Objectives IMMUNIZATION UPDATE. Influenza virus. Case Influenza Vaccine. Current recommendations 8/11/2015

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1 Objectives Michigan Pharmacists Association IMMUNIZATION UPDATE Interpret the most recent changes in the recommendations for immunizations Analyze which patients will most benefit from the changes in vaccine recommendations Of the vaccines discussed distinguish which are live or inactivated and the storage implications Given a patient set up an appropriate vaccine regimen Influenza virus Michael (25 years) takes Grandma Sanchez (67 years) to the pharmacy in September and they both would like to receive the flu shot, but Michael has a significant egg allergy (hives). Grandma received one dose of the flu vaccine last year. Michael is receiving it for the first time ever due to the egg allergy. Mrs. Sanchez says that she heard that the flu vaccine didn t work very well last year. virus labels.jpg Influenza Vaccine Current recommendations influenza vaccine (IIV3, IIV4, RIV3, LAIV4) will contain: A/California/7/2009 (H1N1) like virus A/Switzerland/ /2013 (H3N2) like virus B/Phuket/3073/2013 like virus B/Brisbane/60/2008 like virus Only IIV4 and LAIV4 will have Brisbane Guidelines All persons >6months should be vaccinated. Children 6mo. 8yrs. who have not been fully vaccinated previously should receive 2 doses 4 weeks apart. Those >65 years old may alternatively receive the high dose vaccine. CDC. MMWR 2012;61(No. 32):

2 High dose influenza vaccine Fluzone High Dose (IIV3): 4 times the antigen of the regular vaccine (60mcg vs. 15mcg of each) Not recommended over standard vaccine Studies show higher titers following vaccination with high dose vaccine Studies show a slight increase in effectiveness Vaccine safety was equivalent CDC. MMWR 2012;61(No. 32): Intradermal influenza vaccine Fluzone intradermal (IIV3) Indicated for years Less antigen than IM injection (9mcg vs. 15mcg) Single dose, pre filled syringes of 0.1ml Needle is 0.06 inches Ideally given over the deltoid All ADRs (erythema, induration, pain, swelling and pruritus) > IM except pain CDC. MMWR 2012;61(No. 32): Patients with egg allergies Current recommendations Only hives after egg exposure: Administer RIV (if older than 18 years) OR Administer IIV (egg or cell culture based) NOT LAIV but: Administer by HCP familiar with egg allergies Observe for 30 minutes More severe symptoms after egg exposure: Administer RIV (if older than 18 years) OR Refer to allergist for risk assessment CDC. MMWR 2013;62(No. 18)356 Non egg influenza vaccines Flucelvax (IIV3) (Novartis) Indicated for 18 years Cell culture based vaccine Single dose, pre filled syringes of 0.5ml Flublok (IIV3) (Protein Sciences) Indicated for 18 years and older Produced via recombinant technology Expires 16 weeks after production Influenza information IIV3, 4 Nonsevere (e.g., contact) allergy to latex, thimerosal, or egg Concurrent administration of warfarin LAIV Health care providers that see patients with chronic diseases or altered immunocompetence Breastfeeding Contacts of persons with chronic disease or altered immunocompetence 2

3 Michael (25 years) takes Grandma Sanchez (67 years) to the pharmacy in September and they both would like to receive the flu shot, but Michael has a significant egg allergy (hives). Grandma received one dose of the flu vaccine last year. Michael is receiving it for the first time ever due to the egg allergy. Mrs. Sanchez says that she heard that the flu vaccine didn t work very well last year. Alex, a 33 year old man, is hospitalized following a motor vehicle accident. He has multiple rib fractures and a splenic laceration. He goes to surgery and it is necessary to remove his spleen. Streptococcus pneumoniae Significant cause of respiratory disease, meningitis and sometimes sepsis. Encapsulated bacteria implications for immunity Risk factors Splenectomy, sickle cell disease, etc. Immunocompromised Smokers (2.3x 5.5x increased risk) Asthmatics (2.4x increased risk) N Engl J Med 2005;352:2082.; N Engl J Med. 2000;342(10): S. pneumoniae Vaccines Current recommendations Polysaccharide PPSV 23 valent For high risk and elderly Complicated dosing scheme and still evolving Conjugate PCV valent For children less than 5 and high risk Recommended for elderly On standard immunization schedule PCV 13 Routine vaccination for all children 2 59 months Vaccination of children months with underlying medical conditions Adults with immunocompromising conditions (including CRF), asplenia, CSF leaks and cochlear implants Those 65 years or older Give at least 8 weeks before PPSV23 or 1 year after 3

4 Current recommendations PPSV23 All persons 65 years old or older Functionally or anatomically asplenic Immunocompromised (including CRF) High risk patients (COPD, asthma, CHF, DM, liver disease, alcoholism) Residents of LTC facilities Adults who smoke When giving with PCV 13 give at least 8 weeks after or 1 year before PCV13 Neisseria meningitidis Another encapsulated bacteria Rapidly acting and can be rapidly lethal (<24hrs) Highly transmissible (concern in close contacts) Meningitis belt in North Africa concern for travelers Risk factors mainly those for close contact but also splenectomy and immunocompromised. Vaccines Polysaccharide vaccine still available (Menomune, MPSV) but rarely used Conjugate vaccine most common (MCV4, Menactra or Menveo) Covers serotypes A, C, Y and W 135. Not B! Guillian Barre syndrome 26 confirmed cases within 6 weeks of Menactra CDC unable to determine causal relationship due to unknown expected background rates. Recommendations Adolescents should be vaccinated at age and then a booster at age years. No booster needed in those receiving their first dose between years. Adolescent coverage 62.7% High risk patients should receive 2 doses 2 months apart and then revaccination every 5 years. MMWR 2011; 60(3): Meningitis B Within the last year, two meningococcal B vaccines were approved by the FDA Trumemba 3 dose series Bexsero 2 dose series ACIP recommendations High risk patients >10 years old Asplenic Complement deficiencies Microbiologists Alex, a 33 year old man, is hospitalized following a motor vehicle accident. He has multiple rib fractures and a splenic laceration. He goes to surgery and it is necessary to remove his spleen. MMWR 2015; 64(22):

5 Varicella Charles, a 59 year old man comes to the pharmacy and asks you about vaccines he should receive. You give him your recommendations, which include Zostavax. He says that he already has had shingles and that he now takes valaciclovir for recurrent herpes infections. You, the pharmacist, are currently 5 months pregnant. Virus in the herpes family Causes chicken pox but can reactivate to cause shingles Lies dormant in the dorsal root ganglion of the nerve, reactivation causes dermatomally distributed rash and can cause neuropathy Virus susceptible to acyclovir but requires higher dosing Vaccines Current recommendations Varivax Live vaccine On the standard immunization schedule for children Requires booster Zostavax Same attenuated virus as in Varivax Contains 14 times as much antigen as Varivax ACIP recommends only for those 60 years and older FDA approved for years of age Varivax All susceptible individuals (without evidence of immunity) Zostavax All individuals 60 years or older (FDA approved 50 years or older) Note: pregnant health care workers can administer any vaccine (except smallpox) Co administration New Vaccine on the Horizon Administering varicella and pneumococcal vaccines together Zostavax package insert: In a randomized clinical study, a reduced immune response to ZOSTAVAX as measured by gpelisa was observed in individuals who received concurrent administration of PNEUMOVAX 23 and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks Administering varicella with antivirals Stop acyclovir, famciclovir or valaciclovir 24 hours before vaccination and restart 14 days later MMWR 2008 June 6; 57:RR 5.; Vaccine May 9;29(20): Live attenuated virus vaccine efficacy 51.3% efficacy against occurrence of zoster 66.5% efficacy against post herpetic neuralgia 37.6% efficacy against zoster in >70 yo Subunit vaccine with adjuvant (HZ/su) 97.2% efficacy against occurrence of zoster 98.3% efficacy against zoster in >70 yo 17% incidence of adverse reactions A few years until this vaccine is available NEJM 2015;372:

6 Vaccine Storage Update CDC Recent update on vaccine storage CDC Toolkit New recommendations Biosafe glycol encased temperature probes Digital data loggers that regularly record temps at frequent intervals for 24 hour monitoring Stand alone refrigerator and stand alone freezer No dorm style or bar style refrigerator/freezers Weekly review of expiration dates and rotation of vaccine stock handling toolkit.pdf. Varicella Zoster Pregnancy of recipient's mother or other close contact Immunodeficient family member or household contact Asymptomatic or mildly symptomatic HIV infection Therapy with low dose methotrexate ( 0.4 mg/kg/week), azathioprine ( 3.0 mg/kg/day), or 6 mercaptopurine (1.5 or more mg/kg/day) for treatment of RA, psoriasis, polymyositis, sarcoidosis, IBD, etc. Health care providers or contacts of patients with chronic diseases or altered immunocompetence Unknown or uncertain history of varicella in a U.S. born person Charles, a 59 year old man comes to the pharmacy and asks you about vaccines he should receive. You give him your recommendations, which include Zostavax. He says that he already has had shingles and that he now takes valaciclovir for recurrent herpes infections. You, the pharmacist, are currently 5 months pregnant. Alicia is a 25 year old woman who is 2 months pregnant. You ask her if she has ever received the Tdap vaccine. She says she has received no vaccines since she was in middle school, except for the flu vaccine a couple years ago and a Td booster when she stepped on a nail 5 years ago. Diphtheria, Tetanus and acellular Pertussis Tetanus and Diphtheria used to be devastating diseases now incredibly rare Pertussis is a disease which still has numerous outbreaks. DTaP is the infant form Td is the historic tetanus shot Tdap is the adolescent/adult form and has been the largest focus recently Tdap update Patients 65 years should receive Tdap in place of their next Td, or any time if close contact with infants less than 12 months. Patients 7 10 years of age with incomplete vaccination should receive 1 dose at any time; if they have not received any doses then Tdap should be the first of the 3 dose Td series. MMWR 2011; 60(1):

7 Tdap update All patients can receive a dose of Tdap without respect to the last dose of Td. Pertussis titers decrease significantly within 3 years of boosting Pregnant women should receive Tdap during every pregnancy (regardless of vaccine history) Ideally give during third trimester increased antibody response and passive antibody transfer to baby Give post partum if missed during pregnancy DTaP Fever of 105 F or lower (<40.5 C), fussiness or mild drowsiness after a previous dose of DTP/DTaP Family history of seizures Family history of sudden infant death syndrome Family history of an adverse event after DTP or DTaP administration Stable neurologic conditions (e.g., cerebral palsy, well controlled seizures, or developmental delay) MMWR 2013; 62(7): ; MMWR 2011; 60(1): Tdap DTaP misperceptions, PLUS: Collapse or shock like state within 48 hours after receiving a previous dose of DTP/DTaP Seizure within 3 days after a previous dose of DTaP Persistent, inconsolable crying for > 3 hours within 48 hours after receiving a previous dose of DTP/DTaP History of extensive limb swelling after DTP/DTaP/Td that is not an arthus type reaction Latex allergy that is not anaphylactic Breastfeeding Immunosuppression Alicia is a 25 year old woman who is 2 months pregnant. You ask her if she has ever received the Tdap vaccine. She says she has received no vaccines since she was in middle school, except for the flu vaccine a couple years ago and a Td booster when she stepped on a nail 5 years ago. Hepatitis Nina is a 53 year old woman who comes to your pharmacy with a new prescription for metformin. She says she was just diagnosed with diabetes and has a lot of questions for you. One of them has to do with vaccinations. She read somewhere that she will now need certain vaccines. Hepatitis A Fecal to oral spread (contaminated food) Generally causes acute hepatitis Can be severe in patients with underlying liver disease Risk factors mainly for those traveling to endemic areas Hepatitis B Sexually transmitted or blood borne Rarely causes acute hepatitis More commonly causes long term damage leading to cirrhosis Risk factors similar to those of HIV 7

8 Hepatitis vaccine On standard schedule for children For adults dependent on risk factors A travel and pre existent liver disease B high risk sexual behaviors, IV drug abuse, hemodialysis and healthcare workers Patients with diabetes Unvaccinated diabetics ages For those aged 60 years, administer at the discretion of the treating clinician Nina is a 53 year old woman who comes to your pharmacy with a new prescription for metformin. She says she was just diagnosed with diabetes and has a lot of questions for you. One of them has to do with vaccinations. She read somewhere that she will now need certain vaccines. MMWR 2011; 60(50): Human Papillomavirus Erin inquires at your pharmacy about the HPV vaccine for her 12 year old son. Her daughter, who is now 16, finished her HPV series a year ago. She is a little nervous about giving the vaccine to her son because her daughter fainted after one of the HPV doses. One of the most common STDs Over 100 serotypes Cause of genital warts but of greater concern is the link to cervical, penile, anal and oropharyngeal cancer Annual cancer cases related to HPV: 15,000 (females); 7,000 (males) Vaccine of no use after infection MMWR 2011; 60(50); Vaccines Gardasil 9 Gardasil (HPV4) Covers serotypes 6,11,16,18 Indicated for prevention of cervical cancer and genital warts Only one used in males Adverse effects: pain on injection and syncope Cervarix (HPV2) Covers serotypes 16 and 18 Indicated for the prevention of cervical cancer Only indicated for females Adverse effects: pain on injection and syncope Contains the 4 serotypes in Gardasil 4 plus 5 of the most common other serotypes FDA approved from ages 9 to 26 in females and 9 to 15 in males ACIP recommended its use in males from 13 to 21 and females from 13 to 26, but no preference given over current agents Gardasil 9 will probably replace Gardasil 4 in a few years 8

9 HPV Immunosuppression Previous equivocal or abnormal Papanicolaou test Known HPV infection Breastfeeding History of genital warts Erin inquires at your pharmacy about the HPV vaccine for her 12 year old son. Her daughter, who is now 16, finished her HPV series a year ago. She is a little nervous about giving the vaccine to her son because her daughter fainted after one of the HPV doses. Measles, Mumps and Rubella Alyssa asks your advice. She heard on the news that there is an ongoing outbreak of measles. But she also heard that the measles vaccine and the fact that kids get too many vaccines causes autism. She is not sure what to do (she has not fully vaccinated her 3 year old son, and he has never received MMR). Extraordinarily contagious Multiple outbreaks have occurred Measles in California, December 2014: 131 cases 70% of evaluable patients were unvaccinated Origin of some of the cases possibly from the Phillipines MMWR 2012; 61(15); Measles MMR Vaccine Live vaccine All patients should receive 2 doses Guidelines All infants All health care workers born during or after 1957 All adults born during or after 1957 (at least one dose) 9

10 MMR Positive tuberculin skin test Simultaneous tuberculin skin testing Breastfeeding Pregnancy of recipient's mother or other close or household contact Recipient is female of child bearing age Immunodeficient family member or household contact Asymptomatic or mildly symptomatic HIV infection Allergy to eggs MMR and Autism Updated information on vaccines and autism Original MMR study in Lancet in children with enterocolitis and autism, found to have the measles virus from the vaccine in their intestines Study never able to be replicated Data found to be falsified Lancet retracted the article in 2010 and the author s license to practice medicine was revoked BMJ 2011; 342:c5347 MMR and Autism Mercury and Autism Updated information on vaccines and autism Data on Vaccines and Autism 25 studies have refuted a connection between vaccines and autism 3 studies have suggested a connection one was retracted (Wakefield study) and another was by the same author (Wakefield) Institute of Medicine in 2011 Evidence favors a rejection of a causal relationship between MMR and autism BMJ 2011; 342:c5347; Updated information on vaccines and autism Mercury in vaccines and autism No relationship between thimerosal in vaccines and autism (the risk of autism no greater in children who received vaccines with thimerosal) By 2001 all routine vaccines for kids were made for single use only and the thimerosal removed Currently some influenza vaccine (multi dose vials) is the only vaccine indicated in kids that contains thimerosal Remember thimerosal is ethylmercury NOT methylmercury Too Many Vaccines and Autism CDC study on vaccines and autism 1/3 parents believe relationship; 10% delay or refute vaccines for their kids 256 kids with autism vs. 752 without ( ) Analyzed vaccine antigens in any one day and during first 2 years of life No difference between groups in maximum antigens in any one day or total antigens in first 2 years of life Alyssa asks your advice. She heard on the news that there is an ongoing outbreak of measles. But she also heard that the measles vaccine and the fact that kids get too many vaccines causes autism. She is not sure what to do (she has not fully vaccinated her 3 year old son, and he has never received MMR). DeStefano F, et al. J Pediatr 2013; : 10

11 Hib, Rotavirus and Polio Recommendations Haemophilus influenzae type B is another encapsulated organism which may cause meningitis Rotavirus is a virus which causes profound diarrhea in young infants. Poliovirus is nearly absent from the US but it can still be found endemic in some areas Hib childhood vaccination, splenectomy and immunocompromised Polio childhood vaccination and travelers to endemic areas Rotavirus vaccine Live oral vaccine Must complete entire series by 8 months old General, for all vaccines Mild acute illness +/ fever Mild to moderate local reaction, low grade or moderate fever after previous dose Current antimicrobial therapy Convalescent phase of illness Preterm birth Recent exposure to an infectious disease History of penicillin allergy, other nonvaccine allergies, relatives with allergies, or receiving allergen extract immunotherapy Record Keeping update Review of MCIR Pharmacist accessibility to MCIR Changes related to the 2012 state budget MCIR will continue to be funded but not through the Healthy Michigan Fund Integration between MCIR and pharmacy computer systems Final A 38 year old woman, Sarah, her 13 year old daughter, Mara, and 5 year old son, Carl, have come in for flu shots. In reviewing the records you see they have received all their childhood vaccinations, Sarah had a Td 6 years ago but nothing else, Mara has not received any vaccinations since 8 years old when she received a Td for a puncture wound and Carl has received nothing since he was 2. None have any medical problems or are taking any medications. Sarah smokes 3 cigarettes a day. Final Question Use the immunization schedule to make recommendations for which vaccinations you think the mother, daughter and son need. 11

12 QUESTIONS 12