Vaccines - What`s New in Medicine

Transcript Vaccines - What`s New in Medicine

Shireesha Dhanireddy, MD Associate Professor, Department of Medicine Division of Infectious Diseases, University of Washington September 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 2 nd to 8 th 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?

1 year old child 25 year old HIV+ man 67 year old woman 49 year old female cigarette smoker

 4 million cases/year in US  445,000 hospitalizations/year  22,000 deaths/year

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

Age

<1 1 2-4 5-17 18-34 35-49 50-64 > 65 Total

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

31.4 (142) 24.6 (112) 12.6 (171) 2.2 (111) 3.7 (261) 10.3 (670) 19.5 (1,068) 37.0 (1,291) 12.9 (3,828)

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

0.22 (1) 0.22 (1) 0.15 (2) 0.02 (1) 0.26 (18) 0.65 (42) 1.86 (102) 5.61 (196) 1.22 (363)

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

 Persons > 65 years of age           Persons 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65 years, 1998–2009 Moore, IDSA, 2009 & CDC Unpublished 9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

<5 Age group, years Percent Decrease in Rate (95%IE) 2010-11 2011-12 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.

  Not recommended for most persons Who 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?

1 year old child 25 year old HIV+ man 67 year old woman

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. She should receive Tdap only if she did not receive during her prior pregnancy 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

WHO

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

WHAT

 Boostrix preferred for adults > 65 years (but either okay)

WHEN

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

MMWR 2013;62:131-135

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

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?

Vaccine is contraindicated given her history of diabetes Vaccine not indicated given her history of zoster Check VZV titer to confirm history. If negative, proceed with vaccination 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;356:1338-43 Gann JW, Whitley RJ. NEJM 2002;347:340-6

Study Design N = 38,546 Adults > 60 Randomized, double-blind Followed for mean 3.1 yrs Single dose vaccine vs placebo

Decreased Herpes Zoster by 51.3% Decreased PHN by 66.5%

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

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

Source: Yawn 2007 * PHN defined as ≥ 90 days of pain

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

* PHN = moderate to severe pain lasting >90 days

Ortega-Sanchez. ACIP OCT 2013

Net cost * Vaccinate at 50 Vaccinate at 60 $178.5 Million $169.0 Million Vaccinate at 70 $162.9 Million Cost per HZ prevented Cost per PHN prevented

$11,255 $61,084 $8,455 $19,761 $9,989 $9,607

Cost per QALY saved ** $271,713 $79,967 $38,191

Cost of Vaccination Program

Savings in Cost-of-Illness from Vaccination

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

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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?

Vaccine is contraindicated given her history of diabetes Vaccine not indicated given her history of zoster Check VZV titer to confirm history. If negative, proceed with vaccination

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?

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

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

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 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

Influenza Vaccine Coverage Among US Adults: 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?

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

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

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)