6/8/2018
Immunization Update Anna Meador Lochamy, PharmD, BCACP CTH Pharmacy Director, Christ Health Center [email protected]
Objectives
• Describe the role of the new Shingrix and hepatitis B vaccine • Define the changes to the measles, mumps & rubella (MMR) and human papillomavirus (HPV) vaccine schedule • Match the correct pneumococcal vaccine to the patient • Understand the implications of the yellow fever vaccine shortage
Immunization Schedules • 19 years and older • 18 years or younger
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Recommended immunization schedule for adults aged 19 years or older by age group
Recommended immunization schedule for adults aged 19 years or older by medical condition and other indications
Vaccine acronyms, and brand names for vaccines routinely recommended for children and adolescents
2 6/8/2018
Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
Vaccines that might be indicated for children and adolescents aged 18 years or younger based on medical indications
How to stay up to date
• CDC Website • https://www.cdc.gov/vaccines/schedules/hcp/ • Separate links for Children and Adolescents up to 18 years old & Adults aged 19 years or older • New guidelines released yearly around February • New recommendation can happen up to quarterly • Will be added to the website only, not the immunization schedules to print • Order laminated copies free from CDC • https://wwwn.cdc.gov/pubs/CDCInfoOnDemand.asp x • Usually not available until late in march or Early April
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New Vaccines • Shingrix • Heplisav-B
Varicella Zoster Virus
• Two distinct diseases • Varicella or Chicken pox • Primary infection • Contagious rash found mainly in children • Herpes zoster or Shingles • Reactivation of infection • Localized, usually painful, rash found mainly in adults • Develops into a cluster of clear vesicles then pustules and then scar • 1 in 3 people will develop shingles in their life • Major complications • Postherpetic neuralgia • Herpes zoster ophthalmicus
MMWR, June 6, 2008, 57(05);1-30
Zostavax vs Shingrix
• Zoster vaccine live • Recombinant zoster (ZVL) vaccine (RZV) • Dose: • Dose • 0.65 ml • 0.5 ml • Subcutaneous • Intramuscular • Once • At 0 and 2-6 months • Side Effects: • Side Effects: • Injection site • Injection site reactions (pain, reactions, myalgia, erythema, swelling) fatigue, fever, GI
MMRW, January 26, 2018, 67(3);103–108 Shingrix & Zostavax package insert
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Zostavax vs Shingrix
• Efficacy • Efficacy • 50–59 years:70% • 50–59 years: 96.6% (95% CI = 54–81) (95% CI = 89.6–99.3) • 60–69 years: 64% • 60–69 years: 97.4% (95% CI = 56–71) (95% CI = 90.1–99.7) • ≥70 years: 38% • ≥70 years: 91.3% (95% CI = 25–48) (95% CI = 86.8–94.5) • Duration of Efficacy • Duration of Efficacy • 4 to 12 years • 19 years (based on predictive models)
MMRW, January 26, 2018, 67(3);103–108
CDC recommendations by age group
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
CDC recommendations by medical condition and other conditions
RZV has not been studied in immunocompromised patients
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
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Zoster CDC Footnote
• Administer 2 doses of RZV 2–6 months apart to adults aged 50 years or older regardless of past episode of herpes zoster or receipt of ZVL. • Administer 2 doses of RZV 2–6 months apart to adults who previously received ZVL at least 2 months after ZVL. • For adults aged 60 years or older, administer either RZV or ZVL (RZV is preferred). • “ZVL” has replaced the term “HZV” (herpes zoster vaccine) that was used in past adult immunization schedules to refer to the live zoster vaccine. A row for RZV was added above the row for ZVL and a dashed line was used to separate RZV and ZVL rows to denote that the 2 zoster vaccines are recommended for the same purpose.
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
Simplified Zoster CDC recommendations • 50 years or older • Administer RZV regardless of past episode of herpes zoster or receipt of ZVL. • Administer RZV to adults who previously received ZVL at least 2 months after ZVL. • 60 years or older • Administer either RZV or ZVL • RZV is preferred
True or False
• A patient with unknown chicken pox history should not receive the Shingrix vaccine.
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Hepatitis B
• Transmission • Spread by blood and bodily fluid • Can live on surfaces for up to 7 days • Clinical presentation • Nausea, vomiting, abdominal pain, malaise, fever, anorexia, dark urine, changes in stool color, hepatomegaly, splenomegaly, and jaundice • Some will be asymptomatic • 80-90% of acute infection found in infancy will turn into chronic infections • 1991 first recommendation to vaccinate all infants
MMWR, January 12, 2018, Vol 67,(1);1-31
Current Hepatitis B Vaccines
• Engerix-B & Recombivax-B (HepB-alum) • Administer 3 doses at 0, 1, and 6 months • Uses Aluminum as it adjuvant • Three different dose formulations • Pediatric • Engerix-B AWP is $27.51 • Recombivax-B AWP is $28.59 • Adult dose (20 years and older) • Engerix-B AWP is $68.55 • Recombivax-B AWP is $73.314 • Specific hemodialysis doses and schedules
• Heplisav-B (HepB-CpG) • Adults age 18 years and older • Administer 2 doses at least 4 weeks apart • Uses an immunostimulatory sequence as its adjuvant • Cytidine-phosphate-guanosine oligodeoxynucleotide (CpG- ODN) motifs or 1018 adjuvant • Binds to Toll-like receptor 9 • AWP $138 per dose • Supplied as 5 single dose vials per box • Efficacy • Seroprotective levels were found in 90 – 100% of patients as opposed to 70.5 – 90.2% of those receiving Engerix-B • Safety • Side effect reported were similar to Engerix-B • No data for use in Pregnancy
MMWR, April 20, 2018, Vol 67,(15);455-8
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Hepatitis B Vaccines (cont.)
Engerix-B Recombivax Heplisav-B Approved 1989 1983 2018 Adjuvant Alum Alum CpG AWP/ adult $68.55 $73.31 $138 dose AWP/ adult $205.65 $146.62 $276 series Adverse injection site injection site Injection site reactions and fatigue reaction, fatigue reaction, fatigue and headache and headache
MMWR, January 12, 2018, Vol 67,(1);1-31
CDC recommendations by age group
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
CDC recommendations by medical condition and other conditions
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
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Hepatitis B CDC footnote
• Administer to adults who have a specific risk (see below), or lack a risk factor but want protection, 3-dose series of single antigen hepatitis B vaccine (HepB) at 0, 1, and 6 months (minimum intervals: 4 weeks between doses 1 and 2 for HepB; between doses 2 and 3, 8 weeks for HepB) • Administer HepB to adults with the following indications: • Chronic liver disease (e.g., hepatitis C infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the upper limit of normal) • HIV infection • Percutaneous or mucosal risk of exposure to blood (e.g., household contacts of hepatitis B surface antigen [HBsAg]-positive persons; adults younger than age 60 years with diabetes mellitus or aged 60 years or older with diabetes mellitus based on individual clinical decision; adults in predialysis care or receiving hemodialysis or peritoneal dialysis; recent or current injection drug users; health care and public safety workers at risk for exposure to blood or blood-contaminated body fluids) • Sexual exposure risk (e.g., sex partners of HBsAg positive persons; sexually active persons not in a mutually monogamous relationship; persons seeking evaluation or treatment for a sexually transmitted infection; and men who have sex with men [MSM]) • Receive care in settings where a high proportion of adults have risks for hepatitis B infection (e.g., facilities providing sexually transmitted disease treatment, drug abuse treatment and prevention services, hemodialysis and end-stage renal disease programs, institutions for developmentally disabled persons, health care settings targeting services to injection drug users or MSM, HIV testing and treatment facilities, and correctional facilities) • Travel to countries with high or intermediate hepatitis B endemicity
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
Example of the quarterly update
Interchangeability of Hep B Vaccines • 2-dose HepB vaccine series only applies when both doses consist of HepB-CpG, administered at least 4 weeks apart. • Series consisting of a combination of 1 dose of HepB-CpG and a vaccine from a different manufacturer (HepB-alum) should do the following: • Adhere to the 3-dose schedule minimum intervals of 4 weeks between dose 1 and 2, 8 weeks between dose 2 and 3, and 16 weeks between dose 1 and 3. • However, if HepB-CpG is substituted for dose 2 of HepB- alum, a provider has the option of administering the next dose of HepB-CpG a minimum of 4 weeks from the previous dose for a complete series. • Doses administered at less than the recommended minimum interval should be repeated.
MMWR, April 20, 2018, Vol 67,(15);455-8
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Simplified Hepatitis B CDC Recommendations • Administer Hep B-Alum 3-dose series at 0, 1, and 6 months • Minimum intervals: 4 weeks between doses 1 and 2; 8 weeks between doses 2 and 3 • Administer Hep B-CpG 2-dose series at 0 and 1 month • Minimum interval: 4 weeks between doses 1 and 2 • Administer Hep B to adults with the following indications: • Chronic liver disease • HIV infection • Risk of exposure to blood • Sexual exposure risk • Receive care in settings where a high proportion of risks for hep B infection • Travel to countries with high or intermediate hep B endemicity
Interchangeability of Hep B Vaccines - simplified • 2-doses HepB-CpG at least 4 weeks apart. • 1 dose of HepB-CpG and a vaccine from a different manufacturer (HepB-alum) should do the following: • Adhere to the 3-dose schedule minimum intervals of • 4 weeks between dose 1 and 2 • 8 weeks between dose 2 and 3 • 16 weeks between dose 1 and 3. • HepB-CpG is substituted for dose 2 of HepB-alum, administering the next dose of HepB-CpG a minimum of 4 weeks from the previous dose for a complete series. • Doses administered at less than the recommended minimum interval should be repeated.
Updated Vaccine Recommendations • HPV • MMR
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CDC recommendations by age
CDC recommendations by medical condition
Measles, Mumps and Rubella (MMR) vaccine • MMR II • 2 doses administered 0 and 28 days • Mumps • 2 vaccine doses gives an effectiveness of 88% with a range from (31-95%) • Jan 2016 – June 2017 • 70% of cases had received 2 doses of MMR before developing mumps • 3 doses • Only 1 study showed significant risk reduction the others still reported lower rates of developing mumps • The same study showed higher riskm if the vaccines series was completed more then 13 years ago
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MMR Childhood and Adolescents CDC Footnote
• Routine vaccination: • 2-dose series at 12–15 months and 4–6 years. The 2nd dose may be given as early as 4 weeks after the 1st dose. • Catch-up vaccination: • Unvaccinated children and adolescents: 2 doses at least 4 weeks apart. • International travel: • Infants 6–11 months: 1 dose before departure. Revaccinate with 2 doses at 12–15 months (12 months for children in high-risk areas) and 2nd dose as early as 4 weeks later. • Unvaccinated children 12 months and older: 2 doses at least 4 weeks apart before departure. • Mumps outbreak: • Persons ≥ 12 months who previously received ≤ 2 doses of mumps- containing vaccine and are identified by public health authorities to be at increased risk during a mumps outbreak should receive a dose of mumps-virus containing vaccine.
Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, UNITED STATES, 2018
MMR Adult CDC Footnote
• General information • Administer 1 dose of measles, mumps, and rubella vaccine (MMR) to adults with no evidence of immunity to measles, mumps, or rubella • Evidence of immunity is: • Born before 1957 (except for health care personnel, see below) • Documentation of receipt of MMR • Laboratory evidence of immunity or disease • Documentation of a health care provider-diagnosed disease without laboratory confirmation is not considered evidence of immunity • Special populations • Pregnant women and nonpregnant women of childbearing age with no evidence of immunity to rubella: Administer 1 dose of MMR (if pregnant, administer MMR after pregnancy and before discharge from health care facility) • HIV infection and CD4 cell count ≥ 200 cells/μL for at least 6 months and no evidence of immunity to measles, mumps, or rubella: Administer 2 doses of MMR at least 28 days apart • Students in postsecondary educational institutions, international travelers, and household contacts of immunocompromised persons: Administer 2 doses of MMR at least 28 days apart (or 1 dose of MMR if previously administered 1 dose of MMR) • Health care personnel born in 1957 or later with no evidence of immunity: Administer 2 doses of MMR at least 28 days apart for measles or mumps, or 1 dose of MMR for rubella (if born before 1957, consider MMR vaccination) • Adults who previously received ≤ 2 doses of mumps-containing vaccine and are identified by public health authority to be at increased risk for mumps in an outbreak: Administer 1 dose of MMR • MMR is contraindicated for pregnant women and adults with severe immunodeficiency
Recommended Immunization Schedule for Adults Aged 19 Years or Older, UNITED STATES, 2018
Simplified MMR CDC recommendations
• 1 dose of MMR: • Persons ≥ 12 months who previously received ≤ 2 doses of mumps-containing vaccine and are identified by public health authorities to be at increased risk during a mumps outbreak should receive a dose of mumps-virus containing vaccine. • Adults with no evidence of immunity to measles, mumps, or rubella • Nonpregnant women of childbearing age with no evidence of immunity to rubella • Infants 6–11 months: 1 dose before departure. Must restart proper series at 12 months • 2 doses of MMR: • Children and Adolescents • HIV infection and CD4 cell count ≥ 200 cells/μL for at least 6 months and no evidence of immunity to measles, mumps, or rubella: Administer 2 doses of MMR at least 28 days apart • Students in postsecondary educational institutions, international travelers, and household contacts of immunocompromised persons: Administer 2 doses of MMR at least 28 days apart (or 1 dose of MMR if previously administered 1 dose of MMR) • Health care personnel born in 1957 or later with no evidence of immunity: Administer 2 doses of MMR at least 28 days apart for measles or mumps, or 1 dose of MMR for rubella (if born before 1957, consider MMR vaccination) • MMR is contraindicated for pregnant women and adults with severe immunodeficiency
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Human papillomavirus vaccine (HPV) • Coverage of previous and currently available vaccines • Cervarix: 2vHPV • Gardasil: 4vHPV • Gardasil 9: 9vHPV • All three cover HPV 16 and 18 • 66% of cervical cancers and other HPV-associated cancers in both women and men • 4vHPV & 9vHPV also cover HPV 6 and 11 • Anogenital warts • Only 9vHPV covers HPV 31, 33, 45, 52, and 58 • 15% of cervical cancers
• As of 2016, Gardasil 9 is the only available vaccine
HPV Childhood and Adolescents CDC Footnote
• Routine and catch-up vaccination: • Routine vaccination for all adolescents at 11–12 years (can start at age 9) and through age 18 if not previously adequately vaccinated. Number of doses dependent on age at initial vaccination: • Age 9–14 years at initiation: 2-dose series at 0 and 6–12 months. Minimum interval: 5 months (repeat a dose given too soon at least 12 weeks after the invalid dose and at least 5 months after the 1st dose). • Age 15 years or older at initiation: 3-dose series at 0, 1–2 months, and 6 months. Minimum intervals: 4 weeks between 1st and 2nd dose; 12 weeks between 2nd and 3rd dose; 5 months between 1st and 3rd dose (repeat dose(s) given too soon at or after the minimum interval since the most recent dose). • Persons who have completed a valid series with any HPV vaccine do not need any additional doses. • Special situations: • History of sexual abuse or assault: Begin series at age 9 years. • Immunocompromised* (including HIV) aged 9–26 years: 3-dose series at 0, 1– 2 months, and 6 months. • Pregnancy: Vaccination not recommended, but there is no evidence the vaccine is harmful. No intervention is needed for women who inadvertently received a dose of HPV vaccine while pregnant. Delay remaining doses until after pregnancy. Pregnancy testing not needed before vaccination.
Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, UNITED STATES, 2018
HPV Adult CDC Footnote
• General information • Administer human papillomavirus (HPV) vaccine to females through age 26 years and males through age 21 years (males aged 22 through 26 years may be vaccinated based on individual clinical decision) • The number of doses of HPV vaccine to be administered depends on age at initial HPV vaccination • No previous dose of HPV vaccine: Administer 3-dose series at 0, 1–2, and 6 months (minimum intervals: 4 weeks between doses 1 and 2, 12 weeks between doses 2 and 3, and 5 months between doses 1 and 3; repeat doses if given too soon) • Aged 9–14 years at HPV vaccine series initiation and received 1 dose or 2 doses less than 5 months apart: Administer 1 dose • Aged 9–14 years at HPV vaccine series initiation and received 2 doses at least 5 months apart: No additional dose is needed • Special populations • Adults with immunocompromising conditions (including HIV infection) through age 26 years: Administer 3-dose series at 0, 1–2, and 6 months • Men who have sex with men through age 26 years: Administer 2- or 3-dose series depending on age at initial vaccination (see above); if no history of HPV vaccine, administer 3-dose series at 0, 1–2, and 6 months • Pregnant women through age 26 years: HPV vaccination is not recommended during pregnancy, but there is no evidence that the vaccine is harmful and no intervention needed for women who inadvertently receive HPV vaccine while pregnant; delay remaining doses until after pregnancy; pregnancy testing is not needed before vaccination
Recommended Immunization Schedule for Adults Aged 19 Years or Older, UNITED STATES, 2018
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Simplified HPV CDC recommendations • Female: • 11-12 year old - 26 year old • Male: • 11-12 year old – 21 year old • 22 year old – 26 year old based on clinical decision • Special populations • History of sexual assault begin at 9 years old • Immunocompromised begin at 9 years old • Men who have sex with men through age 26 years • Not recommended in Pregnancy but no evidence of harm • Persons who have completed a valid series with any HPV vaccine do not need any additional doses.
Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, UNITED STATES, 2018
Simplified HPV CDC recommendations (cont.) • Number of doses dependent on age at initial vaccination: • Age 9–14 years at initiation: • 2-dose series at 0 and 6–12 months. • Minimum interval: 5 months • Age 15 years or older at initiation: • 3-dose series at 0, 1–2, and 6 months. • Minimum intervals: 4 weeks between 1st and 2nd dose; 12 weeks between 2nd and 3rd dose; 5 months between 1st and 3rd dose
Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, UNITED STATES, 2018
Pneumococcal Review
14 6/8/2018
CDC recommendations by age
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
CDC recommendations by medical condition
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
Pneumococcal Vaccines
• 13-valent pneumococcal conjugate vaccine (PCV13) • Prevnar • Helps boost immunity • 23-valent pneumococcal polysaccharide vaccine (PPSV23) • Pneumovax
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Match the unvaccinated Patient to Vaccine 1. 65 year old patient A. PPSV23 repeat in 5 with hypertension years 2. 20 year old patient B. PPSV23 repeat at with asthma age 66 3. 62 year old patient C. PCV13, PPSV23 8 with diabetes weeks later 4. 60 year old patient D. PCV13, PPSV23 1 with HIV year later
Pneumococcal Special Populations
• 19 through 64 years with the following chronic conditions: • 1 dose of PPSV23 (at age 65 years or older, administer 1 dose of PCV13, if not previously received, and another dose of PPSV23 at least 1 year after PCV13 and at least 5 years after PPSV23): • Chronic heart disease (excluding hypertension), Chronic lung disease, Chronic liver disease, Alcoholism, Diabetes mellitus, Cigarette smoking • 19 years or older with the following indications • 1 dose of PCV13 followed by 1 dose of PPSV23 at least 8 weeks after PCV13, and a second dose of PPSV23 at least 5 years after the first dose of PPSV23 (if the most recent dose of PPSV23 was administered before age 65 years, at age 65 years or older, administer another dose of PPSV23 at least 5 years after the last dose of PPSV23): • Immunodeficiency disorders, HIV infection, Anatomical or functional asplenia (including sickle cell disease and other hemoglobinopathies), Chronic renal failure and nephrotic syndrome • 19 years or older with the following indications • 1 dose of PCV13 followed by 1 dose of PPSV23 at least 8 weeks after PCV13 (if the dose of PPSV23 was administered before age 65 years, at age 65 years or older, administer another dose of PPSV23 at least 5 years after the last dose of PPSV23): • Cerebrospinal fluid leak, Cochlear implant
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
Pneumococcal Special Populations • 19 through 64 years with the following chronic conditions: • 1 dose of PPSV23 (at age 65 years or older, administer 1 dose of PCV13, if not previously received, and another dose of PPSV23 at least 1 year after PCV13 and at least 5 years after PPSV23): • Chronic heart disease (excluding hypertension), Chronic lung disease, Chronic liver disease, Alcoholism, Diabetes mellitus, Cigarette smoking
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
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Pneumococcal Special Populations • 19 years or older with the following indications • 1 dose of PCV13 followed by 1 dose of PPSV23 at least 8 weeks after PCV13, and a second dose of PPSV23 at least 5 years after the first dose of PPSV23 (if the most recent dose of PPSV23 was administered before age 65 years, at age 65 years or older, administer another dose of PPSV23 at least 5 years after the last dose of PPSV23): • Immunodeficiency disorders, HIV infection, Anatomical or functional asplenia (including sickle cell disease and other hemoglobinopathies), Chronic renal failure and nephrotic syndrome
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
Pneumococcal Special Populations • 19 years or older with the following indications • 1 dose of PCV13 followed by 1 dose of PPSV23 at least 8 weeks after PCV13 (if the dose of PPSV23 was administered before age 65 years, at age 65 years or older, administer another dose of PPSV23 at least 5 years after the last dose of PPSV23): • Cerebrospinal fluid leak, Cochlear implant
Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018
What do you recommend?
• 55 year old patient with diabetes, hypertension, and COPD shows up to your pharmacy with a script for shingles and pneumococcal vaccine. Which vaccine(s) do you administer?
• Do you recommend any additional vaccines?
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Extra information • Yellow Fever • Pharmacy Technicians
Yellow Fever Vaccine
• Recommend for most travelers to Africa and South America (Amazon region) • Some countries require it for visa or entry
• Nationwide shortage • Utilizing an EU approved version called Stamaril on trial basis. • Sites have to be approved for distribution • https://wwwnc.cdc.gov/travel/page/search-for-stamaril- clinics
• Only 2 sites in Alabama • Jefferson County Department of Public Health in Birmingham, AL • Occupation Health Center in Mobile, AL
How can pharmacy technicians help • Flag patients for Pharmacist to evaluate • Patients with diabetes (metformin, glipizide, insulins) • Patients with lung disease (inhalers) • Elderly • Enter scripts per standing order or pharmacy protocol • Gather needs VIS forms • Monitor for updates on VIS forms
18 6/8/2018
Immunization Update Anna Meador Lochamy, PharmD, BCACP CTH Pharmacy Director, Christ Health Center [email protected]
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