H1N1 Vaccine Priority Recommendations

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Abstract

Anticipating a resurgence of novel influenza A (H1N1) cases while at the same time targeted H1N1 vaccines become available in limited quantities in the United States, the Centers for Disease Control and Prevention (CDC) issued recommendations for priority groups in the circumstance that vaccine quantities do not suffice to inoculate all interested individuals.

Purpose of health policy or idea

In June 2009, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) composed recommendations for the allocation of vaccine against a new influenza A (H1N1). The seasonal influenza vaccine is currently available but does not protect against H1N1, and sufficient H1N1 vaccines may not be available immediately to inoculate all interested individuals. 

The United States ordered 195 million doses of H1N1 vaccine from five companies: MedImmune, a unit of AstraZeneca, Sanofi-Aventis, Australia's CSL, GlaxoSmithKline and Novartis. Early results of H1N1 clinical trials suggest both adults and children will be protected by a single 5-microgram dose of the 2009 H1N1 influenza vaccine, much like the seasonal flu shot. Children may need two doses.

The first H1N1 vaccines were expected to be made available to the public in early October 2009. In the event that insufficient vaccines were immediately available, the CDC identified five population groups that ought to be given priority access to the vaccine. These groups have the highest risk for infection or influenza-related complications according to epidemiological data from the initial phase of the H1N1 epidemic in spring of 2009. The committee recommended that providers try to first vaccinate (order not indicating priority):

1. pregnant women,
2. people who live with or care for children younger than 6 months of age,
3. health care and emergency medical services personnel,
4. persons between the ages of 6 months through 4 years of age, and
5. people from ages 5 through 18 years who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems.

These priority groups comprise approximately 159 million people in the United States. Once local priority group vaccination needs have been met, ACIP recommends vaccines be made available to people aged 4-24 years , then adults aged 25-64 years, and lastly adults over 65 as these individuals show some existing immunity to H1N1 influenza. State and local health officials and providers are expected to make decisions about expanding vaccination priorities based on local cirumstances.

These recommendations are purposefully broad to accommodate local variations in need and demand. State and local health departments may provide additional guidance. In the absence of any state and local guidance providers have been instructed to vaccinate individuals in the initial target populations on a first-come, first-served basis. No federal requirement exists for documenting priority group status or penalizing providers who vaccinate outside the priority groups. Some localities have mandated that health care workers receive the H1N1 vaccination, but the federal H1N1 vaccination program is voluntary. 

The United States military has also created priority groups for their mandatory H1N1 vaccination campaign.  All active duty military personnel, National Guard troops on active duty, and civilian Defense Department employees with critical jobs will be vaccinated. Roughly 1.4 million vaccines will go to military personnel, beginning with 1) troops preparing to deploy, 2) other active-duty forces, particularly any who might be needed to quickly respond to a hurricane or other emergency. The vaccine will also be made available to the families of military staff.

 

Main points

Main objectives

The main principle of the federal recommendations for H1N1 vaccination is to vaccinate as many people as quickly as possible. As such, the recommendations aim to first meet the need and demand for vaccination in the populations at highest risk for infection from H1N1 or serious complications upon becoming infected. A secondary objective is to vaccinate critical workers should the epidemic reach crisis levels, e.g. health care workers and military personnel.

Type of incentives

No incentives other than the protection the vaccine confirms are being offered.

Groups affected

Health-care and emergency medical services personnel who have direct contact with patients or infectious material, military personnel, pregnant women, persons who live with or provide care for infants aged <6 months (e.g., parents, siblings, daycare providers), children aged 6 months-4 years, children and adolescents aged 5-18 years who have medical conditions that put them at higher risk for influenza-related complications

Degree of Innovation	traditional		innovative
Degree of Controversy	consensual		highly controversial
Structural or Systemic Impact	marginal		fundamental
Public Visibility	very low		very high
Transferability	strongly system-dependent		system-neutral

The recommended vaccine priority groups are fairly consensual, having evolved out of similar priority group recommendations from WHO and prior U.S.  influenza pandemic planning efforts.  However, if followed, they will substantially impact which individuals are able to receive an H1N1 vaccination and when. Moreover, a non-tiered system like that proposed by ACIP will only work if sufficient vaccines are initially made available.

Political and economic background

The CDC recommendations for vaccination priority groups stems from a series of steps the federal government has taken in preparing for the anticipated resurgence of H1N1 in the fall of 2009. While generally not mandatory, the recommendations prioritize protection of those individuals most vulnerable to H1N1 influenza and critical workers. 

Complies with

Health risk due to the pandemic threat

Purpose and process analysis

Current Process Stages

	Idea	Pilot	Policy Paper	Legislation	Implementation	Evaluation	Change
Implemented in this survey?

Origins of health policy idea

After the H1N1 pandemic was declared in spring 2009, the U.S. Department of Homeland Security and Department of Health and Human Services tasked the National Vaccine Advisory Committee (NVAC) and the Advisory Committee in Immunization Practices (ACIP) with providing recommendations on vaccine prioritization by modifying pre-pandemic planning guidance from 2006 and earlier according to the H1N1 epidemiologic and clinical data and the projected vaccine supply timeline. 

Initiators of idea/main actors

• Government: Federal and state departments of public health support the current vaccine priority recommendations.

• Providers: As long as the vaccine priority lists remain voluntary and not mandatory, providers are supportive of the lists.

• Private Sector or Industry

• International Organisations: The United States government and the World Health Organization initially disagreed about the extent of the pandemic, but now recommend similar vaccine prioritization groups.

Approach of idea

The approach of the idea is described as:
renewed: The priority groups identified by the U.S. were also identified by the World Health Organization and are similar to those used globally in pandemic planning over the past decade.

Stakeholder positions

The recommendations as currently formulated are voluntary and do not involve a tiered system, such that all members of priority groups theoretically have equal access to the first available vaccines. As such the priority group recommendations are fairly uncontroversial. 

Actors and positions

Government
Centers for Disease Control and Prevention	very supportive		strongly opposed
Food and Drug Administration	very supportive		strongly opposed
State government	very supportive		strongly opposed
Providers
Health care workers	very supportive		strongly opposed
Private Sector or Industry
Vaccine manufacturers	very supportive		strongly opposed
International Organisations
World Health Organization	very supportive		strongly opposed

Influences in policy making and legislation

The proposed recommendations do not require legislation.

Legislative outcome

n/a

Actors and influence

Government
Centers for Disease Control and Prevention	very strong		none
Food and Drug Administration	very strong		none
State government	very strong		none
Providers
Health care workers	very strong		none
Private Sector or Industry
Vaccine manufacturers	very strong		none
International Organisations
World Health Organization	very strong		none

Positions and Influences at a glance

Adoption and implementation

When the first H1N1 vaccines become available, state and local health department officials and health care providers are expected to distribute the vaccines. Providers have been instructed to meet the demand for vaccine on a first-come, first-served basis among persons in the initial target groups, followed by all persons age 25 through 64, followed by all persons aged 65 and older. Neither incentives nor punitive measures have been proposed to ensure these recommendations are followed at a local level.

Monitoring and evaluation

No monitoring or evaluative mechanism has been discussed for the recommended H1N1 vaccination priorities.

Results of evaluation

N/A

Expected outcome

It is plausible that providers and health officials will adhere to vaccinating individuals within the recommended priority groups before the rest of the public, particularly if a limited number of vaccines are initally available or large numbers of individials seek vaccination. However, without oversight or regulation it is also plausible that providers will vaccinate all interested individuals on a first-come, first-served basis, regardless of whether the individual belongs to a priority group population. 

Impact of this policy

Quality of Health Care Services	marginal		fundamental
Level of Equity	system less equitable		system more equitable
Cost Efficiency	very low		very high

The vaccine priority group recommendations could fundamentally change the effects of the H1N1 pandemic if followed. Vaccination of the highest risk groups first could prevent or reduce H1N1-related disease burden on medical facilities.  

References

Sources of Information

•  National Center for Immunization and Respiratory Diseases, CDC. Use of Influenza A (H1N1) 2009 Monovalent Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR. 2009;58:1-8. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm
•  CDC H1N1 Flu | Novel H1N1 Vaccination Recommendations. Available at: http://www.cdc.gov/h1n1flu/vaccination/acip.htm
• Pentagon Set To Vaccinate Troops, Assist In Flu Crisis. The Washington Post. Available at: http://www.washingtonpost.com/wp-dyn/content/article/2009/09/29/AR2009092903771.html
• Flu.gov. Vaccination. Available at: http://www.flu.gov/individualfamily/vaccination/index.html
• The White House Press Office. President Announces Plan to Expand Fight Against Global H1N1 Pandemic.  2009. Available at: http://www.whitehouse.gov/the_press_office/President-Announces-Plan-to-Expand-Fight-Against-Global-H1N1-Pandemic/
• Office of the Commissioner. FDA 2009 H1N1 (Swine) Flu Page. Available at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm
• World Health Organization. "Strategic Advisory Group of Experts on Immunization -report of the extraordinary meeting on the influenza A (H1N1) 2009 pandemic, 7 July 2009". Weekly Epidemiological Record. 2009;84(30):301-308. Available at: http://www.who.int/wer/2009/wer8430/en/index.html
• Anthony Fiore, MD, MPH Influenza Division, NCIRD, CDC; Kathy Neuzil, MD, MPH Chair, Influenza Vaccine Workgroup. Advisory Committee on Immunization Practices: Novel Influenza A (H1N1) Vaccine Meeting.  2009. Available at: http://www.cdc.gov.ezproxy.welch.jhmi.edu/vaccines/recs/acip/slides-july09-flu.htm
• Nicole M. Smith, PhD Joseph S. Bresee, MD David K. Shay, MD Timothy M. Uyeki, MD Nancy J. Cox, PhD Raymond A. Strikas, MD. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR: Morbidity and Mortality Weekly Report. 2006;55(RR10):1-42.

Author/s and/or contributors to this survey

Krista Harrison and Gerard Anderson

Suggested citation for this online article

Harrison, Krista and Gerard Anderson. "H1N1 Vaccine Priority Recommendations". Health Policy Monitor, October 2009. Available at http://www.hpm.org/survey/us/b14/2