VACCINES FOR HEALTHCARE WORKERS

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VACCINES FORHEALTHCARE WORKERS

• David Jay Weber, M.D., M.P.H.
• Professor of Medicine, Pediatrics, Epidemiology
• Associate Chief of Staff
• Medical Director, Hospital Epidemiology
  Occupational Health
• University of North Carolina at Chapel Hill

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LECTURE TOPICS

• Impact of immunizations on public health
• Why vaccination of healthcare workers is
  important
• Vaccines recommended for healthcare workers
• Assuring healthcare worker coverage
• Special issues Pregnancy, serologic testing,
  post-immunization work restrictions
• Mumps, measles, rubella, varicella
• Hepatitis B
• Influenza
• Pandemic influenza
• Pertussis

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10 GREAT PUBLIC HEALTH ACHIEVEMENTS, US, 1900-1999

• Immunization
• Motor vehicle safety
• Safer workplaces
• Control of infectious diseases
• Decline in deaths from coronary artery disease
  and stroke
• Safer and healthier foods
• Healthier mothers and babies
• Family planning
• Fluoridation of drinking water
• Recognition of tobacco use as a health hazard

CDC. MMWR 199948241-243
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VACCINE PREVENTABLE DISEASES
27 cases type B lt5 years old Date
from 2008 provisional
MMWR 2009571420-31
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MOVIE CLIP

• Five Pennies, 1959
• Polio in a hospital ward

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IMPACT OF DISCONTINUING A VACCINE PROGRAM
DIPHTHERIA IN THE RUSSIAN FEDERATION
Markina SS, et al. J Infect Dis 2000181(suppl
1)S27-34
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MAJOR INFECTIOUS RISKS FOR HEALTHCARE WORKERS

• Airborne or droplet transmitted diseases
• Varicella, pertussis, meningococcal infection,
  influenza (seasonal novel H1N1), mumps,
  measles, others (e.g., RSV)
• Bloodborne pathogens
• Via percutaneous or mucosal exposure (gt30
  documented)
• Major risks HBV, HCV, HIV
• Contact transmitted diseases (direct, indirect)
• C. difficile, MRSA, herpes simplex, syphilis,
  adenovirus (keratoconjunctivitis)

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WHY IMMUNIZATION OF HEALTHCARE WORKERS IS SO
IMPORTANT!!!

• Infection introduced or propagated by infected
  HCWs leading to large outbreaks
• Mumps, measles, rubella, varicella, pertussis,
  influenza
• Asymptomatic or minimally symptomatic patients
  may transmit infection
• Influenza, chronic hepatitis B (gt25 outbreaks of
  HCW-to-patient transmission documented)
• Patients in prodromal phase of illness may
  transmit infection
• Measles, varicella, influenza

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WHY IMMUNIZATION OF HEALTHCARE WORKERS IS SO
IMPORTANT!!!

• HCWs may acquire infection entering room after
  the infectious patient has left
• Measles (up to 75 minutes)
• Aerosolization of infective fluids may lead to
  infection
• Meningococcus (spinning CSF in laboratory)
• Airborne infections may result from autopsies
  (source cadaver)
• Varicella (Paul N, Jacob ME. Clin Infect Dis
  200643599-601)

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UNC OHS EVALUATIONS, 2005-06
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UNC OHS EVALUATIONS, 2007-08
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PROTECTING HCWs

• Immunizations Pre- and post-exposure
• Hand hygiene Before and after direct patient
  contact
• Personal protective equipment Gloves, masks/N95
  respirators, eye protection, gowns
• Patient isolation precautions
• Contact via direct or indirect contact gloves,
  gowns
• Droplet via large droplets (lt3 feet) mask,
  private room
• Airborne via small droplets (gt3 feet) N95
  respirator (TB) or surgical mask, private room,
  negative air pressure, gt12 air exchanges per
  hour, direct out exhausted air

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ACIP 2009
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ACIP 2009
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KEY DISEASES FOR WHICH VACCINES ARE NOT AVAILABLE

• HIV
• Hepatitis C
• Parvovirus B19
• MRSA

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RECOMMENDED VACCINES FOR HCWs CDC, ACIP, HICPAC

• Measles (MMR preferred)
• Mumps (MMR preferred)
• Rubella (MMR preferred)
• Varicella (V)
• Hepatitis B (OHSA required)
• Seasonal influenza
• Novel H1N1 influenza
• Tetanus (Tdap)
• Diphtheria (Tdap)
• Pertussis (Tdap)
• Required at UNC

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VACCINES IN PREGNANCY

• Indicated
• Td (Tdap?), influenza (inactivated)
• Contra-indicated (attenuated live virus vaccines)
• Mumps, measles, rubella, varicella, attentuated
  influenza, oral polio, typhoid, vaccinia
• Use if indicated (benefits exceed risks)
• Hepatitis A, hepatitis B, meningococcal,
  pneumococcal,

Only vaccine for which pregnancy testing is
recommended for women of child bearing
potential prior to vaccine administration
because it may result in fetal toxicity)
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SEROLOGIC TESTING

• Pre-immunization
• Do not obtain serologic screening for immunity
  unless cost-effective or vaccine contra-indicated
  (e.g., MMR)
• Can be use to demonstrate immunity Varicella
  (wild type infection), mumps, measles, rubella,
  hepatitis B (gt10 mIU/mL), rabies
• Not available or inaccurate for demonstrating
  immunity Varicella (s/p vaccine), tetanus,
  pertussis, influenza
• Post-immunization
• Rarely indicated
• Indicated for hepatitis B (HCWs), rabies (high
  risk)

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WORK RESTRICTIONPOST-IMMUNIZATION

• Live attenuated influenza vaccine Restrict from
  working in a stem cell transplant unit (i.e.,
  protected environment for 7 days)
• Vaccinia Lesions must be maintained under a
  porous dressing and under clothes
• Varicella Furlough if generalized rash develops
• No other work restrictions recommended (i.e.,
  immunized employees may work with neonates,
  pregnant women, and immunocompromised patients)

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ASSURING HCW COVERAGE

• Employee Groups
• Healthcare facility employees - requirement for
  employment
• Medical staff - include in credentialing process
• Students - require for attending class
• Volunteers - require
• Contract workers - require in contract
• Emergency responders require
• Mandatory (employment conditional on being
  immune only medical contra-indication recognized
  as reason for not receiving vaccine if required
  for immunity)

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SPECIAL USE VACCINES IN HCWs

• Anthrax Post-exposure
• BCG Pre-exposure (high risk)
• Hepatitis A Post-exposure, outbreak, research,
  travel
• Japanese encephalitis Research, travel
• Meningococcal Outbreak, laboratory (spinning
  CSF), travel
• Polio Research, travel
• Rabies Post-exposure, research, travel
• Typhoid Research, travel
• Vaccinia Pre-exposure?, post-exposure, research
• Yellow fever Research, travel

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PROVIDING VACCINES

• Employee name and identification number
• Vaccine
• Dose, Site, Route of Administration
• Date given
• Manufacturer, Lot number
• Name, title, address of person providing vaccine
• Date next dose due
• Signed informed consent

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MUMPS, MEASLES, RUBELLAISSUES FOR HEALTHCARE
FACILITIES

• Mumps
• Droplet transmission
• No post-exposure prophylaxis
• Recent outbreaks in US
• Measles
• Airborne transmission
• Post-exposure prophylaxis Ig
• Many cases imported
• Rubella
• Droplet transmission
• No post-exposure prophylaxis
• Concern about congenital infection

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MMWR 200956(53)1-94
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MUMPS OUTBREAK, IOWA 2006
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Loreen Herwaldt, personal communication
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MMWR 200956(53)1-94
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MEASLES OUTBREAKS

• More than 30 reports in the literature of
  outbreaks in healthcare facilities
• Between 1985 and 1989, 3.5 of all case acquired
  in a medical facility (Atkinson Wl, et al. Am J
  Med 199191(S 3B)320-24S
• Investigation of individual outbreaks has
  revealed that 17 to 53 were acquired in a
  medical facility
• Nosocomial outbreaks have led to hospitalization
  of medical staff and severe complications in
  infected patients including death
• Cost of outbreaks has ranged from 28,000 to more
  than 100,000

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MUMPS, MEASLES, RUBELLAIMMUNIZATION OF HCWs

• Mumps
• Immunity MD diagnosed disease, positive
  serology, immunization
• Vaccination 2 doses (consider 1 dose if born
  before 1957, except in outbreak setting provide
  2nd dose)
• Measles
• Immunity MD diagnosed disease, positive
  serology, immunization
• Vaccination 2 doses (consider at least 1 dose
  if born before 1957)
• Rubella
• Immunity Positive serology, immunization
• Vaccination 1 dose

Written documentation required
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VZVISSUES FOR HEALTHCARE FACILITIES

• Communicable (1-2 days) before rash appears
• Multiple outbreaks reported in hospitals
• Airborne transmission
• Highly communicable
• Life threatening disease in immunocompromised
  persons and neonates
• Infection in pregnant woman may lead to
  congenital malformations
• Seropositivity lower in persons born in tropical
  countries
• For near future, how to manage HCWs with remote
  immunization

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DECLINING VZV IN THE US
MMWR 200956(53)1-94
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CHICKENPOX FROM AN IMMUNO-SUPPRESSED INDEX CASE
WITH ZOSTER
Faizallah R, et al. BMJ 19822851022-1023
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Gustafson TL, et al. Pediatr 198270550-6
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VARICELLAIMMUNIZATION IN HCWs

• Immunity Self report, serology, MD diagnosed
  disease, 2 doses vaccine
• To prevent disease and nosocomial spread of VZV,
  healthcare institutions should ensure that all
  HCWs have evidence of immunity to varicella
• Birth before 1980 is NOT considered evidence of
  immunity
• Serologic screening before vaccination of
  personnel who have a negative or uncertain
  history of varicella and are unvaccinated is
  likely to be cost effective
• Institutions may elect to test all HCWs
  regardless of disease history because a small
  proportion of persons with a positive history
  might be susceptible
• Institutions should consider precautions for
  personnel in whom rash occurs after vaccination.
  HCWs in who a vaccine related rash occurs should
  avoid contact with persons without evidence of
  immunity who are at risk for severe disease

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PROOF OF IMMUNITY FOR HCWS
? Proposed changes
Recommendation is to consider vaccine
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HEPATITIS BISSUES FOR HEALTHCARE

• Hepatitis B stable in the environment for at
  least 1 week
• Highly infectious
• Risk via needlestick
• HBeAg positive source 22.0 to 30.0
• HBeAg negative source 1.0 to 6.0
• Examples of transmission
• Nurse with eczema while obtaining blood gases
• File cards used in a microbiology laboratory
  (paper cuts)
• Fomites Glucose measuring devices (multiple),
  multi-dose medication vials, vaccine
  administration devices

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Estimated Incidence of HBV infections among HCP
and General Population, United States, 1985-1999
Healthcare Personnel
General U.S. Population
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HEPATITIS B VACCINE

• Dose Recombivax 1.0 ml (10 ug), Engerix 1.0 ml
  (20 ug)
• IM dose into deltoid 1-1.5 needle, 20-25 gauge
• May mix and match vaccine from different
  companies
• Schedule 0, 1, 6 mo OR 0, 1, 2, 12 mo (more
  rapid antibody rise)(Engerix)
• Prior to administration do not routinely perform
  serologic screening for hepatitis B unless cost
  effective
• After 3rd dose, test for immunity (i.e., gt10
  mIU/mL)OSHA required if inadequate provide 3
  more doses and test again for immunity if
  inadequate consider as nonresponder
• If non-immune after 6 (or 3) doses, test for HBsAg

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Influenza Disease Burden to U.S. Societyin an
Average Year
Deaths 25,000 - 72,000
Hospitalizations 114,000 - 257,500
Physician visits 25 million
Infections and illnesses 50 - 60 million
Thompson WW et al. JAMA. 2003289179-86. Couch
RB. Ann Intern Med. 2000133992-8. Patriarca PA.
JAMA. 199928275-7. ACIP. MMWR.
200453(RR06)1-40.
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INFLUENZA VACCINE INDICATIONS

• Children aged 6 mo to 18 years
• Women who will be pregnant during influenza
  season
• Persons aged gt50 years
• Children (6 mo18 yr) receiving aspirin (risk for
  Reye syndrome)
• Adults and children with chronic
  cardio-respiratory illnesses
• Adults and children with chronic metabolic
  disorders, immune deficiencies, or
  immunosuppression
• Adults and children with any chronic condition
  that compromised respiratory tract function or at
  increased risk for aspiration
• Persons who live with people at high risk for
  influenza complications
• Residents of extended care facilities of any age
• Healthcare workers

CDC/ACIP. MMWR 200958(RR-8)
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INFLUENZA IN HEALTHCARE FACILITIES

• More than 25 outbreaks described in literature in
  acute care hospitals
• Infected staff may initiate outbreak or aid in
  propagation
• HCW infection may lead to absenteeism and
  disruption of health care
• Attack rates in HCWs have ranged from 25 to 80
• More than 15 outbreaks described in literature in
  extended care facilities
• Important morbidity and mortality among residents
  may result
• High rates of immunization (gt60) among staff may
  lead to decreased attack rate in residents

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Indirect Benefits of Influenza Vaccination of
Health Care Workers
Mortality of residents was significantly reduced
(10 vs 17) in nursing homes where the staff
was vaccinated (SV) compared to facilities where
they were not (S0)
20
Vaccine groups
SV (n490) SO (n561)
(P0.0009)
Total patient mortality ()
10
0
0
20
40
60
80
100
120
140
Time in days
Potter J et al. J Inf Dis. 19971751-6.
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REDUCTION IN OUTCOMES IN HCWs RECEIVING INFLUENZA
VACCINE
Influenza infection
Sick days due to respiratory illness
Days lost from work
Patient mortality
Patient mortality
28
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41
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88
Saxen 1999
Carmen 2000
Potter 1997
Wilde 1999
Wilde 1999
Talbot TT, Weber DJ, et al. ICHE 200526882-890
Attack rate unvaccinated 13.4
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INFLUENZA VACCINE COVERAGE IN HEALTHCARE WORKERS,
NCHS
Walker FJ, et al. ICHE 200627257-265
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BARRIERS AND SOLUTIONS TO HCW INFLUENZA VACCINE
CONCERNS

• Access to vaccine, inconvenience
• Off-hours clinics
• Use of mobile vaccination carts
• Vaccination at staff and department meetings
• Cost
• Provision of vaccine free of charge
• Concerns for adverse events
• Targeted education, including specific
  information to dispel vaccine myths

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BARRIERS AND SOLUTIONS TO HCW INFLUENZA VACCINE
CONCERNS

• Fear of needles
• Use of LAIV for eligible HCWs
• Other
• Strong and visible leadership
• Visible vaccination of key leaders
• Surveillance of HCW-associated influenza
• Accurate tracking of individual and unit-based
  compliance
• Active declination for HCWs who do not wish to be
  or cannot be vaccinated

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ARGUMENTS IN FAVOR AND AGAINST CONDITIONAL
(MANDATORY) USE OF INFLUENZA VACCINE IN HCWs

• In favor of conditional vaccine use
• Key principle First do no harm (nosocomial
  transmission linked to infected staff)
• Protects the staff and their families
• Institutional benefit Decreased absenteeism,
  cost effective
• Against conditional vaccine use
• Feasibility Difficult to capture all employees
  each year
• May result in staff dissatisfaction
• Union concerns

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MANDATORY INFLUENZA VACCINE EXPERIENCE OF
WASHINGTON UNIVERSITY, 2008

• Setting 11 acute care and 3 long term care
  facilities
• gt25,000 employees
• Annual influenza vaccine campaigns
• 1997-2006 40-54 compliance
• 2007 (active declination forms added) 71
  compliance
• Mandatory vaccine 2008 (policy compliant
  99.96)
• Vaccinated 25,561 (98.4)
• Medical exemptions 321 (1.24) required MD
  note
• Religious exemptions 90 (0.35) required
  letter
• Non-compliant 8 (0.03)

Babcock H, et al. Presented at SHEA, 2009
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Hampson AW, Mackenzie JS. MJA 2006185S39-43
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ESTIMATES OF NOVEL H1N1 IMPACT
Presidents Council of Advisors on Science and
Technology, 7 Aug 2009
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NOVEL INFLUENZA H1N1, 2009CURRENT EPIDEMIOLOGY

• Unique strain Includes genetic components of
  human, avian, and swine origin
• Worldwide outbreak
• Efficient human-to-human transmission documented
• Susceptible to antivirals (oseltamivir and
  zanamivir) but oseltamivir resistance described
• Median age, US 12 (highest infection incidence,
  5-24 years)
• Older individuals may have cross-reacting
  antibodies (i.e., partial protection)
• Risk factors
• Obesity (BMI gt30) and morbid obesity (BMI gt40) a
  newly described risk for severe illness
• Pregnant women Death rate 4x higher than general
  public

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ILI REPORTED BY US OUTPATIENT ILINet
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NOVEL H1N1
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H1N1 SURVEILLANCE, UNC
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H1N1 VACCINE

• Made in a similar fashion to seasonal influenza
  vaccine
• Egg based production
• Single dose syringes and inhaled vaccine are
  thimerosal free
• Multi-dose vials have miniscule amount of
  thimerosal (no human harm demonstrated from
  thimerosal per IOM report)
• No adjuvant
• Risk of Guillain-Barre 1 additional case per
  1,000,000 vaccinated
• Both inactivated and live-attenuated vaccines
  will be available
• Licensed by FDA 15 September 2009 CSL Limited,
  MedImmune LLC, Novartis Vaccines and Diagnostic
  Limited, and Sanofi Pasteur Inc.
• Available for clinical use in early to
  mid-October
• Requires one dose in adults, 2 doses in children
  Robust immune response produced in healthy adults
  in 8-10 days (15ug dose 96.7)
• Vaccine provided free by Federal Government

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TARGET GROUPS FOR H1N1 VACCINE
(estimated 159 million)
(estimated 42 million)
MMWR 200958(RR-10)
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TARGET GROUPS FOR H1N1 VACCINE

• Initial
• Pregnant women
• People who live with or care for infants younger
  than 6 months of age
• Healthcare and emergency medical personnel
• Anyone from 6 months through 24 years of age
• Anyone from 25 through 64 years of age with
  certain chronic medical conditions or a weakened
  immune system
• As more vaccine become available, these groups
  should also be vaccinated
• Healthy 25 through 64 year olds
• Adults 65 years and older
• Children through 9 years of age should get 2
  doses of vaccine about a month apart

CDC. 2 October 2009
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FDA APPROVED 2009 H1N1 VACCINESINACTIVATED
VACCINES

• CLS (indicated for persons gt18 years of age)
• Single dose prefilled syringes, thimerosal free
  multi-dose vials contain thimerosal
• Novartis Vaccines and Diagnostics Limited
  (indicated for persons gt4 years of age)
• Single dose prefilled syringes contain a trace
  amount of thimerosal multi-dose vials contain
  thimerosal
• Sanofi Pateur Inc. (indicated for persons gt6
  months of age)
• Single dose prefilled syringes, thimerosal free
  multi-dose vials contain thimerosal

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FDA APPROVED 2009 H1N1 VACCINES
CONTRA-INDICATIONS WARNINGS

• Inactivated vaccines (contra-indications)
• Anaphylaxis to a previous dose of influenza
  vaccine
• Hypersensitivity to eggs or chicken proteins
• Hypersensitivity to gelatin (Sanofi),
  formaldehyge (Sanofi), polymyxin (Novartis, CSL),
  neomycin (Novartis, CSL), nonylphenol ethoxylate
  (Novartis)
• Inactivated vaccines (warnings)
• Guillain-Barre syndrome within 6 weeks of a
  previous dose of influenza vaccine
• Immunocompromised persons may have a diminished
  immune response

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FDA APPROVED 2009 H1N1 VACCINESLIVE ATTENUATED
VACCINES

• MedImmune LLC (indicated for persons 2-49 years
  of age)
• Thiomerosal free

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FDA APPROVED 2009 H1N1 VACCINES
CONTRA-INDICATIONS WARNINGS

• Live attenuated vaccine (contra-indications)
• Anaphylaxis to a previous dose of influenza
  vaccine
• Hypersensitivity to eggs, chicken protein,
  gelatin, gentamicin, or arginine
• Live attenuated vaccine (warnings and
  precautions)
• Do not administer to persons with asthma or
  children lt5 years of age with recurrent wheezing
• Guillain-Barre syndrome within 6 weeks of a
  previous dose of influenza vaccine
• Pregnant women
• Immunocompromised persons
• Persons at high risk of complications from
  influenza

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PERTUSSISISSUES FOR HEALTHCARE FACILITIES

• Multiple outbreaks reported in hospitals
• Droplet transmission
• Highly communicable
• Prolonged communicable period (gt3 weeks)
• Life threatening disease in neonates and infants
• PCR for diagnosis may not be available
• Initial symptoms nonspecific
• Post-exposure prophylaxis available
  (azithromycin, TMP-SMX)

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PERTUSSIS, US, 1977-2007
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Pertussis Stages, Communicability
period of communicability
Catarrhal runny nose, sneezing, low- grade
fever, mild cough Paroxysmal severe spasms of
cough, thick mucus, whoops, vomiting,
exhaustion Convalescent gradual recovery with
less frequent and less severe cough
paroxysmal cough onset
exposure
2
4
-1
1
3
5
6
8
9
10
11
12
-2
0
7
weeks of cough
catarrhal stage
paroxysmal stage
convalescent stage
CDC. Epidemiology and Prevention of
Vaccine-Preventable Diseases. PHF 2004
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OUTBREAK MAYO CLINIC, ROCHESTER, MN
Leekha S, et al. SHEA (abstract), 2206
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PERTUSSISIMMUNIZATION FOR HCWs

• ACIP recommendations
• Provide to HCWs unless Td within past 2 years or
  vaccine contra-indication
• Indicated for HCWs 18 to 65
• No serologic test available to assess immunity
• Immunized HCWs still need post-exposure
  antibiotic prophylaxis (azithromycin, TMP-SMX)

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VACCINES INDICATED FORPOST-EXPOSURE PROPHYLAXIS

• Mumps No post-exposure prophylaxis available
• Measles lt3 days post-exposure (alternative Ig)
• Rubella No post-exposure prophylaxis available
• Varicella lt4 days post-exposure (alternative
  VZIG or acyclovir)
• Hepatitis B lt7 days post-exposure /- HBIG
  (alternative HBIG)
• Influenza Vaccine not indicated may use
  oseltamivir or zanamivir x 5 days
• Pertussis Vaccine not indicated (use
  antibiotics azithromycin, TMP-SMX)
• Tetanus Post-wound /- TIG (no time limit
  Tdap preferred)
• Rabies Prior to symptoms plus RIG (avoid RIG
  if previously vaccinated)
• Vaccinia lt4 days post-exposure (may also be
  indicated for monkey pox)
• Outbreak control Hepatitis A, pertussis,
  meningococcal

May need to be provided with an immunoglobulin
preparation
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SELECTED REFERENCES

• Bolyard EA, et al. Guideline for infection
  control in health care personnel, 1998.
  www.cdc.gov/ncidod/dhqp/pdf/guidelines/InfectionCo
  ntrol98.pdf
• CDC. Immunization of health-care workers.
  199746(RR-18)
• Weber DJ, Rutala WA. Vaccines for health care
  workers. In Vaccines (Plotkin S, Orenstein W,
  Offit P, eds). 5th ed. Saunders, 2008.
• Decker MD, Weber DJ, Schaffner W. Vaccination of
  healthcare workers. In Hospital Epidemiology amd
  Infection Control (Mayhall CG,ed). 3rd ed.
  Lippencott Williams Wilkins, 2004.
• For complete slide set see http//www.unc.edu/dept
  s/spice/

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