Pennsylvania Academy of Family Physicians Foundation & UPMC 43rd Refresher Course in Family Medicine 

CME Conference March 10‐13, 2016 

 Immunizations 

Donald Middleton, MD & 

Richard Zimmerman, MD  

Disclosures:   Dr. Middleton:  Advisory board on vaccines for Pfizer, Merck, and Sanofi Pasteur Dr. Zimmerman: Research grants from Pfizer & Merck (adolescent vaccine) and Sanofi Pasteur    The speakers have attested that their presentation will be free of all commercial bias toward a specific company and its products.  The speaker indicated that the content of the presentation will not include discussion of unapproved or investigational uses of products or devices.  Speaker has no disclosures and there are no conflicts of interest.    

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Donald B Middleton MDRichard K Zimmerman, MD MPH

University of Pittsburgh School of Medicine

www.PittVax.pitt.edu

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Dr. Zimmerman: Research grants from Pfizer & Merck (adolescent vaccine) and Sanofi Pasteur

Dr. Middleton: Advisory board on vaccines for Pfizer, Merck, and Sanofi Pasteur

No conflict of interest exist.

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Recommend pneumococcal vaccines appropriately

Discuss pertussis outbreaks and Tdap

Describe influenza vaccination options by age group

Improve immunization rates in your clinical setting using a standardized approach like the 4 Pillars Toolkit

Review questions from the office

Update reference sources: Shots Immunizations by STFM

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Is the vaccine effective?

Is the vaccine safe?

Is the public health impact based on amount of potentially preventable disease sufficient?

Is it programmatically feasible to add more injections?

Is it cost-effective?

ACIP uses GRADE to make recommendations Explicit, evidence-based grading process

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RIV (Flublok): indicated for ≥18 years of age (no longer any upper age limit) for those with egg allergy

LAIV (FluMist): Contraindications: influenza antiviral use within the last 48 hours, immune suppression, egg allergy, and pregnancy Precautions: asthma and chronic lung diseases;

cardiovascular, renal, and hepatic diseases; and diabetes and other conditions

One brand (Afluria) is available by needle-free jet injector Intradermal vaccine is quadrivalent this season New adjuvanted vaccine Fluad for those > 65

Strains are A/California/7/2009 (H1N1), A/Switzerland/2013 (H3N2), and B/Phuket/2013 (Yamagata)

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Age group years

IIV IIV ID RIV for egg allergic

Cell-culture IIV

LAIV IIV High Dose

IIVadjuvanted

18-49 X X X X X

50-64 X X X X

>65 X X X X X

RIV = FluBlokCell-culture = FlucelvaxIIV adjuvanted = Fluad

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Two type B lineages: Victoria and Yamagata

In advance, hard to know which will circulate: sometimes both lineages

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60 mcg per strain compared to 15 mcg typically Prefilled syringes No adjuvant or preservative Currently only trivalent; A strains dangerous for

elderly Licensed in December 2009 13 million doses used in first three seasons Penetrance in market 20% among elderly in past Higher antibody titers Does it actually work better???

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NEJM 2014: 2 year study: 32,000 seniors ≥65 yrsold; 2011-12 (mild)/2012-13 (moderate).

HD 24.2% [9.7%-36.5%] more effective in preventing LABORATORY CONFIRMED flu then regular dose Fluzone; absolute reduction low however as flu incidence low

Lancet 2014: 1 mil HD vs 1.6 mil reg; 22% reduction in flu illness (rapid Dx) + hospitalization

CID 2015: no diff in VA pts. unless age ≥85 yrs; one year study

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Fluad

MF59 adjuvant Squalene

Natural 30 carbon compound; e.g., shark liver oil, wheat germ

Oil-in-water - surfactant More local and systemic reactions Price unknown Available Fall 2016 in US Used in 30 countries

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Study of 282 participants including 84 cases Mean age 83

Vaccine effectiveness Unadjusted: 35% for ATIV vs. -12% for TIV Adjusted: 58% for ATIV; TIV ineffective Adjusted VE 72% when limited to community dwelling (not long-term

care)

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An 18 year old girl has had 2 of the 3 required shots of Trumenba, but we only have Bexsero. Can I give her a Bexsero to finish the series?

A 27-year-old man was cut on a chainsaw at work. The wound is dirty. He had a Tdap 6 years ago. He needs a tetanus booster but we only have Tdap. Can I give him a Tdap even though it will be his second one?

A 72 year old woman just recovered from shingles after 3 months of debilitating pain. She wants to get a shingles vaccine (Zostavax). Should I give it to her now?

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Two types: PPSV 23 – 23 valent pneumococcal polysaccharide PCV13 – 13 valent pneumococcal conjugate They share 12 strains

Pneumovax23 is FDA licensed for adults ≥ age 50 yrs Prevnar13 is FDA licensed for adults at ≥ age 50 yrs

Serotypes 1, 3, 4, 5, 6A (not in PPSV23), 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F

Herd immunity from childhood vaccination coupled with adult vaccination. In adult IPD: 71% reduction in PCV7 strains; 53% reduction in all strains.

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ACIP Meeting 14

ACIP Meeting15

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1. PCV13-type IPD rate among adults >65 years old in the US. CDC, ABCs, 2013

2. Simonsen et al Lancet Resp. Med 2014

3. Nelson et al. Vaccine 2008

4. CAPITA

5. Number-needed-to vaccinate (NNV) =1 / (Ratebaseline – Ratevaccinated)

Outcome(PCV13-type)

Baselineincidence(per 100,000 population)

Vaccine efficacy (95% CI)

Number needed to vaccinate5

IPD 6.51 75% (41%, 91%)4

20,400 (16,950 - 37,000)

Caveat: VE vs. placebo

Inpatient CAP 137.52 45% (14%, 65%)4

1,620 (1,110 - 5,130)

Baselineestimates assume 10% of all CAP due to PCV13 -types

Outpatient CAP 2013 45% (14%, 65%)4

1,110(760-3,500)

Total CAP - - 656(454-2,110)

• PCV13 should be given first when possible

• Interval between pneumococcal doses: 1 year

• Immunocompromised persons ≥19 yrs old, • Both vaccines• PCV13 first and then PPSV23, at least 8 weeks later

• If PPSV23 given first, then wait 1 year for PCV13

• One PPSV23 revaccination 5 years after first PPSV23

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Household members responsible for 75%–83%: Parents (55%) Siblings (16%-20%) Aunts/uncles (10%) Friends/cousins/others (10%-24%) Grandparents (6%)

WendelboeAM, et al. Transmission of Bordetellapertussis to Young Infants. PediatrInfect DisJ 2007;26: 293–299.

Bisgard KM, et al. Infant pertussis: who was the source? PediatrInfect DisJ 2004; 23(11):985-989.

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VAERS does not show any signals of concern for mother or fetus

Review of manufacturer’s pregnancy registry did not reveal signals of concerns

Td and TT used extensively in pregnant women

Data and expert opinion support that Tdap is acceptably safe to both a pregnant woman and unborn fetus

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Adults > 19 years who have not previously received Tdap should receive a single Tdap. ONCE

Tdap can be administered regardless of interval since the last tetanus- or diphtheria-toxoid containing vaccine.

Tdap should be administered during each pregnancy, at 27-36 weeks (preferred but any better than none)

Many unanswered questions about repeat Tdap Tdap duration in adolescents <4 years; unknown in adults Less if primed with DTaP than DTP Imbalance in Th1/Th2 immune response with Tdap

whereas balanced with disease Manufacturers are conducting repeat Tdap booster trials

and when thru FDA will lead to a review by CDC

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Uptick in hepatitis B: Kentucky, West Virginia, Tennessee MMWR 2016;65(3); injection drug use one cause; nonurban cases increasing; 25% of adults age ≥19 years are vaccinated.

12.5% of children and adolescents (9 million!) remain susceptible to measles

Meningococcus is rare but when it occurs it is devastating

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Tdap: 20% HCP 42%

HPV: ≥1 dose in 19-26 years: Women 40%; Men 8%

Zoster: ≥60 years 28%

Hepatitis B: 25%; Diabetics 19-59 years 24%

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Increase Patient Demand Patient reminders

Enhance Access Office hours express vaccination After hours express vaccine-only clinics

Provider Reminders and Office Systems Standing order programs (SOPs) Prompts in EMRs

Combination of 2 or 3 strategic approaches led to a 16% point increase in rates.

Multiple interventions within a single strategic approach increased rates only 4% points.

0%2%4%6%8%

10%12%14%16%18%

Increase in rates

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1. Convenience

2. Patient notification

3. Enhanced office vaccination systems

4. Motivation via an immunization champion

4pillarstoolkit.pitt.edu34

Extended vaccination season Starts when influenza vaccine arrives Continues into the influenza disease season for unvaccinated

Season unpredictable & some benefit possible 2 waves of influenza may occur

Express vaccination services Vaccination only services:

Dedicated evening or weekend vaccine-only services

Walk-in vaccination station Nursing vaccination visits

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Convenient Vaccination Services

Notification MethodsAutodialer; Email/text; Office posters/videos; Answering service “on-hold” messages; Mail

Physician recommendation is essential

MMWR 1988;37:657-61 36

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Providers should discuss serious nature of vaccine preventable diseases

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Assessment of vaccination as a routine part of the office visit by nursing staff at check-in/rooming: Prompts in EMR Health maintenance or immunization section review Routinely address “Is vaccination status up to

date?” as part of vital signs

Empowering staff to vaccinate by standing orders

Combination of assessment and SOPs should reduce missed opportunities

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• Ongoing motivation is a key to success• Set goals for improving rates• Identify an Immunization Champion • Champion monitors weekly progress towards

goals • Shares progress with team• Celebrate achievements

• Consider rewards

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Effective office manager and lead physician (Immunization Champions)

Leaders inspired staff to take responsibility for assessing vaccination status and vaccinating patients, using SOPs

Staff appreciated regular feedback on performance and comparison with other sites

Staff believed that their performance made the difference vaccination rates

Age group

2010 (before 4 pillars toolkit)

2011 (after 4 pillars toolkit)

P value

18-49 years

23% 32% <.001

49-64 years

35% 46% <.01

≥65 years

52% 69% <.001

Influenza vaccination rates in one urban practice

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Staying Current

www.cdc.gov/emailupdates/index.html– Automatic notification of new information

www.cdc.gov/vaccines– Can download Adult Scheduler– Can download Shots 2016

www.immunizationed.org www.stfm.org

– Home site for Shots 2016

• www.immunize.org– Site for Immunization Action Coalition

www.cdc.gov/vaccines/recs/acip/default.htm– ACIP web site

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