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Engagement Project Report: Meningococcal Vaccines and Infants/Toddlers

Meningococcal Vaccines for Children: 2011 Public and Stakeholder Engagement

In 2011, the National Center for Immunization and Respiratory Diseases at CDC undertook a project designed to get the views from interested organizations and members of the public on issues related to meningococcal vaccines and infants/toddlers. The project included two national stakeholder meetings and four public meetings, with the public meetings being held in Concord (New Hampshire), Chicago, Seattle and Denver. The public and stakeholder meetings were intended to augment CDC and the Advisory Committee on Immunization Practices’ (ACIP) immunization decision-making processes. This report details the project, including its key findings and activities. It also provides summaries from the stakeholder and community meetings.

 

Executive Summary

In the summer of 2011, the Centers for Disease Control and Prevention (CDC) held four public meetings across the country and engaged 277 local stakeholders and interested members of the public in a pilot project designed to get input regarding the values that could inform ACIP recommendations about whether or how to add new vaccines to the childhood immunization schedule. Participants had a general discussion about vaccines that protect children from rare but severe illnesses and a specific discussion about recently licensed and soon‐to‐be licensed meningococcal vaccines for infants.

The four public meetings were part of a process that also engaged national‐level stakeholders in the same discussion. There was one national stakeholder meeting in advance of the public meetings (May 25, 2011) and one meeting after the four public meetings (October 5, 2011). The stakeholder meetings involved participants from a number of organizations, including the American Academy of Pediatrics, the American Academy of Family Physicians, the National Association of Pediatric Nurse Practitioners, the Heritage Foundation, the National Meningitis Association, Meningitis Angels, and Women in Government.

The public and stakeholder meetings were intended to augment the Centers for Disease Control and Prevention’s (CDC) and the Advisory Committee on Immunization Practices’ (ACIP) immunization decision‐making processes. A primary purpose of these meetings was to gain insights into the values that people and organizations use to inform vaccine decisions. This information was summarized and provided to ACIP and the leadership of CDC’s National Center for Immunization and Respiratory Diseases (NCIRD).

The values that surfaced most often during stakeholder and public meeting discussions were:

  • Choice – Freedom; the ability to choose; having options with respect to immunizations; giving parents the facts and letting them decide; recommending, but not requiring; recommending, but not aggressively
  • Awareness – Parents should be aware of, and have access to, infant meningococcal vaccines (or any FDA licensed vaccines)
  • Access/Affordability – Cost/financial considerations should not be a barrier to vaccines
  • Availability – If a vaccine is FDA licensed, parents should be able to get it; a permissive recommendation should not inhibit vaccine availability
  • Safety – Few side effects; no serious risks from a vaccine
  • Equity – In education, awareness, access, availability, and choice

The public and stakeholder participants used these values – informed by the discussion and deliberation with other participants, and the information provided by CDC experts during the meeting – to work through some of the vaccine program decisions facing the ACIP. The structured public meeting agenda used a number of polling questions to foster discussion, including a final question at the end of the meeting that asked participants to specifically consider the options the ACIP has with respect to new vaccines. In the final question, participants were asked, when it came to meningococcal vaccines and infants, which of the options most aligned with their values.

Overall, about two thirds of participants indicated that a universal recommendation was most in line with their values, but for some, behind this preference was the desire for access and choice. Many recognized that adding a universal vaccine recommendation to the childhood immunization schedule would provide clear direction for physicians and parents; foster the greatest vaccine education, awareness, access, and use; address the need for education and resources; and prompt more health care providers to talk with parents about meningococcal vaccination for infants. Concerns about a universal recommendation centered on three things:

  1. whether the total number of meningococcal disease cases in infants and toddlers and the number of cases that would be prevented justified a universal vaccination recommendation;
  2. the number of vaccinations in the schedule; and
  3. the lack of serogroup B meningococcal protection for infants and toddlers. It should be noted that this polling was not intended to generate scientifically valid data, but rather to generate discussion.

About one third of the public meeting participants favored a permissive recommendation when it came to meningococcal vaccines and infants. Some saw this choice as most in line with a value of personal choice. Many recognized that this approach would limit awareness, access, and availability of these vaccines; foster confusion and send mixed messages regarding their need; lead to inconsistencies in meningococcal vaccine use; and foster inequities in use and access of these vaccines. Some favored the addition of these vaccines to the Vaccines for Children Program (VFC) as a way to foster availability and access. Others did not favor this approach because it could result in access inequities.

Many participants expressed dissatisfaction with the available options (i.e., universal or permissive). They did not believe that meningococcal disease incidence and/or protection provided by vaccines warranted a universal recommendation; however, they also did not believe a permissive recommendation would result in physician or parent awareness of vaccines, availability of vaccines, or consistency regarding use of meningococcal vaccines for infants. Medical professionals said that doctors do not have enough time with patients to discuss all of the permissive vaccines. As such, many participants believed there should be an effort to find another recommendation option.

After reviewing the results from the public meetings, the stakeholders deliberated in their second meeting and offered these views:

The process should, at some point, factor in cost‐effectiveness and economic considerations.

The process of public and stakeholder review of meningococcal vaccines for infants highlighted the challenges related to immunization financing and vaccine costs, including pricing. When cases of disease are relatively rare, the cost‐effectiveness of vaccines can be quite low. Many public and stakeholder meeting participants said there was a need to formally factor in cost‐effectiveness and economic/financial consideration. Some suggested that CDC or HHS needed a new and rigorous decision‐making process that would apply standardized cost‐effectiveness analyses or criteria that could be used during or after deliberations related to whether to add a vaccine to the immunization schedule.

Immunization recommendations should ensure equity and foster access to FDA‐licensed vaccines for infants and children.

The emphasis on economic considerations during the stakeholder meetings prompted concerns that ACIP and CDC would focus too much attention on economic considerations to the detriment of equity and access. Many of the stakeholders placed a high priority on access to new meningococcal vaccines for all children. They wanted to ensure that ACIP carefully considered in their recommendations the risk of unequal access to infant meningococcal vaccines. The stakeholders wrestled with the possibility that a permissive recommendation would lead to unintended inequities with some health care providers offering the vaccine and educating parents about meningococcal disease and other providers using their limited time with parents to talk about other vaccines or other health topics to the exclusion of information about meningococcal disease.

It would be helpful to examine and/or expand ACIP’s options when it comes to newly licensed childhood vaccines.

The stakeholders echoed sentiments from the public meetings and highlighted the advantages of a broader and more nuanced set of ACIP recommendation options—for example, an option that would allow for broad education and access without making meningococcal vaccination routine for all children. The stakeholder meeting participants also considered the public meetings’ call for an education strategy that recognizes the desire of many parents to have a more active role when it comes to childhood vaccines.

Vaccine recommendations should come with provider, parent, or public education and other resources to foster awareness, adoption, and assessment of success.

The public and stakeholder engagement made it clear that wanting options or wanting access to meningococcal vaccines for infants was not the same thing as wanting or believing there should be a recommendation that all children be vaccinated. Many participants believed that parents and providers should be aware of and have access to vaccines even if there is not a universal vaccination recommendation. Many participants recognized that adding a universal vaccination recommendation to the childhood schedule created the broadest parent and physician awareness and access.

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