Contraindications To Vaccination

1

• Contraindications To Vaccination

William L. Atkinson, MD, MPH National Center for
Immunization and Respiratory Diseases
North Carolina Immunization Conference Greensboro,
North Carolina August 12-13, 2009
2
Disclosures

• The speaker is a federal government employee with
  no financial interest or conflict with the
  manufacturer of any product named in this
  presentation
• The speaker will not discuss the off-label use
  any vaccine
• The speaker will not discuss vaccines not
  currently licensed by the Food and Drug
  Administration

3
To Vaccinate or Not To Vaccinate?

• All vaccination decisions should be based on the
  benefit from vaccine (immunity) versus the risk
  from the vaccine (adverse reaction)
• Risk depends on characteristics of the vaccine
  and recipient
• Risk may be difficult to quantify for some
  special populations because of lack of data

4
What are the Risks?Inactivated Vaccines

• Local adverse reactions (pain, redness, swelling)
• most studies indicate an increasing incidence of
  local reaction with increasing number of doses
• higher with vaccines that contain adjuvant
• No evidence of increased risk of serious adverse
  events with increasing doses

aluminum hydroxide, aluminum phosphate, aluminum
potassium sulfate
5
Local Adverse Events Following Td
Williams and Ellingson, Ann Emerg Med
19851433-35
6
What are the Risks?Live Attenuated Vaccines

• Adverse events (except allergic reactions) occur
  as a result of viral replication
• Susceptible immunocompromised person may
  experience overwhelming viremia and organ damage
• Viral replication is limited or does not occur in
  an immune person
• Immunity from previous infection or vaccination
  does not decrease as a result of
  immunocompromising conditions (except HSCT)

7
Adverse Events Reported Following Varicella
Vaccine Doses
8
Classification of Vaccines

• Live
• MMR
• Varicella/zoster
• Rotavirus
• LAIV
• Yellow fever
• Oral typhoid
• Smallpox (vaccinia)
• BCG
• Inactivated
• All others

9
Contraindication and Precautions

• Contraindication
• a condition in a recipient that greatly increases
  the chance of a serious adverse reaction
• Precaution
• a condition in a recipient that might increase
  the chance or severity of an adverse reaction, or
• might compromise the ability of the vaccine to
  produce immunity

10
Contraindications and Precautions

• Permanent contraindications to vaccination
• severe allergic reaction to a vaccine component
  or following a prior dose
• encephalopathy not due to another identifiable
  cause occurring within 7 days of pertussis
  vaccination

11
Contraindications and Precautions
Condition Allergy to component Encephalopathy Pre
gnancy Immunosuppression Severe illness Recent
blood product
Live C --- C C P P
Inactivated C C V V P V
Ccontraindication Pprecaution Vvaccinate if
indicated except HPV and Tdap. MMR and
varicella-containing (except zoster vaccine) only
12
Immunosuppression

• Disease
• Congenital immunodeficiency
• Leukemia or lymphoma
• Generalized malignancy
• Chemotherapy
• Alkylating agents
• Antimetabolites
• Radiation
• Corticosteroids
• Immunomodulators?

13
The Spectrum of Altered Immunocompetence
Do not vaccinate or poor response
Vaccinate
No or little suppression
Severe suppression
Immunomodulators
High dose steroids
Post-transplant Rx
Low dose steroids
SCIDS
BM ablation
Chemotherapy
Intermittant/LD chemo
Asplenia
Autoimmune diseases
Live vaccines
14
Immunosuppression

• The amount or duration of corticosteroid therapy
  needed to increase adverse event risk is not well
  defined
• Dose generally believed to be a concern
• 20 mg or more per day for 2 weeks or longer
• 2 mg/kg or more per day
• NOT aerosols, topical, alternate day, short
  courses (less than 2 weeks)
• Delay live vaccines for at least 1 month after
  discontinuation of high dose therapy

MMWR 2006 55(RR-15)
15
Vaccination of Immunocompromised Persons

• Immunocompromised persons may receive
  inactivated, recombinant, subunit, conjugate and
  toxoid vaccines when indicated
• Response to vaccine may be suboptimal
• Persons vaccinated during immuno-suppressive
  therapy or radiation should be revaccinated 3
  months or longer after therapy discontinued

MMWR 2006 55(RR-15)
16
Vaccination of Immunocompromised Persons

• It is preferable to vaccinate an
  immunocompromised person and obtain a
  less-than-optimal response than to withhold the
  vaccine and obtain NO response

inactivated vaccines only
17
Vaccination of Immunocompromised Persons

• Susceptible immunocompromised persons are at
  increased risk of adverse events following live
  vaccines
• Live vaccines may be administered 3 months or
  longer following termination of therapy (at least
  1 month after high-dose steroids)
• MMR and varicella vaccines should be administered
  to susceptible household and other close contacts

MMWR 2006 55(RR-15)
18
Revaccination

• Immunity to vaccine-preventable diseases
  established prior to immunosuppression is not
  lost because of the immunosuppression
• Routine revaccination following immunosuppression
  is not necessary except for vaccines received
  during immunosuppression

except HSCT recipients
19
New Categories of Immunosuppressive Agents

• Immune mediators
• Colony stimulating factors, interferons,
  interleukins
• Immune modulators
• BCG, levamisol
• Isoantibodies
• Tumor necrosis factor inhibitors
• Effect of these agents on the safety of live
  vaccine is not certain
• Prudent to manage like high-dose steroids

20
Vaccination of Asplenic Persons

• Persons with functional or anatomic asplenia are
  at increased risk of infection with encapsulated
  bacteria
• Vaccines recommended (in addition to those
  routinely recommended for age)
• Pneumococcal polysaccharide (2 doses 5 years
  apart)
• Meningococcal conjugate (2 through 55 years of
  age) or polysaccharide (56 or older)
• Hib

Children with anatomic or functional asplenia
24-59 months of age are also candidates for
pneumococcal conjugate vaccine. MMWR
200857(5152).
21
Persons with HIV Infection

• Persons with HIV/AIDS are at increased risk for
  complications of measles and varicella
• Increased risk of complications of influenza and
  pneumococcal disease

22
Recommendations for Routine Immunization of
Persons with HIV/AIDS

• Documented Td series with booster doses every 10
  years (Tdap once)
• Annual influenza vaccination (TIV)
• Pneumococcal polysaccharide (2 doses separated by
  5 years)
• Hepatitis A and B (and other inactivated
  vaccines) if indicated
• Some live vaccines depending on level of
  immunosuppression

off-label ACIP recommendation. MMWR
200655(RR-15)
23
Live Attenuated Vaccines for Persons with
HIV/AIDS
Vaccine Varicella Zoster MMR MMRV LAIV Rotavirus Y
ellow fever
Asymptomatic Yes No Yes No No No Consider
Symptomatic No No No No No No No
Yesvaccinate Nodo not vaccinate
see specific ACIP recommendations for details.
24
Vaccination of Hematopoietic Stem Cell Transplant
Recipients

• Antibody titers to VPDs decline during the 1-4
  years after allogeneic or autologous HSCT if the
  recipient is not revaccinated
• HSCT recipients may be at increased risk of some
  VPDs, particularly pneumococcal disease
• Revaccination recommended beginning 6-12 months
  post-transplant

MMWR 200049(RR-10)
25
Vaccination of Hematopoietic Stem Cell Transplant
Recipients

• Inactivated influenza vaccine at least 6 months
  following transplant and annual thereafter
• Inactivated vaccines (DTaP/Td, IPV, hepatitis B,
  Hib, PCV, PPV) at 12 months
• MMR and varicella vaccines at 24 months if
  immunocompetent
• Meningococcal and Tdap vaccines
• few data on the safety and efficacy
• case by case decision by the clinician

MMWR 200049(RR-10) and MMWR 200655(RR-15)
26
Vaccination of Household Contacts of
Immunosuppressed Persons

• Healthy household contacts of immunosuppressed
  persons should receive MMR and varicella
  vaccines and annual influenza vaccination

27
FDA Pregnancy Categories
Source FDA website
28
Vaccination in Pregnancy

• ACIP recommendations for pregnant women do not
  reflect FDA pregnancy categories
• Hepatitis B and influenza vaccine are category C
  but recommended because of or during pregnancy
• HPV vaccine is category B but not recommended
  during pregnancy
• Wording in ACIP statements varies widely

29
Vaccination in Pregnancy

• Risk to a developing fetus from vaccination of
  the mother during pregnancy is mostly theoretical
• Only smallpox (vaccinia) vaccine has ever been
  shown to injure a fetus
• All vaccines administered to adolescents and/or
  adults are pregnancy category C
• The benefits of vaccinating usually outweigh
  potential risks

except anthrax vaccine, which is category D
30
Vaccination in Pregnancy

• Inactivated vaccines
• Routine (influenza)
• Vaccinate if indicated (hep B, Td, MPSV, rabies)
• Vaccinate if benefit outweighs risk (all other)
• HPV vaccine not recommended during pregnancy
• Live vaccine do not administer
• Exception is yellow fever vaccine

MMWR 2002 51(RR-2)1-36
31
Pregnancy and Inactivated Influenza Vaccine

• Risk of hospitalization more than 4 times higher
  than nonpregnant women
• Risk of complications comparable to nonpregnant
  women with high risk medical conditions
• ACIP recommends vaccination for ALL women who
  will be pregnant during influenza season

MMWR 200554(No. RR-8)1-40
32
Yellow Fever Vaccination in Pregnancy

• No evidence of harm to fetus from vaccination of
  mother
• Pregnant women who must travel to areas where the
  risk for yellow fever is high should receive the
  vaccine

CDC Travel Health. www2.ncid.cdc.gov/travel/
33
Use of Tdap Among Pregnant Women

• Infants 6 months of age and younger at highest
  risk for complications and death from pertussis
• Passive maternal antibody could help protect
  young infants
• Most pregnant women have little or no antibody to
  pertussis (hence no transfer to infant)
• Tdap vaccination of childbearing-age women could
  boost maternal antibody
• Concern by some experts that passive antibody
  could blunt infants response to DTaP
• No safety data among pregnant women

MMWR 200857(RR-4)
34
Use of Tdap Among Pregnant Women

• Any woman who might become pregnant is encouraged
  to receive a single dose of Tdap (Adacel only)
• Women who have not received Tdap should receive a
  dose in the immediate post-partum period
• Td generally preferred during pregnancy
• Clinician may choose to administer Tdap to a
  pregnant woman in certain circumstances (such as
  during a community pertussis outbreak)
• Pregnancy is not a contraindication for Tdap

MMWR 200857(RR-4)
Provisional recommendations approved by ACIP
June 28, 2006
35
Vaccination of Household and Other Close Contacts

• Household and other close contacts (including
  healthcare providers) should receive all
  recommended vaccines, including live vaccines and
  annual influenza vaccination (including LAIV if
  indicated)
• Little or no risk of transmission of vaccine
  viruses

36
Summary of all ACIP recommendations for
vaccination of pregnant women is avaialable on
the CDC Vaccines and Immunization website
at www.cdc.gov/vaccines/pubs/preg-guide.htm
37
CDC Vaccines and ImmunizationsContact Information

• Telephone 800.CDC.INFO
• Email nipinfo_at_cdc.gov
• Website www.cdc.gov/vaccines/
• Vaccine Safety
• http//www.cdc.gov/od/science/iso/