While the majority of people support immunizations and recognize their value in reducing the incidence of disease around the world, there are a handful of people who cling to the preposterous idea that some big vaccine conspiracy exists that will lead the ”sheeple” to their doom. They claim conspirators include doctors, scientists, pharmaceutical companies and government agencies. However, by familiarizing ourselves with the reporting structure of immunization related agencies, and the way in which vaccine recommendations and policies are developed and disseminated (as outlined in the image below) it’s easy to see the value of our current policies and procedures and dismiss these conspiracy claims.
One important part of the puzzle is the work of The Advisory Committee on Immunization Practices (ACIP). Having recently returned from the latest ACIP meeting, I can honestly say that the committee is an impressive group of medical and public health experts who are committed to making decisions that are in the best interest of the American public. Not only do they develop recommendations on how to use vaccines to control diseases in the United States, their role is to also ensure that the recommended vaccines remain safe and effective.
The ACIP consists of 15 voting members, fourteen of which have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine, and one additional member who provides perspectives on the social and community aspects of vaccination as the community representative. In addition to these 15 members, ACIP also includes 8 ex officio members who represent various federal agencies each responsible for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise. Remarkably, this committee was first established 50 years ago and is still an integral part of immunization policy today.
It’s important to note that all those who serve on the committee do so voluntarily and their applications are heavily screened to ensure there is no conflict of interest in regards to vaccine-related activities. In addition to the three yearly meetings that are held, ACIP members also participate in “working groups” which study a specific topic and specialize in providing data and safety information in regards to that topic. The work these subcommittees do is critical to sharing the latest scientific information that then helps members make appropriate immunization recommendations.
For instance, this week’s meeting included the following agenda items and outcomes:
A great deal of time was devoted to evaluating the scientific data related to seasonal influenza vaccine effectiveness and safety, specifically in comparing the live attenuated influenza vaccine (LAIV), also known as the nasal flu mist, to the inactivated influenza vaccine (IIV). A review of the safety data (from VAERS, VSD & CISA) indicated that LAIV and IIV have comparable safety profiles when given to those 18 and younger, with no new safety concerns. While the reports also indicated that LAIV was slightly more effective for children in comparison to the IIV, the committee decided to postpone a vote on the preferential recommendation of the LAIV to children at this time. The committee intends to resume discussion on this topic in June to allow time for the members to formulate their opinions on whether a proposed recommendation is appropriate.
2.) Meningococcal Vaccine
In regards to meningococcal vaccine there were several specific discussions. First the discussion focused on whether the vaccine should be recommended for men who have sex with men (MSM) due to recent outbreaks in that population. There was also a similar consideration based on HIV positive patients and whether there should be a formal meningococcal vaccine recommendation for that specific population as well. Due to a lack of convincing data among these populations, no formal recommendations were considered at this time.
There was also an overview provided regarding the use a serogroup type B meningococcal vaccine during an outbreak on the Princeton and UC Santa Barbara college campuses this past fall/winter. While the B strain vaccine is not currently licensed or approved for use in the U.S., it is in other countries and was given special consideration in order to contain the outbreak. The committee received detailed data and safety information that was gathered during the outbreaks.
3.) Pneumococcal Conjugate Vaccine (PCV)
One of the most sensitive items on the agenda pertained to the possibility that the committee may soon vote on whether they recommend reducing the schedule of PCV13 vaccine for children from four shots to three. In preparation for this vote, the committee received detailed studies that evaluated the effectiveness and herd effects of PCV 13 in the U.S., an comparative analysis of other countries that use an alternate dose series, and a presentation of the scientific evidence that examined whether it would be safe and feasible if a dose were to be removed. The committee has serious considerations to weigh. Reducing the number of doses may inadvertently mean that there are additional victims of disease, (possibly two and a half more deaths annually and 1500 additional hospitalizations). While these numbers may be seen as “statistically” insignificant for scientific purposes, a public comment from PKIDSexecutive director Trish Parnell reminded the committee that we must not dehumanize these statistics. Even one or two additional deaths represents the loss of life that could have been avoided. With such a difficult discussion on the table, the committee spent a great amount of time addressing the various considerations and conclusions that could be drawn from the evidence they were provided and opted to delay the vote on this issue until the next ACIP meeting in June.
4.) Safety of Tdap Vaccine
Since October 2012, when the ACIP recommended the use of Tdap during every pregnancy irrespective of the patient’s prior history of receiving Tdap, the committee intends to continue to monitor safety surveillance in this population. At this meeting there was an extensive safety review that included enhanced surveillance of VAERS, as well as a detailed examination of the safety and coverage data from the Vaccine Safety Datalink (VSD). The analysis concluded that there was no increased risk of adverse birth outcomes as a result of Tdap vaccination during pregnancy and no new safety concerns noted.
5.) Human Papillomavirus (HPV) Vaccine
In anticipation of a new 9-valent HPV vaccine expected to come to market in early 2015, the committed received a report that detailed HPV type attribution in cervical precancers and HPV-associated cancers, as well as a review of the clinical trial data for the new 9-valent HPV vaccine and a revisit of the ACIP statement of bivalent and quadrivalent HPV vaccines. The committee will continue to investigate the trial data during their June and October meetings, with an anticipated vote for a recommendation to be held in February of 2015.
While I’ve highlighted the items on this meeting’s agenda in a few short sentence, it’s important to note that each topic included an hour or two of in-depth analysis of scientific data that was presented along with a follow-on discussion of the findings. Other discussions included information pertaining to Yellow Fever vaccine, adult immunizations, vaccine supply, storage and handling, and smallpox vaccine.
Since the public is able to review the proposed agendas, examine the past meeting notes and slide presentations, and even watch the meeting via live links on the CDC website, I’ve managed to stay informed regarding the ACIP recommendations for several years now. However my presence at this meeting allowed me to see the work behind the policy decisions in a new light. As I witnessed 50 committee members sitting around a table, and another 50-100 people watching the committee conduct it’s business, it was clear to me that the ACIP plays an important role in establishing our nation’s immunization policies. They are committed to doing their best, both personally and professionally, to ensure that they make appropriate vaccine recommendations based on scientifically sound safety and efficacy data. While no system can be perfect, I hope parents can see that the system in place is extremely thorough, responsive, and indeed, trust worthy.
For more information regarding the structure and role of the ACIP and their role in immunization policy, see the following:
Immunization Policy Development in the United States: The Role of the Advisory Committee on Immunization Practices, Annals of Internal Medicine, 6 January 2009.