80 FR 18424 - Solicitation of Written Comments on the National Vaccine Advisory Committee's Draft Report and Draft Recommendations for Consideration for Addressing the State of Vaccine Confidence in the United States

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 65 (April 6, 2015)

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various federal agencies involved in vaccine and immunization activities. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in her capacity as the Director of National Vaccine Program on matters related to vaccine program responsibilities. Recognizing that immunizations are given across the lifespan and there are likely to be important differences in vaccine acceptance at different stages of life, in February of 2013 the National Vaccine Advisory Committee accepted an initial charge from the Assistant Secretary for Health (ASH) to report on how confidence in vaccines impacts the optimal use of recommended childhood vaccines in the United States, including reaching Healthy People 2020 immunization coverage targets. Focus of such a report may include understanding the determinants of vaccination acceptance among parents, what HHS should be doing to improve parental confidence in vaccine recommendations and how to best measure confidence in vaccine and vaccination to inform and evaluate interventions in the future. Through a series of teleconferences, electronic communications, presentations and public discussions during the NVAC meetings, a working group identified a number of draft recommendations to further understand and address issues of vaccine confidence in the United States. On behalf of NVAC, NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in June 2015 at the quarterly NVAC meeting.

[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18424-18426]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on the National Vaccine Advisory 
Committee's Draft Report and Draft Recommendations for Consideration 
for Addressing the State of Vaccine Confidence in the United States

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, National Vaccine Program Office, Department of Health and Human 
Services

ACTION: Notice.

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SUMMARY: The National Vaccine Advisory Committee (NVAC) was established 
in 1987 to comply with Title XXI of the Public Health Service Act (Pub. 
L. 99-660) (Sec.  2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose 
is to advise and make recommendations to the Director of the National 
Vaccine Program on matters related to program responsibilities. The 
Assistant Secretary for Health (ASH) has been designated by the 
Secretary of Health and Human Services (HHS) as the Director of the 
National Vaccine Program. The National Vaccine Program Office (NVPO) is 
located within the Office of the Assistant Secretary for Health (OASH), 
Office of the Secretary, U.S. Department of Health and Human Services 
(HHS). NVPO provides leadership and fosters collaboration among the 
various federal agencies involved in vaccine and immunization 
activities. The NVPO also supports the National Vaccine Advisory 
Committee (NVAC). The NVAC advises and makes recommendations to the ASH 
in her capacity as the Director of National Vaccine Program on matters 
related to vaccine program responsibilities.
    Recognizing that immunizations are given across the lifespan and 
there are likely to be important differences in vaccine acceptance at 
different stages of life, in February of 2013 the National Vaccine 
Advisory Committee accepted an initial charge from the Assistant 
Secretary for Health (ASH) to report on how confidence in vaccines 
impacts the optimal use of recommended childhood vaccines in the United 
States, including reaching Healthy People 2020 immunization coverage 
targets. Focus of such a report may include understanding the 
determinants of vaccination acceptance among parents, what HHS should 
be doing to improve parental confidence in vaccine recommendations and 
how to best measure confidence in vaccine and vaccination to inform and 
evaluate interventions in the future.
    Through a series of teleconferences, electronic communications, 
presentations and public discussions during the NVAC meetings, a 
working group identified a number of draft recommendations to further 
understand and address issues of vaccine confidence in the United 
States.
    On behalf of NVAC, NVPO is soliciting public comment on the draft 
report and draft recommendations from a variety of stakeholders, 
including the general public, for consideration by the NVAC as they 
develop their final recommendations to the ASH. It is anticipated that 
the draft report and draft recommendations, as revised with 
consideration given to public comment and stakeholder input, will be 
presented to the NVAC for adoption in June 2015 at the quarterly NVAC 
meeting.

DATES: Comments for consideration by the NVAC should be received no 
later than 5:00 p.m. EDT on May 6, 2015.

ADDRESSES: 
    (1) The draft report and draft recommendations are available on the 
Web at http://www.hhs.gov/nvpo/nvac/subgroups/nvac-vaccine-confidence-wg.html.
    (2) Electronic responses are preferred and may be addressed to: 
[email protected].
    (3) Written responses should be addressed to: National Vaccine 
Program Office, U.S. Department of Health and Human Services, 200 
Independence Avenue SW., Room 733G, Washington, DC 20201. Attn: Vaccine 
Confidence Working Group.

FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, 
Office of the Assistant Secretary for Health,

[[Page 18425]]

Department of Health and Human Services; telephone (202) 690-5566; fax 
(202) 690-4631; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Vaccination confidence is one of a number of factors that affect 
individual and population-level willingness to accept a vaccine. 
Vaccine confidence means having confidence in the safety and efficacy 
of a vaccine, having confidence in the competence of the health 
professionals who administer the vaccine, and having trust in the 
motivations of the policy-makers who decide which vaccines are needed 
and when. Vaccine confidence has been shown to influence vaccine 
decision making, but to what extent remains unclear. This is partly due 
to a lack of consensus on how best to quantify the confidence of an 
individual and a population. Gaining this understanding along with 
identifying factors which drive public confidence is critical for 
assessing the magnitude of the problem in the U.S., as well as 
designing and evaluating potential intervention strategies.
    Through their analysis and discussion, the NVAC proposes the 
following recommendations:

Focus Area 1: Measuring and Tracking Vaccine Confidence

    1.1 NVAC recommends development of an ``index,'' composed of a 
number of individual and social dimensions, to measure vaccine 
confidence. This index should be capable of (1) a rapid, reliable and 
valid surveillance of national vaccine confidence; (2) detection and 
identification of variations in vaccine confidence at the community 
level; and (3) diagnosis of the key dimensions that affect vaccine 
confidence.
    1.2 NVAC recommends continuing the use of existing measures for 
vaccine confidence, including systems that measure vaccine coverage as 
well as vaccine-related confidence, attitudes and beliefs while the 
science of understanding and tracking vaccine confidence is being 
advanced.
    1.3 NVAC recommends the development of measures and methods to 
analyze the mass media environment and social media conversations to 
identify topics of concern to parents, healthcare providers, and 
members of the public.
    1.4 NVAC recommends that existing approaches and systems for 
monitoring vaccination coverages and vaccine-related cognitions, 
attitudes, and behaviors be strengthened and enhanced. These include: 
(1) Immunization Information Systems (IIS) and Electronic Health 
Records (EHRs) to collect and capture delays and refusals; (2) Reliable 
and valid measures (or surveys) of cognitive factors, such as adults 
and parents' confidence, attitudes, and beliefs regarding vaccines and 
recommended vaccinations; (3) Surveys of provider attitudes and beliefs 
towards vaccination; and (4) Integration of data from all existing 
systems to track trends of vaccination confidence over time and to 
detect variations across time and geography.

Focus Area 2: Communication and Community Strategies

    2.1 NVAC recommends healthcare providers, immunization programs, 
and those involved in promoting recommended vaccinations actively 
reinforce that vaccination according to the Advisory Committee on 
Immunization Practices (ACIP) recommended schedule is the social norm 
and not the exception. Misperceptions that vaccination in line with the 
ACIP recommended schedule is not the norm should be appropriately 
addressed.
    2.2 NVAC recommends consistent communications assessment and 
feedback pertaining to vaccine confidence. These include:
    2.2.1 Creation of a Communication Assessment Infrastructure to 
assess vaccine sentiment and provide timely, accurate and actionable 
information related to vaccination confidence and acceptance to 
relevant stakeholders. This system should have the capability to 
regularly assess vaccine-related messaging environment (e.g., to 
identify new or emerging concerns and questions) to assess 
understanding and effectiveness of population education and information 
materials and resources.
    2.2.2 Identification, evaluation and validation of communication 
resources and approaches in terms of their effects on enhancing vaccine 
and vaccination confidence so that effective (``evidence-based/
evidence-informed'') interventions and best practices can be shared and 
more widely used.
    2.2.3 Creation of a repository of evidenced-based best practices 
for informing, educating, and communicating with parents and others in 
ways that foster or increase vaccine or vaccination confidence. This 
repository would be maintained and expanded as future evidence is 
compiled regarding messages, materials, and interventions that 
positively affect vaccine or vaccination confidence.
    2.3 NVAC recommends the development of systems to support parent 
and community efforts that seek to promote vaccine confidence and 
vaccination.
    2.4 NVAC recommends support for a community of practice or network 
of stakeholders who are actively taking steps to foster or grow vaccine 
confidence and vaccination; such a network can foster partnerships and 
encourage sharing of resources and best practices.

Focus Area 3: Healthcare Provider Strategies

    3.1 NVAC recommends the development and deployment of evidence-
based materials and toolkits for providers to address parent questions 
and concerns. These materials and toolkits should continue to be 
revised to incorporate the latest science and research.
    3.1.1 A repository of evidence-based effective practices for 
providers should be an output of this effort.
    3.2 NVAC recommends curriculum and communication training that 
focuses on vaccine confidence (e.g., strategies and approaches for 
establishing or building confidence) be developed and made available 
for healthcare providers, including doctors, nurses, alternative 
providers, and ancillary care providers.
    3.2.1 This training should encompass ``providers-in-training,'' 
such as students, residents, and interns as well as currently 
practicing physicians, nurses, and other healthcare providers through 
Continuing Medical Education (CMEs).
    3.2.2 Clear and accessible information on vaccinations, the 
schedule and any changes to the immunization schedule should be 
developed specifically for providers and made available to them through 
resources they utilize most.
    3.3 NVAC recommends the development of: (i) Provisional billing 
codes for vaccine counseling when vaccination is ultimately not given; 
and (ii) Pay for performance initiatives and incentives as measured by: 
(a) Establishment of an immunizing standard within a practice; and (b) 
Continued improvement in immunization coverage rates within a 
provider's practice.

Focus Area 4: Policy Strategies

    4.1 NVAC recommends states and territories with existing personal 
belief exemption policies should assess their policies to assure that 
exemptions are only available after appropriate parent education and 
acknowledgement of the associated risks of not vaccinating, to

[[Page 18426]]

their child and community. Policies that do not do this should be 
strengthened.
    4.1.1 Increased efforts should be made to educate the public and 
state legislatures on the safety and value of vaccines, the importance 
of recommended vaccinations and the ACIP schedule, and the risks posed 
by low or under-vaccination in communities and schools.
    4.2 NVAC recommends information on vaccination rates, vaccination 
exemptions, and other preventative health measures (e.g., whether a 
school has a school nurse, etc.) for an educational institution be made 
available to parents.
    4.2.1 Encourage educational institutions and childcare facilities 
to report vaccination rates publicly (e.g., via a school health grade 
or report).
    4.3 NVAC recommends ``on-time vaccination'' should be included as a 
Quality Measure for all health plans, public and private, as a first 
line indicator of vaccine confidence. NVAC acknowledges that other 
issues, such as access, can also effect on time vaccination.

Final Recommendation

    5.1 The NVAC recommends that the National Vaccine Program Office 
(NVPO) should work with federal and non-federal partners to develop an 
implementation plan to address vaccine confidence, including metrics, 
and report back to NVAC on progress, annually.

II. Request for Comment

    NVPO, on behalf of the NVAC Vaccine Confidence Working Group, 
requests input on the draft report and draft recommendations. Please 
limit your comments to three (3) pages.

III. Potential Responders

    HHS invites input from a broad range of stakeholders including 
individuals and organizations that have interests in immunization 
efforts and the role of HHS in advancing those efforts.
    Examples of potential responders include, but are not limited to, 
the following:

--General public;
--advocacy groups, non-profit organizations, and public interest 
organizations;
--academics, professional societies, and healthcare organizations;
--public health officials and immunization program managers;
--pediatric provider groups including all physician and non-physician 
providers that administer healthcare services to children, including 
pharmacists; and
--representatives from the private sector, including those from health 
insurance organizations.

    When responding, please self-identify with any of the above or 
other categories (include all that apply) and your name. Anonymous 
submissions will not be considered. Written submissions should not 
exceed three to five (3-5) pages. Please do not send proprietary, 
commercial, financial, business, confidential, trade secret, or 
personal information.

    Dated: March 31, 2015.
Bruce Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine 
Program Office, Executive Secretary, National Vaccine Advisory 
Committee.
[FR Doc. 2015-07778 Filed 4-3-15; 8:45 am]
BILLING CODE 4150-44-P