Preventing Infections Adult Vaccines: Update 2017 Thomas M File, Jr MD MSc MACP FIDSA FCCP Chair, Infectious Disease Division Summa Health, Akron, Ohio; Professor of Internal Medicine, Chair of Infectious Disease Section, Master Teacher Northeast Ohio Medical University, Rootstown, Ohio
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Preventing Infections Adult Vaccines: Update 2017 · Adult Vaccines: Update 2017 Thomas M File, Jr MD MSc MACP FIDSA FCCP Chair, Infectious Disease Division Summa Health, Akron, Ohio;
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Preventing Infections Adult Vaccines: Update 2017 Thomas M File, Jr MD MSc MACP FIDSA FCCP
Chair, Infectious Disease Division
Summa Health, Akron, Ohio;
Professor of Internal Medicine, Chair of Infectious
Disease Section, Master Teacher
Northeast Ohio Medical University,
Rootstown, Ohio
Review new developments in adult vaccines Focus on Influenza and pneumococcal
vaccines Additional comments: Zoster, Tdap, HPV,
Meningococcal B
Objectives
3 Vaccine evaluation center 2015
•Falling rates
•Success of past vaccines oLack of awareness of disease that is prevented
•Effects of anti-vacccine movement oFear, mistrust, ignorance
Threats to Vaccines
GA Poland 2011
Adult Immunization Coverage, US
MMWR. Feb 5, 2016. http://www.cdc.gov/mmwr/volumes/65/ss/ss6501a1.htm
Healthy People 2020 Objectives on Immunization and Infectious Disease. www.Healthypeople.gov/2020/.
1. DiazGranados CA, et al. N Engl J Med. 2014;371:635-45.; 2.
Influenza Vaccine Adjuvanted Vaccine
aIIV3, adjuvanted vaccine (Fluad) • Trivalent inactivated influenza vaccine plus a proprietary adjuvant that
is proposed to recruit immune cells at the site of injection and enhance antigen uptake
oResults in potentially greater immunogenic response in elderly patients
• Indication: Patients ≥65 years.
• Clinical trials show non-inferiority with IIV3 based on seroconversion and geometric mean titers
oNo data yet available that demonstrate decrease in influenza disease
Fluad™ (influenza vaccine, adjuvanted) Prescribing Information. Sequiris, Inc., Holly Springs, NC. March 2016.
Case Exercise 2 Which vaccine for:
A 19-year-old with history of severe allergic reaction (i.e., respiratory distress) to eggs?
A. IIV4, standard
B. aIIV3 (Fluad)
C. RIV3 (Flublok)
D. No vaccine/refer to specialist
Influenza Vaccine in Egg Allergies Cell-Cultured and Recombinant Vaccines
• ccIIV4 (Flucelvax® Quadrivalent) o In place of chicken eggs, uses animal cells (Canine Kidney) as host
(reference strain obtained from virus originally grown in eggs);
quadrivalent
o Approved for ages ≥4 years
• RIV3 (Flublok®) o Recombinant vaccine— egg-free hemagglutinin influenza vaccine
produced by recombinant DNA technology using a baculovirus (a virus
that infects insects) that produces virus-like particles, hemagglutinin
(vaccine of choice for true egg allergy)
o Approved for ages >18; only 16-week shelf-life; trivalent
• Adverse events similar to other inactive vaccines
Flucelvax® Quadrivalent (influenza vaccine) Prescribing Information. Sequiris, Inc., Holly Springs, NC. April 2016.
Flublok® (influenza vaccine) Prescribing Information. Protein Sciences Corp., Meriden, CT. September 2016.
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Influenza and Pregnancy
• Pregnant woman at high risk for severe complications and death o Cellular immune response diminished
• Maternal influenza associated with increased (Zaman et al. NEJM 2008) o Maternal hospitalization o Fetal malformation o Other illnesses
• Prevention is best approach • Newborns are at high risk for severe complications o Several reports of 2nd MRSA infection o No approved vaccine for infants < 6 months of age o All care givers need to be free from possible transmission
to this vulnerable population
Benefits/Obligations of Influenza
vaccine for Healthcare providers
• As HCW we all have an obligation to protect our patients o Transmission may occur without illness
• May be asymptomatic carriers • Infectious prior to onset of symptoms
o Studies show reduced transmission after vaccination
• Protection form acute illness oFor H1N1 greatest morbidity and mortality is in ‘healthy’
individuals aged 20-50.
• Protection of family members (especially if very young or with medical conditions)
• Mandatory immunization of all HCW being implemented at SUMMA
77% of Influenza ‘asymptomatic’
•Flu Watch Study1 oCourse of influenza over 5 cohorts (2006-11) oSerology; PCR; Weekly assessment for RTI
• Findings o77 % appeared to asymptomatic oOnly 17% of PCR-confrimed infection sought medical attention
• “A large number of well individuals in the community make a substantial contribution to transmission.”2
1. Hayward et al. Lancet Resp Med. 2014; 2: 445-54;
2. 2. Horby Lancet Resp Med. 2014; 2: 430
INFLUENZA VACCINE Reduction in Hospitalizations for Cardiac disease and
Strokes (Nichols et a. NEJM 348, April 3, 2003)
• Observational studies of large cohorts (140,000; 146,000), ’98-’99 AND ’99-’00, 3 HMOs, age 65
• Vaccination against influenza associated with reduction in hospitalization for : o Cardiac disease (19% both seasons) o Cerebrovascular disease (16%; 23%) o Pneumonia and Influenza (32%; 29%) o All cause Death (48%; 50%)
• Possible mechanisms: infection cause alterations in clotting factors, platelet aggregation, amount of inflammatory- response cytokines which enhance thrombosis
• Lower risk of Cardiovascular complications (JAMA. 2013;310(16):1711-1720)
Influenza ‘Nuts and Bolts’1
•Vaccination season: Soon as available to
~April o Influenza season unpredictable-can start Oct
o Immunity will last for almost all patients (no concern for
waning immunity for most))
oLate season vaccination important and underutilized
oLAIV can be safely used in MOST healthcare settings as
alternative to TIV2
•Egg allergy NO LONGER contraindication3
oAnaphylaxis is EXCEEDINGLY rare [<10 documented
cases]
oFlublok if concern
oOK to give egg-based if not history of severe anaphylaxis
• If vaccinated, should be observed ~30 minutes in office 1. Centers for Disease Control and Prevention. Inactivated Influenza Vaccine 2011-12. Available at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-flu.pdf
2. Talbot TR, et al. Infect Control Hosp Epidemiol. 2010;31:987-995.
3. Kelso JM, Wang J. UpToDate. 2011. Available at: http://www.uptodate.com/contents/influenza-vaccination-in-individuals-with-egg-allergy.
A 66-year-old man with COPD who has not received any immunization in the past 15 years. What do you recommend today?
A. Influenza vaccine
B. Pneumococcal vaccine
C. Zoster vaccine
D. A and B only
E. A, B, and C
Centers for Disease Control and Prevention. 2010. Active Bacterial Core Surveillance Report,
Emerging Infections Program Network, Streptococcus pneumoniae, 2009.
http://www.cdc.gov/abcs/reports-findings/survreports/spneu09.pdf. Accessed February 3, 2011.
Pneumococcal Diseases causes more deaths per
year in US than Breast Cancer or Prostate Cancer
Xu. Et al. Deaths: Prelimanary data for 2007. Natl Vital Stat Rep. 2009; 58: 1-51
Pneumococcal Vaccines-adults
• 90 known serotypes of S. pneumoniae
• Pneumococcal polysaccharide vaccine (PPSV23)
Inactive vaccine; contains 23 serotypes which account for majority (75-
80%) of clinical disease.
Approved for use in adults of any age; ? Efficacy for pneumonia
• Pneumococcal conjugate vaccine (PCV13) approved
for use in adults age 50 and older
Inactive vaccine, conjugated with diptheria CRM 197 protein); 13 serotypes
which account for approx 45-50% of invasive disease
Approval from FDA announced December 30, 2011 for adults 50 years and
older
Previously approved and recommended for use in children
CDC’s Advisory Committee on Immunization Practices (ACIP)
recommends use for patients who are immunocompromised
Strategies for sequential use of Conjugate and
Polysaccharide vaccine use in adults
• Conjugate vaccine more immunogenicity (higher antibody levels) and can have booster effect o 13 serogroups (accounts for approx 50% of invasive cases of
pneumococcal disease
• Polysaccharide vaccine less immunogenecity and NO booster effect (may have hyporesponsiveness) o But has 23 serogroups (accounts for approx 89% of invasive cases)
• Give Conjugate first followed by polysaccharide for potentially optimal effect
• If polysaccharide given initially wait one year to administer the conjugate vaccine (reduce ? Hyporesponsiveness)
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35 Source: Designed by National Foundation for Infectious Disease based on CDC recommendations; 2012
CDC Recommendations 2015 for aged > 65
Which Vaccine(s)
24 year with asthma has not previously received any
pneumococcal vaccine
A. Conjugate 13
B. Conjugate 13 followed by Polysaccharide 23
one year later
C. Polysaccharide 23
D. Pneumococcal vaccine not indicated
Which Vaccine(s)
24 year with asthma has not previously received any
pneumococcal vaccine
PPSV23 now; PCV age 65 followed by PPSV 6-12 months
later
Which Vaccine(s)
28 year old woman with HIV infection received
one dose PPSV23 a year ago.
A. Conjugate 13
B. Conjugate 13 followed by Polysaccharide 23
one year later
C. Conjugate 13 followed by Polysaccharide 23
4 years later
D. Polysaccharide 23
Patient Scenario
28 year old woman with HIV infection received one
dose PPSV23 a year ago.
One dose PCV now (> one year since PPSV); 2nd dose
PPSV23 age 32 (> 5 years since PCV); 3rd dose PPSV age 65
Which Vaccine(s)
66 year old male, CHF, received PPSV23 age 55
A. Conjugate 13
B. Conjugate 13 followed by Polysaccharide 23
one year later
C. Conjugate 13 followed by Polysaccharide 23
4 years later
D. Polysaccharide 23
Patient Scenarios
66 year old male received PPSV23 age 55
One dose PCV13 now followed by PPSV 23 in one year
Another one:
68 year old who received PPSV23 age 66???
ACIP Tdap Recommendations
Specific Priority Groups
•Pregnant women at 27-36 weeks' gestation
oAT EACH PREGNANCY!
•Adults, regardless of age, who are in close contact with infants younger than age 12 months (e.g., parents, grandparents, or child-care providers)
•Healthcare Providers
Zoster Vaccine (Zostavax ™)
oLive vaccine
• Not for pregnancy, immunocompromised
oApproved for the prevention of herpes zoster
(shingles) in persons aged 50 years and older.
(CDC ≥ 60)
oSingle SC injection within 30 minutes of
reconstitution • In 38,000 patient study, reduced the incidence of shingles by 51% in persons aged 60 years and older (less effective in older patients)
• Incidence of postherpetic neuralgia less by 39%.
Zoster Vaccine (Zostavax ™)
Most common questions
oWhat if no history of chicken pox? • OK to give oWhat if past zoster? • Give after resolution of past episode; no specific time interval recommended
oIs it covered by Medicare •Covered by Part D not Part B. Insurance payment varies by plan.
•To be covered by ACA oShould I receive if around pregnant or immunosuppressed persons? •YES--not transmitted
Zoster: Special Consideration
• Simultaneous administration of pneumococcal vaccine o One study showed the average titer against varicella zoster virus (VZV)
was lower in persons who received zoster and PPSV at the same visit compared to persons who received these vaccines 4 weeks apart
o However, a large study was subsequently conducted that showed that zoster vaccine was equally effective at preventing herpes zoster whether it was administered simultaneously with PPSV or 4 weeks earlier
o CDC continues to recommend that HZV and PPSV be administered at the same visit if the person is eligible for both vaccines.
NEW Zoster vaccine (Shingrix™): subunit recombinant, adjuvant
• Recombinant: VZV glycoprotein E (target of both humoral and cellular immune responses) with novel adjuvant
• High and sustained efficacy in clinical trials o ZOE-50: associated with a risk of herpes zoster that was 97.2% lower
than that associated with placebo in age 50 and older.1
o 2nd trial (ZOE-70) for 70 + demonstrated 89% efficacy and reduced PHN.2
o Pooled analysis: 91% efficacy against zoster; 89% against PHN
• 2 doses; AEs comparable.
• Recommended unanimously by ACIP advisory committee (approved by CDC 10/20/2017)
1. Lal H, et al. N Engl J Med. 2015;372:2087-2096.
2. Cunningham AL, et al. N Engl J Med. 2016;375:1019-1032.Mar 12, 2015)
HPV Vaccine
• HPV 9-valent vaccine (Gardasil 9, Merck)
• The vaccine is indicated for females aged 9 to 26
years and males aged 9 to 21 (22-26 high risk) years,
and for cancers caused by HPV types 6,11, 16, 18, 31,
33, 45, 52 and 58 and for the prevention of genital
warts caused by HPV type
• 97% effective in preventing cervical, vulvar and vaginal
cancers
• Last year CDC recommended reducing to 2 doses
• No apparent adverse effect if inadvertently given in
pregnancy (Quad; Scheller et al. NEJM 2017; 376:1223)
•Group B not in the Quadrivalent (A,C,Y,W) •High-risk individuals oComplement deficiencies, oanatomic or functional asplenia, omicrobiologists routinely exposed to N. meningitidis isolates
o serogroup B meningococcal disease outbreak •2 Vaccines: oTrumenba™ • 3 doses for high-risk; 2 doses* (6 months apart) healthy
oBexsero™: • 2 doses series
Meningococcal Serogroup B Vaccines
* ACIP Oct 2016
A. Pneumococcal
B. Hemophilus influenzae B
C. Meningococcal quadrivalent
D.Menigococcal B
E. All above
28 y/o male had splenectomy after MVA. Which vaccines should be administered after the splenectomy?
06.01.2016 Summa Health Sample Preso 50
51
A. Pneumococcal
A. PCV13; then PPSV23 > 8 weeks; PPSV23 in 5 years and at age 65
B. Hemophilus influenzae type B (Hib)
A. If not previously received
C. Meningococcal quadrivalent (ACWY)
A. Menveo™ or Menactra™ (2 doses each, 2 months apart)
D.Meningococcal B
E. All above
28 y/o male had splenectomy after MVA. Which vaccines should be administered after the splenectomy?
06.01.2016 Summa Health Sample Preso 52
The wars of the world: Saving lives
through vaccination
• Without the safe and effective vaccines that we too
often take for granted now, more than 300 million
who lived full and rewarding lives during the 20th
century would have died prematurely of a vaccine-
preventable disease. Compare this with the 160
million estimated to have been killed in all wars
combined during the same century. Stated another
way, vaccines saved twice as many lives as were lost