2/16/2015 IMMUNIZATION UPDATE Kelly Ridgway, RPh February 21, Today s Overview NEW RECOMMENDATIONS

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1 IMMUNIZATION UPDATE 2015 Kelly Ridgway, RPh February 21, 2015 Today s Overview Pneumococcal Vaccine Recommendations Meningococcal Vaccine Recommendations HPV Vaccine Recommendations Patient Cases Summary Assessment Test NEW RECOMMENDATIONS 1

2 PNEUMOCOCCAL VACCINE RECOMMENDATIONS PNEUMOCOCCAL VACCINE HISTORY 1977: 14 valent polysaccharide vaccine 1983: 23 valent polysaccharide vaccine (PPSV23) 2000: 7 valent polysaccharide conjugate vaccine (PCV7) 2010: 13 valent polysaccharide conjugate vaccine (PCV13) replaced PCV7 and expanded the number of antigens PCV 13 RECOMMENDATIONS Prevnar 13 (Wyeth/Pfizer) Pneumococcal CONJUGATE vaccine Replacement for PCV 7 valent vaccine Protects against 61% of strains causing invasive pneumococcal disease in children under 5 years old Vaccine Efficacy 97% effective against invasive disease 73% effective against pneumococcal pneumonia 7% reduction in otitis media cases Dose and Route 0.5 ml intramuscularly 2

3 PCV13 INDICATIONS BY AGE GROUP Infants and Children <2 years old 4 dose 2 months, 4 months, 6 months, 12 to 15 months Children 2 to 5 years of age Healthy children months who are not completely vaccinated= 1 dose Children months with certain underlying medical conditions = 1 2 doses Children 6 to 18 years of age Single dose of PCV13 given in patients with certain medical conditions Adults A single dose may be given to adults 19 years and older with certain medical conditions September 2014: A single dose should be given to all adults 65 years and older UNDERLYING MEDICAL CONDITIONS PCV 13 MINIMUM DOSING INTERVAL Pediatrics: 4 8 weeks, with at least 2 months between doses 3 and 4 Note: If PCV13 & PPSV23 are both indicated: Give PCV13 first, then PPSV23 at least 8 weeks later (if 65years and older must wait 6 to 12 months) If patient already received PPSV23, wait 1 year before giving PCV13 to avoid interference between the two vaccines 3

4 PPSV23 RECOMMENDATIONS Pneumovax 23 (Merck) Pneumococcal POLYSACCHARIDE vaccine Protects against 88% of strains known to cause pneumococcal disease More efficacious against bacteremia than pneumonia Not adequately effective in patients <2 years old Vaccine Efficacy 60% to 70% effective against invasive disease Less effective against pneumococcal pneumonia Dose and Route 0.5 ml intramuscularly or subcutaneously PPSV23 INDICATIONS Age 65 and older Age 2 through 64 years with any of the following: Lung, heart, liver, or kidney disease Immunocompromising conditions Asthma, COPD, or emphysema Diabetes Alcoholism Cigarette smoker Functional or anatomic asplenia CSF leaks Cochlear implant Resident of nursing home or LTC facility PPSV23 MINIMUM DOSING INTERVAL If first dose given before age 65, wait at least 5 years before second dose Note: If PCV13 and PPSV23 are both indicated: Give PCV13 first, and PPSV23 at least 8 weeks later (if 65 years + must wait 6 to 12 months) If patient has already received PPSV, wait 1 year before giving PPSV23 to avoid interference between the two vaccines 4

5 ACIP RECOMMENDATION SEPTEMBER 2014 Both PCV13 and PPSV23 should be administered routinely to all adults aged 65 years and older Unvaccinated patients age 65 and older should receive a dose of PCV13 first, followed by a dose of PPSV23 6 to 12 months later Patients age 65 and older previously vaccinated with PPSV23 should receive a dose of PCV13 at least one year after receipt of most recent PPSV23 dose. Recommendation will be re evaluated in 2018 and revised as needed 5

6 MENINGOCOCCAL VACCINATION RECOMMENDATIONS MENINGOCOCCAL VACCINES 1978: Meningococcal polysaccharide vaccine (Menomune ) 2005: First meningococcal conjugate vaccine (Menactra ) 2010: Second meningococcal conjugate vaccine (Menveo ) 2014: First meningococcal serogroup B vaccine approved (Trumenba ) 2015: Second meningococcal serogroup B vaccine approved (Bexsero ) MENOMUNE (SANOFI PASTEUR) Meningococcal polysaccharide vaccine (quadravalent) MPSV Available since 1978 Approved for children 2 years and older MPSV is preferred in adults 56 years and older ONLY for short term travel or in outbreak situations MPSV dose must be reconstituted with diluent provided. Shake to dissolve and inject 0.5 ml subcutaneously Multi dose vials must be used within 10 days of reconstitution; single dose vials must be used within 30 minutes of reconstitution Avoid in patients with severe latex allergies 6

7 MENACTRA (SANOFI PASTEUR) Meningococcal conjugate vaccine (quadrivalent) MCV4 Meningococcal polysaccharide diphtheria toxoid CONJUGATE vaccine Approved in 2005 for ages 9 months to 55 years. Does not require reconstitution. Draw up 0.5 ml and inject IM. Avoid use in patients allergic to diphtheria toxoid containing products Menveo (Novartis) Meningococcal conjugate vaccine (quadrivalent) MCV4 CRM Tetravalent meningococcal oligosaccharide diphtheria CRM 197 CONJUGATE vaccine Approved in 2013 for ages 2 months to 55 years Dose must be reconstituted prior to administration: Avoid use in patients allergic to diphtheria toxoid containing products MCV4 DOSING SCHEDULE Routine Vaccination: (ages years): 1 dose at age 11 12years (MCV4) 1 booster at age 16 (MCV4) Catch up: If primary dose given at age years then give booster dose at age years If primary dose given at age 16 years then no booster dose is needed 7

8 MENINGOCOCCAL SEROGROUP B VACCINES Trumenba (Pfizer) and Bexsero (Novartis) Newly approved Oct 29 th 2014 and Jan 23 rd 2015, respectively Contain 4 (Trumenba ) and 3 (Bexsero ) B serogroup strains of Neisseria meningitidis Dosing and Schedule: Both are 0.5 ml IM, pre filled syringes Trumenba is a 3 dose series for patients years given on a 0, 2, 6 month schedule Bexsero is 2 dose series for patients years given at least 1 month apart Formal ACIP review planned Feb 2015 HPV VACCINATION RECOMMENDATIONS 8

9 HUMAN PAPILLOMAVIRUS HPV Facts: 79 million people in the U.S. are currently infected with genital HPV 14 million new diagnoses each year 12,000 women are diagnosed with cervical cancer and 4,000 women die in the U.S. each year and worldwide the incidence/deaths are 470,000/233,000) 1% of sexually active men and women in the U.S. have genital warts. GARDASIL (MERCK) Tetravalent recombinant virus vaccine Protects against 4 HPV types: Types 16 and 18 (high risk) Types 6 and 11 (low risk) Protects against cervical cancer in women, as well as genital warts and cancers of the anus, vagina and vulva. Approved for females and males age 9 through 26 years old. CERVARIX (GSK) Bivalent recombinant virus vaccine Protects against 2 HPV types: 16 and 18 (high risk) Protects against cervical cancer in women Approved for females age 10 through 25 years old 9

10 *NEW* GARDASIL 9 (MERCK) Approved December 2014: Females age 9 through 26 Males age 9 through 15 Protects against 5 additional HPV types: 31, 33, 45, 52 and 58 which cause approximately 20% of cervical cancers and are not covered by previously FDAapproved HPV vaccines. HPV VACCINATION RECOMMENDATIONS Routine vaccination: Adolescents at age Series may be started as early as 9 years old at clinician's discretion Catch up vaccination: Females years old Males years old (males may be vaccinated as determined by a provider) Dosing schedule: 3 dose series: administer at 0, 1 2 months, and 6 months. Third dose should be at least 6 months after first dose HPV VACCINATION RECOMMENDATIONS Efficacy: Both Gardasil and Cervarix prevent nearly 100% of precancerous cervical cell changes caused by the types of HPV each vaccine covers for up to 8 years* after vaccination. (*likely longer, but no long term studies yet). Among males, efficacy for prevention of genital warts caused by 4 HPV types found in Gardisil was 89.3%. Possible Adverse Reactions: Pain at injection site: 20 90% Fatigue: 42 55% Headache: 45 54% Fever: 10 13% Syncope: (rare) Patient should be monitored for 15 minutes following vaccination. 10

11 PATIENT CASES PATIENT CASE 1 J.R. is a 65 year old male approaches your pharmacy counter and inquires about a pneumonia shot. The patient states they received some sort of pneumonia shot when he was diagnosed with diabetes in his early 40s. He heard on the news that he should receive this shot when he turned 65 and he is wondering if he needs another one even though he already received it. The only chronic medical conditions he has are diabetes and high blood pressure. PATIENT CASE 1 1. You confirm on ASIIS that J.R. received 1 dose of PPSV23 at age 40. Does J.R. need another pneumococcal vaccination? If so, which one? Yes. The CDC and ACIP now recommend that all patients age 65 years or older receive both PCV13 Answer and PPSV23. 11

12 PATIENT CASE 1 2. How long should J.R. wait between each vaccination? What is the dose and route of each vaccine? It is recommended to give PCV13 first, followed by PPSV months later. If PPSV23 is given first the patient must wait at least 1 year before receiving PCV13. Answer PCV13 is 0.5mL dose given IM. PPSV23 is also 0.5mL but can be given SC or IM. PATIENT CASE 1 3. Will J.R. need to receive a booster shot? No, once the patient has received these vaccinations after the age of 65 they will not require any additional pneumococcal vaccinations. Answer PATIENT CASE 1 4. What if J.R. had received a dose of PPSV23 at age 63 instead of his early 40s? Would this change your recommendations? The patient should still receive PCV13. The patient is still eligible for PPSV23, however the minimum interval between PPSV23 Answer vaccinations should be at least 5 years. Therefore, he should return at age 68 to receive another dose of PPSV23. 12

13 PATIENT CASE 2 Jane Smith is a 47 year old female who was recently referred to the outpatient clinic that you work in. She was diagnosed with chronic renal failure last year secondary to a history of uncontrolled blood pressure. She has no other medical conditions. Her PCP would like you to review her immunization record and give any that you believe she needs. From her immunization records you notice she has remained up to date on all vaccinations except for pneumococcal. PATIENT CASE 2 1. Assuming the patient has never received a pneumococcal vaccination, how would you approach this situation? Since Jane has not received either PPSV23 or PCV13, she will require both vaccinations. ACIP recommends she should receive PCV13 first, followed by PPSV23 at least 8 weeks later. Notice this differs from the typical 6 12 month Answer time difference for administration of PPSV23. This is an ACIP/CDC specific recommendation due to the fact that chronic renal failure is considered an immunocompromising condition. PATIENT CASE 2 2. Will this patient require a booster shot? Yes, since she has an immunocompromising condition she will require a booster for PPSV23 in least 5 years. She will also need another dose at age 65 as part Answer of standard recommendations. No future doses of PCV13 are necessary. 13

14 PATIENT CASE 2 3. You inadvertently administer both vaccinations on the same day, what do you do next? Giving both vaccinations simultaneously can cause a diminished response. Specifically, PPSV23 is thought to diminish the response to PCV13, but not vice versa. Therefore, the dose of PPSV23 should count as valid. The next Answer step would be to follow recommended administration timing and give PCV13 at least 1 year later. PATIENT CASE 3 You work in a community pharmacy that provides many vaccinations, including travel vaccines. BT is a 65 year old woman who has been experiencing recurrent cold sores. Today she is picking up her acyclovir prescription at your pharmacy. While at pick up, BT asks about receiving her flu and pneumonia vaccine as well. During this encounter she also tells you that 3 weeks from now she is travelling to a region with a rising number of cases of meningitis. BT states that she went to this region about 7 years ago, and prior to leaving she was immunized with Menactra (MCV4 D). She will be there for close to a year. You know this patient well and know that she has no serious medical conditions or immunocompromising conditions. PATIENT CASE 3 1. Assuming the patient has never received a pneumococcal vaccination, how would you approach this situation? Yes, according to standard guidelines and vaccination schedules she should receive an influenza vaccine annually, two pneumococcal vaccines at age 65 (PCV13 and PPSV23), and a Answer single dose of meningococcal vaccine if travelling to an area with a meningitis epidemic. 14

15 PATIENT CASE 3 2. Will BT s acyclovir prescription reduce the effectiveness of these vaccines? According to new guidelines the patient should receive PCV13 (Prevnar) now, followed by PPSV23 (Pneumovax) 6 12 months later. Answer PATIENT CASE 3 3. You have both Prevnar (PCV13) and Pneumovax (PPSV23). Which one should the patient receive today? When should she return? According to new guidelines the patient should receive PCV13 (Prevnar) now, followed by PPSV23 (Pneumovax) 6 12 months later. Answer PATIENT CASE 3 4. Currently, you do not have any meningococcal vaccinations in stock. You go to place an order for this vaccination. Which product is the best choice for BT: Menveo, Menactra, or Menomune? What are the doses and routes of administration for each vaccine? ACIP recommends off label use of quadrivalent meningococcal conjugate vaccine (MCV4) for people age 56 and older who travel to regions where meningococcal disease is an epidemic if they have previously received MCV4 or if long term travel is expected. The CDC defines long term travel as >6 months, and the patient has received MCV4 in the past. For people who remain at risk it is recommended to receive a booster every 5 years. Answer Given this information, Menomune (MPSV4) is not the best choice because it is a polysaccharide vaccine. If BT had not previously received MCV4 and was not staying for an extended period of time, then Menomune would be preferred according to ACIP. Menomune is a 0.5mL dose given SC. Continue.. 15

16 PATIENT CASE 3 4. Currently, you do not have any meningococcal vaccinations in stock. You go to place an order for this vaccination. Which product is the best choice for BT: Menveo, Menactra, or Menomune? What are the doses and routes of administration for each vaccine? Continue.. Prevnar and Menveo may be administered simultaneously, but ACIP recommends to have at least a 4 week separation between administration of Prevnar and Menactra. BT is leaving in 3 weeks, making Menactra not the best choice. Therefore, Menveo is the best choice. Both Menveo and Menactra are 0.5mL given IM. A good resource to keep in the pharmacy: PATIENT CASE 3 5. You have heard recently that giving Prevnar simultaneously with inactivated influenza vaccines may reduce the response to Prevnar. You also find that this is suggested in the package insert of Prevnar. Should you still proceed giving both at the same time? If not, how long should separation be? ACIP still recommends that if both influenza and Prevnar are indicated, they should be administered on the same day. The Answer patient should receive both vaccinations today. PATIENT CASE 3 6. About a year later this patient returns to your pharmacy for their PPSV23 vaccination. You notice this time that have not received a shingles vaccination. Upon research, you notice the package insert of Zostavax states it should not be given simultaneously with PPSV23. Should BT receive both today? If not, how long should separation be? What are the doses and routes of administration for these vaccinations? ACIP has not changed its recommendation on the simultaneous administration of these two vaccines (i.e., they can be given at the same time or any time before Answer or after each other). Zostavax is 0.65mL and is given SC. PPSV23 is 0.5mL and can be given IM or SC. 16

17 PATIENT CASE 4 Jane Doe is a 12 year old female at your pharmacy with her mother. Her mother is here to have her daughter s immunization record reviewed. She would like Jane to receive any vaccinations that are recommended. Her mother states that Jane s last visit to a physician was about a year ago, and at that time the doctor said everything was up to date. Review Jane s immunization record and screening questionnaire below and make your recommendations. PATIENT CASE 4 Jane Doe PATIENT CASE 4 1. What vaccinations would you recommend for Jane today? Can they be given on the same day? In what order should you give these vaccinations? Jane should receive Tdap, Meningococcal conjugate, and the 2nd dose of HPV today. These may all be given on the same day. When giving multiple injections, starting with the least painful is Answer often the best practice. For this reason, starting with meningococcal, followed by Tdap and HPV is preferred. 17

18 PATIENT CASE 4 2. You review the screening questionnaire and confirm that Jane received a flu shot 4 weeks ago, and her medical conditions include asthma. Does Jane have any contraindications to any vaccines that she will be receiving today? What is the dose and route for each vaccine? No. Based on the screening questionnaire she does not have any contraindications. Always verify Answer these questions with the parent prior to administration. All three of these vaccines are 0.5 ml and are given intramuscularly. Patient Case 4 3. Will the meningococcal vaccine protect against all serogroups? No. The MCV4 vaccines protect against serogroups A, C, Y, and W 135. Serogroups C and Y account for about two thirds of invasive meningococcal disease in the United States. Serogroup B, which accounts for about a third of Answer invasive disease, is not included in the vaccine. Bexsero, a vaccine for serogroup B, was just approved in January 2015 as a 2 dose series for people ages Routine recommendations have not been developed yet. PATIENT CASE 4 4. Will Jane need to return for additional doses/boosters for any of these vaccinations? If so, when? Yes, Jane will have to return for the 3rd (final) dose of the HPV vaccine series after at least 3 months. She should also receive a booster dose of meningococcal Answer conjugate at age 16. The Td (tetanus and diphtheria toxoids) should be given every 10 years. 18

19 PATIENT CASE 4 5. Janes HPV series was delayed, should it be restarted? Is there an accelerated schedule for this series? There is no need to restart if the series is delayed, just pick up where they left off and finish the last 2 doses. Give the 2nd dose now. The third dose may be given 12 weeks later since the 1st dose was given almost a year ago (minimum interval between 1st and 3rd dose is 24 weeks, but Answer between the 2nd and 3rd dose the minimum interval is only 12 weeks). There is no accelerated schedule for this vaccine. The standard schedule is 0, 1 2, and 6 months. ASSESSMENT QUESTIONS HPV Which of the following statements is true regarding the HPV vaccines Cervarix and Gardasil? 1. They are exactly the same, just different manufacturers. 2. Only Gardasil has an approved indication for males. 3. Cervarix only needs to be given twice, while Gardasil has to be given three times. 4. Gardasil is a live vaccine, but Cervarix is inactivated. By what route are both Cervarix and Gardasil administered? 1. ID 2. SC 3. IM 4. IO True or False: If a dose of HPV vaccine is delayed by more than 1 year, the series must be restarted. 1. True 2. False 19

20 Pneumococcal What are the brand names for the PCV13 and PPSV23 vaccinations? 1. PCV13 = Pneumovax, PPSV23 = Prevnar 2. PCV13 = Pneumozone, PPSV23 = Pneumovax 3. PCV13 = Prevnar, PPSV23 = Pneumosil 4. PCV13 = Prevnar, PPSV23 = Pneumovax New recommendations supported by ACIP and CDC state that at the age of 65 everyone should receive both PCV13, if not previously received, and PPSV23. should be given first, followed by at least _(time)_ later. 1. PCV13; PPSV23; 6 12 months 2. PCV13; PPSV23; 3 months 3. PPSV23; PCV13; 5 years 4. PPSV23; PCV13; 6 12 months Pneumococcal If PPSV23 is given first, how long should the patient wait before receiving PCV13? Why should they wait? 1. They should wait 6 12 months because PCV13 is thought to decrease the effectiveness of PPSV They should wait at least 1 year because PPSV23 is thought to decrease the effectiveness of PCV The patient no longer needs to receive PCV13 if PPSV23 is given first. 4. They should wait at least 5 years since PCV13 will act as a booster dose. Which of these patients is not routinely recommended to receive PPSV23? year old male recently diagnosed with HIV year old pregnant female year old male with DM type 2 and a history of CHF year old female who smokes at least 1 pack of cigarettes per day Meningococcal Which of the following patients should be vaccinated against meningococcal disease? 1. Adolescents age Military recruits 3. People who travel to countries where meningococcal disease is an epidemic 4. All of the above The meningococcal polysaccharide vaccine is known as: 1. Menactra 2. Menomune 3. MenHibrix 4. Menveo Which of the following is a contraindication to receiving Menactra? 1. Allergy to latex containing products 2. Episode of fainting from previous flu vaccine 3. Allergy to diphtheria toxoid containing products 4. Immunocompromising condition Which meningococcal vaccine is given subcutaneously? 1. Menactra 2. Menomune 3. MenHibrix 4. Menveo 20

21 QUESTIONS? 21