Shireesha Dhanireddy, MDAssociate Professor, Department of MedicineDivision of Infectious Diseases, University of WashingtonSeptember 2014

Discussion of indications for the following vaccines Pneumococcal Vaccine Tdap Influenza Vaccine Zoster vaccine

Exemptions dropped from 6.2% in 2009-2010 to 4.7% in 2011-2012 though

Went from 2nd to 8th highest in the country for exemptions

MMWR 2012;61(33);647-52

For which of the following patients is the 13 valent pneumococcal conjugate vaccine (PCV13) not indicated currently?

A.1 year old childB.25 year old HIV+ manC.67 year old womanD.49 year old female cigarette smoker

4 million cases/year in US445,000 hospitalizations/year22,000 deaths/year

Cox CM. CDC Manual for the Surveillance of Vaccine Preventable Diseases. 2012

Cox CM. CDC Manual for the Surveillance of Vaccine Preventable Diseases. 2012

Age Disease Incidence Cases/100,00 (# of cases)

Death Rate Deaths/100,000(# of deaths)

<1 31.4 (142) 0.22 (1)

1 24.6 (112) 0.22 (1)

2-4 12.6 (171) 0.15 (2)

5-17 2.2 (111) 0.02 (1)

18-34 3.7 (261) 0.26 (18)

35-49 10.3 (670) 0.65 (42)

50-64 19.5 (1,068) 1.86 (102)

> 65 37.0 (1,291) 5.61 (196)

Total 12.9 (3,828) 1.22 (363)

Persons > 65 years of agePersons age 19-64 with:

Chronic lung disease (asthma or COPD) Chronic heart disease (except HTN) Chronic liver disease CSF leak Smokers Diabetes Alcoholism Functional or anatomic asplenia Immunocompromising conditions

MMWR 2010. 59(34);1102-1106

Direct effects of PPSV23 vaccination in the elderly controversial

Cochrane Review Strong evidence for PPSV23 efficacy

against invasive disease Inconclusive efficacy for pneumonia Not associated with significant decrease

in mortality

Moberley S. Cochrane Review. 2008

Rates of IPD caused by PCV7 serotypes and additional serotypes in PCV13, adults >65

years, 1998–2009

Moore, IDSA, 2009 & CDC Unpublished 9

ACIP Meeting FEB 2012

47% reduction in IPD

Moore. ACIP, OCT 2013

12

Age group,

years

Percent Decrease in Rate (95%IE)

2010-11 2011-12

 <5 67 (62, 70) 88 (86, 89)

 5-17 35 (22, 45) 59 (48, 66)

 18-49 33 (26, 38) 65 (60, 68)

 50-64 24 (18, 28) 54 (51, 58)

 >65 23 (13, 31) 47 (39, 53)

Statistically significant reductions in vaccine-type IPD in all age groups within first 2 years after

PCV13 introduction.

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Not recommended for most personsWho should be revaccinated?

Persons aged 19-64 with▪ Functional or anatomic asplenia▪ Immunocompromising conditions

Multiple vaccinations not recommended

MMWR 2010. 59(34);1102-1106

PPSV23 – contains polysaccharide antigens PCV13 – contains immunogenic proteins

conjugated to pneumococcal polysaccharides

Prevnar 13 (PCV13) recommended for some immunocompromised adults FDA approved for adults age > 50 age

12/2011 ACIP advisory committee approved use in

immunocompromised adults 6/2012

MMWR 2012. 61(21);394-5

ACIP votes to recommend PCV13 vaccine in adults age > 65 years (8/13/2014) Not previously vaccinated with PCV13 or

unknown vaccine history even if have received PPSV23

Recommendations will be reevaluated in 2018

For which of the following patients is the 13 valent pneumococcal conjugate vaccine (PCV13) not indicated currently?

A.1 year old childB.25 year old HIV+ manC.67 year old womanD.49 year old female cigarette smoker (Give the polysaccharide vaccine)

A 27 year old pregnant woman presents for her routine obstetrics visit at her 32 week gestation visit . She is G2P1. She has a healthy 2 year daughter at home. Which statement is correct regarding Tdap in pregnancy?

A.She should receive a Tdap today only if she has not had in the past 5 years. B.She should receive Tdap only if she did not receive during her prior pregnancyC.She should receive Tdap today

Whooping cough Highly contagious, caused by Bordetella

pertussis Infected adults reservoir for infection of

children 3 phases

▪ Catarrhal phase – last 1-2 weeks, cold symptoms, including tearing and conjunctival injection

▪ Paroxysmal phase – paroxysmal cough, can last 2-3 month untreated

▪ Convalescent phase - resolution

WHOAll adolescents aged 11 through 18 years (age 11-12 preferred)All adults aged 19 through 64 who have not received a doseAll adults aged > 65 years (2/2012)All pregnant women during each pregnancy

WHATBoostrix preferred for adults > 65 years (but either okay)

WHENRegardless of interval between last Td if has not received TdapDuring each pregnancy for pregnant women – optimum timing is 3rd trimester (27-34 weeks)

MMWR 2013;62:131-135

A 27 year old pregnant woman presents for her routine obstetrics visit at her 32 week gestation visit . She is G2P1. She has a healthy 2 year daughter at home. Which statement is correct regarding Tdap in pregnancy?

A.She should receive a Tdap today only if she has not had in the past 5 years. B.She should receive Tdap only if she did not receive during her prior pregnancyC.She should receive Tdap today

A 64 year old woman with a self-reported history of shingles 2 years ago and type II diabetes presents to clinic. What do you recommend regarding the zoster vaccine?

A. Vaccine is contraindicated given her history of diabetes

B. Vaccine not indicated given her history of zosterC. Check VZV titer to confirm history. If negative,

proceed with vaccinationD. Recommend zoster vaccine

Develops in 30% of people over a lifetime (1million + cases a year in US)

Incidence increases with age 8-10x more likely in people >

60 May lead to postherpetic

neuralgia (PHN) “pain that persists more than

30 days after the onset of rash or after cutaneous healing”

Kimberlin DW, Whitley RJ. NEJM 2007;356:1338-43Gann JW, Whitley RJ. NEJM 2002;347:340-6

Study DesignN = 38,546Adults > 60Randomized, double-

blindFollowed for mean 3.1

yrsSingle dose vaccine vs

placebo

Oxman MN et al. NEJM 2005;352:2271-84

Decreased Herpes Zoster by 51.3%Decreased PHN by 66.5%

Age Specific Recommendations:All persons > 60 years*

Excludes those with contraindications to live vaccine

Includes those with history of zoster or have chronic medical conditions

Dose:Single dose

MMWR 2008;57(RR-5):1-40

October 2008: the ACIP recommended a dose of HZV for all adults >60 years unless they have contraindications

March 2011: FDA approved use of Zostavax in adults aged 50-59 years

Should we be administering HZV at ages 50-59 years?

Cost: $160/dose

Implications: Varicella vaccine recipients

CDC Vaccine Price List

Source: Yawn 2007

*PHN defined as ≥ 90 days of pain

Source: Yawn 2007

Source: Lin 2000

74% of HZ-related hospitalizations in persons ≥60 years

Herpes Zoster (Shingles) Vaccine Coverage Among US AdultsNational Health Interview Survey, 2008-2012

National Immunization Survey (NIS), 2007; National Health Interview Survey (NHIS), 2008-2012

Ortega-Sanchez. ACIP OCT 2013* PHN = moderate to severe pain lasting >90 days

Vaccinate at 50

Vaccinate at 60

Vaccinate at 70

Net cost* $178.5 Million

$169.0 Million

$162.9 Million

Cost per HZ prevented

$11,255 $8,455 $9,989

Cost per PHN prevented

$61,084 $19,761 $9,607

Cost per QALY saved **

$271,713

$79,967 $38,191

* NC =Cost of Vaccination Program - Savings in Cost-of-Illness from Vaccination

** Does not including indirect cost savings Ortega-Sanchez. ACIP OCT 2013

• Affirms existing recommendation for routine vaccination of persons 60 years of age and older Burden of HZ disease in increases with age HZ vaccine administration should be timed to

achieve the greatest reduction in burden of HZ and its complications

There is insufficient evidence for long term protection offered by the HZ vaccine

Providers should counsel persons who are vaccinated at 50-59 years of age that the duration of protection offered by the vaccine is uncertain; therefore they may not be protected when the incidence of HZ and its complications are highest.

A 64 year old woman with a self-reported history of shingles 2 years ago and type II diabetes presents to clinic. What do you recommend regarding the zoster vaccine?

A. Vaccine is contraindicated given her history of diabetes

B. Vaccine not indicated given her history of zosterC. Check VZV titer to confirm history. If negative,

proceed with vaccinationD. Recommend zoster vaccine

67 year old man with moderate COPD presents for his routine visit in the fall.

Which of the following is most appropriate regarding immunization against influenza?

A. Live attenuated vaccine should be given as it has been found to be more effective than the inactivated vaccine.

B. High-dose, trivalent, inactivated vaccine should be administered.

C. Standard-dose, trivalent, inactivated vaccine should be administered

2013–14 U.S. trivalent influenza vaccines will contain an A/California/7/2009 (H1N1)–like virus, an H3N2 virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011, and a B/Massachusetts/2/2012–like virus.

Quadrivalent vaccines will include an additional vaccine virus strain, a B/Brisbane/60/2008–like virus.

High dose vaccine contains 4 times as much hemagglutinin (HA) as standard

Licensed for persons > 65 years of age in 12/2009 but with requirement to show clinical benefit (had shown safety and superior immunogenicity)

18-64 years >65 years

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Sanofi Pasteur. ACIP OCT 2013

Randomized, blinded study in US, Canada (N = 32,000)

2011-12 (mild) & 2012-13 (moderately severe) seasons

Lab confirmed influenza: 1.43% HD vs. 1.89% SD Relative efficacy 24.2% (9.7, 36.5)OR: 4-5 fewer cases/1000 vaccinated 217 vaccinations to prevent one additional case

Cost HD: ~$25 VS. SD: ~$12

Safety: AE comparable for HD and SD

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2011-12

BRFSS; *internet panel survey

67 year old man with moderate COPD presents for his routine visit in the fall.

Which of the following is most appropriate regarding immunization against influenza?

A. Live attenuated vaccine should be given as it has been found to be more effective than the inactivated vaccine.

B. High-dose, trivalent, inactivated vaccine should be administered.

C. Standard-dose, trivalent, inactivated vaccine should be administered

Discussion of indications for the following vaccines Pneumococcal Vaccine Tdap Zoster vaccine Influenza Vaccine

Consider vaccines at every routine visit, particularly in pregnant patients and elderly patients

For elderly patients over 65 years of age, give PCV13 instead of PPSV23 (consider high dose flu vaccine)