Michel Disco, RPh Amy Bachyrycz, Pharm.D., RPh Joe Anderson, Pharm.D., RPh Caroline Montoya, CNP Bernadette Johnson, Pharm.D., RPh DISCLOSURE The presenter of this program has no financial conflict or interest with the manufacturer of any product named during this

presentation. CLASS Vaccination Principles Vaccines and diseases Pink Book Storage and handling - safety Childhood Schedule - cases Nuts and Bolts of Practice Your Tool Kit - Protocol/Regulations the law Injection techniques and practice ROLE OF THE PHARMACIST

ADVOCATE Immunization educate and advocate FACILITATOR Host immunization clinics IMMUNIZER - DO IT/ENJOY IT!! VACCINES ARE DRUGS

Pharmacists are responsible for drugs Pharmaceutical care responsible for patients health and outcomes. Cure of disease Elimination/reduction of symptoms Arresting or slowing disease process Preventing disease or symptoms VACCINE-PREVENTABLE INFECTIOUS DISEASES

OBJECTIVES 1. Describe the principles of active and passive immunity. 2. Identify the differences in immunologic response and contraindications between live attenuated and inactivated vaccines. 3.

Identify the recommended vaccines for vaccine-preventable diseases for both children and adults. 4. Develop a vaccination plan, given a patients age, immunization history, and medical history. 5. Educate a patient or caretaker on the benefits and risks

associated with vaccines. 6. Distinguish between appropriate and inappropriate reasons for deferring vaccination. 7. Recognize possible adverse reactions. VACCINES THAT WILL

BE COVERED Influenza Measles, Mumps, and Rubella Varicella Zoster Diptheria, Tetanus, and Pertussis Pneumococcal Meningococcal Rotavirus Inactivated poliovirus Human Papillomavirus Hepatitis A and B

Haemophilus influenzae type b Rabies PREVENTING DISEASE Sanitation Immunization DISEASE MORBIDITY COMPARISON IN U.S.

PRE-VACCINE ERA (Cases/Year) Cases in 2006 Diptheria 175,885 0

Measles 503,282 55 Mumps 152,209 6,534

Pertussis 147,271 15,632 Paralytic Polio 16,316 0

Rubella 47,745 11 Tetanus 1,314 41

Smallpox SMALLPOX Global Eradication Program in 1966 Last case reported in U.S. was in 1949 Routine vaccination discontinued 1972 Last indigenous case reported on earth was in 1977


virtually eliminated from the U.S., so my child does not need to be vaccinated. Some vaccine preventable diseases are no longer endemic in the U.S. These diseases may still be prevalent or even epidemic in other parts of the world. Outbreaks in the U.S. are often associated with foreign travel. Without vaccination, few cases could quickly become tens or hundreds of thousands. MYTH OR REALITY

Aborted fetuses are used to make vaccines. Varicella, rubella, hepatitis A, and one rabies vaccine are made in fetal embryo fibroblast cells. Obtained from therapeutic termination of two pregnancies in 1960s. These same embryonic cells are used today. Rubella vaccine prevents congenital abnormalities and miscarriages. TRUE OR FALSE The amount of aluminum found in vaccines is

similar to the amount found in 1 liter of infant formula? A. True B. False True. Aluminum is used as an adjuvant in some vaccines and is closely monitored by the FDA. ADDRESSING PARENTS CONCERNS Establish rapport

Be open and honest Identify concerns Identify their sources of information Be prepared to respond with evidence-based information Appeal to civic duty and risk COMMUNITY BENEFIT Untreated children become threat to others Some individuals cannot be vaccinated and rely on herd immunity

Even with a fully immunized population, infection is still possible Costs on community PHARMACISTS RESPONSIBILITY Promote vaccination Public Health issue Ensure proper storage and administration Observe correct timing and appropriate intervals of vaccinations Follow contraindications and precautions

RESOURCES CDC vaccine safety - Flu info - Local flu info - Immunization Action Coalition - American Academy of Pediatrics - Childrens Hospital of Philidelphia Vaccine Adverse Event Reporting System (VAERS) ADVERSE EVENT REPORTING Vaccine Adverse Event Reporting System (VAERS)

FDA and CDC Voluntary reporting (by anyone) Adverse reaction Side effect caused by vaccine Adverse event Temporal event following vaccination An adverse event can be an adverse reaction Vaccine Injury Compensation Program (1986) Routinely recommended childhood vaccines

PRINCIPLES OF IMMUNITY PRINCIPLES OF IMMUNITY Immune System Distinguishes self from non-self Ability to recognize and eliminate infectious agents PRINCIPLES OF

IMMUNITY Antigen A live or inactivated substance that is capable of inducing immune response Antibody Protein molecules produced by the B lymphocytes that assist in the elimination of antigens PRINCIPLES OF IMMUNITY Passive Immunity

Transferred protection from exogenous source Maternal/transplacental Blood products Temporary (wanes with time) PRINCIPLES OF IMMUNITY Active Immunity Produced protection by persons own immune system

Exposure to infectious disease Vaccination Live attenuated vaccine Inactivated vaccine Usually permanent ACTIVE IMMUNE RESPONSE TO PRIMARY EXPOSURE Primary Response Innate immune response (rapid) Adaptive response (delayed)

Antibody titers peak around 2-6 weeks post-exposure Titers fall gradually with memory Bcells being produced ACTIVE IMMUNE RESPONSE TO SECONDARY EXPOSURE Secondary Response Delayed response Memory cells rapidly make antibodies Host often unaware that exposure ever occurred ANTIBODY PRODUCTION

FOLLOWING VACCINATION VACCINATION PRINCIPLES Successful vaccination relies on active immunity of individual Immunologic response is similar to natural infection (without risk of disease) Response and persistence of protection is determined by several factors: Live attenuated vs inactivated Host characteristics and immune status

Administration IMMUNIZING AGENTS Immunoglobulins (acute protection) Vaccines (viral or bacterial) Live attenuated vaccine Inactivated vaccine Whole Fractional Protein (toxoid or subunit) Polysaccharide-based (pure or conjugate)

IMMUNIZING AGENTS - COMPONENTS Suspending fluid Typically sterile water or saline Preservatives, stabilizers, and antibiotics Used to prevent contamination or to stabilize the antigen

Includes such materials as: Mercurials (thimerosal) Gelatin Specific antibiotics (neomycin) Adjuvants Typically aluminum salts Added to inactive vaccines to enhance immune response LIVE ATTENUATED

VACCINES Weakened form of infectious agent Does not cause disease Requires replication to produce a sufficient response Most resembles the immune response produced by natural infection Usually effective with one dose (unless oral) May be contraindicated in: Immunosuppressed patients Pregnant women

AVAILABLE LIVE VIRUS VACCINES Viral Measles/Mumps/Rubella Bacterial

BCG Varicella/Zoster Typhoid (oral) Rotavirus Influenza (Intranasal LAIV) Plague* Yellow Fever Vaccinia (smallpox) Oral polio (OPV)* *Not available in US THE VARICELLA VACCINE AND

THE ZOSTER VACCINE ARE COMPOSED OF THE SAME LIVE VACCINE VIRUS Which vaccine is used in adults and at what age is the vaccine administered? Zoster vaccine is used in adults 60 years or older. New approval 50 and older NOT ACIP recommended YET INACTIVATED VACCINES

Contains fractional antigen or whole dead infectious agent Does not cause disease Generally not as effective as live vaccines Larger doses Multiple doses (3-5) Boosters may be necessary May administer to immunosuppressed patients and pregnant women Circulating maternal antibody does not interfere with vaccine


Polio Rabies Hepatitis A Japanese encephalitis Fractional Hepatitis B Influenza

Human papillomavirus Anthrax *Not available in US Whole Cholera* Plague* Pertussis* Fractional

Acellular pertussis Pneumococcal (PPV, PCV) Meningococcal (MPSV, MCV) Typhoid Vi Haemophilus influenzae type B Diptheria toxoid Tetanus toxoid PURE

POLYSACCHARIDE VACCINES Not consistently immunogenic in children <2 years of age Induce T-cell-independent immune response Antibody with less functional activity No booster response Immunogenicity improved by conjugation POLYSACCHARIDE CONJUGATE VACCINES Stimulates T-cell-dependent immunity

Enhanced antibody production, especially in young children Repeat doses elicit booster response IMMUNIZATION SCHEDULES Children and Adolescent Schedule Revised and Available January 2017 Collaborative effort of: Advisory Committee on Immunization Practices (ACIP) American Academy of Pediatrics American Academy of Family Physicians

Adult Schedule Revised and available January 2017 Collaborative effort of: Advisory Committee on Immunization Practices (ACIP) American Academy of Family Physicians American College of Physicians American College of Obstetricians and Gynecologists

IMMUNIZATION SCHEDULE FOR AGES 018 YEARS See schedule online IMMUNIZATION SCHEDULE FOR AGES 0-18 YEARS COMBINED What vaccinations should be given within the first year of life? Are these live attenuated or inactivated vaccines? Hep B, RV, DTaP, Hib, PCV, IPV, influenza (All inactivated)

The 4th dose of DTaP may be administered as early as age 12 months, provided what (stated in footnote)? 6 months have elapsed since the third dose How many doses are in the MMR series? Is this a live attenuated or inactivated vaccine? 2 doses (Live vaccine administered after 1 year old) IMMUNIZATION SCHEDULE FOR AGES 018 YEARS What is the pediatric version of Tdap?

DTaP What is the minimum age for administration of HPV vaccination? 9 years old IMMUNIZATION SCHEDULE FOR ADULTS BY AGE IMMUNIZATION SCHEDULE FOR ADULTS BY INDICATION

IMMUNIZATION SCHEDULE FOR ADULTS How often should the Td booster be given? Every 10 years, first booster should be Tdap What is the maximum age of administration for HPV vaccination? 26 years old Which vaccinations are contraindicated in pregnant women and immunocompromised

patients? Live vaccines For example, MMR (or MMRV), Varicella, Zoster ADMINISTRATION Simultaneous administration is recommended No contraindications for any vaccines Increases likelihood of receiving all vaccines We are NOT overloading the immune system If two LIVE vaccines are not administered simultaneously, they should be given at least 4 weeks

apart (does not apply to inactivated) ADMINISTRATION Dosing intervals Do not administer before the minimum recommended AGE Do not administer before the minimum recommended INTERVAL Minimum interval is determined by the component with the longest required interval Increasing the interval between doses in a series does not diminish response DO NOT RESTART

SERIES SOME VACCINES CANNOT BE ADMINISTERED DURING THE FIRST YEAR OF LIFE BECAUSE: a) the infants immune system will be overwhelmed if he/she receives too many vaccinations. b) circulating maternal antibodies inactivate the vaccine antigen. c) administration increases the infants risk for autism.

d) the infant may develop the disease from the vaccine. CONTRAINDICATIONS OR PRECAUTIONS Severe allergic reaction to vaccine or component Encephalopathy occurring within 7 days of pertussiscontaining vaccine Conditions that increase chance of serious reaction or may compromise ability to produce immune response Immunosuppression Pregnancy

Severe illness (Delay) Recent administration of blood product (Delay live vaccines) INVALID CONTRAINDICATIONS Antibiotic therapy Breastfeeding Premature birth Mild disease low-grade fever, URI, otitis media, mild diarrhea Pregnancy or immunosuppression in household Warfarin

ADVERSE REACTIONS Local pain, swelling, redness (common with inactivated) Systemic fever, malaise, headache Allergic reaction Syncope most common in adolescents have them wait 20 min PHARMACY INFLUENZA CLINIC WITH A NONPRODUCTIVE COUGH. SHE HAS NO OTHER SYMPTOMS AND HAS NEVER RECEIVED AN INFLUENZA VACCINE IN THE PAST. SHE

RECENTLY RECEIVED HER 5TH DTAP VACCINATION 3 WEEKS AGO AND HAS NO OTHER CONTRAINDICATIONS TO VACCINATION. YOU: a. Delay the vaccination until the patient is feeling better. b. Delay the vaccination for one week, because patient received her DTaP shot three weeks ago. c. Give her an influenza vaccination and tell her to return in 4 weeks for a second. d. I have no idea what you are talking about Dean Disco because Ive been on

Facebook. DISEASES AND VACCINES INFLUENZA INFLUENZA Single-stranded RNA genome Classified into three distinct types on the basis of antigenic differences: Influenza A responsible for pandemics

Hemagglutinin Neuraminidase Influenza B Influenza C INFLUENZA Epidemic: Outbreak confined to one location (e.g., city, town, country) Pandemic: Severe outbreaks that rapidly progress to involve all parts of the world INFLUENZA

Antigenic variation occurs frequently Drift (epidemics) minor changes like point mutations Shift (pandemics) major genetic changes resulting in alterations of antigen structure usually caused by reassortment Explains why influenza continues to be a major epidemic disease of humans Severity is dependent upon: Antigenic variation Transmission capability 2016-2017

INFLUENZA All 2015-2016 influenza vaccine is made to protect against the following three viruses: an A/California/7/2009 (H1N1)pdm09-like virus an A/Switzerland/9715293/2013 (H3N2)-like virus a B/Phuket/3073/2013-like virus. (This is a B/Yamagata lineage virus Some of the 2015-2016 flu vaccine also protects against an additional B virus INFLUENZA VACCINES

Inactivated (IIV) intramuscular trivalent (A/H3N2, A/H1N1, B (Massachusetts) quadrivalent (A/H3N2, A/H1N1, B(Massachusetts), B(Brisbane) duration of immunity 1 year or less

Live attenuated vaccine (LAIV) intranasal quadrivalent (A/H3N2, A/H1N1, B(Yamagata), B(Victoria) duration of immunity at least 1 year 65 FLUBLOK

Recombinant Influenza Vaccine (RIV3) Trivalent Uses a baculovirus vector (virus which infects insects)

Approved for persons 18 through 49 years of age No egg protein 66 FLUCELVAX

Inactivated Influenza Vaccine manufactured by Novartis IIV3 Initial reference strains from WHO have been passaged in eggs, therefore can not be considered to be completely egg-free

Trivalent Grown in Madin-Darby Canine Kidney Cells Approved for persons 18 years old 67

FLUZONE INTRADERMAL Licensed by FDA in May 2011 Approved only for persons 18 through 64 years of age

Dose is 0.1 mL administered in the deltoid area by a specially designed micro-needle and injector system Formulated to contain more HA (27 mcg) than a 0.1 mL dose of regular Fluzone formulation (9 mcg) 68 CHOICE OF

INFLUENZA VACCINE The choice should primarily be driven by the ageindication and contraindications and precautions No current preference for quadrivalent vs trivalent

No current preference for high-dose vs standard dose No current preference for IIV vs LAIV in any age group for whom either is indicated 69 INACTIVATED INFLUENZA VACCINE CONTRAINDICATIONS AND

PRECAUTIONS Contraindication: severe allergic reaction to a vaccine component (e.g., latex) or following a prior dose of vaccine Precautions: moderate or severe acute illness

history of Guillian-Barr syndrome within 6 weeks following a previous dose of IIV 70 SEVERE ALLERGY TO EGG Most influenza vaccine available for the 2015-2016 season will be produced in hens eggs ovalbumin concentrations up to 1.4 mcg per mL

In clinical studies of egg-allergic persons IIV was tolerated without serious reactions Flucelvax not manufactured in egg (MDCK cells) but consists of strains isolated in eggs (amount of ovalbumin 50 femtograms)

FluBlok not manufactured in eggs (baculovirus vector) 71 INFLUENZA VACCINATION EGG ALLERGY Addition of the following: For individuals with no known history of exposure to egg, but who are suspected of being egg-allergic on the basis of previously performed allergy testing:

Consultation with a physician with expertise in the management of allergic conditions should be obtained prior to vaccination Alternatively, RIV3 may be administered if the recipient is 18 through 49 years of age 72 SEASONAL VACCINE

Side effects: Injection site reactions Muscle aches and fatigue Fever Nausea Headache

Contains egg components, trace amounts of neomycin, gelatin, and arginine SEASONAL FLU TARGET GROUPS No target groups this year everyone over the age of 6 months INFLUENZA

TREATMENT Relenza (zanamavir) 5mg/inhalation Tamiflu (oseltamivir) 75mg capsules Both are antiretrovirals May be used in the treatment or prophylaxis of: Seasonal influenza H1N1 influenza

Do not induce immune response MMR-MMRV Measles Mumps Rubella (German Measles) Varicella MEASLES Rubeolla virus (not to be confused with rubella) Respiratory transmission

Presentation: Cough, coryza (runny nose), conjunctivitis Stepwise increase in temperature to 103F or higher Koplik spots Maculopapular rash 1,000,000 children still die worldwide

Measles may be more severe in adults Paramyxovirus MUMPS Respiratory transmission Presentation: Lower respiratory infection Swelling and tenderness of salivary glands (parotitis in 3040%) Occurs primarily in school-aged children and

adolescents Course of infection rarely exceeds two weeks Complications: arthralgias, orchitis, death (usually from encephalitis) MUMPS RESURGENCE Previous outbreaks in 1987 and 1988 2006 was the largest mumps epidemic in past 20 years 5783 cases in 45 states and the District of Columbia Majority reported in 7 midwest states Majority were college students who had received at least 1 dose of vaccination

Attributed to waning immunity group and crowding RUBELLA Togavirus Humans are only reservoir Respiratory transmission Presentation: Mild illness Rash that is more pronounced on face, but doesnt coalesce like measles

No longer endemic in US Biggest concern is in regards to Congenital Rubella Syndrome (CRS) CONGENITAL RUBELLA SYNDROME Mother may be asymptomatic Infection during first trimester is most severe Permanent complications of CRS

Deafness, cataracts, heart defects (triad) Bone alterations Mental retardation Liver and spleen damage Premature delivery Miscarriage VARICELLA/ZOSTER

Herpesvirus Humans are only reservoir Highly contagious Transmitted by direct contact with lesions VARICELLA (CHICKENPOX) Primary infection results in varicella Pruritic vesicles concentrated on trunk 13% of individuals have more than one primary infection Asymptomatic primary infections

unusual Complications: Lesion infections Encephalitis Pneumonia Congenital Varicella Syndrome (CVS) Death - Adults are 25% more likely to die from varicella HERPES ZOSTER (SHINGLES)

Recurrent infection results in herpes zoster Reactivation of latent varicella Unilateral vesicular rash and pain on singular dermatome Can occur decades after initial infection Generally associated with aging or immunosuppression Lifetime risk of 20 % 50% of Individuals > 80 years will develop zoster

HERPES ZOSTER ZOSTER COMPLICATIONS Post-herpetic neuralgia (PHN) No effective treatment for pain Depression Sleep disturbances Opthalmic zoster (blindness) Dissemination into CNS, lungs, liver, and pancreas

MMR-MMRV VACCINE Live virus components Single primary dose Second dose is given to ensure close to 100% immunity Damaged vaccine Present maternal antibody No more than 2 doses/lifetime Single antigens are available through Merck

VARICELLA AND ZOSTER VACCINES All vaccines contain Oka-Merck vaccine strain Varicella Varivax (1400 pfu) MMRV or Pro-quad (9,800 pfu) 2 doses given 12-15 months and 4-6 years Zoster Zostavax approved 2006 (19,000 pfu)

EVIDENCE OF IMMUNITY Born before 1966 Vaccination documentation History documented by healthcare provider Laboratory evidence Current: 2 doses or titer (UNMH) HERPES ZOSTER VACCINE Single dose for > 60 years (50 years approved FDA)

Unknown if additional doses will be needed Should be given whether or not individual reports prior episode of shingles Do not need to screen for varicella disease or vaccine Contraindicated in immunocompromised or pregnant patients WHAT ARE THE CONTRAINDICATIONS FOR THE MMR-MMRV VACCINE? I. Contraindicated in pregnant women II. Contraindicated in patients with allergy to vaccine components (egg allergy, neomycin, gelatin)

III. Contraindicated in severely immunocompromised patients a. I only b. III only c. I and II d. II and III e. I, II, and III CONTRAINDICATIONS Allergy Pregnancy Immunosuppression Administer to HIV-infected children with CD4

counts >15% Administer to HIV-infected adults with CD4 counts >200cells/mm3 Coadministration of recent blood products MMR-MMRV VACCINE IN PREGNANCY 321 women vaccinated 324 live births No observed CRS 95% confidence limits 0%-1.2%

MMR-MMRV VACCINE ADVERSE REACTIONS Live attenuated vaccines mimic s/s of infection Common: Rash or zoster (measles, rubella, varicella) Joint symptoms (mumps, rubella) Rare: Thrombocytopenia (rubella) Parotitis (mumps) Deafness (mumps) Encephalopathy (measles, mumps, rubella)

MMR VACCINE AND AUTISM Flawed Wakefield studies suggested that MMR caused intestinal inflammation that allowed absorption of proteins that are harmful to the brain Numerous studies that reject causal role Signs and symptoms may be temporal (diagnosis of autism often made in second year of life) CDC, Vaccine Injury Compensation Program, and Institute of Medicine do not support the association Autism has both genetic and environmental component

MMR VACCINE AND AUTISM 1. Madsen KM, Hviid A, Vestergaard M, et al. A population-based study of measles, mumps, rubella vaccination in autism. N Engl J Med 2002;347:1477-1482. 2. Kaye JA, Melero-Montes M, Jick H, et al. Mumps, measles, rubella vaccine and the incidence of autism recorded by general practitioners: A time trend analysis. BMJ 2001;322:460-463. 3. Farrington CP, Miller E, Taylor B, et al. MMR and autism: Further evidence against a

causal association. Vaccine 2001;19:3632-3635. 4. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, nonspecific colitis, and pervasive developmental disorder in children. Lancet 1998;351:637-641. WHICH OF THE FOLLOWING ARE FALSE? A. The MMRV vaccine contains live attenuated virus components of measles, mumps, rubella, and varicella.

B. The MMRV vaccine may prevent CRS. C. The second dose of MMRV ensures nearly 100% immunity. D. The first dose of MMRV vaccine should be given at 6 months of age. Live vaccines Please list the live vaccines that are recommended in both the childhood and adult schedules. When should patients receive these vaccines? Influenza yearly (age 2-49) Measles, Mumps, Rubella, and Varicella at age 1

and before entering school between the ages of 46 Zoster ages >60 A PARENT REFUSES THE MMR VACCINE BECAUSE THE PARENT DOES NOT WANT THEIR CHILD EXPOSED TO MERCURY (THIMEROSAL) FOR FEAR THAT IT WILL CAUSE AUTISM IS THERE CHILD. WHAT CAN YOU TELL THIS PARENT TO ENCOURAGE THEM TO HAVE THEIR CHILD VACCINATED? 1. Ask them where they obtained their information. 2. Let them know that MMR does not contain thimerosal.

3. The Institute of Medicine conducted several studies and found no correlation between the MMR vaccine and autism. 4. CDC and Vaccine Injury Compensation Program also do not support the association. 5. Appeal to their civic duty to the community. 6. Remind them that their child will be at risk for these diseases. Name three things that can affect vaccine response and persistence of protection. Type of vaccine (live or inactivated)

Host characteristics and immune status Administration and storage Which type of vaccine is not consistently immunogenic in children <2 years of age? Pure polysaccharide vaccines Why are aluminum salts added to inactivated vaccines? They are adjuvants that increase the rate of response and the duration of immunity If two LIVE vaccines are not administered simultaneously, how long should you delay vaccination with the 2nd LIVE vaccine? And why? 4 weeks because the second vaccine will not induce an effective response Which of the following is a TRUE contraindication to vaccination?

a. b. c. d. Severe illness Premature birth Breastfeeding Warfarin therapy DTAP DT TD TDAP Diphtheria

Tetanus Pertussis DTAP-DT-TD-TDAP Diphtheria and Tetanus Toxoids DT = pediatric Follows DTaP schedule For individuals that have contraindication to pertussis Td = adult (every 10 years after Tdap)

Diphtheria, Tetanus, and Acellular Pertussis DTaP = pediatric Tdap = adult (1st booster) DIPHTHERIA Corynebacterium diptheriae Transmitted by droplet spread or direct contact with cutaneous infection

Some strains are able to produce diptheria toxin Infects mucous membranes Presents as pharyngitis (membraneous) or tonsillitis Fever not high but patient appears toxic DIPTHERIA COMPLICATIONS Respiratory obstruction Myocarditis and heart failure CNS complications including neuritis and

paralysis Clostridium tetani TETANUS Found in soil and animal feces Acquired through surgery, puncture, laceration, wound, IVDU, tattoo, diabetesrelated infections (rusty nail) Incubation period of 4 days-several weeks Minimal or no inflammation at primary site of infection

Neurotoxin results in unopposed firing of motor neurons TETANUS COMPLICATIONS Pulmonary embolism Aspiration pneumonia Fractures Death (25% mortality) respiratory failure DIPTHERIA AND

TETANUS TOXOIDS Inactivated toxins Aluminum-precipitated (or adsorbed) preparation is more immunogenic Prevents disease, not acquisition or carriage DIPTHERIA AND TETANUS TOXOIDS Available in combination, not as single antigen: Diptheria, tetanus, and acellular pertussis

Diptheria and tetanus Adult formulations contain lower concentrations of diptheria toxoid (to prevent local reactions) Reported local site reactions higher with each additional dose PERTUSSIS Bordetella pertussis Humans are only reservoir for disease Spread by airborne droplets

Highly contagious with no strong seasonal pattern Presents as URI Milder in adolescents/adults Catarrhal stage PERTUSSIS 100 DAY COUGH 1-2 weeks cough gradually worsens Maximum communicability

Paroxysmal cough 1-6 weeks Local tissue damage with thick mucous production Whooping cough Cyanosis, vomiting Antibiotics have little effect on course of disease by this stage

Convalescence Gradually improves over weeks to months Complications: seizures, cerebral bleeding, encephalopathy, death PERTUSSIS VACCINE 1930s available as whole cell vaccine Associated with greater side effects and seizures No longer distributed in U.S.

Acellular vaccine Purified components of Bordetella pertussis and detoxified pertussis toxin Efficacy is comparable to whole cell vaccine but with decreased side effects PERTUSSIS VACCINE Precautions Temperature greater than 40.5C within 48 hours of prior dose without identifiable cause Convulsions occurring within 3 days

May use acetaminophen 15mg/kg at time of vaccination, then Q4h for 24h Contraindications Encephalopathy within the 7 days following previous administration DTAP-DT-TD-TDAP Childrens formulations: DTaP and DT Boosters: Tdap, Td Adult formulations contain lower concentrations of diptheria toxoid and acellular

pertussis vaccine Reported local site reactions higher with age and each additional dose DTAP Approved for children 6 weeks through 6 years Number of doses depends on childs age at the first dose If <12 months, 4 doses are recommended If >12 months, 3 doses are recommended

1st booster at 4-6 years: DTaP 2nd booster at ages 11-12 years: Tdap Following boosters: Tdap once for adolescent, then once as adult, then Td every 10 years AN 11-YEAR OLD PATIENT IS IN YOUR CLINIC TO RECEIVE HIS TETANUS/DIPTHERIA BOOSTER. HE RECEIVED HIS DTAP SERIES AT 13 MONTHS, 14 MONTHS, 15 MONTHS, AND A DTAP BOOSTER AT 4 YEARS OLD. HE HAD NO REACTION TO HIS PREVIOUS VACCINATION. WHAT DO YOU WANT TO GIVE HIM TODAY?

Tdap WHEN SHOULD HE COME BACK FOR HIS BOOSTER AND WHICH FORMULATION SHOULD HE RECEIVE? Tdap in 10 years, then Td every 10 years thereafter PNEUMOCOCCAL DISEASE Streptococcus pneumoniae 90 serotypes

Type-specific antibody protection PNEUMOCOCCAL MENINGITIS Most common cause of bacterial meningitis High fatality rates (80%) in children <2 years old and adults >65 years old PNEUMOCOCCAL PNEUMONIA Most common complication

100,000-135,000 cases requiring hospitalization per year Responsible for up to 30% of CAP and 50% of HAP PNEUMOCOCCAL VACCINE 23-valent polysaccharide vaccine (PPSV) 13-valent polysaccharide conjugate vaccine (PCV) the former vaccine was 7-valent

Prevnar-13 PNEUMOCOCCAL POLYSACCHARIDE VACCINE (PPSV) 23 serotypes account for 88% of pneumococcal disease Schedule is one dose for ages > 65 High risk patients may receive 1 dose with selective revaccination (>5 years) Duration of immunity is at least 6 years

NOT EFFECTIVE IN CHILDREN <2 YEARS PNEUMOCOCCAL CONJUGATED VACCINE (PCV) Covers 13 serotypes of S. pneumoniae Conjugated to nontoxic diptheria toxin Conjugation improves immunologic response in children <2 years old New dosing with PCV13 No special contraindications or adverse reactions PNEUMOCOCCAL

CONJUGATE VACCINE (PCV) Approved in children 6 weeks-9 years old Risk is greatest <24 months ACIP recommends ages 6 weeks 59 months 3-dose series recommended at 2, 4, 6 months First dose may be given as early as 6 weeks Booster given at 12-15 months Unvaccinated children >7 months of age require less doses Everyone age 65 and older once Available resources per CDC and MMWR

YOU ARE ADMINISTERING THE 4TH PNEUMOCOCCAL VACCINE TO A 12MONTH OLD LITTLE GIRL AND YOU REALIZE THAT YOU GAVE HER THE PURE POLYSACCHARIDE PNEUMOCOCCAL VACCINE INSTEAD OF THE CONJUGATED VACCINE. YOU: a. You record this PPSV dose as her 4th dose to complete her pneumococcal series. b. You tell her to come back for her PCV, but she must wait 4 weeks.

c. You administer the PCV today. d. You administer an additional PPSV at age 2. MENINGOCOCCAL DISEASE Neisseria meningitidis 13 serotypes 5 serotypes cause 90% of cases (A, B, C, Y, and W-135) Respiratory transmission Less common in U.S. but associated with high mortality (912%) Symptoms progress rapidly and can lead to death within 2448 hours

CLINICAL MANIFESTATIONS OF NEISSERIA MENINGITIDIS Bacteremia 43.3% Pneumonia 6.0% Arthritis 2.0% Meningitis 47.3%

Otitis media 1.0% Epiglottitis 0.3% INDIVIDUALS AT RISK FOR NEISSERIA MENINGITIDIS INFECTION Persons with anatomic or functional asplenia Persons with terminal complement deficiency Laboratory personnel exposed to N. meningitidis College freshmen

Military recruits Foreign travelers MENINGOCOCCAL VACCINES Quadrivalent polysaccharide vaccine Quadrivalent conjugatedpolysaccharide vaccine MENINGOCOCCAL POLYSACCHARIDE VACCINE (MPSV) Quadrivalent polysaccharide vaccine (A, C, Y, W-135)

MPSV contains thimerosal Approved for individuals >2 years of age 80-90% effective No longer routinely used Duration of immunity is short (<5 years) MENINGOCOCCAL CONJUGATE VACCINE (MCV) Quadrivalent polysaccharide vaccine (A, C, Y, W-135) conjugated to inactivated diptheria toxin (2005) >90% effective with single dose

Routinely recommended for 11-18 year olds Revaccination not currently recommended unless in high-risk group ROTAVIRUS GASTROENTERITIS Most common cause of severe dehydrating gastroenteritis in children Almost all children have been infected by 5 years of age Five strains account for 90% of isolates (G1-4, G9) 1st infection after 3 months of age is the most severe with temperatures >102F

GI symptoms generally resolve in 3-7 days Low mortality but high healthcare burden ROTAVIRUS VACCINE Live, oral vaccine ROTATEQ Contains five reassortment rotaviruses Nonhuman rotaviruses used Manipulated to express human rotavirus antigens on surface

Have low pathogenicity for humans Replicate, but do not cause disease ROTAVIRUS VACCINE- ROTATEQ 3-dose series beginning at about 2 months of age Vaccination should not be initiated for infants older than 15 weeks ACIP recommends immunization of all

infants without a contraindication No special contraindications or adverse reactions WHICH VACCINE IS INEFFECTIVE IN CHILDREN UNDER 2 YEARS OF AGE? A. PPV (Pneumococcal polysaccharide vaccine) B. PCV (Pneumococcal conjugate vaccine)

C. Rotavirus vaccine POLIOMYELITIS Enterovirus with three distinct serotypes (1,2,3) Oral-fecal transmission Immunity to one does not protect against the others Most infections are asymptomatic Infection spreads to CNS causing destruction of motor neurons

PARALYTIC POLIO Some or all motor function may be recovered 1:200 develop permanent paralysis (usually asymmetric) Sensory function remains intact Severity increases with age Fatal in 2-5% of cases POLIO EPIDEMIC IN U.S. 1920s outbreaks crippled and killed

thousands, with the epidemic peaking in 1952 (57,628 cases) 1955 vaccine was developed and reduced incidence by 90% within 2 years Eradicated in the U.S. Hundreds of new cases are still reported each year worldwide Will be the 2nd virus eradicated from the planet by vaccine THE IRON LUNG

POLIO VACCINE 1955 Inactivated vaccine (IPV) 1963 Oral Polio Vaccine (OPV) 1979 Last case of wild virus reported 1987 Enhanced IPV (Original IPV taken off the market) 2000 OPV use discontinued in U.S. 2004 Last imported case INACTIVATED POLIO VACCINE IPV contains 3 viruses No special contraindications

IPV is safe (if not the safest vaccine) OPV still widely used outside of U.S. INACTIVATED POLIO VACCINE Children 99% effective after 3 doses 4th dose given as booster given before school entry Adults who are not vaccinated Not recommended unless traveling to polio-endemic

areas Only require 3 dose series of same dose Any 4 dose combination of IPV and OPV may be used HUMAN PAPILLOMAVIRUS (HPV) More than 100 types of HPV

Transmitted through direct skin-to-skin contact Over 40 types infect mucosal surfaces, including anogenital epithelium Most common sexually transmitted infection 20,000,000 Americans currently infected with HPV Up to 30% are infected with multiple strains HUMAN PAPILLOMAVIRUS (HPV) Certain strains increase risk for cancer High-risk oncogenic strains (16,18) Low-risk oncogenic strains (6, 11)

Approximately 11,000 women diagnosed with cancer in 2007 (3500 deaths) Most individuals are able to clear infection 70% become HPV DNA negative within one year 90% become HPV DNA negative within two years QUADRIVALENT HPV VACCINE Inactivated vaccine Protects against four HPV types (6,11,16,18)

3-dose series ideally received before sexually active (0,2, 6 months) Cover strains that are responsible for 70% of cervical cancers (types 16, 18) and 90% of genital warts (types 6, 11) QUADRIVALENT HPV VACCINE FDA Approval 2006 for women 9-26 years old for genital

warts and cervical cancer October 2009 for men 9-26 years old for genital warts and anal cancers ACIP recommends use of vaccine in girls ages 11-12 Cervical cancer screen recommendations have not changed QUADRIVALENT HPV VACCINE Studied in 11,000 females (ages 9-26)

100% effective in preventing cervical precancers >95% effective in preventing vulvar and vaginal precancers and genital warts Duration of protection unknown No serious side effects Efficacy studies in males is ongoing VAERS REPORTING 26,ooo,ooo doses have been dispensed 15,037 VAERS reports Non-serious (93%)

Syncope requiring patients to wait 15 minutes Serious (7%) Blood clots - Majority had risk factors (e.g. oral contraceptives Deaths 44 reports with no pattern that would suggest they were caused by the vaccine HPV VACCINE CONTRAINDICATIONS Severe allergic reaction to a vaccine component or following a prior dose

Defer in pregnancy even if series was already initiated HEPATITIS A VACCINE 2-dose series Pediatric dose for 0-18 years of age Adult dose for > 19 years of age Recommended for children, and also adults that are high-risk:

International travelers MSM IVDU Occupational risk Chronic liver disease Available in single or combo formulations

HEPATITIS B VACCINE 3-dose series Pediatric dose for 0-19 years of age Adult dose for > 20 years of age Recommended for children, and also adults that are highrisk:

MSM Heterosexuals with multiple partners Persons diagnosed with STD Prostitutes IVDU Inmates of long-term correctional facilities Healthcare workers

Available in single or combo formulations that are interchangeable No need for booster HEPATITIS A/B COFORMULATION - TWINRIX 3-dose series approved for >18 years Each contains pediatric dose of hepatitis A Twinrix in combination with hepatitis A vaccine 2 Twinrix + 1 hepatitis A 1 Twinrix + 2 hepatitis A

HAEMOPHILUS INFLUENZAE TYPE B VACCINE Available in single or combo formulations (DTaP-Hib or Hepatitis B-Hib) All vaccines are interchangeable for primary series and booster dose 3-dose series with one booster Children who fall behind may not need all of the remaining

doses Not recommended in children >59 months unless high risk: Asplenic Immunosuppressed HSCT RABIES Post-Exposure Pre-Exposure now recommended Veterinarians Forest workers Zoo workers

CASES CASE #1 RS is a 3-year-old male adopted from Russia. He is seeing you in clinic for the first time in November. He appears healthy today. PMH: HIV+ with CD4 of 13%. He has no history

of chickenpox. Vaccination history: BCG at birth OPV at birth, 1, 3, 4 months DPT at birth, 1month, and 3 months Measles vaccine at 10 months 1st dose of seasonal influenza vaccine 5 weeks ago, 1st time patient has ever received influenza

Completed Hib and PCV vaccine at 2, 4, 6, and 12 months CASE #1 What vaccinations does RS need today? Hepatitis B #1 (#2 in 4 weeks) DTaP #2 (#3 in 4 weeks) IPV #3 (# 4 at 4-6 years of age) Influenza #2 (will need 1 annually there after) MMR #1 (#2 at 4-6 years of age)

Varicella #1 (#2 next at 4-6 years of age) Hepatitis A #1 (#2 in 6 months) CASE #1 Does he have any contraindications to the vaccinations that he will need today? MMR, Varicella, and live seasonal flu May administer when CD4 >15% When should RS return to clinic and what vaccinations will he need at her next visit? 4 weeks to receive hepatitis B #2, DTaP #3

CASE #2 Vaccination history: MR is a 25-year-old female nurse that was just hired to work in the IPV completed at age 4 UNMH emergency department this October. There has been a recent MMR completed at age 4 reported pertussis outbreak in community served by hospital since her hire and several cases

Diptheria, tetanus, and have been seen in ED. Two pertusis hospital staff have been diagnosed Temp of 105F following 1st with pertussis in the last month. She is seeing you at the employee health clinic for the first time. She appears healthy today. PHM: No significant PMH. Chickenpox at age 5, with no documentation.

dose of DTP at 2 months of age. Completed series with pediatric DT at age 4 Adult Td booster 16 months ago Hepatitis A and B completed September 2007 Influenza in 2007

CASE #2 What vaccinations does MR need today? HPV #1 (#2 in 2 months) Tdap booster with tylenol (booster in 10 years) Influenza (should receive annually) Varicella?? Does she have any contraindications to the vaccinations that she will need today? No, prior history is considered a precaution. Risk as provider during outbreak outweighs risk of side effect.

10 years is recommended interval to decrease the local reactions. CASE #2 When should MR return to clinic and what vaccinations will she need at her next visit? 2 Months for HPV #2 Varicella potentially - serotesting needs to be completed for confirmation of varicella protection CASE #3 Your 16-year old patient returns home from

summer camp, where a bunkmate was sent to the hospital for invasive meningococcal disease. You proceed to: (select all that apply) A. Monitor the patient for illness. Advise the family to watch patient closely for symptoms such as fever, aches, chills and rash for at least 10 days since last exposure to the ill bunkmate. B. Review the patients immunization status, and, if not yet received, immunize the patient with quadrivalent meningococcal conjugate vaccine; two doses are recommended, the first at 11 or 12 years of age, with a booster dose at age 16. C. Offer the patient a brief course of an appropriate antibiotic to further reduce the risk of contracting meningococcal disease.

D. If the patient was previously immunized, reassure the patient and family that antibiotic prophylaxis is not needed. CASE #3 ANSWERS: A, B, and C are correct. D is incorrect. Close contacts of people with invasive meningococcal disease are at risk of becoming ill and should receive appropriate antibiotic prophylaxis regardless of prior immunization. Current meningococcal conjugate vaccines are not designed to protect

against serogroup B meningococcus, associated with 30% of cases in California.

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