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  • 1. Adult Vaccinations: An UpdateBernard J Dunn School of PharmacyShenandoah University03/13/2013
  • 2. Objectives● Evaluate pneumococcal vaccine Menveo®● Compare Menveo® with other meningococcalvaccines● Provide new Advisory Committee on ImmunizationPractices (ACIP) recommendations for vaccinations
  • 3. Menveo®● FDA approved 2010 for active immunization againstinvasive meningococcal disease caused by Neisseriameningitidis serogroups: A, C, Y and W-135.● Initially, Menveo® was only indicated for use for persons11-55 years old. Coverage expanded in June 2011 toinclude children ages 2-10.● Administered as a single dose IM.Menveo package insert, 2011
  • 4. Menveo - EfficacyClinical Trial for the safety and efficacy of Menveo in children 2-10 years oldstudy designMENVEO in subjects 2-55 years old was assessed by comparingthe serum bactericidal antibody (SBA) responses to immunizationwith Menveo®● Two randomized, multicenter, active controlled clinical studiescomparing the hSBA responses following one dose of Menveo® orMenactra®.● Primary endpoint - hSBA seroresponse to each serogroup 28 days aftervaccination. Seroresponse was defined as:- post vaccination hSBA titer of ≥1:8 for subjects with a baseline hSBA titer of <1:4 ORat least 4-fold higher than baseline titers for subjects with a pre-vaccination hSBA titer ≥1:4.Menveo package insert, 2011
  • 5. Menveo - Efficacy● Population – (1170) Menveo® and (1161)Menactra®● Demographics were similar between the twogroups
  • 6. Menveo - Efficacy● Results (28 days after vaccination)Ages 2-5 (seroresponse in %)Menveo® was non-inferior to Menactra® for subjects with aseroresponse for serogroups C (60 vs. 56), W-135 (72 vs. 58) and Y(66 vs. 45) , but not for serogroup A (72 vs. 77)Ages 6-10Menveo® was non-inferior to Menactra® for subjects with aseroresponse for serogroups C(63 vs. 57), W-135 (57 vs. 44) and Y(58 vs. 39) , but not for serogroup A (77 vs. 83)
  • 7. Menveo - EfficacyAges 11-18Menveo® was non-inferior to Menactra in all four serogroups A(75 vs. 66), C (76 vs. 73), W-135(75-63) and Y(68 vs. 41) for theproportion of subjects with a seroresponse.Ages 19-55Menveo® was non-inferior to Menactra in all four serogroups A(67 vs. 68), C (68 vs. 60), W-135(50-41) and Y(56 vs. 40) for theproportion of subjects with a seroresponse.
  • 8. Menveo® - SafetyStudy design● Ages 2-10: four randomized clinical trials.● Population - 3181 subjects received Menveo® and 2116 received either Menomune®or Menactra®.● 51% male in both populations and mean age was 5.2 years old.● Safety of a second dose of Menveo administered 2 months following a first dose wasassessed in 351 children ages 2-5 years old.● Ages 11-55: five randomized trials.● Population - 5286 subjects received Menveo® , 209 subjects received Menomune®and 1757 patients Menactra®.● Average ages on Menveo® were 23.5 years (SD 12.9 years), Menacta® 29.2 years (SD13.4), Menomune® 14.2 years (sd 1.8 years)● Subjects were monitored for 7 days following vaccinations, 28 days for adverseevents and serious adverse events 6 months after vaccination.
  • 9. Menveo● Results - Adverse reactionsAges 2-10Injection site pain(31%), erythema (23%), irritability (18%),induration (16%), sleepiness (14%), malaise (12%), andheadache (11%)Ages 11-55Injection site pain (41%), headache (30%), myalgia (18%),malaise (16%) and nausea (10%)These adverse reactions when compared to Menactrawere not significantly different.
  • 10. Menveo®-pregnancy● Pregnancy Category B – Animal Studies performed in females rabbits at a dose 20xthe human dose revealed no evidence of impaired fertility or harm to the fetus.● Among 5065 adolescent and adult women enrolled:– 43 were found to be pregnant during the 6-month follow-up period aftervaccination.– 37 pregnancies occurred among 3952 Menveo® recipients7 spontaneous abortions, no congenital anomalies– 6 pregnancies occurred among 1113 Menactra® recipientsno spontaneous abortions, one congenital anomaly (hydrocephalus)● Women who are pregnant or become aware that they are pregnant at the time ofMenveo injection should contact the Novartis Vaccines and Diagnostics Inc.pregnancy registry at 1-877-311-8972
  • 11. Menveo® vs Menactra®Menveo® Menactra®Pathogen N. meningitidis N. meningitidisSerotypes A, C, Y, W-135 A, C, Y, W-135Age 2-55 y/o 9 months – 55 y/oCost 5 pack-single dose vials:$110.725 pack-single dose vials:$112.72Bottom Line:●Menveo is non inferior to Menactra in the prevention of serogroups A, C, Y, W-135caused by N. meningitidis. At this moment, based on cost and its age of approval, Iwould not recommend it for the addition to the formulary. More studies on its long-term safety profile would be beneficial for re-evaluation.
  • 12. Menveo® vs. Menomune®Menveo® Menomune®Pathogen N. meningitidis N. meningitidisSerotypes A, C, Y, W-135 A, C, Y, W-135Age 2-55 y/o ≥2 y/oCost 5 pack-single dose vials:$110.725 pack-single dose vials:$112.72
  • 13. Menhibrix®● Approved June 2012 for infants and children ages 6weeks - 18 months, for prevention of invasivedisease caused by Neisseria meningitidis serogroupsC and Y and Haemophilus influenzae type b.● Administered as four IM doses at 2, 4, 6 and 12through 15 months of age. The first dose may begiven as early as 6 weeks of age. The fourth dosemay be given as late as 18 months of age.
  • 14. New vaccines 2013● Flublok® (influenza vaccine)● Approved January 2013● Trivalent influenza vaccine made using an insect virus (baculovirus) expressionsystem and recombinant DNA technology – does not use the influenza virus or eggsin its production.● Indication - active immunization against influenza virus subtypes A and type B● Flublok® is approved for use in persons 18 through 49 years of age.Flublok® package insert, 2013
  • 15. Vaccine recommendation updatesPneumoccocal Polysaccharide Vaccine2012● Individuals 65+ y/o vaccinated with PPSV23 before age 65 years and for whom at least 5 years haspassed since their previous dose should be vaccinated with PPSV.2013● Individuals who have received 2 doses of PPSV23 before age 65 years are recommended to receivePPSV23 at age 65 years, as long as it has been 5 years since the most recent dose.● Pneumococcal Conjugate Vaccine 13 (PCV13) vaccine – recommended for adults aged 19 years orolder with immunocompromising conditions including chronic renal failure, cerebrospinal fluidleaks and cochlear implants.● Individuals not previously vaccinated with PCV13 or PPSV23 should receive a single dose of PCV13
  • 16. Vaccine recommendations updatesPneumoccocal Polysaccharide VaccineNotes- Individuals 65 years and older, individuals ages 2-64 with long termhealth problems including: heart disease, lung disease, sickle cell disease,diabetes, alcoholism, cirrhosis, leaks if CSF should get the vaccine.● Individuals ages 2-64 with immunocopromising conditions e.g. kidneyfailure, HIV, organ transplant should also be vaccinated.● Individuals ages 2-64 who on long term steroids, oncology drugs shouldalso be vaccinated.● Adults 19-64 years old who are either smokers or have a history of asthma
  • 17. Vaccine recommendations updatesInfluenza2012● Infants 6 months or older can receive trivalent inactivated vaccine (TIV).● Health care professionals caring for persons in a protected environment should receive TIV.● Health care professionals younger than 50 y/o may receive either the live attenuatedinfluenza vaccine or TIV as long as they do not have any contraindications.2013● The influenza vaccination footnote (footnote 2) will now use the acronym IIV for inactivateinfluenza vaccine.● The acronym TIV has been dropped for trivalent inactivated vaccine.● 2013–14 influenza season – LAIV will be available only in a quadrivalent formulation; IIV maybe available in both trivalent and quadrivalent formulations.Notes- Pregnant women, children 6 months and older, health care personnel, persons living in anursing home, individuals with a weakened immune system or have a long term chronicillness should be vaccinated.
  • 18. Vaccine recommendations updatesTetanus, Diptheria, Pertussis (Tdap)2012● Persons who are close contacts of infants younger than 12 months of age e.g.parents, grandparents, and child care providers and who have not received Tdappreviously are recommended to receive the vaccine.● ACIP recommends pregnant women to receive the vaccination preferentially after 20weeks gestation.● Other adults in close contacts of children younger than 12 months are also advised toreceive a one-time dose of Tdap vaccine.2013● Adults aged 65 years or older should receive the vaccine.● Pregnant women are now recommended to receive the Tdap vaccine with eachpregnancy.Notes● Recommended as a booster to the DTaP vaccine in children 11-12 years old.● Adults 19-64 years old should also receive one dose of Tdap and a booster Tdvaccine every 10 years.
  • 19. Vaccine recommendation updatesHuman Papillomavirus (HPV) vaccine2012● While the HPV vaccine is not recommended for health careemployees, they should receive the vaccine if they are inthe specified age group.● Males 11-12 years or males 13-21 years requiring catch upvaccination may receive the quadrivalent humanpapillomavirus (HPV4) vaccine.● Males aged 22 to 26 years may also be vaccinated withHPV4 vaccine.2013● No changes
  • 20. Vaccine recommendation updatesHuman Papillomavirus (HPV) vaccineNotesGardasil® is approved for:- Females ages 9-26 to protect against cervical cancerand to prevent genital warts- Males ages 9 - 26 to prevent genital wartsCervarix® is approved for:- Females age 10 - 26 to help protect against cervicalcancer
  • 21. Vaccine recommendations updatesHerpes Zoster vaccination2012● Although zoster vaccination is not specificallyrecommended for health care employees, they shouldreceive the vaccine if they are in the recommended agegroup.● The Herpes Zoster vaccine is FDA-approved for use inpersons aged 50 years or older – however ACIP continuesto recommend that vaccination begin at age 60 years.2013● Persons ≥ 60 years with or without underlying healthconditions are recommended to receive the Zoster vaccine.
  • 22. Vaccine recommendations updatesMumps, Measles, Rubella (MMR) Vaccine2013● A health care provider diagnosis of measles, mumps, or rubella is not consideredacceptable evidence of immunity.● Previously, a provider diagnosis of measles or mumps but not rubella was consideredacceptable evidence of immunity.Notes- Children 12-15 months should get the vaccine and a second shot should beadministered when the child is 4-6 years old- Adults born after 1956 should be vaccinated
  • 23. Vaccine recommendations updatesHepatitis A and B2012● Hepatitis B vaccination is now recommended forindividuals with diabetes who are ≤60 years or ifover 60 and requires glucose monitoring.2013● The hepatitis A vaccination is now recommendedfor persons with a history of either injection ornon-injection illicit drug use.
  • 24. Vaccine recommendations updatesHepatitis ANotes- Recommended for all children 1 year and older, people travelling to Asia, Africa,South America and the Caribbean- Also recommended for individuals at higher risk including IV drug users, personswith chronic liver disease, men who have sex with other men, employees of childdaycare centers, persons living in long term care facilities- If you have had hepatitis A in the past this vaccination is not required.Hepatitis BNotes- High risk individuals including health care workers, persons on dialysis, people
  • 25. Vaccines in pregnancyRecommendedInfluenza (Inactivated), TdapContraindicatedInfluenza (LAIV), MMR, Varicella, Zoster● Hepatitis B may be recommended in some circumstances: HIVrisk, treatment for STD, recent or current injection drug use● Meningococcal and Pneumococcal lack sufficient data forrecommendation during pregnancy
  • 26. References1. Novartis Vaccines and Diagnostics, Inc. Menveo® package insert. Cambridge, MA:2011, January2. Anon. CDC Vaccine Price List. (http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html) . Updated 7 March 2013. Accessed 19 March 2013.3. GlaxoSmithKline Biologicals, Inc. Menhibrix® package insert. Pixensart, Belgium:20124. Anon. Recommended Adult Immunization Schedule: United States, 2012*. AnnIntern Med. 2012 Feb;156(3):211-217.5. Anon. Recommended Adult Immunization Schedule: United States, 2013* . Ann.Internal Med. 2013 Feb;158(3):191-199.6. Anon. Guidelines for Vaccinating Pregnant Women. (http://www.cdc.gov/vaccines/pubs/preg-guide.htm#hepa) Updated March 2013. Accessed 19March 2013.7. Anon. Protein Science Corp. Flublok® package insert. Meriden, CT:2013, January
  • 27. Questions