Sarah Schreur's Policy Paper

Physicians, health administrations, and medical personnel in today’s medical field promote the use of vaccinations in an attempt to decrease outbreaks of preventable bacterial and viral diseases. Vaccinations are designed to assist in the prevention of pathogen infections by inserting live, weakened forms of the pathogen, killed or inactivated forms, or purified materials; all forms are unable to replicate. With inoculation of the destroyed virus, or bacteria, the foreign materials are recognized by the immune system which induces a defense mechanism to prepare individuals for future injurious pathogens; vaccinations are vital pre-emptive strikes.
Streptococcus pneumoniae is one such disease made highly preventable by vaccinations. Pneumococcal infection is a leading cause of death throughout the world and sets the foundation for diseases such as pneumonia, bacteremia, meningitis, and otitis media (4). Today, pneumonia is also one of the few infectious diseases that remain the leading cause of death in the United States. The risk of developing pneumococcal disease is prominent in young children, lowest in older children and young adults, and increases with age (2). In 2006 alone, S. pneumoniae caused 100,000-135,000 hospitalizations for pneumonia, 6 million cases of otitis media, and 60,000 cases of invasive pneumococcal disease: 3% of which were caused by pneumococci non-susceptible to at least one drug and 15% due to a strain non-susceptible to 3 or more drugs (1). With the recognition that many people with serious pneumococcal disease will die of their illness in spite of antibiotic treatment, the importance of preventing the disease in high-risk populations is crucial. More importantly, the increasing prevalence of pneumococcal strains resistant to penicillin and a variety of other antimicrobial agents (e.g., erhthromycin, trimethoprim-sulfamethoxazole, and extended-spectrum cephalosporins) augments the need to develop a vaccination system against pneumococcal disease (4).
Considered to be one of the most cost effective forms of prevention, the new pneumococcal polysaccharide-protein-conjugate vaccine prevents many infections due to drug-resistant penumococci. The vaccine, licensed in 2000 is an inactivated vaccine, which provides immunity against the 7 strains of the pneumococcal bacterium and is ~90% effective against invasive diseases (1). The pneumococcal conjugate vaccine is recommended for all children less than 24 months old and for children between 24 and 59 months who are at high risk of disease. Older children and adults with risk factors may receive the capsular polysaccharide vaccine (1). A study of the pneumococcal capsular polysaccharide vaccine demonstrates effectiveness as seen below:

“…demonstrated 57% overall protective effectiveness against invasive infections caused by serotypes included in the vaccine in persons ≥ 6 years of age, 65-84% effectiveness among specific patient groups (e.g., persons with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia) and 75% effectiveness in immunocompetent persons aged ≥ 65 years of age (4).”

Despite evidence of the effectiveness of the protein-polysaccharide conjugate vaccines and capsular polysaccharide vaccines, both are widely unused. Two-thirds or more of patients with serious pneumococcal disease had been hospitalized at least once within 5 years before their pneumococcal illness, yet few had received any pneumococcal vaccine (3). Likewise, in 1985, less than 10% of the 48 million persons considered to be at an increased risk of serious pneumococcal infection were estimated to have never received the pneumococcal vaccine (3). The ability to prevent infections could improve through prolonged use of the capsular polysaccharide vaccine for adults and through the use of the conjugate vaccine for infants and young children. Campaigns for judicious use of antibiotics along with the new vaccine may slow or setback emerging drug resistance (1). This widespread overuse of antibiotics contributes to the emerging drug resistance; yet, with appropriate policies and guidelines for the pneumococcal vaccinations, persons may be properly protected, and microbial resistance can be maintained.
A new policy providing information on vaccine affordability and availability is to be introduced by a federal government financing program. The federal program can help increase knowledge of the available pneumococcal vaccines for all ages. This policy will set the guidelines for program spending in order to further immunization rates among U.S. children and high risk individuals as well as the financial efficiency of the efforts. Focus will be on the distribution of vaccines and improving and clarifying the vaccine injury compensation program. Policy concentration will also be placed on the effort to reduce bacterial resistance via vaccination.

I. POLICY
A. Federal program will require and fund health providers to properly inform individuals at high risks of pneumococcal contraction of vaccine availability, affordability, and the importance of vaccination steps along with benefits and risks of such vaccinations. Such high risk persons will be defined as below:
i. The elderly, children under two years old, blacks, American Indians and Alaska Natives, children who attend group day care centers, and persons with underlying medical conditions including HIV infection and sickle-cell disease (3).

B. Federal program financing will produce and distribute public information regarding availability of vaccines, accessibility of
vaccination health care facilities, and the importance of pneumococcal vaccinations in individual health and against microbial
resistance.
i. Public may potentially be defined as national media, such as television, radio, newspaper, and magazines, non-profit organizations, schools or specific employment sites.

C. Government federal program financing will allocate partial coverage of medical expenses of the pneumococcal vaccine not covered
by an individual’s insurance company. Additionally, individuals without insurance will receive partial vaccination coverage. The administrative fee must be covered by the intended parties. Funding will be distributed on financial need basis, and proper applications for requesting funds will be instated and required. Program funding will encourage persons to utilize the offered financial assistance, which will facilitate vaccinations in an attempt to decrease the use of antibiotics involved in bacterial related health complications.

D. Government federal program financing will be required to finance follow-up treatment, if necessary, for vaccine-related illnesses.
The injury compensation plan will be awarded to injuries deemed to have been associated with ACIP (Advisory Committee on Immunization Practices) recommended vaccinations. Provisions will be allowed to pay for the pneumococcal related medical care, lost employment income, and death benefits. Such provisions will allow individuals to vaccinate with the assurance of financial support in the event of vaccine-related illnesses.

E. Government and insurance companies will not be obligated to cover medical instances, such as antibiotic use, where a
Streptococcus pneumoniae disease was contracted and the pneumococcal vaccine was not used prior to the infection, despite healthcare insistence to do so. Such measures will encourage individuals to vaccinate in an effort to reduce personal medical expenses and ultimately reduce antibiotic resistance via pre-emptive efforts.

All policy grievance cases will be presented to the federal program administrator’s council for further consideration. Policies may be amended when two thirds of the committee council deem it necessary; amendments will be proposed, and with two-thirds vote, policy amendments may be ratified.
Funding will be allocated by publicly funded vaccine programs, such as Medicaid, the State Children’s Health Insurance Program, and Vaccines for Children (3). Congress and other vaccination programs will be responsible for funding as stated in the above policy. Recommended guidelines will be installed on who should receive the pneumococcal vaccination as the federal government aims to circulate a surplus of seven million doses of the vaccine. Funding not supplied by government financing will be covered by the parties’ insurance company or as a personal expense.
In an effort to predict cost-effectiveness of the pneumococcal vaccination in children and the elderly, several studies have been conducted to review such potential vaccination systems. Projected cost-effectiveness of the pneumococcal conjugate vaccination of healthy infants and young children is as stated:

“Vaccination of healthy infants would prevent more than 12000 cases of meningitis and bacteremia, 53000 cases of pneumonia, 1 million episodes of otitis media, and 116 deaths due to pneumococcal infection. Before accounting for vaccine costs, the vaccination program would save $342 million in medical and $415 million in work-loss and other costs from averted pneumococcal disease. However, to achieve cost savings, its cost would need to be lower than the manufacturer’s list price (of $58 per dose) (6).”

Based on invasive pneumococcal infections, immunizations with conjugate pneumococcal vaccine would save an estimated 222 lives per million children vaccinated per year (5). The pneumococcal vaccine program would result in net direct costs (projected immunization costs minus savings from reduced illness) between $0.08 and $2.42 per child (5). The vaccine is cost savings in all cases except when the incidence of disease and death rates are lowest and the cost of the vaccine series is $150 (5).
Cost-effectiveness of the vaccination against pneumococcal bacteremia among elderly people was cost saving via both the reduction of medical expenses and improved health. For people aged 65 years and older, the vaccination saved $8.27 and gained 1.21 quality-adjusted days of life per person vaccinated (7). Vaccination of the 23 million elderly people unvaccinated in 1993 would have gained about 78000 years of health life and saved $194 million; today, there would be an increase in the years of health life and saved money (7). In an analysis, the results remained cost saving except for when doubling vaccination costs, including future medical costs of survivors, and lowering vaccination effectiveness (7). These results would support the recommendation of public and private efforts to improve vaccination rates.
Pneumococcal resistance remains a matter of concern as reports show an increase of not only resistant rates, but also the proportion of highly resistant strains. Preventing infections through the expansion of the pneumococcal vaccination may slow or reverse this emerging drug resistance as it decreases the chances of contracting illnesses related to the Streptococcus pneumoniae bacterium. Led by a federal government financing program, a pneumococcal vaccination policy can provide knowledge about the affordability and availability of such vaccinations. The policy’s effort to create a federal program that results in the increase and improvement of immunization rates amongst United States citizens is strategic in preventing the widespread overuse of antibiotics and its resulting bacterial resistance.

References
1. “Drug-resistant Streptococcus pneumoniae Disease.” Centers for Disease Control and Prevention. 13 April 2008.
Retrieved Oct 2, 2008 from <http://www.cdc.gov//ncidod/dbmd/diseaseinfo/drugresisstreppneum_t.htm>
2. Whitney, Cynthia G. “Vaccination against pneumococcal disease: current questions and future opportunities.” BioMed Central.
11 Dec 2000. Retrieved Oct 2, 2008 from <http://www.biomedcentral.com/1471-8219/1/7>
3. “Recommendations of the Immunization Practices Advisory Committee Pneumococcal Polysaccharide Vaccine MMWR.”
Centers for Disease Control and Prevention. Oct 1998. Retrieved Oct 2, 2008 from
<http://wonder.cdc.gov/wonder/prevguid/p0000212/p0000212.asp#head008000000000000>
4. “Pneumovax® 23 (Pneumococcal Vaccine Polyvalent).” US Food and Drug Administration. Jan 2008. Retrieved Oct 2, 2008
from <http://www.fda.gov/cber/label/pneumovax23lb.pdf>
5. Hueston WJ, AG Mainous 3rd, and N. Brauer. “Predicting cost-benefits before programs are started: looking at conjugate vaccine
for invasive pneumococcal infections.” PubMed. 25 Feb 2000. Retrieved Oct 2, 2008 from
<http://www.ncbi.nlm.nih.gov/pubmed/10706207?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=5&log$=relatedarticles&logdbfrom=pubmed>
6. Lieu, TA, GT Ray, SB Black, JC Butler, JO Klein, RF Breiman, MA Miller, and HR Shinefield. “Projected cost-effectiveness of
pneumococcal conjugate vaccination of healthy infants and young children.” PubMed. 15 March 2000. Retrieved Oct 2, 2008 from
<http://www.ncbi.nlm.nih.gov/pubmed/10732936?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=1&log$=relatedarticles&logdbfrom=pubmed>
7. Sisk JE, AJ Moskowitz, W Whang, JD Lin, DS Fedson, AM McBean, JF Plouffe, MS Cetron, and JC Butler. “Cost-effectiveness
of vaccination against pneumococcal bacteremia among elderly people.” 19 Jan 2000. Retrieved Oct 2, 2008 from
<http://www.ncbi.nlm.nih.gov/pubmed/9343464?dopt=AbstractPlus&holding=f1000,f1000m,isrctn>

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