An Immunization Safari: Highlights from the 2015 ACIP Adult Immunization Schedule HANDOUT

Transcription

1 An Immunization Safari: Highlights from the 2015 ACIP Adult Immunization Schedule HANDOUT Sandra Adamson Fryhofer, MD, MACP Practicing General Internist, Atlanta, GA Adjunct Associate Professor of Medicine, Emory University School of Medicine Past President, American College of Physicians ACP Liaison to ACIP

2 ACIP Adult Immunization Schedule

3 ACIP (Advisory Committee on Immunization Practices) 15 voting members (appointed by DHSS Secretary) 8 ex officio reps; 30 non-voting liaisons Charge: immunization recommendations for vaccine preventable diseases for the country. meets three times a year at CDC ACIP work groups for specific vaccines (present recommendations to ACIP) ACIP recs do not become official CDC policy until: signed by the CDC director, accepted by DHSS Secretary & published in MMWR

4 ACIP- Evidence based approach October 2010, adopted an evidencebased process -GRADE (Grading of Recommendations, Assessment, Development and Evaluation). evaluates quality of evidence benefits/harms values and preferences of affected populations economic impact

5 Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Types of Recommendations Category A recommendation For all persons in an age or risk factor based group Category B recommendation For individual clinical decision making Evidence tables summarize the benefits and harms and the strengths and limitations of the body of evidence.

6 ACIP recs: coverage clout under new ACA plans New health plans will be required to cover new ACIP recommendations made after September 2009 without cost-sharing in the next plan year that occurs one year after the date of the recommendation. Does not apply to Medicare.

7 FDA versus ACIP ACIP recommendations are not always consistent with FDA licensing. FDA (Food and Drug Administration) licensing ACIP (Advisory Committee on Immunization Practices) ACA: ACIP recs have coverage clout New health plans: ACA requirement coverage without cost sharing one year after recommendation is made. Does not apply to Medicare.

8 FDA Licensing Process IND: Investigational New Drug Application Includes protocol for human studies Preclinical licensure trials: Phase 1 studies (small study) Phase 2 Studies (larger study- hundreds of patients) Phase 3 Studies (vaccine effectiveness and safety- thousands of patients) BLA: Biologics License Application request Accelerated Approval Pathway (fast track) based on early evidence of effectiveness May not satisfy comprehensive ACIP GRADE evidence assessment

9 Vaccine Information Statements (VIS)

10 FLU FACTS On average each year: Up to 20% of US get flu More than 200,000 hospitalized Up to 49,000 die

11 FLU: Everyone 6 months & older needs flu vax every year

12 Flu Vaccination MAKEOVER for Trivalent vaccines will contain: A/California/7/2009 (H1N1)-like virus (same as ) A/Switzerland/ /2013 (H3N2)-like virus (NEW) B/Phuket/3073/2013-like virus-yamagata lineage (NEW) Quadrivalent vaccines: the above + B/Brisbane/60/2008-like virus- Victoria lineage(same as )

13 Flu Vaccination for Adults When more than one type of vaccine is appropriate and available, ACIP does not express a preference for use of any particular product over another.

14 Flu Prevention: Which flu vaccine to give? Inactivated flu shot High dose Intradermal Needleless Nasal flu vaccine

15 High dose flu shot for Seniors (Fluzone High Dose) for seniors 65 and older Inactivated vaccine contains four times more hemaglutinin per dose than standard flu vaccine designed to improve immune response. Downsides More injection site reactions cost (almost double the price) Covered by Medicare B : CPT code 90662, admin code 90471

16 Efficacy of High-Dose versus Standard- Dose Flu Vaccine in Older Adults NEJM 2014; 371: flu seasons / 26 centers (US & Canada) 32,000 adults, 65 & older : low flu activity- good match between vaccine & circulating strains : high flu activity -mismatch between vaccine & circulating strains Results: High dose flu vaccine better antibody response, less likely to get sick (lab confirmed flu) relative efficacy 24.2% over standard dose

17 Intradermal Flu Vaccine: Fluzone Intradermal: age (going all quadrivalent in )

18 Needle Free Technology PharmaJet Stratis No Needles Flu vaccine Delivers an injectable liquid Affluria flu vaccine-- narrow, precise fluid stream injection, penetrates the skin in 1/10 second Reusable,spring-operated, requiring no external power source Sterile, single-use, auto-disabling syringe injection site reactions were more common than with sterile needle & syringe Age 18-64

19 Nasal Flu Vaccine (LAIV) age 2-49 & healthy Live attenuated nasal influenza vaccine Option: healthy, non-pregnant adults < 50 Not for pregnant women (different from package insert) Pregnant women: high risk for flu complications but should only receive inactivated vaccine.

20 Mild (hives only) Egg Allergy Can get the inactivated flu shot. That s what s been studied. They can t get the nasal flu vaccine. Person giving the vaccine should be familiar with manifestations of egg allergy Observe patient for at least 30 minutes May receive IIV, cciiv, RIV3

21 Cell Culture based Inactivated Influenza Vaccine (cciiv3, Flucelvax by Novartis) Trivalent Almost egg-free Ovalbumin no directly measured Estimated to contain max of 5x10 (-8) mcg/0.5 ml dose ONLY for 18 and older

22 Recombinant Influenza Vaccine (RIV 3, Flublok) Trivalent For 18 and older Totally egg free Can be given to age appropriate with egg allergy of any severity

23 Severely Egg Allergic Journal of Allergy and Clinical immunology 2012; 130: e review of published data 4172 egg allergic patients with history of severe allergic reactions No anaphylaxis after IIV3 Some milder reactions did occur HOWEVER, occasional cases of anaphylaxis in egg allergic people have been reported to VAERS (Vaccine Adverse Event Reporting System)

24 Babies and FLU Babies under six months old: too young to get flu shot too young for anti-virals. little ones are most at risk more likely to be hospitalized more likely to die if they get the flu. Family members and care givers of babies need flu vaccination.

25 Tdap : A Family Affair (tetanus/diptheria/pertussis) Last 10 years- surge in pertussis related deaths in infants Cocoon in circle of familial protection Household members are to blame for 83% of transmission

26 Who needs Tdap? Adolescents need Tdap booster Unvaccinated dads need one time Tdap booster Grandparents need one time Tdap booster Pregnant women need Tdap in each pregnancy (in late 3 rd trimester between weeks)

27 February 2012 ACIP Tdap for Adults : Universal Recs Adults age 65 & + had higher rates of hospitalization than those age Expand Tdap booster to ALL adults age 65 and older not just those with close contact with infants Universal Tdap booster for ALL adults!

28 Tdap vaccines: Age indications are different Licensed for single dose; (Multiple Tdap boosters is off -label use ) BOOSTRIX (GlaxoSmithKline Biologicals) * ADACEL (sanofi pasteur) Age Indication (years) 10 and older 10 through 64 Usage Active booster immunization for prevention of tetanus, diphtheria, and pertussis as a single dose * Product label available at Product label available at 5

29 ACIP guidance statement MMWR, June 29, 2012 / 61(25); vaccinating with either product is preferable to a missing a vaccination opportunity. Currently, only a single booster dose of Tdap is recommended (except for pregnancy) October 2012: Pregnant women need Tdap in EACH pregnancy (Multiple Tdap boosters is off label use )

30 HPV related cancers Females: cervical, vulvar, and vaginal cancer Males: penile cancer Both males and females: anal cancer & oropharyngeal cancer

31 HPV Vaccines HPV 2v vaccine: 16,18 Bivalent Vaccine FDA approved only for females in 2009 Brand name:cevarix (GlaxoSmithKline) HPV 4v vaccine- 6, 11, 16, 18 Quadrivalent Vaccine FDA approved in 2006: males & females Brand name : Gardasil (Merck ) HPV 9v (NEW Nine Valent) vaccine 6,11,16,18 plus 31,33,45,52,58 FDA approved in Dec for males (9-15) & females (9-26) Brand name : Gardasil 9 (Merck )

32 HPV Types 16 and 18 (covered by all 3 vaccines) Cause majority (64%)of all HPV cancers 21,300 cases of cancer each year: Males: 63% of all HPV related cancers in males, Females: 65% of all HPV related cancers 66% of all cervical cancers

33 HPV Types 6, 11 (covered by HPV 4v and HPV 9v) Cause 90% of all cases of anogenital warts.

34 HPV Types 31, 33, 45, 52, 58 (covered only by HPV 9v) 10% of HPV related cancers- about 3400 cancer cases each year- Males: 4% additional cancer protection. Females: 14% additional of HPV cancers overall 15% of cervical cancers 25% of cervical pre cancers. Most of the added protection is for females

35 HPV related cancers in US Cancers overall: HPV 16 or 18: 64% of cancers Five extra types (HPV 31, 33, 45, 52, 58): 10% 14% for females / 4% for males HPV 9: 78% for females/ 68% for males Cervical cancer: HPV 16 or 18: 66% Five extra types (HPV 31, 33, 45, 52, 58): 15% HPV 9 vaccine prevents : 81% Cervical pre-cancers CIN2 : HPV 16 or 18: 50% Five extra types (HPV 31, 33, 45, 52, 58): 25% Anogenital warts: HPV 6 or 11 : 90%

36 ACIP recommendation for HPV vaccination (March 27, 2015 MMWR) Three HPV vaccine doses (0, 1-2 months, 6 months) Routinely start at age 11 or 12 (can begin as early as age 9) All females: through age 26 All males: through age 21 (through age 26: immunocompromised males, HIV, MSM) FDA approval of HPV 9v for males is only through age 15, however ACIP reviewed on HPV9v in males Which can be used start, continue, or complete the series? Females: use HPV2v, or HPV 4v or HPV 9v Males: use HPV 4v or HPV 9v

37 Guidance on ACIP website: Additional HPV 9 vaccine doses / Completing HPV vaccination There is NO ACIP recommendation for routine additional HPV9v vaccination for anyone that s already completed HPV 4v or HPV 2v vaccination series. No serious safety concerns giving HPV 9 after 3 dose HPV 4v series (but more injection site reactions) Additional HPV 9v protection: mostly limited to females (cervical cancers & pre-cancers)

38 HPV vaccine FAQ Q- Can you get HPV infection from getting the vaccine? A No, the vaccine does not contain any viral DNA so there is no way to become infected with the virus by getting the vaccine.

39 HPV vaccine FAQ Q- Do you have to do pregnancy test before giving vaccine? A No, but neither vaccine should be given to women who are pregnant or are planning to get pregnant soon.

40 HPV vaccine FAQ Q- Can you get HPV vaccine while nursing? A Yes, ACIP says lactating women can receive HPV vaccine.

41 HPV vaccine FAQ Q- Can the HPV vaccine be used to treat abnormal pap smear? A- NO. They are not meant to be a treatment for HPV infection or HPV related disease.

42 HPV vaccine FAQ Q- Do you still have to get cervical cancer screening if you get HPV vaccine? A- Yes. HPV Vaccines are prophylactic vaccines. They work best if given before exposure to HPV virus. They are not meant to be a treatment for HPV infection or HPV related disease. Women must still get regular cervical cancer screening. (begin at age 21)

43 Hep B FACTS Chronic Infection 800,000 to 1.4 million people suffer from it 3000 cases of acute Hepatitis B each year Can lead to liver cancer

44 Hepatitis B Transmitted by exposure to infected blood or body fluid Who needs Hep B vax? Hepatitis B series (3 dose) : All health care workers; All diabetics < 60; > 1 sex partner over last 6 months

45 Shingles FACTS If had chickenpox at risk for shingles More that 90% of all adults in the United States infected with varicella zoster virus one million cases / yr Lifetime risk: 30% Risk increases with age (starting at age 50)

46 Key HZ symptom: Pain Pain prior to rash onset: 84% of cases Starts as abnormal skin sensation, itching or tingling Precedes rash by 1-5 days but occasionally weeks or more Diagnostic dilemmas & work-ups (e.g., cardiac, gallbladder) Pain once rash develops: 89% of cases

47 Shingles Pain excruciating (like renal colic, childbirth) aching, burning, stabbing, shock-like Continuous or paroxysmal Altered or painful sensitivity to touch (paresthesia, dysesthesia) Provoked by trivial stimuli like bed sheets (allodynia) Exaggerated, prolonged response to pain (hyperesthesia) Unbearable itching Post herpetic neuralgia (PHN) May persist months / years

48 Risk Factors for PHN (Post Herpetic Neuralgia) Gender: risk greater in women Dermatome possibly increased after HZ involving eye Immunosuppression? : NO NOT strongly associated with PHN Age is the key risk factor for developing PHN. rare in HZ patients <40 yrs Risk of pain at >30 days: 14.7-fold in HZ patients >50 yrs Risk of pain at >60 days: 27.3-fold in HZ patients >50 yrs Risk of pain at >60 days: 12% for each incremental yr of age Increasing age increases risk of shingles AND risk of progression to PHN.

49 The Shingles Prevention Study NEJM June 2, ,500+ patients 60 and older Vaccine Effectiveness: reduced incidence shingles by 51% reduced incidence of PHN by 66.5% risk of PHN (post herpetic neuralgia) increases after age 50.

50 Shingles vaccine: for prevention of shingles Who should get it? May FDA approved: Age 60 & older October 2006: ACIP recommends dose at age 60+ March FDA approved- expanded to works even better in this younger age group Reduced shingles risk by nearly 70% (69.8%) Vaccine supply problems: June 2011: ACIP still recommends start at age 60+ Vaccine supply stabilized Concerns that those vaccinated at younger age (50-60) might not be protected at older ages when the risk of severe disease is higher ACIP says : Start vaccinating at age 60+ (Cost: $187)

51 Shingles Vaccine: ACIP Recommendations You don t have to check varicella history or titers before administering HZV Just about everyone 60 has serologic evidence of prior varicella, even if they do not recall having the illness No evidence that giving Shingles vaccine to someone without prior varicella raises safety concerns Determining varicella history: a major and unnecessary barrier to vaccination

52 Varicella-Zoster: How does Shingles vaccine differ from the Chickenpox vaccine? Chickenpox vaccine- Varivax FDA approved in March 1995 Shingles vaccine- Zostavax FDA approved May 2006 Both are made from Oka Merck strain of live attenuated varicella zoster virus. Shingles vaccine (Zostavax) is about 10 times stronger.

53 Chickenpox vaccine (Varivax) 2 doses, at least 4 weeks apart Generally- if born in U.S. before 1980 you are considered to be immune - But this does not apply to health-care personnel and pregnant women,- Birth before 1980 should not be considered evidence of immunity Check the footnotes on the adult schedule for further details. Target new mothers and women of child bearing potential

54 Shingles (Herpes Zoster) Vaccine : Storage & Handling Must be stored frozen Must be stored at freezer temperature ( 5º F) HZV is the ONLY freezer-requiring vaccine for adults Need dedicated freezer only: combined fridge/freezer models may not work can reduce fridge temps below freezing and ruin refrigerated vaccines Unused HZV must be discarded 30 min after reconstitution

55 Who should NOT get it? (Shingles vaccine) live attenuated virus vaccine It should NOT be given to people with immune system problems Women who are or may be pregnant Anyone allergic to vaccine components including gelatin, neomycin Contraindicated in those with immune system problems including patients on high dose steroids (20 mg or + daily)

56 HEADS UP: Investigational Subunit Adjuvanted Shingles Vaccine (HZ/su) NEJM 2015; 372: Randomized, placebo-controlled phase 3 study More than 15,000 patients, age 50 and older Conducted in 18 countries Study indicated vaccine efficacy of 97.2% More injection site & systemic reactions as compared to placebo Duration of protection? So far- mean follow up 3.2 yrs Trial underway to compare with currently available live attenuated herpes zoster vaccine

57 Pneumococcal Infection FACTS about Streptococcus pneumonia (aka the pneumococcus) Kills 4000 in US each year (mostly adults) Leading cause of serious illness: bacteremia, meningitis, pneumonia Source: MMWR Oct 12, 2012,

58 Two Pneumococcal vaccines- FDA approved for adults Pneumococcal Polysaccharide vaccine (PPSV 23- Pneumovax 23 by Merck) licensed for routine use in adults 50 & older and age 2 49 with certain risk factors Private sector cost: $ 72 (source CDC) Pneumococcal Conjugate vaccine (PCV 13- Prevnar by Pfizer) FDA approved for use in adults age 50 and older in December 2011 NOTE: Prevnar 13 is NOT FDA approved for age 18 to 49! Private sector cost: $152 (source CDC)

59 Invasive Pneumococcal Disease: Risk is increased in immunocompromised adults MMWR Oct 12, 2012, **Risk in immunocompromised can be 20 times than for adults without high risk medical conditions** June 2012: ACIP recommended routine PCV 13 conjugate for immunocompromised adults: (off label use- not FDA approved for adults < 50) This recommendation applies to immunocompromised asplenic high risk immunocompetent (CSF leaks / cochlear implants)

60 Invasive Pneumococcal Disease: Risk is increased in older adults MMWR Oct 12, 2012, **Risk of invasive disease in older adults is 10 times higher than in younger adults ** Risk of invasive disease Adults 18-64: 3.8 per 100,000 Adults 65 &older: 36.4 per 100,000 ( 10 times higher )

61 Pneumococcal Infection in Adults 2013: Estimated 13,500 cases of invasive pneumococcal disease (IPD) in adults 65 and older In adults 65 and older: PCV 13 serotypes were to blame for 20-25% of IPD 10% of community-acquired pneumonia (CAP) Potentially preventable with PCV 13 vaccine ACIP recs are now evidence based Wait for CAPiTA results--presented to ACIP June 2014

62 CAPiTA Community Acquired Pneumonia Immunization Trial in Adults Randomized controlled trial of PCV 13 85,000 seniors: PCV 13 or placebo PCV 13 was effective! 75% effective in preventing vaccine type invasive pneumococcal disease (IPD) 45% effective in preventing vaccine type non bacteremic pneumonia (NBP)

63 Emergency ACIP Meeting on August 13, 2014 Purpose: vote on routine use for PCV 13 for all seniors VOTE: 13 to 2- in favor of Routine PCV 13 vaccination for all age 65 /+ (in addition to PPSV 23) Based on strong quality evidence

64 Pneumococcal Vaccine Timing & interval rules PCV13 & PPSV23 should not be given at same visit. When possible, administer PCV 13 first. CURRENTLY (when indicated), only a single dose of PCV13 is recommended for adults. Intervals: CONFUSING PCV 13...( ) PPSV23 --For immunocompromised/asplenic/ cochlear implants, CSF leaks: 8 weeks --For 65 & older: (OLD August 2014: 6-12 months) NEW June 2015: at least a year.harmonizes with Medicare coverage PPSV 23 (at least a year) PCV 13 PPSV 23 (if revax needed: 5 years) PSV23

65 HARMONY: Pneumococcal vaccination is covered under Medicare Part B Source: Medicare Part B (Medical Insurance) covers a pneumococcal shot to prevent pneumococcal infections also covers a different second shot 11 months after the first shot. ACIP Recs (June 2015) for 65 and older PCV 13 at least a year..ppsv23 PPSV23 at least a year.pcv13

66 Pneumococcal Vaccination Review Who needs which vaccine (s) and when! HINT: Check the Adult Schedule footnotes!

67 Age 19-64: Immunocompetent Chronic medical conditions: PPSV 23 only Chronic heart disease (not hypertension) Chronic lung disease (including asthma) Chronic liver disease (including cirrhosis & alcoholism) Diabetes Miscellaneous: PPSV 23 only Smokers Reside in nursing home of long term care facility

68 Age 19-64: High Risk Immunocompetent PCV 13, then one dose PPSV 23 Cerebrospinal fluid leaks cochlear implant

69 19-64: Immune system problems Need PCV 13 then PPSV 23 (8 week interval), then revax with 2nd PPSV 23dose in 5 years: Immunocompromising conditions: Congenital or acquired immunodeficiency HIV (B cell, T cell, complement deficiencies, phagocytic disorders except chronic granulomatous disease) Chronic renal failure/ nephrotic syndrome Leukemia, lymphoma, Hodgkin s, generalized malignancy, multiple myeloma Solid organ transplant Iatrogenic immunosuppression( long term steroids or radiation therapy) Functional or anatomic asplenia (including sickle cell)

70 Adults Age 65 and older Need both PCV 13 (if not already received) and (interval of at least a year) PPSV 23 NOTE: If already received PPVS 23, wait interval of 5 years before vaccinating again with PPSV 23.

71 In Footnotes: Pneumococcal vaccinewhether and when to revaccinate with PPSV 23 For patents under age 65: one time PPSV 23 revaccination after five years for high risk chronic renal failure, nephrotic syndrome, sickle cell disease, asplenic immunocompromised patients. When previously PPSV23 vaccinated patients reach age 65: One time PPSV 23 revaccination: if more than five years have passed since the last vax & patient < 65 at time of primary vaccination.

72 Meningococcal Disease Facts Each year: estimated 1,400-2,800 cases occur in the United States. 10%-14% of cases are fatal. Of patients who recover : 11%-19% have permanent hearing loss, mental retardation, loss of limbs, or other serious sequelae.

73 Meningococcal vaccine: Adult Immunization Schedule 2012 First-year college students up through age 21 years who are living in residence halls should be vaccinated if they have not received a dose on or after their 16th birthday.

74 Meningococcal vaccination Five main serogroups of Neisseria meningitidis : A, B, C, Y, and W B, C, Y: cause most disease in US Meningococcal Vaccines covering A,C,W-135, Y Polysaccharide vaccine: Menomune [MPSV4] Conjugate vaccines: Menactra [MenACWY-D] Menveo [MenACWY]) None of them cover serotype B

75 Meningococcal B Facts Men B causes half of all cases of meningococcal disease in those age Each year, about young people age get sick with Men B. strikes quickly, unforgiving, often deadly. Men B NOT limited to college campuses. About 30-60% of cases occur in young people NOT in college.

76 Meningococcal B outbreaks Princeton University: March cases (students) and 1 case (prospective student) Dec 2013: > 5000 students received 1 st dose Feb 2014: > 4500 students received 2 nd dose University of California, Santa Barbara : November confirmed cases Feb & March 2014: > 9000 students received 1 st dose

77 Meningococcal B vaccine Used during recent outbreaks IND (Investigational New Drug) application to FDA to use Serogroup B meningococcal vaccine- licensed in Europe, Canada, & Australia

78 Men B Vaccines MenB-FHbp: brand name Trumenba (Pfizer) three-dose series (1, 2, and 6 months) FDA approved on October 29, 2014 MenB-4C brand name Bexsero (Novartis) two-dose series (0 and 1-6 months) FDA approved on January 23, 2014 already licensed in 37 other countries. Both are FDA approved only for those age

79 Men B vaccination (June 12, 2015 MMWR) ACIP expanded age indication to anyone age 10 & older at increased risk of Men B disease: Category A recommendation Patients with complement deficiencies Patients with anatomic or functional asplenia Microbiologists at risk through work exposure Those exposed during outbreaks.

80 NEW ACIP Recommendation for Men B Vaccination (June 24, 2015) Category B recommendation May be administered to age Preferred vaccination age range: Either vaccine product may be used The same product should be used for all doses in the series. Both Pfizer & GSK have studies underway looking at need for a booster.

81 Mumps can have serious consequences (after puberty): inflammation of the testicles (orchitis) Can (rarely) lead to sterility inflammation of the brain/spinal cord covering (encephalitis / meningitis) inflammation of the ovaries (oophoritis) and/or breasts (mastitis) can cause deafness (temporary or permanent)

82 MMR Vaccine Measles Mumps Rubella If unsure if you re immune : get antibody titers checked or get the shot!

83 ACIP Adult Immunization Schedule (Read the footnotes!)

84 Travel Immunizations Country specific travel immunization & health recommendations Yellow fever Typhoid Hepatitis A Japanese encephalitis Malaria prophylaxis (medication- there is not a vaccine) Meds in case get Traveler's diarrhea Insect repellant (DEET)

85 ?? Questions?? THE END