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Katherine Tromp, Pharm.D. ktromp@lecom.edu March 8, 2011 Immunizations Slide 2 Objectives Differentiate between active versus passive immunity, and recognize which immunologics induce each type Identify similarities and differences between inactivated and live-attenuated vaccines Identify which vaccines contain live organisms and when to avoid their use Differentiate between polysaccharide and conjugate polysaccharide vaccines Discuss timing and spacing of vaccines Utilize the childhood/adolescent and adult immunizations schedules recommended by the Advisory Committee on Immunization Practices (ACIP)/CDC Be able to recommend patient-specific immunizations Recognize the differences in immunization of special populations (neonates and infants, pregnancy, immunocompromised, transplant) Identify contraindications and precautions to immunizations Recognize the burden of human papillomavirus (HPV), seasonal influenza, pneumococcal infection, and herpes zoster (shingles) and the role of vaccines in preventing morbidity and mortality Discuss general immunization adverse events, Guillain-Barre Syndrome (GBS) risk, and autism risk Counsel on importance of immunizations Recognize the role of the pharmacist in immunization as an advocate, partner, and provider Slide 3 Vaccine Preventable Diseases Anthrax Cervical Cancer Diphtheria Hepatitis A Hepatitis B Haemophilus influenzae type b (Hib) Human Papillomavirus (HPV) H1N1 (Swine Flu) Influenza (Seasonal Flu) Japanese Encephalitis (JE) Lyme Disease Measles Meningococcal Monkeypox Mumps Pertussis (Whooping Cough) Pneumococcal Poliomyelitis (Polio) Rabies Rotavirus Rubella (German Measles) Shingles (Herpes Zoster) Smallpox Tetanus (Lockjaw) Tuberculosis Typhoid Fever Varicella (Chickenpox) Yellow Fever Slide 4 Immunization Definition Process of introducing an antigen into the body to induce protection against the infectious agent without causing disease Antigen Live or inactivated substance (protein, polysaccharide) capable of producing an immune response Antibody Protein molecules (immunoglobulins) produced by B lymphocytes to help eliminate an antigen Slide 5 How can a person develop immunity? 1. Exposure to disease 2. Antibody transfer from mother to fetus 3. Administration of immune globulin 4. Vaccination Slide 6 Vaccines & the Immune Response Vaccines (contain antigens) Antibodies attack and destroy antigen Results in production of antibodies Antigens are recognized by immune system and evoke an immune response T cells activated B cell activated Antigen is eliminated Memory B & T cells are formed Conjugate vaccines Polysaccharide vaccines Slide 7 How Do Memory B & T Cells Provide Immunity? Memory B & T cells circulate through the body monitoring for the antigen If the antigen is recognized, memory cells: Activate the immune response immediately Produce antibodies quickly Prevent disease from occurring because the antigen is eliminated rapidly Slide 8 Active versus Passive Immunity Active Protection produced by a persons own immune system Durability depends on vaccine Ex: vaccines (influenza, HPV), toxoids (diphtheria, tetanus) Passive Protection transferred from another person or animal as an antibody transplacental, breastfeeding Temporary protection Ex: immunoglobulins (hepA/B, measles, varicella) Slide 9 Types of Immunizations Vaccines (influenza, HPV) Derived from the organism itself Toxoids (diphtheria, tetanus) Inactivated bacterial toxins Stimulate production of antibodies against the bacterial toxins as opposed to the infecting bacterial pathogens Immunoglobulin (hepA, hepB, measles, varicella) Sterile solutions containing antibody Human (immunoglobulin) Indicated for induction of passive immunity Often given after exposure to protect immunodeficient patients Slide 10 Live-Attenuated Vaccines Made from viruses or bacteria Induce immune response more consistent with natural infection May result in life-long immunity with one dose (like primary natural infection) Severe reactions possible Unstable Interfere with circulating antibodies CAUTION in immunocompromised patients, pregnant women, and infants Slide 11 Killed/Inactivated Vaccines Do not replicate/cause disease in recipient Whole or split particles derived from pathogen Often bacterial vaccines Killed, whole bacteria or specific bacterial antigens or conjugates Usually need multiple doses to induce life-long, effective immunity Additional doses at varying time intervals (booster doses) are often required to maintain immunity Slide 12 Vaccine Classification Herpes zoster Influenza (intranasal) H1N1 (intranasal) MMR Rotavirus Varicella Diphtheria, tetanus, pertussis Haemophilus influenza type B Hepatitis A Hepatitis B Poliovirus Meningococcal Pneumococcal Rabies Influenza (IM) H1N1 (IM) LiveInactivated Slide 13 Polysaccharide vs. Conjugate Polysaccharide Vaccines PolysaccharideConjugate Polysaccharide Stimulate T-cell independent immunity Stimulate T-cell dependent immunity - Stimulate B cells without assistance of T helper cells - Immunity is short lived - No booster effect - Not consistently immunogenic in childrenSlide 14 Other Active & Inert Ingredients Suspending agents Water, saline, complex fluids containing protein (ex. albumin) Preservatives, stabilizers, antibiotics Help maintain integrity of the product Immunized individuals may respond with allergic reactions not to the immunobiologic agent itself but to the other components Slide 15 Vaccine Storage In general, must be refrigerated Frozen: varicella, zoster vaccines Refer to package insert for each product http://www2a.cdc.gov/vaccines/ed/shtoolkit/pages/st orage_practices.pdf Careful attention to storage is imperative to maintain potency Slide 16 Factors Affecting Response Vaccine factors Viability of antigen Dose of antigen Type of vaccine Route and site of administration Host factors Age Presence of maternal antibody Coexisting disease (s) Determines immunization schedule recommendations Slide 17 Timing & Spacing of Vaccines Antigen CombinationMinimum Interval of doses 2 or more inactiveSimultaneously or at any interval Inactive and liveSimultaneously or at any interval 2 or more live4-weeks, if not simultaneously General Rule: All vaccines can be administered at the same visit as all other vaccines Slide 18 Timing and Spacing of Vaccines Multi-dose Vaccine Series The minimum interval between most vaccine doses is 4 weeks Typically, 5-6 months should elapse between the next-to-the-last and last doses of primary immunizing series Exception: Do not count doses given before minimum intervals and ages! 4 days early is allowed Increasing the interval between doses does not diminish effectiveness, but does delay the response Decreasing the interval between doses may interfere with antibody response and protection Delays in immunization do not necessitate restarting series or adding doses Slide 19 Vaccine Administration Subcutaneous Thigh of infant, upper arm of older children and adults 5/8-inch, 25 gauge needle Intramuscular Upper thigh of infants and toddlers, deltoid muscle of upper arm for older children and adults At least 1 inch needle for patients weighting 90kg Avoid using the buttock Slide 20 Vaccine Administration Oral Rotavirus vaccine Squeeze tube of vaccine toward inner cheek of child Re-administration not recommended if child spits out vaccine Nasal Live-attenuated influenza vaccine One spray in each nostril If person sneezes during or after administration, dose does not need to be repeated Slide 21 Adult Vaccine Recommendations All adults Tetanus, MMR, Varicella, Influenza 60+ y/o Herpes Zoster 65+ y/o Pneumococcal Immunizations for specific needs HepA, meningitis, vaccines for international travel, Lyme disease, others based on individual circumstances Slide 22 Immunization Schedule - Adults Slide 23 Adults with Medical or Other Conditions Schedule differentiates immunizations for specific groups of people Pregnancy HIV DM, heart disease, COPD, alcoholism Asplenia Chronic liver disease Kidney failure, ESRD, hemodialysis Healthcare personnel Includes contraindications Slide 24 Immunization Schedule Slide 25 Immunizing Special Populations Neonates & Infants Live vaccines are not administered until maternal antibodies have waned Generally by 12 months of age Premature infants use the same schedule & doses Breastfed infants use the standard schedule & doses Pregnancy Most vaccines are category C Live vaccines generally avoided Inactivated vaccines given when benefit > risk Influenza vaccine is recommended if pregnant during influenza season Tetanus-diphtheria (Td) recommended if >10 years since last dose Slide 26 Immunizing Special Populations Immunocompromised Includes: diabetes, alcoholics, cancer, HIV, etc Should not receive live vaccines Other vaccines may be indicated but responses may be suboptimal Glucocorticoids suppress vaccine response Prednisone 20mg+ daily or 2mg/kg daily for at least 2 weeks Wait _________ month before administering vaccines Chronic pulmonary, renal, hepatic, or metabolic disease Can receive both live and killed vaccines Often need higher doses & more frequent doses Transplant patients When possible, immunize before transplant Live vaccines generally not given Slide 27 Contraindications Temporary Immunosuppression Pregnancy Time interval must elapse based on dose of immunoglobulin before a live vaccine can be administered Unexplained encephalopathy within 7 days of a pertussis vaccine dose Anaphylactic reactions to vaccine or inactive ingredient Slide 28 Contraindications and Precautions Anaphylactic Allergy to:Avoid these Vaccines: EggsInfluenza? GelatinVaricella, MMR NeomycinMMR, Polio, Varicella StreptomycinPolio Polymyxin BPolio AspirinLAIV, Varicella Slide 29 NOT Contraindications Mild-moderate local reactions Mild acute illness Prematurity Family history of adverse events Diarrhea Breast-feeding Current antibiotic use Slide 30 Immunization History & Vaccine Delivery Obtain from every patient Ideally, verify with patient record Federal and State-based immunization programs Vaccines for Children (VFC) General rule: Risks associated with overimmunization are minimal relative to the risks associated with contracting vaccine- preventable diseases Slide 31 Vaccine Delivery CDC: Every health care visit, regardless of purpose, is an opportunity to review immunization status and administer needed vaccines May be the most cost-effective medical practice available Slide 32 Whooping Cough Pertussis Vaccine Slide 33 Pertussis Illness caused by bacteria Bordetella pertussis Characterized by coughing spells associated with thick mucus Acellular pertussis vaccine contains pertussis toxin and other bacterial components Vaccine is recommended at 2, 4, 6, and 15-18 months of age 5 th dose given age 4-6 years Commonly given as DTaP Additional dose at age 11-18 years is recommended Up to age 64, pertussis-containing vaccine is recommended with all Td booster shots Slide 34 Pertussis Vaccine Side Effects: Fever in 3-5% Very rare: High fever, febrile seizures, persistent crying spells, hypotonic hyporesponsive episodes Allergy and encephalopathy seen within 7 days are a contraindication for future doses Slide 35 Pneumococcal Slide 36 Streptococcus pneumoniae ~40,000 deaths annually from infection Most in elderly or with underlying medical conditions Most common cause of bacterial pneumonia requiring hospitalization Rates of invasive infections Highest at 65 y/o Slide 37 Pneumococcal Vaccine Polysaccharide (PPSV) Pneumovax 23 IM or SQ > 2 y/o Indicated for: 65 y/o 2 64 y/o with chronic illness, functional anatomic asplenia, cochlear implants & those living in special environments (nursing homes) Revaccination if high risk or 65+ y/o and received initial dose 2 y/o with Pneumovax Must wait at least 2 months before using Pneumovax Slide 38 Pneumococcal Vaccine Polysaccharide (PPSV) No adverse effects seen in newborns whose mothers had vaccine Side Effects: Local reactions within 48 hrs Rare: Photophobia, chills, fever, weakness, myalgia, headache Conjugate polysaccharide (PCV) Side effects: Injection site reactions Fever Slide 39 Chicken Pox and Shingles Varicella and Zoster vaccines Slide 40 Varicella-Zoster Virus Caused by a virus that results in fever, malaise, and pruritic vesicles that crust over Virus remains dormant in dorsal ganglia and can be reactivated as herpes zoster (shingles) Reasons for reactivation are not certain, but may include age and immunosuppression Slide 41 Varicella Vaccine Live-attenuated vaccine Must be kept frozen and out of light Subcutaneous injection Unknown if a booster dose is needed Immunization schedule: 1 st dose: 12-18 months of age 2 nd dose: 4-6 years of age Older adults who have not had the disease and have not been immunized yet Recommended for people who are in close contact with immunocompromised patients Slide 42 Varicella Vaccine Can be used post-exposure if given within 3-5 days Contraindicated in pregnant women and immunocompromised individuals Exception is children with asymptomatic or mildly symptomatic HIV Avoid using salicylates for 6 weeks after vaccination Side effects: Injection site reactions, fever Varicella-like rash in 4% Typically mild with few lesions Slide 43 Herpes Zoster (Shingles) Lifetime risk: 30% in U.S. 500,000 1 million cases annually Rate increases dramatically starting at age 50 Complications Postherpetic neuralgia Generalized skin eruptions CNS involvement Slide 44 Herpes Zoster Vaccine Zostavax Live varicella vaccine Same strain in varicella vaccine, but much higher dose Indication for prevention of Herpes Zoster (shingles) Postherpetic neuralgia Approved for persons 60+ y/o Due to declining cellular immunity to varicella-zoster Whether or not they report a prior episode of shingles Do NOT need to screen for previous varicella disease Single SQ dose Slide 45 Herpes Zoster Vaccine Vaccine should not be used in people who are immunocompromised, pregnant women, and patients with untreated active tuberculosis Duration of protection is unknown Estimated at 4 years Slide 46 Seasonal Influenza Slide 47 Influenza Transmission Large-particle droplets Airborne transmission Incubation Typical incubation period is 1-4 days Adults can be contagious before symptoms Viral shedding Adults: up to 5 days after onset Children: 10 or more days Severely immunocompromised: weeks or months Slide 48 Influenza Symptoms Symptom Type 100F Chills Sweats HA Myalgia Malaise Substernal soreness Photophobia Fever, >99F Lassitude Confusion Slide 49 Flu versus Common Cold Signs & SymptomsFluCold OnsetSuddenGradual Fever Characteristic, high (>101 F); lasting 3 to 4 days Rare CoughNonproductive; can become severeHacking HeadacheProminentRare Myalgia (aches and pains)Usual; often severeSlight Fatigue; weaknessCan last up to 2 to 3 weeksVery mild Extreme exhaustionEarly and prominentNever Chest discomfortCommonMild to moderate Stuffy noseSometimesCommon SneezingSometimesUsual Sore throatSometimesCommon Slide 50 Month of Peak Influenza Activity, United States, 1976-2009 Slide 51 Influenza Annual influenza epidemics in U.S. ~ 40,000 deaths ~ 226,000 hospitalizations Rates of severe illness and mortality are highest among: Persons aged 65 years Children aged < 2 years Persons at increased risk for complications from influenza Slide 52 Influenza Complications Secondary bacterial pneumonia, sinusitis, or otitis Coinfections with other viral or bacterial pathogens Exacerbate underlying pulmonary or cardiac disease Encephalopathy Myositis, myocarditis, pericarditis Death 2-fold increase in fatal myocardial infarction and ischemic heart disease Slide 53 Influenza Conditions that increase the risk of influenza complications: Age Adults >50 years Children 6 to 59 months old Immunosuppression, including HIV infection Women pregnant during influenza season Chronic medical conditions Pulmonary (emphysema, asthma), cardiovascular, metabolic (diabetes), renal dysfunction, hemoglobinopathy Residents of long-term care facilities Compromised respiratory function or aspiration risk Slide 54 Types of Influenza Influenza A, B, & C Influenza A viruses are categorized into subtypes based on two major surface antigens: Hemagglutinin (H): H1, H2, H3 (primarily) Neuraminidase (N): N1, N2 Causes moderate to severe disease in all ages Change the hemagglutinin and neuraminidase surface antigens over time to evade the immune system 2 major types of antigenic change are known: Antigenic drift Antigenic shift Slide 55 Yearly Change of Influenza Vaccine Antigenic Drift Gradual change in proteins due to mutations, substitutions, and deletions Adaptation to human antibodies Occurs yearly Antigenic Shift Drastic change in hemagglutinin (H) or neuraminidase (N) Responsible for pandemics Slide 56 Influenza Vaccine Formulated annually Trivalent Influenza Vaccine (TIV) Contains 2 influenza A and 1 influenza B strains 2011-2012 trivalent virus strains: A/California/7/2009 (H1N1)-like A/Perth/16/2009 (H3N2)-like B/Brisbane/60/2008-like Grown in hens eggs Slide 57 Influenza Vaccine In the past indicated for Anyone who wants to reduce the likelihood of becoming ill with influenza or spreading it to others Persons with conditions that increase the risk of influenza complications Caregivers for high-risk persons Healthcare personnel Household contacts of: Children < 5 years, especially those < 6 months Adults > 50 years, Those with comorbitities that put them at high risk for complications People living in dormitories or in crowded conditions Now indicated forEVERYONE!!! Slide 58 Influenza Vaccine Fluzone, Fluvirin, Fluarix, FluLaval, Afluria All contain same influenza strains, but approved for different age groups Inactivated vaccine Intramuscular injection Approved for persons aged > 6 months Children less than 9 years getting TIV for the first time should get 2 doses 4 weeks interval between doses Can be given simultaneously with other vaccines Slide 59 Influenza Vaccine FluMist Live attenuated influenza vaccine (LAIV) Intranasal administration Approved for healthy persons aged 2-49 years Children age 2-8 getting influenza vaccine for the first time should get 2 doses of LAIV 6-10 weeks interval between doses If not given simultaneously, space live vaccines 4 weeks apart Was reformulated to no longer require frozen storage Slide 60 Trivalent Influenza Vaccine (TIV) vs. Live-Attenuated Influenza Vaccine (LAIV) TIVLAIV Type of vaccineInactivatedLive Route of administrationIMIntranasal Approved age 6 months2-49 y/o Administer to persons with chronic medical conditions YesNo Administer to close contacts of immunosuppressed YesNo Slide 61 Can influenza vaccines cause influenza? Inactivated vaccine No, because it is inactivated Live-attenuated vaccine No, because it cannot replicate in the temperature of the lower respiratory tract Slide 62 Influenza Vaccine Side Effects Injection site tenderness Low-grade fever starting 6-12 hours after injection and lasting 1-2 days Treat with aspirin or acetaminophen??? Guillain-Barr syndrome Runny nose, headache, sore throat with LAIV Fever, vomiting, abdominal pain, myalgia in children Slide 63 GENERAL Vaccine Adverse Reactions Local Pain, swelling, redness at site of injection Common with inactivated vaccines Usually mild and self-limiting Systemic Fever, malaise, HA Allergic rare Minimized risk by screening Warning: Syncope Observe for 15 minutes Slide 64 Why people do NOT receive vaccines Concern about vaccine adverse events Insufficient time or inconvenience Reliance on homeopathic medicines Avoidance of all medications Fear of needles Perception of a low personal risk of infection If everyone else gets one, then I dont need one Slide 65 Guillain-Barre Syndrome (GBS) Rare, neurological disorder Autoimmune disorder affecting peripheral nerves Acute inflammatory demyelinating polyneuropathy (AIDP) Usually triggered by an acute infectious process Muscle weakness and paralysis Whether or not vaccinated 1 to 2 people out of every 100,000 in U.S. Two studies suggested ~ 1 additional person out of 1 million vaccinated people may be at risk for GBS associated with the seasonal influenza vaccine Slide 66 Thimerosal & Autism Thimerosal: Mercury-based preservative used for decades in the U.S. in multi-dose vials of meds and vaccines Institute of Medicine (IOM) concluded that "the evidence favors rejection of a causal relationship between thimerosal-containing vaccines an autism. CDC supports the IOM conclusion. http://www.cdc.gov/vaccinesafety/Concerns/Autism/Index.html Slide 67 Adverse Event Reporting Vaccine Adverse Event Reporting System (VAERS) Nationwide reporting system of the FDA Providers must report all clinically significant AEs within 30 days To report an adverse event, call (800) 822-7967 or online at http://VAERS.hhs.gov National Vaccine Injury Compensation Program (VICP) Federal "no-fault" system of the Health Resources and Services Administration Compensating those who have been injured by childhood vaccines Slide 68 Vaccine Information Resources Slide 69 References Various websites at www.cdc.gov Hermsen ED, Rupp ME. Influenza. In: Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A Pathophysiologic Approach, 7th ed. Singapore:McGraw-Hill Companies, Inc.;2008:1791-1800. Hayney MS. Vaccines, Toxoids, and other Immunobiologics. In: Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A Pathophysiologic Approach, 7th ed. Singapore:McGraw-Hill Companies, Inc.;2008:2041- 2064.