflict of interest.

Examples of ACIP conflict of interest issues:

• Advisory committee members own patents for vaccines under consideration
• The CDC grants conflict of interest waivers to every ACIP member
• Former committee chair, Dr. John Moldin, owned stock in Merck & Co.
• The advisory committee has only a single consumer representative

Criticism

Vaccination critics believe that ACIP's crowded immunization schedule is unsafe. They have expressed concerns that "vaccine overloads" may cause serious side effects because of an excessive burden on the 'immature' immune systems of children.

The Advisory Committee attracted attention in 2006, when it was reported that it might not approve an effective vaccine against HPV, the human papillomavirus. HPV is a sexually transmitted disease that affects more than half of all Americans at some point in their lives. The virus directly leads to cervical cancer, killer of almost 5000 American women each year. Health officials affiliated with the Bush administration, as well as many conservative and Christian groups, claimed that inoculation of teenage girls against a sexually transmitted disease could encourage them to become sexually active. ACIP member Dr. Reginald Finger was quoted in the press as stating that, should an HIV vaccine become available, ACIP would have to carefully consider its effects on sexual activity.

See also

• Herd immunity
• Joint Committee on Vaccination and Immunisation, the National Health Service counterpart in the United Kingdom