US Pharm. 2008;33(3):28-47.

Vaccines are medical miracles, saving more lives and preventing more deaths than any other medical advance in the last century. Vaccines stimulate protective immune responses against acute and chronic infectious diseases, as well as some infectious diseases that cause cancer.1-4 Benefits of vaccines include protection from symptomatic illness, improved quality of life and productivity, and prevention of death.5 When the U.S. Department of Health & Human Services (HSS) developed Healthy People 2010, a comprehensive, nationwide health-promotion and disease-prevention campaign, one of their main areas of focus was improving immunization rates in the United States.6-8

The pharmacist's role in immunization has progressed considerably in the last decade.6 Currently, 46 states allow pharmacists to administer immunizations under a collaborative-practice agreement with physicians.9 The goal of this article is to educate and update practitioners on immunization statistics; vaccine-preventable diseases; current immunization schedules; administration essentials; available vaccines; vaccine adverse event reporting and patient information; vaccine controversies; and the unique and empowering role pharmacists can play in improving the U.S. public health.

Immunization Statistics

Despite widespread education, more than 100,000 people are affected by vaccine-preventable diseases in the U.S. each year. Twenty percent of children and approximately 50% of adolescents have not received at least one recommended immunization.10,11 It has been estimated that, in every birth cohort, vaccination with seven of the 12 routinely administered childhood vaccines prevents 33,000 deaths, prevents 14 million cases of disease, saves $10 billion in direct costs, and saves society an additional $33 billion in costs that include disability and lost productivity.1

Immunization Schedules
National recommendations currently provide guidance for use of vaccines to prevent or eliminate 17 diseases, namely, diphtheria; pertussis; tetanus; poliomyelitis; measles; mumps; rubella; influenza; invasive Haemophilus influenzae type b (Hib); hepatitis A; hepatitis B; rotavirus; varicella; herpes zoster (shingles); and disease caused by many of the most important types of Streptococcus pneumoniae, Neisseria meningitides, and human papillomavirus (HPV).1 These recommendations are made by the Advisory Committee on Immunization Practices (ACIP). The ACIP states that any person or institution that provides vaccination services should adopt these standards to improve vaccination delivery and protect infants, children, adolescents, and adults from vaccine-preventable disease.5

The current ACIP immunization schedules for age 0 to 6 years and age 7 to 18 years appear in FIGURES 1 and 2, respectively; for the catch-up immunization schedule for age 4 months to 18 years, visit 12

Vaccine-Preventable Diseases
Diphtheria, Tetanus, Pertussis13-17: Diphtheria is an acute toxin-mediated infectious disease caused by toxin-producing strains of Corynebacterium diphtheriae. This bacterium lives in the nose and throat of an infected person and is easily spread by coughing and sneezing. The toxin can cause severe or fatal illness characterized by membranous inflammation of the upper respiratory tract and damage to the myocardium and nervous system. Tetanus is caused by a potent endotoxin released by Clostridium tetani, a bacterium commonly found in soil, dust, and manure, and occurs when the bacterium comes in contact with an open wound. It manifests primarily as neuromuscular dysfunction, rigidity, and painful spasms of skeletal muscle. Once an individual is infected, it can take three to 21 days for symptoms to appear. Tetanus is not contagious, and only about 50 cases are reported in the U.S. each year; however, one of every 10 cases is fatal. Pertussis (whooping cough) is a respiratory-tract disease caused by Bordetella pertussis. Children with pertussis develop thick, sticky mucus in the windpipe, which causes coughing spells. Pertussis is highly contagious and can cause serious and often fatal disease, particularly in infants under 6 months old. The roles of the different components produced by B pertussis in the disease process are not fully understood.

Polio18: Poliovirus is an enterovirus belonging to the picornavirus family. Poliovirus infections are generally asymptomatic or cause minimal symptoms, but about 2% of infected individuals have central nervous system involvement and develop paralytic disease. Polio has been controlled in the U.S. with the use of vaccines, but worldwide eradication has not occurred. As a result, the ACIP continues to recommend vaccination against poliovirus as a standard part of the childhood immunization schedule.

Hepatitis A17,19,20 : Hepatitis A, a member of the picornavirus family, is the most frequently reported type of hepatitis in the U.S., causing an estimated 125,000 to 200,000 cases yearly. About a third of these cases occur in children younger than 15 years. The virus, found mainly in feces, is spread through personal contact or by consuming contaminated food or water. The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to fulminant hepatitis and death. Hepatitis A does not cause long-term illness or liver damage,Ü but about 100 people each year die from liver failure caused by severe hepatitis A.

Hepatitis B21,22 : Hepatitis B is one of several hepatitis viruses that cause a systemic infection, with the major pathology in the liver. Currently there is no specific treatment for this disease. The Centers for Disease Control and Prevention (CDC) estimates that the U.S. has more than 125 million chronic carriers of hepatitis B. For the entire U.S. population, the overall risk of contracting the virus is less than 20%. Serious complications and sequelae of hepatitis B infection include massive hepatic necrosis, cirrhosis of the liver, and chronic active hepatitis; it also is associated with an increased risk of hepatocellular carcinoma. Modes of transmission include sexual contact with an infected individual, percutaneous or mucosal exposure to infectious blood, and perinatal exposure to an infected mother.

Hib23-26: Prior to the introduction of Hib conjugate vaccines, this bacterial infection was the most frequent cause of bacterial meningitis and a leading cause of serious, systemic bacterial disease in young children worldwide. Invasive disease usually occurs in children younger than 5 years of age and has a mortality rate of 5%. Up to 35% of survivors develop neurologic sequelae including seizures, deafness, and mental retardation.

HPV27: HPV causes squamous cell cervical cancer, its associated precursor lesions, cervical adenocarcinoma, 35% to 50% of vulvar and vaginal cancers, and genital warts. The CDC estimates that 20 million U.S. women and men had HPV in 2005. Many people with HPV may not show signs or symptoms. HPV is transmitted through sexual activity involving genital contact with an infected person. Traditionally, cervical cancer screening focused on routine screening and early intervention, with a reduced cancer rate of 75%. Vaccination protects against certain types of HPV, but it may not protect everyone and does not prevent all types of cervical cancer; therefore regular cervical cancer screening is recommended.

Influenza28-31 : Influenza is a significant cause of death; along with pneumonia, it is the seventh leading cause of death across generations. Rates of infection are highest among children, and the virus causes more pediatric hospitalizations than any other vaccine-preventable disease. Influenza vaccination is the primary method of preventing influenza and its severe complications. As of February 27, 2008, the ACIP recommends that all children age 6 months to 18 years receive an annual flu vaccination.

Measles, Mumps, Rubella 17,32-35: Measles, mumps, and rubella are viral childhood diseases that may be associated with serious complications and/or death. Measles, which is highly contagious, is characterized by a rash over the entire body and can cause pneumonia and encephalitis. Children who are exposed and are not immune probably will get the disease. Mumps is characterized by swelling of the cheeks and jaw with resulting inflammation of the salivary glands; it can lead to aseptic meningitis, deafness, and orchitis. Rubella is generally a mild disease, but the greatest danger is to unborn babies. If a woman gets rubella in early pregnancy, there is an 80% chance that the baby will be born deaf or blind, with a damaged heart or small brain, or mentally retarded. These three diseases are transmitted through coughing, sneezing, or breathing. Since vaccination of these diseases began, five decades ago, the number of cases has declined more than 99%.

Meningococcal Disease 36,37: N meningitidis causes both endemic and epidemic meningococcal disease, principally meningitis, severe swelling of the brain and spinal cord, and meningococcemia. Because childhood immunization programs have led to decreased rates of H influenzae and S pneumoniae infection, N meningitidis has become the leading cause of bacterial meningitis in children and young adults in the U.S. The incidence of disease is rare; only 1,400 to 2,800 cases are reported in the U.S. However, the fatality rate remains at around 11.5%, even with the administration of appropriate antibiotics.

Pneumococcal Disease 17,38,39: Disease caused by S pneumoniae is a significant source of morbidity and mortality in all ages worldwide. In children older than 1 month, S pneumoniae is the leading cause of invasive disease. Children at highest risk are between the ages of 1 month and 2 years. Pneumococcal meningitis in children has been associated with an 8% mortality rate and may result in neurologic sequelae and hearing loss in survivors.

Rotavirus40: A leading cause of severe acute gastroenteritis in infants and young children, rotavirus infects more than 95% of children by 5 years of age. While many children may have few or no symptoms, rotavirus can cause fever and episodes of vomiting and diarrhea lasting up to nine days that may lead to dehydration and hospitalization. Only certain disinfectants can kill rotavirus. The most severe cases occur in children aged 6 to 24 months.

Varicella41,42 : Varicella (chickenpox), which is caused by the varicella-zoster virus, is a highly contagious disease affecting both children and adolescents. The disease generally manifests as 300 to 500 maculopapular and/or vesicular lesions and is accompanied by a fever exceeding 100F. Between 1980 and 1994, approximately 3.5 million cases were reported each year, and the peak age for disease occurrence was years 5 to 9. Although varicella is usually a benign, self-limiting disease, it can be associated with serious complications (e.g., bacterial superinfection, pneumonia, encephalitis, Reye's syndrome) and death.

Vaccine Essentials
The ACIP has developed general recommendations for vaccine administration (for the complete document, see The immunization schedule is based on many factors, including the nature of the vaccine and the age and immune status of the recipient. Vaccines are recommended for members of the youngest age group at risk for the disease for whom efficacy and safety data have been reported.5 The following sections summarize specific information that is important for pharmacists administering vaccinations.

Pharmacists administering vaccines should adhere as closely as possible to the recommended immunization schedules. In some circumstances, patients may need to receive a vaccination earlier than required, such as when they are behind schedule or planning to travel. Except for oral typhoid vaccine, an interruption in the vaccination schedule does not require restarting of the entire vaccine series or the addition of an extra dose. Pharmacists should accept only written, dated records as evidence of vaccination (with the exception of influenza and pneumococcal vaccines). If the patient's records cannot be located, the patient should be considered susceptible and should be started on the age-appropriate vaccination schedule.5

Simultaneous Administration: The ACIP encourages the simultaneous administration of vaccines. The practice of administering all eligible vaccines during the same visit increases the chances of a patient's being fully vaccinated by the appropriate age.5,43 The use of combination vaccines also may reduce the number of injections a patient receives and increases the likelihood that the immunization series is completed. Licensed combination vaccines can be used whenever any component of the combination is indicated and the other components are not contraindicated. When vaccines are given simultaneously, they should never be mixed in the same vial or syringe; they should be administered at separate sites with different syringes. The only exception to simultaneous administration is when two injectable or nasally administered live vaccines are to be administered; they should be spaced out by more than four weeks. Oral live vaccines can be administered with other live or inactivated vaccines.5

Interchangeability of Vaccines: For several vaccine-preventable diseases, multiple brands are available from different manufacturers. Due to differences in antigen content, amount, and method of formulation, the ACIP recommends that the same brand be used throughout the immunization series whenever feasible. If the same brand is not available or the brand previously used is unknown, however, do not defer vaccination. 5,44,45

Contraindications and Precautions: A vaccine should never be administered if a contraindication is present. The only universal contraindication for vaccines is a history of severe allergic reaction after a previous dose of a vaccine or vaccine constituent. Live vaccines generally should not be used in severely immunocompromised patients; live-attenuated vaccines should not be used in pregnant women.5 See Reference 15 for specific contraindications for vaccines with a pertussis component.

A precaution might compromise a vaccine's ability to produce immunity. Vaccination generally should be deferred when a precaution exists; however, vaccination may be indicated if the benefit of protection outweighs the risk of adverse reaction. Precautions for all vaccines include moderate or severe acute illness and unstabilized evolving neurologic conditions in children. All vaccines can be administered during minor acute illness, and studies indicate that failure to vaccinate during a minor illness can impede overall vaccination efforts.5,46 Patients with clotting-factor disorders are at risk for hematoma formation after intramuscular (IM) injection. The ACIP has issued a caution for this population: If, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered IM with reasonable safety, IM administration can be used.5 See Reference 15 for specific precautions for vaccines with a pertussis component.

Injection Route and Site: All currently recommended pediatric and adolescent vaccines are administered IM. This is due mainly to the presence of an adjuvant in the vaccine. If given subcutaneously or intradermally, local irritation, induration, skin discoloration, inflammation, and granuloma formation could occur. Also, deviation from the recommended IM route could result in decreased vaccine efficacy.5,47,48 IM injections are administered at a 90 angle to the skin, preferably into the anterolateral aspect of the thigh or the deltoid muscle of the upper arm, depending on the patient's age.5 See the package insert for specific administration information.

FDA-Approved Vaccines

In recent years, vaccines have been combined to reduce the number of injections given to infants and adolescents. The availability of multiple brands for the same vaccine-preventable disease and the development of combination products for different indications can be confusing for providers administering vaccines. See TABLE 1 for a list of each vaccine with indications, adverse events, and additional important information. The common abbreviation for the vaccine (e.g., DT), the vaccine's makeup, and brand name(s) are included due to interchangeability in various immunization references.

Vaccine Adverse Event Reporting System

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act (NCVIA) of 1986, requires that the health care provider record the manufacturer's name and the lot number of the vaccine administered in the recipient's permanent medical record, along with the date of administration and the name, address, and title of the provider who administered the vaccine. The NCVIA also requires the health care provider to report the occurrence of certain adverse events to the HSS Vaccine Adverse Event Reporting System (VAERS).5 See for a table of specific reportable events. VAERS forms are available at

Vaccine Controversies

There has been much controversy about whether vaccines and autism are linked. This purported link dates to a 1998 study published in The Lancet that described 12 children with inflammatory bowel conditions and regressive developmental disorders, mostly autism.53,54 In eight of these cases, the child's parent(s) or physician believed that the measles-mumps-rubella (MMR) vaccine may have contributed to onset of the disorder.54 Independent researchers have been unable to replicate this syndrome, and no correlation has been found with onset of regression.53,55,56 After reviewing data on MMR vaccine and risk of autism-spectrum disorders, the Immunization Safety Review Committee (ISRC) of the Institute of Medicine (IOM) concluded that the data favor rejection of a causal relationship.53,57

It has been speculated that thimerosal, a mercury-containing preservative long used in vaccines, is linked to the increased rates of autism. However, it was found that while autism's incidence and prevalence in Sweden and Denmark grew rapidly in the 1990s, average thimerosal exposure had begun to decrease in the late 1980s and was virtually eliminated in those countries by the early 1990s.53,58 Another study has suggested that the associations found in some studies may have been chance findings.59 The IOM ISRC determined that evidence is sufficient to reject a causal association.57,59 The U.S. Public Health Service and the American Academy of Pediatrics has called for the removal of thimerosal from infant vaccines as a precautionary measure.58 To date, many vaccines no longer contain thimerosal and the remaining vaccines that do are using other preservatives or are being switched over to preservative-free formulations.59

Pharmacist's Role
The American Public Health Association recently issued a policy statement calling on pharmacists to increase their involvement in public health.60 The expanded role of pharmacists in administering vaccines is an excellent beginning. In 2007, the State of New Mexico began allowing pharmacists to prescribe and administer vaccines after taking a 12-hour continuing-education program. This innovative program has resulted in substantial gains in increased immunization rates, especially in rural, underserved areas.61 Due to easy access, advanced clinical training, and pre-existing relationships with many patients, pharmacists are uniquely positioned to become significantly involved in immunization education and administration and in improving public health in the U.S.

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14. Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) package insert. Swiftwater, PA: Sanofi Pasteur; Mar 2003.
15. Infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) package insert. Research Triangle Park, NC GlaxoSmithKline Beecham; Aug 2007.
16. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) package insert. Swiftwater, PA: Aventis Pasteur; Dec 2003.
17. CDC. Parents' guide to childhood immunizations. Accessed Mar 4, 2008.
18. Pediarix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, hepatitis B [recombinant] and inactivated poliovirus vaccine combined) package insert. Research Triangle Park, NC: GlaxoSmithKline; Jun 2007.
19. Havrix (hepatitis A vaccine, inactivated) package insert. Research Triangle Park, NC: GlaxoSmithKline; Dec 2006.
20. Vaqta (hepatitis A vaccine, inactivated) package insert. Whitehouse Station, NJ: Merck & Co; Dec 2007.
21. Engerix-B (hepatitis B vaccine [recombinant]) package insert. Research Triangle Park, NC: GlaxoSmithKline; Dec 2006.
22. Recombivax HB (hepatitis B vaccine [recombinant]) package insert. Whitehouse Station, NJ: Merck & Co; Dec 2007.
23. Comvax (haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) package insert. Whitehouse Station, NJ: Merck & Co; Aug 2004.
24. ActHIB (haemophilus b conjugate vaccine [tetanus toxoid conjugate] package insert. Swiftwater, PA: Sanofi Pasteur; Dec 2005.
25. HibTITER (haemophilus b conjugate vaccine [diphtheria CRM197 protein conjugate] package insert. Philadelphia, PA: Wyeth Pharmaceuticals; Jan 2007.
26. Liquid PedvaxHIB (haemophilus b conjugate vaccine [meningococcal protein conjugate]) package insert. West Point, PA: Merck & Co; Jan 2001.
27. Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, and 18) vaccine, recombinant) package insert. Whitehouse Station, NJ: Merck & Co; Dec 2007.
28. Fluzone (influenza virus vaccine) package insert. Swiftwater, PA: Sanofi Pasteur; Jun 2007.
29. Fluvirin (influenza virus vaccine) package insert. Emeryville, CA: Novartis Vaccines and Diagnostics; Apr 2007.
30. FluMist (influenza virus vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune Vaccines; Sept 2007.
31. CDC. Press release. Accessed Mar 4, 2008.
32. M-M-R II (measles, mumps, and rubella virus vaccine live) package insert. Whitehouse Station, NJ: Merck & Co; Dec 2007.
33. Attenuvax (measles virus vaccine live) package insert. Whitehouse Station, NJ: Merck & Co; Sept 2002.
34. Mumpsvax (mumps virus vaccine live) package insert. Whitehouse Station, NJ: Merck & Co; Sept 2002.
35. Meruvax II (rubella virus vaccine live) package insert. Whitehouse Station, NJ: Merck & Co; Feb 2006.
36. Menomune (meningococcal polysaccharide vaccine, groups A, C, Y and W-135 combined) package insert. Swiftwater, PA: Sanofi Pasteur; Dec 2005.
37. Menactra (meningococcal [groups A, C, Y and W-135 polysaccharide diphtheria toxoid conjugate vaccine) package insert. Swiftwater, PA: Sanofi Pasteur; Oct 2007.
38. Prevnar (pneumococcal 7-valent conjugate vaccine [diphtheria CRM197 protein]) package insert. Philadelphia, PA: Wyeth Pharmaceuticals; Dec 2007.
39. Pneumovax 23 (pneumococcal vaccine polyvalent) package insert. Whitehouse Station, NJ: Merck & Co; Sept 2007.
40. RotaTeq (rotavirus vaccine, live, oral, pentavalent) package insert. Whitehouse Station, NJ: Merck & Co; Sept 2007.
41. Varivax (varicella virus vaccine live [Oka/Merck]) package insert. Whitehouse Station, NJ: Merck & Co; Feb 2007.
42. ProQuad (measles, mumps, rubella and varicella virus vaccine live) package insert. Whitehouse Station, NJ: Merck & Co; Jan 2008.
43. National Vaccine Advisory Committee. Standards for child and adolescent immunization practices. Pediatrics. 2003;112:958-963.
44. CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1997;46:1-25.
45. CDC. Use of diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine as a five-dose series. Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2000;49:1-8.
46. Szilagyi PG, Rodewald LE. Missed opportunities for immunizations: a review of the evidence. J Public Health Manag Pract. 1996;2:18-25.
47. Shaw FE, Guess HA, Roets JM, et al. Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination. Vaccine. 1989;7:425-430.
48. Zuckerman JN. The importance of injecting vaccines into muscle. Different patients need different needle sizes. BMJ. 2000;321:1237-1238.
49. TriHIBIT (haemophilus b conjugate vaccine [tetanus toxoid conjugate]) package insert. Swiftwater, PA: Sanofi Pasteur; Dec 2005.
50. Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) package insert. Research Triangle Park, NC: GlaxoSmithKline; Jun 2007.
51. Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) package insert. Swiftwater, PA: Sanofi Pasteur; Jan 2006.
52. Vaccine Adverse Event Reporting System. Reportable events table. Accessed Feb 25, 2008.
53. DeStefano F. Vaccines and autism: evidence does not support a causal association. Clin Pharmacol Ther. 2007;82:756-759.
54. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet. 1998;351:637-641.
55. Fombonne E, Chakrabarti S. No evidence for a new variant of measles-mumps-rubella-induced autism. Pediatrics. 2001;108:E58.
56. Richler J, Luyster R, Risi S, et al. Is there a ëregressive phenotype' of autism spectrum disorder associated with the measles-mumps-rubella vaccine? A CPEA study. J Autism Dev Disord. 2006;36:299-316.
57. Immunization Safety Review Committee. Immunization Safety Review. Vaccines and Autism. Board of Health Promotion and Disease Prevention, Institute of Medicine. Washington, DC: National Academy Press; 2004.
58. Stehr-Green P, Tull P, Stellfeld M, et al. Autism and thimerosal-containing vaccines: lack of consistent evidence for an association. Am J Prev Med. 2003;25:101-106.
59. FDA. Thimerosal in vaccines.
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