Presentation on theme: "Wendy Rosenthal, Pharm.D.. True or False? Vaccines are among the greatest achievements of biomedical science & public health."— Presentation transcript:
Wendy Rosenthal, Pharm.D.
True or False? Vaccines are among the greatest achievements of biomedical science & public health.
Since widespread use of vaccines, the annual number of cases has fallen by: >99% for diphtheria, measles, poliomyelitis, rubella, smallpox & Haemophilus influenzae type B >90% for pertussis, tetanus & mumps >80% for hepatitis A & B & varicella 34% for pneumococcal disease JAMA 2007;298(18):
Basics of Immunity
Active immunity produced by vaccine Immunity and immunologic memory similar to natural infection but without risk of disease Epidemiology and Prevention of Vaccine-Preventable Diseases 9 th ed
Live attenuated Weakened form of the original Must replicate in body to be effective Generally require one dose Severe reactions possible Examples: measles, varicella, intranasal influenza Epidemiology and Prevention of Vaccine-Preventable Diseases 9 th ed
Inactivated Composed for whole viruses or bacteria or fractions Cannot replicate Generally require more than one dose Antibody titer diminishes over time Examples: pneumococcal, HPV, influenza Epidemiology and Prevention of Vaccine-Preventable Diseases 9 th ed
Vaccine Adverse Reactions Local Pain, swelling, redness at injection site Usually mild & self-limited Systemic Fever, malaise, headache Live attenuated vaccines: may produce mild symptoms after incubation period of 7 – 21 days Allergy Due to vaccine components
Contraindications & Precautions C=contraindication P=precaution V= vaccinate if indicated VCImmunosuppression VCPregnancy PP Severe illness CC Allergy to component InactivatedLiveCondition
VaccineManufacturer Vaccine* Distributor Vaccine* Provider’sOffice Vaccine* Patient * *Vaccine is transported in a refrigerated or frozen state, as appropriate (refrigerator 35° - 46°F (2° - 8°C); freezer 5° F (-15°C) or colder), using an insulated container or a refrigerated truck.
Maintain freezer temperature at 5°F (-15°C) or colder Maintain refrigerator temperature at °F (2-8°C) MMR* Varicella Herpes Zoster DTaP, DT, Td Tdap, Hib, Hepatitis A, Hepatitis B, HPV, Influenza (TIV & CAIV-T) IPV, MMR* Meningococcal Pneumoccal (PPV & PCV) *MMR may be stored in either the freezer or refrigerator
Almost 16 million cases per year in the U.S. among people <20 years of age About 4.5 million per year in the U.S. among the elderly Influenza-related pulmonary and circulatory deaths 1990–1999: average 36,000 Rates of death/100, –0.6 aged 0–49 years 7.5 aged 50–64 years 98.3 aged ≥65 years JAMA. 2003;289:179–86.
Single-stranded RNA virus Three strains Type A Moderate to severe illness All age groups Subtypes determined by surface antigens: hemagglutinin & neuraminidase Type B Milder diseases Primarily affects children Type C Rarely reported in humans
Antigenic Shift Occur only in type A Drastic changes in hemagglutinin or neuraminidase Responsible for epidemics & pandemics Antigenic Drifts Occur in all three types Minor change in surface antigens May result in epidemic
Contains surface proteins of virus strains Most likely to circulate in the coming winter Generally two type A and one type B Epidemiological data reviewed and strains chosen 6–9 months before distribution
Trivalent Inactivated Vaccines (TIV): Fluzone® (Sanofi Pasteur) Approved for > 6 mo of age Fluvirin® (Chiron) Approved for > 4 years of age Fluarix® (GlaxoSmithKline) Approved for > 18 years of age FluLaval® (GlaxoSmithKline) Approved for > 18 years of age Afluria (CSL Limited) Approved for > 18 years of age Cold-adapted Influenza Vaccine Trivalent : FluMist® (MedImmune) Approved for 2 to 49 years of age
Inactivated influenza vaccine 70 – 90% effective among healthy persons <65 yo 30 – 40% effective among frail elderly 50 – 60% effective in preventing hospitalization 80% effective in preventing death Cold-adapted influenza vaccine-trivalent 87% effective in pediatric population Among healthy adults, 18 – 37% fewer days of healthcare provider visits
Persons at Increased Risk for Complications Persons aged 50 years Residents of nursing homes and chronic-care facilities Adults with chronic heart or lung disorders, including asthma Adults with: Chronic metabolic disease (e.g., diabetes) Renal dysfunction Hemoglobinopathies Immunosuppression (e.g., HIV)
Persons at Increased Risk for Complications Adults with conditions that can compromise respiratory function or the handling of secretions or that can increase the risk for aspiration Cognitive disorders Spinal cord injuries Seizure disorders Other neuromuscular disorders Women who will be pregnant during the influenza season MMWR. 2007
Persons Who Can Transmit the Virus to Those at High Risk Health care workers Employees of chronic-care facilities or residences for persons in groups at high risk Persons providing home care to persons in groups at high risk Household members (including children) of persons at high risk Household contacts and out-of-home caretakers of children aged <2 years MMWR. 2007
Healthy Individuals 2–49 Years of Age Who wish to decrease their risk of influenza Who are in close contact with persons at high risk for influenza-related complications
Influenza vaccination as personal protection versus Immunization for the greater public good
Which of the following statements is true regarding the peak month for influenza? 1. There has been great variability over the past 30 years 2. Peak most commonly occurs in February 3. Can peak as late as April & May
Inactivated vaccine Staggered administration based on need High risk/health care workers– can get as early as Sept, Oct or Nov is ideal Nursing homes – October or later Healthy – November or later Cold-adapted trivalent Starting in October
Inactivated Dose: 0.50 ml IM injection in deltoid Cold-adapted Trivalent Dose: 0.5 mL intranasally Half dose to each nostril No need to inhale No need to repeat if sneezing or coughing occur
Soreness at injection site Fever, malaise, myalgia Immediate allergic reaction Sneezing or cough (intranasal)
Inactivated vaccine Egg allergy History of anaphylactic reaction to components of the vaccine Cold-adapted trivalent vaccine Egg allergy History of anaphylactic reaction to components of the vaccine Aged 50 years Persons with chronic diseases Pregnant women
True or False? You can contract influenza from the IM vaccine.
Reactivation of dormant varicella zoster virus Likelihood for reactivation related to: Age Immune status
90% of U.S. population has serologic evidence of varicella 50% of persons who live to age 85 will develop herpes zoster More than 500,000 cases occur yearly in U.S.
Symptoms Sharp, stabbing pain & tenderness along the nerve Lesions appear 3 – 5 days later Papules vesicles pustules Heal in 7 – 10 days Present on only one side of the body Contagious until dry crusts appear: 5 – 10 days Pain can occur during the prodrome and/or eruptive phase
Based on pain research, which of the following is correct? 1. Labor pain > HZ pain 2. HZ pain > labor pain 3. HZ pain = labor pain
Serious complications Postherpetic neuralgia (PHN) 90% pain-free 1 month after acute attack; 95% pain-free at 3 months & 97% pain-free after 12 months Incidence & duration directly correlate with patient age Difficult to treat Scarring, bacterial superinfection, cranial and motor neuron palsies, pneumonia, encephalitis, visual impairment, hearing loss
Live, attenuated varicella-zoster virus Indication: prevention of HZ in individuals 60 and older Stimulates the patient’s immune system to reestablish memory cells Dose: 0.65 ml subQ
Advisory Committee On Immunization Practices (ACIP) recommendations Routinely administer to all people 60 years of age and older This includes those who have had a previous episode of the disease
What is the potency of Zostavax compared to Varivax? 1. Zostavax > Varivax 2. Zostavax < Varivax 3. Zostavax = Varivax
Must be kept frozen at -15º C (+5º F) Reconstitute straight from freezer and use immediately Adverse effects: injection site reactions
History of anaphylactic reaction to gelatin, neomycin, or other component of the vaccine Immunodeficiency (leukemia, lymphomas, other bone marrow or lymphatic neoplasms, HIV) Immunosuppressive therapy Active, untreated tuberculosis Pregnancy
Efficacy Efficacy with respect to incidence of zoster was 63.9% among those 60 – 69 yo compared with 37.6% in those 70 years and older Reduced incidence of postherpetic neuralgia by 67% Duration of time patients experienced pain was significantly lower in those who received the vaccine N Engl J Med 2005:352;
DNA tumor virus Skin virus About 40 genital types 15 to 18 of these associated with cancer Sexually transmitted disease Intercourse Genital, oral & skin to skin contact
HPV TypesManifestations High-Risk Types 16, 18, 31, and 45 Low-grade cervical changes High-grade cervical changes Cervical cancer Anogenital and other cancers Low-Risk Types 6 and 11 Benign low-grade cervical changes Condylomata acuminata (Genital warts)
HPV “clearance” 80 – 90% of infections resolve in 2 years Average duration of infection 9 – 13 months Unclear if eradicated or latent HPV “persistence” 10 – 20% of infections persist Major risk factor for cancer Clearance & persistence are age related
6.2 million new cases of sexually transmitted HPV occur in the U.S. each year 20 million people in the U.S. currently have a detectable genital HPV infection 50% of sexually active men and women acquire genital HPV infection at some point in their lives $1.6 billion in direct annual medical costs for treating symptoms of genital HPV infection
What % of women tested positive for HPV DNA within 12 months of intercourse with FIRST male sex partner? 1. 5% 2. 13% 3. 28% 4. 42%
1 million new cases annually; two thirds in women Present in 15% of general population Transmitted during vaginal or anal sex with infected partner
Can spontaneously disappear without treatment May remain unchanged or increase in size and/or number Treatment options Provider applied topical medications Patient applied topical medications Freezing, laser and surgical excision Recurrence rates of 30-40%
Indication: Approved for use in females aged 9 to 26 for prevention of the diseases caused by HPV types 6,11,16 & 18: Cervical cancer Genital warts And the following precancerous or dysplastic lesions: Cervical adenocarcinoma in situ (AIS) Cervical intraepithelial neoplasia (CIN) grade 2 & 3 Vulvar intraepithelial neoplasia (VIN) grade 2 & 3 Vaginal intraepithelial neoplasia (VaIN) grade 2 & 3 Cervical intraepithelial neoplasia (CIN) grade 1
HPV types 16 & 18 account for 70% of all cervical cancers HPV types 31,33,35,39,45,51,52,56,58,&59 account for an additional 20% Gardasil provides cross-protection reducing incidence for precursor lesions by 38% 45% protection with types 31 &45
Advisory Committee On Immunization Practices (ACIP) recommendations Routinely administer to all girls when they are 11 – 12 years old Immunize females 13 – 26 who have not previously received the vaccine At their discretion, physicians could vaccinate girls as young as 9
Administration Given as 3 separate IM injections over 6 months 1st dose: at elected date 2nd dose: 2 months after 1st dose 3rd dose: 6 months after 1st dose Available in single-dose vial or prefilled syringe No dilution or reconstitution necessary
Conclusions from pivotal trials Vaccine was well tolerated No differences between its ADRs and the placebo Most common complaints: pain at injection site & headache There was complete protection against persistent HPV types 16 & 18 infection and associated cervical lesions in the fully vaccinated cohort Obstet Gynecol 2006;107:18-27 Lancet Oncol 2005;6:271-8
Pain, swelling & erythema at injection site No serious reactions have been reported Contraindicated for persons with history of immediate hypersensitivity to yeast or any vaccine components
True or False? Once a female has received the complete Gardasil vaccine series she no longer needs routine PAP smears.
90,000 Americans die of vaccine- preventable infections every year Most visited health care providers in the year preceding their deaths but were not vaccinated Influenza and pneumonia are the fifth leading cause of death for Americans 65 Most American adults are inadequately vaccinated Am J Health Syst Pharm 2003;60:
Advocate Motivating people to be vaccinated Screen for needed vaccines and refer Facilitator Hosting others who vaccinate Immunizer Administering vaccines
As of August 2007
In the typical American household, which family member has the most accurate & up-to-date immunization record on file? 1. The parents 2. The children 3. The pets