1.  Carolyn A. Parry, MPH CDC Public Health Advisor Montana Immunization Program 2016 Regional Immunization Workshops

2.  Pneumococcal o Background for the recommendations o Immunization Schedules Childhood Adult High-risk patients o Resources  Meningococcal B o Background for the recommendations o Routine and Permissive recommendations o Vaccines

3. 2014 National Immunization Survey (NIS) Data Healthy People 2020 objective

4. 2014 Montana Behavioral Risk Factor Surveillance System (BRFSS) Healthy People 2020 objective

5.  Streptococcus pneumoniae isolated in 1881  More than 80 serotypes described by 1940  Initial interest in developing a vaccine declined with advent of penicillin o Patients were still dying despite antibiotic treatment  By 2011, 92 serotypes have been documented o 10 most common cause 62% of invasive disease worldwide  Symptoms o Abrupt onset of fever, chills or rigors, chest pain, productive cough, shortness of breath, rapid breathing, rapid heart rate, malaise, weakness *Epidemiology and Prevention of Vaccine-Preventable Diseases, 13 th ed, pages 279-295

6.  Pneumococcal pneumonia (lung infection) o 400,000 hospitalizations per year in U.S. o Up to 36% of adult community-acquired o Complication of influenza o Case-fatality rate 5%-7%, higher in elderly

7.  Pneumococcal bacteremia (blood infection) o More than 12,000 cases per year in U.S. o Case-fatality rate ~20%; up to 60% among the elderly  Pneumococcal meningitis o Pneumococci cause over 50% of all cases of bacterial meningitis in U.S. o Est. 3,000-6,000 cases per year in U.S. o Case-fatality rate 8% among children; 22% among adults

8.  Certain conditions that increase risk: o Immunocompromising conditions, including HIV infection o Functional or anatomic asplenia, particularly sickle cell disease o Chronic heart, pulmonary, liver or renal disease (includes asthma in 19+) o Cigarette smoking (19+) o Cerebrospinal fluid leak (CSF) leaks o Cochlear implant o Child care attendance (children) o Alaska native, African American, American Indian (Navajo and White Mountain Apache) (children)

9.  In children age 2 years and younger o Bacteremia without known site of infection - approximately 70% of invasive disease o Bacteremic pneumonia caused 12%-16% of invasive pneumococcal disease  In children age 5 years and younger o S. pneumoniae leading cause of bacterial meningitis  Pneumococci are a common cause of acute otitis media  Before the conjugate vaccine: o children less that 1 year of age had the highest rates of pneumococcal meningitis (10 cases per 100,000) o 17,000 cases of invasive disease each year, 13,000 were bacteremia and 700 meningitis o 200 children died each year as a result of invasive disease o 5 million cases of otitis media

10.  In 2011, estimated 35,000 cases and more than 4,200 deaths from invasive disease o More than half these occurred in adults who were recommended to receive the PPSV23 vaccine  Data suggests PCV has had an impact on invasive disease in young children o 99% decrease in 7 serotypes o some increases in disease by serotypes not included in PCV7 o In 2008, data indicated approximately 61% of invasive pneumococcal disease in children younger than 5 years due to serotypes included in PCV13 43% caused by serotype 19A (included in PCV13)  Indirect effects from PCV13 use in children might effect disease incidence in adults.

11. YearVaccine 197714-valent polysaccharide vaccine licensed (no longer in U.S.) 198323-valent polysaccharide vaccine licensed (PPSV23) 20007-valent polysaccharide conjugate vaccine licensed (PCV7) 201013-valent PCV licensed (PCV13)

12. Children:  Routinely administered PCV13 at 2, 4, 6, and 12-15 months

13.  Doses administered before 12 months of age, the minimum spacing between doses is 4 weeks  Doses administered on or after 12 months of age, the minimum spacing is 8 weeks

14.  Healthy children aged 7-59 months who have not been vaccinated with PCV13 should receive 1-3 doses of PCV13, depending on when vaccination begins. o Infants 7-11 months – 3 doses o Children aged 12-23 months – 2 doses o Children 24 months and older Unvaccinated healthy children – 1 dose Age at first dose# of DosesBooster 7-11 months2 dosesYes 12-23 months2 dosesNo 24-59 months1 doseNo

15.  Unvaccinated children 24-71 months with underlying medical conditions – 2 doses, 8 weeks apart o Chronic heart and lung disease o Diabetes o Anatomic or functional asplenia (including sickle cell disease); o Immunocompromising conditions such as HIV-infection, those resulting from disease or treatment of disease o Cochlear implant o Cerebrospinal fluid leak (CSF) leaks

16.  Administer 1 dose of 13-valent pneumococcal conjugate vaccine (PCV13) to children 6 years of age and older who have not received PCV13 previously and are at increased risk: o Anatomic or functional asplenia (including sickle cell disease); o Immunocompromising conditions such as HIV-infection o Cochlear implant; o Cerebrospinal fluid leak (CSF) leaks  Administer PCV13 first, wait 8 weeks before administering PPSV23.  For 24mo – 18 years: If PPSV23 has been administered, wait 8 weeks before administering PCV13.  For 19 years+: If PPSV23 has been administered, wait 1 year before administering PCV13.

17.  Children and adults 2 years of age and older with the following conditions should receive PPSV23: o Chronic illness Heart disease, lung disease, diabetes, alcoholism, chronic liver disease, cirrhosis, CSF leaks, cochlear implant o Anatomic or functional asplenia o Immunocompromised o Asthma and cigarette smoking (19 year of age and older)

18.  A repeat dose at least 5 years after the first dose is recommended for those with: o Anatomic or functional asplenia o Immunocompromising conditions such as HIV-infection, leukemia, lymphoma, Hodgkin disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, transplant, treatment with immunosuppressive drugs  Those receiving a 2 nd dose before 65 years of age should receive a 3 rd dose after 65 years of age (minimum spacing - 5 years).

19. Adults:  PCV13 (for PCV13 naïve adults) and PPSV23 are routinely administered to adults 65 years of age and older o PCV13 should be administered first o PPSV23 should be administered 1 year after PCV13

20. Notes: "For immunocompetent adults who previously received PPSV23 when aged <65 years and for whom an additional dose of PPSV23 is indicated when aged ≥65 years, this subsequent PPSV23 dose should be given ≥1 year after PCV13 and ≥5 years after the most recent dose of PPSV23. For adults aged ≥65 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants, the recommended interval between PCV13 followed by PPSV23 is ≥8 weeks." Please refer to the footnotes in the respective schedules for further details about pneumococcal vaccination.

21. http://www.immunize.org/catg.d/p2019.pdf

22. http://www.cdc.gov/vaccines/schedules/downloads/child/job-aids/pneumococcal.pdf

23.  Date of Birth – 02/25/2014  PCV #1 – 10/31/2014  PCV #2 – 03/15/2015  When is the next dose due?  How many more doses are needed?

24.  Date of Birth – 04/10/2013  PCV #1 – 08/13/2014  When is the next dose due?  How many more doses are needed?

25.  A 16 year old with an immunocompromising condition presents in your clinic. Pneumococcal vaccine is recommended. The adolescent received 4 doses of PCV7 as a child.  What should this individual receive and when?

26.  A 65 year old who smokes occasionally is in your clinic today for vaccinations. At age 63 years (2 years ago) a PPSV23 was administered.  What should this individual receive and when?

27.  Meningococcal disease is an acute, potentially severe bacterial illness caused by Neisseria meningitidis.  Disease was first reported in the 16 th century  Neisseria meningitidis is the leading cause of bacterial meningitis and sepsis in U.S.  Epidemic in sub-Saharan Africa  Almost all invasive disease is caused by serogroups A, B, C, Y, and W  U.S. is experiencing a historic low in meningococcal disease incidence -.18 per 100,000 *Epidemiology and Prevention of Vaccine-Preventable Diseases, 13 th ed, pages 231-245

28.  Disease o Abrupt onset of fever, headache, stiff neck, nausea, vomiting, sensitivity to light, confusion, rash o Incubation period is 3 to 4 days, with a range of 2 to 10 days o Case-fatality rate 10%-15%  Meningococcal meningitis o Most common presentation of invasive disease  Meningococcemia (bloodstream infection) o May occur with or without meningitis o Case-fatality rate up to 40% o Up to 20% of survivors have permanent sequelae including hearing loss, neurologic damage, or loss of limb.

29.  Certain medical conditions are at highest risk: o Deficiencies in the terminal common complement pathway o Functional or anatomic asplenia o Certain genetic factors  Environmental factors o Preceding viral infection o Household crowding o Active and passive smoking o Microbiologists - occupational

30.  Annually 50 to 60 cases and 5 to 10 deaths o 80% of these cases occur in 16-23 year olds  Since 2009, seven outbreaks have occurred on college campuses resulting in 41 cases and three deaths o 40-70% of cases in 18-23 year olds occur in college students Meningococcal B disease incidence in college students aged 18-23 years -.09 per 100,000 Meningococcal B disease incidence in non-college students aged 18- 23 years-.21 per 100,000

31.  Vaccine will protect against most strains of serogroup B  No concerning patterns of adverse events following vaccination  Data not yet available on effectiveness against clinical disease endpoints or duration of protection  Potential impact on carriage and herd protection is inconclusive

32.  Considered vaccinating all adolescents o Concluded that vaccinating at 16-18 years would probably provide protection during the highest risk period o Determined insufficient evidence to make a routine recommendation for all adolescents Category and

34. Routine Recommendation:  Persons 10 years of age and older who are at increased risk for meningococcal disease should receive Men B vaccine o Persons with persistent complement component deficiencies o Persons with anatomic or functional asplenia o Microbiologists routinely exposed to isolates of Neisseria meningitidis o Persons identified at increased risk because of a serogroup B meningococcal disease outbreak. Permissive Recommendation:  One of the Meningococcal B vaccines may be administered to adolescents and young adults aged 16-23 years to provide short term protection against most strains of serogroup B meningococcal disease.  The preferred age for vaccination is 16-18 years

35.  MenB-4C (Bexsero ® ) Novartis o 2 doses administered at 0 and > 1 month schedule o Licensed in the U.S. on January 23, 2015  MenB-FHbp (Trumenba ™ ) Pfizer o 3 doses administered at 0, 2, 6-month schedule o Licensed in the U.S. on October 29, 2014  The MenB vaccines are not interchangeable.