Advisory Committee on Immunization Practices
The Advisory Committee on Immunization Practices (ACIP), founded in 1964, provides advice and guidance on effective control of vaccine-preventable diseases in the U.S. civilian population. The ACIP 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 U.S., and are published by the Centers for Disease Control and Prevention.
Purpose and impact
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. In the U.S., immunizations have resulted in the eradication of smallpox, polio, measles, and rubella, and disease rates from vaccine-preventable diseases have been reduced by 99%.[1]
Both private insurers in the United States and the federal government use ACIP recommendations to determine which vaccines they will pay for.[2]
Most states in the U.S. have adopted ACIP vaccine recommendations and mandate immunization before enrollment in public school,[3] while allowing religious or philosophical exemptions to vaccination.[4]
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 eight eligible ACIP members are present. Eligible voters are those members who do not have a conflict of interest. If there are not eight eligible voting members present, the ACIP executive secretary can temporarily designate ex officio members as voting members, as provided in the committee charter.[5] Meetings are advertised and open to the public, and are now available online via webcast. The minutes of each meeting are available on the CDC website within 90 days of the conference.[6]
In October 2010, ACIP adopted the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework.[7] 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. Each piece of evidence is judged as very low, low, moderate, or high quality. Problems such as lack of reliability and biases are taken into account and the quality of the evidence is adjusted accordingly. If ACIP decides the evidence provides proof that the benefits of the vaccine outweigh the costs to the majority of America, they give a Category A, or strong recommendation. A Category A decision forces insurance companies to pay for the vaccine, and puts it on the mandated schedule for the recommended age group. Category B is reserved for vaccines which, while proven adequate in some areas, are lacking evidence for others. These vaccines, if inducted into the VFC program, are also covered by insurance companies, but are offered to be administered at the discretion of the attending physician.
At meetings the ACIP may vote to include new vaccines into the VFC program or to modify existing vaccine schedules. These votes are codified as VFC resolutions. In most cases, a resolution takes effect after establishing a CDC contract for the purchase of that vaccine in the necessary amounts.[8]
Recommendations are then forwarded to the CDC Director for approval. Once approved, the recommendations appear in the CDC's Morbidity and Mortality Weekly Report and represent the official CDC recommendations for immunizations in the US.[9]
Working groups
To ensure thorough review of available information, ACIP often appoints working groups to assist drafting its recommendations, composed of ACIP members, CDC staff and others with immunization expertise. Work groups work year round to catalog specific vaccines and safety information. They review all available scientific information about vaccines which will be discussed at the next ACIP meeting so that they can present the relevant information after the vaccine is licensed at the meeting. Work groups do not vote on the final recommendation.
Members
The ACIP nominally contains fifteen regular members, each an expert in one of the following fields:[5]
- immunization practices and public health
- use of vaccines and other immunobiologic agents in clinical practice or preventive medicine
- clinical or laboratory vaccine research
- assessment of vaccine efficacy and safety
- consumer perspectives and/or social and community aspects of immunization programs; at least one member must be an expert in this category.
No-one who is currently employed by or involved with any employees of vaccine manufacturing companies or who holds a patent for a vaccine can be a member of ACIP. In addition, the ACIP includes ex officio members from Federal agencies involved with vaccine issues, and non-voting liaison representatives from medical and professional societies and organizations.[10]
Recent recommendations
On February 26, 2015, ACIP voted to deliver a Category A recommendation for administering MenB vaccines to persons older than 10 years who were at higher risk of meningococcal disease.
On June 24, 2015, ACIP heard the arguments for recommending Pfizer and Novartis's serogroup B meningococcal vaccines for everyone in the 16-22 age group. The vaccines were licensed to be administered to persons 10 to 25 years of age. ACIP was unable to grade all of the evidence according to the GRADE system, but they considered the evidence given to be of enough quality to consider a recommendation. The proposed wording was as follows:
“A serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age. (Category B)”[11]
The motion was passed, 14 to 1.
See also
- Joint Committee on Vaccination and Immunisation, the National Health Service counterpart in the United Kingdom
References
- ↑ "Vaccine timeline". National Center for Immunization and Respiratory Diseases. 2006-10-19. Archived from the original on 24 February 2008. Retrieved 2008-01-31.
- ↑ "Rising Costs Complicate Vaccine Guidelines". 2011-07-20. Retrieved 2011-08-20.
- ↑ Diekema DS, American Academy of Pediatrics Committee on Bioethics (2005). "Responding to parental refusals of immunization of children". Pediatrics. 115 (5): 1428–31. doi:10.1542/peds.2005-0316. PMID 15867060.
- ↑ LeBlanc S (2007-10-17). "Parents use religion to avoid vaccines". USA Today. Retrieved 2007-11-24.
- 1 2 "ACIP charter". National Center for Immunization and Respiratory Diseases. 2014-04-01. Retrieved 2015-11-20.
- ↑ "ACIP Agendas, Minutes, Videos, Presentations | Immunization Practices | CDC". www.cdc.gov. Retrieved 2015-11-19.
- ↑ "New Framework (GRADE) for Development of Evidence-Based Recommendations by the Advisory Committee on Immunization Practices". www.cdc.gov. Retrieved 2015-11-19.
- ↑ "The ACIP-VFC vaccine resolutions". National Center for Immunization and Respiratory Diseases. 2015-06-30. Retrieved 2015-11-20.
- ↑ "ACIP | Home | Advisory Committee on Immunization Practices | CDC". www.cdc.gov. Retrieved 2015-11-19.
- ↑ "ACIP members". National Center for Immunization and Respiratory Diseases. 2015-09-30. Retrieved 2015-11-20.
- ↑ "ACIP Agendas, Minutes, Videos, Presentations | Immunization Practices | CDC". www.cdc.gov. Retrieved 2015-11-19.