Small Group Guide

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Small Group Discussion GuideVaccine Safety Curriculum for Medical

Residents

Cite the multiple epidemiologic studies that have shown no linkbetween vaccines and autism.

[http://www.cdc.gov/vaccinesafety/Concerns/Autism/Index.html] Youcan be very specific that MMR was not linked to autism in a largeepidemiologic in Denmark comparing children who did and did notreceive MMR. There was no difference in rates of autism. (Madsen etal, N Engl J Med 2002;347:1477) Similarly you can be very specificabout the lack of a link between thimerosal and autism. Sincethimerosal has been removed from pediatric vaccines in the Californiarates of autism have not changed. [Schechter et al, Arch GenPsychiatry 2008;65:19-24)

Cite the fact that autism is very heritable, more so than breast cancer.

What can you say to address the concern that vaccine overwhelm theimmune system?

No evidence that children get more infections in the period after theyare immunized

Your immune system responds to thousands of antigens every day Vaccine are more pure today than 20 years ago so even though we

give more vaccines children are exposed to fewer antigens.

What can you say to address the concern that we give too many vaccinestoo soon?

We give vaccines as soon as we can in order to protect infants fromdiseases when they are most vulnerable

Infants are the most susceptible to severe outcomes from infectionsbecause their organs are still developing

Infants spend many hours per day in very close contact with others-asituation that leads to transmission of things like pertussis from familymembers to infants

What can you say to address the concern that natural immunity is better? Acknowledge that for some diseases that is true (e.g. varicella)

But also point out that natural immunity isnt better for other diseases(e.g. pneumococcus) for which the vaccine contains multipleserotypes. Natural infection only protects against the one serotypeyou happen to get

Remind parents that natural immunity comes at a price-deafness,brain damage, death as a result of the disease. You are rolling thedice that your child will not be one of the ones who suffers severelyfrom a vaccine preventable disease

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What can you say to address the concern that the vaccine schedule is amoney-fueled

conspiracy? Remind parents that the schedule is developed and endorsed by

physicians and public health officials, not the companies Challenge them by saying, Do you really think all the pediatricians in

the country are conspiring to promote a schedule that we dont thinkis safe and the best for children?

Challenge them by saying, Do you really think I would recommendsomething that I didnt think was best for your child?

Question 2: Where do parents with concerns about vaccines gettheir information?

Answer: Likely sources include web sites (mostly anti-vaccine), blogs,television, popular magazines, playground discussions, relatives

Exercise: Type Vaccines into Google and review the first 20 sitesquickly. How many could be classified as anti-vaccine sites. Readand discuss some of the theories put forth on these sites.

Discussion:How can you point out in a respectful way that the information parents arereading is not scientifically based and is incorrect?

Point out some of the inconsistencies you find on these sites Ask them why they are taking medical advice from an celebrity,

friend, relative, magazine instead of from their childs doctor Emphasize the lack of scientific studies and reiterate the basic tenet

of science-an observation needs to be repeated by independentgroups before we can really have confidence that it is correct. Noneof the claims about serious problems from vaccines have beenreproduced.

What are the characteristics of a web site, specific article, or author thatgives it/their credibility?

The source of the information is reliable/stable (e.g. AmericanAcademy of Pediatrics, World Health Organization, National Library ofMedicine, NIH)

The individuals/groups posting the information are identified andprovide contact information?

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Residents People with a scientific/medical background contribute the material or

at least review it The information is dated and current-vaccine science changes quickly

The scientific evidence is referenced with a citation, not juststatements like studies show or it has been shown that...

There is no obvious conflict of interest (e.g. selling a book) The site doesnt rely on anecdotes (e.g. My child got a vaccine and

then got XXX) The purpose of the site is to provide accurate information. The

purpose is not to sell something

Where can parents find credible information about vaccine safety, especiallyinformation about autism?

NNII (www.immunizationinfo.org)

VEC (www.vaccine.chop.edu)IAC (www.immunize.org)CDC/NIP (www.cdc.gov/nip)AAP (www.aap.org)AAFP (www.aafp.org/)IVS (www.vaccinesafety.edu)Vaccine Page (www.vaccines.org)Every Child by Two (www.ecbt.org)

Exercise: Go to http://www.immunizationinfo.org/ and find thesection on Evaluating Information About Vaccines on the Internet in theImmunization Issues section

Question 3: Why is the Sears schedule unnecessary and what arethe risks of seeking natural immunity?

Answer: The Sears schedule is unnecessary because it is based on thepremise that spreading out vaccines will avoid vaccine ingredients that arenot linked to adverse outcomes (e.g. aluminum and autism). So you aretaking steps to avoid something for no good reason.

Discussion:What is wrong with following a delayed vaccine schedule like the Searsschedule?

Following a delayed vaccine schedule does just that-it delaysprotection. Challenge the parent by saying, You dont delay puttingyour baby in a car seat, why do you want to delay protection from

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Residentsvaccines?

Children remain susceptible to the disease that we can preventthrough immunization. Some of them get them and suffer. Recent

examples include the 5 Hib cases in Minnesota and published in 2009(MMWR 2009;58:58-60) or [cite any recent local experiences here] Susceptible children contribute to outbreaks of disease Missed opportunities to immunize often stay missed and these children

never get fully immunized. Sears schedule is wrong because it is untested with regard as to

whether there is interference between vaccines that are given togetherin his schedule and not in the recommended one. Concomitant usestudies must be done by Pharmaceutical companies before vaccinescan be given together in patients to assure one vaccine does notinhibit the response of another. The Sears schedule ignores this

possibility and could lead to impaired antibody responses in somecases.

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Case #2: Parents seeking a waiver for their 4-year old toenter preschool.

Learning Objectives:a) Describe what the school entry requirements are in your stateb) Clearly describe the strengths and weaknesses of herd

immunity.c) Concisely convey the risk/benefit ratio of deferring vaccines

when vaccine-preventable diseases are still present in manycommunities.

d) Allay parental concerns about common minor reactions tovaccines.

Case Presentation:

Both parents come in, without their 4-year old child, to request that you signa waiver of vaccination they need in order to enroll their child at a newpreschool. The child has received some vaccines, but the parents haveselectively refused certain immunizations, mainly the live-virus vaccines(MMR, Varicella, and Rotavirus). They have general concerns about vaccinesafety including the concern that vaccines causing autism and aboutreactions their child has had to vaccines in the past.

Question 1: What are the school entry requirements in your state?

Can parents avoid immunizations required for school entry on the basisof a religious exemption? How does their religious exemption need tobe documented?

Can parents avoid immunizations required for school entry on the basisof a personal belief exemption? How does that need to bedocumented?

Do all states allow exemptions from school entry requirements?Answer: Some states only allow medical exemptions. A minority allowexemption based on personal belief.

What is the impact of exemptions from school entry requirements?Answer: Children who are exempted from vaccines have an 2-17-foldencreased risk of developing pertussis.[Feikin, JAMA, 2001;284:3145]

Question 2: Why it is important for young children enrolled inchildcare and school to be vaccinated?Answer: Herd immunity is crucial to prevent outbreaks of disease. Onceimmunization coverage levels drop below a threshold (e.g. 90% for measles)outbreaks of disease predictably occur. Outbreaks involve not onlyunimmunized children but immunized ones as well. This occurs because novaccine is 100% effective so once an outbreak gets started even immunized

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Residents(but still susceptible) children develop disease.

Discussion:

How can you convey the concept of herd immunity? Walk through a scenario where a child with measles is placed in a fully

immunized classroom compared to one with a 30% exemption rate. Talk about the likelihood that unimmunized children will come in

contact with the index case. Talk about how once an outbreak getsstarted, even immunized children can become infected since MMRvaccine is 90% to prevent outbreaks (Hethcote HW.Am J Epidemiol.1983;117(1):213)

For pertussis the rate is probably similar to that required to preventoutbreaks of measles.

What are some examples of what happens when herd immunity slips belowan adequate level?

Ongoing outbreaks of measles in UK, Switzerland other Europeancountries

Measles outbreak in San Diego in a school with very high exemptionrates [Sugerman, Pediatrics2010;125:747-755]

Question 3: How can you convey to parents that by leaving theirchildren unimmunized they are exposing them to greater risk than ifthey were immunized?

Answer: It is important to simply and clearly convey the concept ofrisk/benefit. You need to make the risk of vaccine preventable diseasesreal.You need to convey just how rare any serious side effects are from vaccines.

Discussion:How can you make disease risk real to parents?

Discuss recent cases of vaccine preventable disease in yourcommunity (deaths, severe outcomes, recent large outbreaks).

Discuss your personal experience with vaccine preventable diseases.How many cases of pneumococcal pneumonia or bacteremia have youseen? How many cases of severe vaccine side effects have you seen?

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Residents Paint the visual picture for how rare something is that occurs in

1:100,000.

How can you convey the safety of vaccines? Describe how we know vaccines are safe. Talk about the Vaccine

Safety Datalink [Baggs J, The Vaccine Safety Datalink: a model formonitoring immunization safety. Pediatrics 2011;127 Suppl 1: S45-S53;http://www.cdc.gov/vaccinesafety/Activities/VSD.html]

Describe how many children have received MMR, hepatitis B, orwhatever vaccine around the world over as many as 50 years!

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ResidentsCase #3: Mother refusing HPV vaccination for heradolescent daughter.Learning Objectives:

a) Address parental and patient concerns about real safety concerns.b) Discuss vaccine safety topics in short and concise conversations.c) Clearly describe general testing and monitoring systems that ensure

the safety of vaccines.

Case Presentation:You are performing a physical for a 13-year old female to participate incheerleading. The patient is accompanied by her mother today. The girlappears healthy and reports not participating in any high-risk behaviors suchas substance abuse or sexual activity. The girl is up-to-date on allimmunizations except HPV. The mother states she has heard the vaccine is

unsafe and contains dangerous ingredients. She also has moral issues withthe vaccine since it protects against an STD and will not allow her daughterto receive HPV vaccine until she is much older.

Question 1: How can you convey the importance of HPV vaccine?Answer: Point out how common HPV infection is and that once someone isinfected nothing can be done to eliminate the infection. A subset of infectedpeople will go on to develop cancer from their HPV infection (MMWR, 2007;56(RR02):1-24).Discussion:

Discuss the fact that more than 3000 women die every year from HPV-

related cervical cancer. Point out that HPV infection usually occurs within a few years of sexual

debut. Challenge the parents by asking Did you parents know whenyou started being sexually active?

Review with parents that we immunize at a young age to make sureadolescents are protected before they become sexually active.

Question 2: How can you concisely explain the testing andmonitoring process for vaccines.Answer: Describe how vaccines are tested for safety including newelectronic medical record based systems that allow much largergroups to be studied than before.Discussion:

Discuss the clinical trial and FDA approval process. Vaccines aretested in thousands of individuals and in combination with othervaccines prior to licensure. Rigorous standards for both efficacy andsafety need to be met before a vaccine can be licensed.

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Residents Talk about post-licensure studies such as those conducted by the

Vaccine Safety Datalink (Baggs J, The Vaccine Safety Datalink: a model formonitoring immunization safety. Pediatrics 2011;127 Suppl 1: S45-S53;

http://www.cdc.gov/vaccinesafety/Activities/VSD.html).

No clinical trial can detect rare adverse events (events withfrequencies less than 1:2000-10,000). We now have robust post-marketing surveillance systems that take advantage of electronicmedical records to scan large numbers of people for rare adverseevents. As an example after the use of pandemic H1N1 influenzavaccine in 2009-2010, the medical records of more than 10 millionvaccine recipients were evaluated for rare side effects.

Describe how many people have received MMR, hepatitis B, orwhatever vaccine around the world over as many as 50 years!Billions of people have received some vaccines. If they clearly causeda significant side effect, we would know about it.

Question 3: What should you do in your clinic to ensure the patientssafety?

Answer: Standard immunization delivery includes precautions toavoid immediate adverse events such as syncope.

Discussion: Syncopal reactions may occur in as many as 76% of adolescents

receiving HPV vaccine. Vaccine providers, particularly when vaccinating adolescents, should

consider observing patients for 15 minutes after vaccination todecrease risk for injury should they faint. (MMWR 2008;57:457-60)

Patients should be observed seated or lying down to reduce the chanceof a fall.

More serious systemic reactions, such as anaphylactic reactions, arerare, especially following IPV immunization. Clinics should be equippedto manage them and have oxygn and epinephrine available shouldanaphylaxis occur.

Question 4: Patients and parents cope with adverse reactionsfollowing vaccines if they are informed about what the patientmight expect in the days following injection. What should you tellthis patient and mother about what to anticipate in one to five dayspost vaccine?

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Answer: Mild to moderate pain (35-45%), swelling (6-8%) and redness (7-9%)at the injection site are seen following IPV vaccine in males and somewhat

more often in females (61-63%, 10-15%, and 9-15% respectively.)

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Case #4: Immunizations for immunosuppressed patients

(child & adult versions)Learning Objectives:

a) Clearly describe why live-virus vaccines should generally be avoidedin immunosuppressed patients, but other vaccines are safe andrecommended.

b) Concisely explain the safety of household contacts receiving live-virus vaccines.

c) Clearly convey the importance of cocooning animmunosuppressed patient.

d) Describe the risk/benefit ratio of receiving vaccines whenimmunosuppressed.

Case Presentation (child):A 5-year old child is accompanied by his parents for a routine check-upfollowing treatment for ALL. He was diagnosed at 3 years of age andsuccessfully completed chemotherapy 30 days ago. The family has surviveda harrowing struggle and wants to make sure their son is healthy and safe inthe future. As you talk about the effects of the chemotherapy and returningto a normal life, you introduce the topic of the child receiving vaccines. Theparents have concerns about the safety of an immunosuppressed child andthe people around that child getting vaccines because they are afraid thevaccines will make the child sick because of his weak immune system.Case Presentation (adult):A 43-year old patient is being seen today for a routine check-up following alumpectomy. Stage II breast cancer was removed 3 months prior with nocomplications and the patient is currently undergoing radiation therapy. Asyou talk about the effects of the radiation and returning to a normal life,you introduce the topic of vaccines. The patient has concerns about thesafety of an immunosuppressed person, and contacts, getting vaccinesbecause she is afraid the vaccines will make her sick because of her weakimmune system.

Question 1: Why are some vaccines safe and others arent forimmunosuppressed patients?Answer: Some vaccine are live-attenuated vaccines that can replicate andpotentially cause disease in immunosuppressed individuals (CDC GeneralRecommendations on Immunization, MMWR 2011;60:1-60)

Discussion:Which vaccines are live attenuated vaccines?

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Residents MMR Varicella vaccine Zoster vaccine

LAIV Yellow fever vaccine Rotavirus vaccine (selected patients)

Question 2: Is it safe for household contacts to receive livevaccines?Answer: Yes, all of the live vaccines except oral polio vaccine (no longerused in the U.S.) can be given to household contacts of immunosuppressedpatients. The Centers for Disease Control monitors the use of live vaccinesamong high risk populations to ensure that such events are identified. Thereis no evidence that household transmission from household contacts has

resulted in severe infection among the immunocompromised member of thehousehold.

Discussion:

What are the recommendations for use of LAIV (nasal infleuza vaccine)in household contacts of immunosuppressed patients?The only restrictions for use of LAIV in contacts of immunosuppressedpatients are for severely suppressed individuals (e.g. bone-marrowtransplant patients in a protected environment (MMWR,2010;59(rr08):1-62).

Can healthcare workers who work with oncology patients receive LAIV?Yes, healthcare workers who work with general oncology patients (seerestriction for bone marrow transplant patients), ICU patients, NICUpatients, and HIV-infected patients can receive LAIV (MMWR,2010;59(rr08):1-62).

Are there any published reports of a healthcare worker receiving LAIV,transmitting to a patient, and making them ill?No, there are no published examples of such transmission (MMWR,2010;59(rr08):1-62).

Can healthcare workers receive varicella or zoster vaccine and stillwork?Yes, however rarely recipients of these vaccine develop a rash aftervaccination (typically 1-2 weeks after vaccination). These rashes maycontain live vaccine virus and thus individuals with rash may becontagious and should take appropriate precautions.

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ResidentsQuestion 3: What are the risks involved when immunosuppressedpatients receive vaccines?Answer: Live attenuated vaccines can cause disease similar to the natural

infection.Discussion: What might happen if an HIV-infected patient with a CD4 count of 100

was given MMR vaccine?Cases of measles have occurred in severely suppressed individualsimmunized with MMR vaccine. Therefore, these children must receiveimmunoglobulin after any exposure to measles disease because theyare susceptible to measles and could develop severe and potentiallyfatal infection. Similarly, immunosuppressed individuals that receivevaricella vaccine can develop varicella disease. Fortunately thesecases can be treated with acyclovir since the vaccine strain of VZV is

susceptible to antiviral medications.

Can a patient on steroids for rheumatoid arthritis receive zostervaccine? Persons with impaired humoral immunity may be vaccinated. No data havebeen published concerning whether persons without evidence of immunity receiving only

inhaled, nasal, or topical doses of steroids can be vaccinated safely. However, clinical

experience suggests that vaccination is well-tolerated among these persons. Personswithout evidence of immunity who are receiving systemic steroids for certain conditions

(e.g., asthma) and who are not otherwise immunocompromised may be vaccinated if they

are receiving 2 weeks may be vaccinatedonce steroid therapy has been discontinued for >1 month, in accordance with the generalrecommendations for the use of live-virus vaccines (MMWR 2011;60:1-60).

Vaccination of leukemic children who are in remission and who do not have evidence of

immunity to varicella should be undertaken only with expert guidance and with the

availability of antiviral therapy should complications ensue. Patients with leukemia,lymphoma, or other malignancies whose disease is in remission and whose chemotherapy

has been terminated for at least 3 months can receive live-virus vaccines. When

immunizing persons in whom some degree of immunodeficiency might be present, only

single-antigen varicella vaccine should be used.

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Case #5: Immunizations for pregnant women

Learning Objectives:a) Clearly describe what is known about the safety of administering

vaccines during pregnancy.b) Define the risks of complications from diseases and the benefit of

receiving vaccines during pregnancy.c) Clearly convey the importance of cocooning infants.d) Explain the importance and safety of vaccine ingredients.

Case Presentation:A 20-year old pregnant woman complains of mild congestion. She is 20weeks pregnant and not taking any medications. She is single and lives with

her parents and younger brother. After examining her and discussing hercurrent complaint, you review her chart and notice she is missing Tdap andinfluenza vaccines. When you suggest she be vaccinated she expressesconcerns about receiving vaccine during pregnancy.

Question 1: How can you describe the risk/benefit ratio ofvaccinating during pregnancy when there is limited data to supportit?Answer: Although in general it is best to avoid medications andimmunizations during pregnancy, there are certain diseases to whichpregnant women are more susceptible than non-pregnant women of thesame age. There is actually quite a bit of experience with use of somevaccines during pregnancy (e.g. influenza vaccine, Td vaccine) even thoughin many cases they have not been studied in clinical trials. Women shoulddiscuss the benefits and the potential risks of each vaccine when consideringimmunization during pregnancy.Discussion:

What vaccines are specifically recommended during pregnancy?Influenza vaccine and Tdap; others (e.g. hepatitis B vaccine) should beconsidered if otherwise indicated. Influenza disease is more severe inpregnant women and maternal immunization not only protects thepregnant woman but also confers immunity to the infant (Louie JK et al.,N Engl J Med 2009;362:27-35; Zaman K, N Engl J Med 2008;359:1555-1564; Eick A, et al. , Arch Pediatr Adolesc Med 2010;165(2): E1-E8). Nounusual adverse events associated with influenza vaccine duringpregnancy have been reported to the VAERS system (Moro P, BroderKR et al. , American Journal of Obstetrics and Gynecology2011;204(2):146.e1-e7).

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What vaccines are contraindicated during pregnancy?MMR, varicella, LAIV, zoster. These are live virus vaccines and thus

pose a theoretical risk of infecting the fetus. However it is important tonote that there have been no published reports of MMR, Varicella, LAIV,or zoster vaccine leading to infection of the fetus and no adverse fetaloutcomes have been reported.

Have any vaccines been shown to harm the fetus?No. Obviously many women are inadvertently immunized whilepregnant, in many cases before they know they are pregnant. This hasbeen happening for more than 40 years with MMR vaccine and noadverse fetal outcomes have ever been reported. Similarly influenzavaccine has been recommended for pregnant women for many years

now and there are no reports of adverse fetal outcomes related toinfluenza vaccine.

Can we infer anything from the lack of reports of adverse eventsduring pregnancy in the VAERS system?The VAERS system serves to identify possible vaccine adverse events.Since it is a passive reporting system one cannot interpret a lack ofreports as an indication that no adverse events have occurred.However, VAERS does usually identify adverse events well.

Question 2: What is the purpose of vaccine ingredients and how do

we know they are safe?Answer: Each ingredient is there to preserve vaccine potency or sterility orenhance the immune response.Discussion:

What is thimerosal and why is it in vaccines? What do we know aboutits toxicity?Thimerosal is a mercury-based preservative that has been in vaccinesfor decades. There is no known toxicity related to thimerosal exposureas a result of immunization. Thimerosal has been voluntarily removedfrom most vaccines based on theoretical concerns rather than basedon any demonstrated toxicity.

What is alum and why is it in vaccines?Alum is an aluminum-based adjuvant that has been in vaccines fordecades. Without alum, many vaccines would not induce an adequateimmune response. There is no known toxicity related to alumexposure through immunization.

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Residents What are squalene-based vaccine adjuvants?

Squalene is a naturally occurring organic compound (produced byplants, fish and other animals (including humans) that is used as a

component of some vaccine adjuvants. As with aluminum andthimerasol, there has been no toxicity demonstrated as a result ofexposure to squalene. It has been a component of influenza vaccinesin Europe since 1997.

To which vaccine ingredients are pregnant women exposed from othersources?Pregnant women are exposed to many of the ingredients in vaccinesthrough interaction with their routine environment. For exampleconsuming seafood (especially tuna) results in more exposure tomercury than does immunization. Aluminum is ubiquitous in the

environment.

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Case #6: Hospital healthcare worker refusing Tdap and

Influenza vaccineLearning Objectives:

a) Clearly explain how vaccines cannot cause disease in a healthyadult.

b) Allay concerns of common minor reactions to vaccines.c) Address the social responsibility of healthcare workers to protect

their patients against disease through vaccination.d) Effectively address an individuals personal right to refuse

vaccination.Case Presentation:A healthy 43 yo male is in your office because of a minor work injury. He is ahealthcare worker employed at a long-term care facility. The laceration onhis forearm requires wound management prophylaxis with Tdap. You alsosuggest he gets a flu vaccine while hes in the office, but he refuses becausehe says the flu shot gave him the flu a few years ago.

Question 1: Why do healthcare personnel think that the flu shotgives them the flu? Can it?Answer: Myalgia and fever can occur after influenza vaccine, particularlythe first time someone is immunized. In addition many people dont reallyknow what the symptoms of influenza are and misinterpret symptomsrelated to other viral infections (e.g. gastrointestinal disturbances, rhinorhea)as being from their influenza vaccine (LaVela SI et al, Infect Control HospEpidemiol 2004;25:933-40; Mah MW et al, Am J Infect Control 2005:33:243-50).

Discussion:

What is the frequency of myalgia and fever following influenzavaccine? Does the frequency decrease with subsequent doses?In placebo-controlled studies among adults, the most frequent sideeffect of vaccination was soreness at the vaccination site (affecting10%--64% of patients) that lasted


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Residents What are some common reasons healthcare personnel give for not

getting a flu vaccine?Healthcare personnel claim:

The flu vaccine made me sickI never get sick so I dont need a flu shotIm not in a group recommended to get a flu shotThe flu vaccine doesnt workAdd in other reasons from your own experience..

None of these are valid reasons to avoid immunization.

Question 2: Why is it especially important that healthcare workersreceive vaccines?Answer: Duh, they give their patients the flu! And they are potentially at

higher risk for contracting influenza due to contact with ill patients (Potter Jet al, J Infect Dis 1997;175:1-6).Discussion:Why do HCP give their patients influenza?Unimmunized HCP are susceptible to influenza and are exposed to influenzain their workplaceHCP still come to work when they are ill and as a result transmit infections topatientsIndividuals with influenza are contagious up to 24 hours before they havesymptoms and thus unknowingly spread infection before they know they aresick.

HCP do not wash their hands frequently enough to control nosocomialinfections

What percent of healthcare personnel receive an influenza vaccineevery year?

In 2009 (the year of H1N1 vaccination) only 60% of HCP received any type ofinfluenza vaccine (MMWR 2010;59(12):357-362).http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5912a1.htm?s_cid=mm5912a1_e%0d%0a

Question 3: Should we mandate HCP influenza vaccination?

Answer: Many hospitals have turned to mandatory policies becausevoluntary programs have not been successful in achieving adequateHCP vaccination rates. (Babcock HM, et al. 2010, Clinical InfectiousDisease 2010;50:459-64)

Discussion:

What vaccines are already mandated for HCP?Most HCP are already required to be immunized with MMR, hepatitis B,

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Residentsand varicella vaccines if not already immune.

What about people with medical or religious reasons not to getvaccinated?

Exemptions to influenza vaccination mandates should be allowed onlyfor medical contraindications to vaccination, specifically allergy to eggsand prior allergic or severe adverse reactions to influenza vaccine.Most religions do not prohibit vaccination.

What about HCP who request a personal belief or philosophicalexemption to influenza vaccination, eg, for those who do not believe inthe need for influenza vaccination or for those who are opposed to theconcept of mandatory vaccination?Personal belief or philosophical exemptions should not be allowed. Theallowance of personal belief exemptions for schoolentry vaccination

requirements has been associated with an increased risk of theacquisition and transmission of vaccinepreventable diseases. Althougha few facilities and systems have been successful in achieving highvaccination rates in the setting of personal belief exemptions,allowance of personal belief exemptions runs counter to the conceptthat HCP influenza vaccination is a core patient safety interventionfrom which the HCP cannot merely opt out, particularly given theknown safety and efficacy of influenza vaccination.http://www.jstor.org/stable/10.1086/656558

Wont vaccine mandates be overturned by the courts or labor relationsboards?

No, influenza vaccine mandates for HCP have been in place in somelarge institutions in the U.S. since 2006 and have withstood legalchallenge. In many case some accommodation has been required forHCP who wont be immunized (e.g. allowing them to wear a mask allday long while working) but the fundamental policies have beenupheld.

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Case #7: Senior refusing vaccines

Learning Objectives:a) Clearly describe general testing and monitoring systems that ensure

the safety of vaccines.b) Define the risks of complications from diseases and the benefit of

receiving vaccines.c) Clearly explain how vaccines cannot cause disease in a healthy

adult.d) Discuss vaccine safety topics in short and concise conversations.

Case Presentation:A 66-year old woman is being seen today for a follow-up visit for new blood

pressure medications that were started 30 days ago. When you suggest shereceive influenza, pneumococcal and zoster vaccines, she states she doesnot want them. She has concerns about their safety and begins to tell you anumber of stories about acquaintances who have experienced variousproblems with vaccines.

Question 1: How do you know vaccines are safe?Answer: Describe the basic elements of vaccine safety monitoring.Discussion:

Discuss the clinical trial and FDA approval process. Vaccines aretested in thousands of individuals and in combination with othervaccines prior to licensure. Rigorous standards for both efficacy andsafety need to be met before a vaccine can be licensed.

No clinical trial can detect rare adverse events (events withfrequencies less than 1:2000-10,000). We now have robust post-marketing surveillance systems that take advantage of electronicmedical records to scan large numbers of people for rare adverseevents. As an example after the use of pandemic H1N1 influenzavaccine in 2009-2010, the medical records of more than 10 millionvaccine recipients were evaluated for rare side effects.

Talk about post-licensure studies such as those conducted by theVaccine Safety Datalink(http://www.cdc.gov/vaccinesafety/Activities/VSD.html) [Baggs J,Pediatrics2011; 127 No. Supplement 1:S45 -S53]The Vaccine SafetyDatalink (VSD) project is a collaborative project between the Centersfor Disease Control and Prevention and 8 managed care organizations(MCOs) in the United States. Established in 1990 to conduct

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Residents5). Additional information from this trial published separately indicated thatefficacy among those aged 70 years was 57% (95% CI = -36%--87%),similar to younger persons. However, few persons aged >75 years

participated in this study, and the wide confidence interval for the estimateof efficacy among participants aged 70 years could not exclude no effect(i.e., included 0) (Thijs C, Lancet Infect Dis 2008;8:460-1). Influenza vaccineeffectiveness in preventing MAARI among the elderly in nursing homes hasbeen estimated at 20%--40%, and reported outbreaks among well-vaccinated nursing home populations have suggested that vaccination mightnot have any significant effectiveness when circulating strains are driftedfrom vaccine strains (MMWR 2010; 59(rr08):1-62).http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5908a1.htm?s_cid=rr5908a1_

What is the risk of serious illness from influenza in seniors? Emphasizethe risk as you discuss the value of inluenza vaccine with seniors.

Hospitalization rates during typical influenza seasons are substantiallyincreased for persons aged 65 years compared with younger age groups.One retrospective analysis based on data from managed-care organizationscollected during 1996--2000 estimated that the risk during influenza seasonamong persons aged 65 years with underlying conditions that put them atrisk for influenza-related complications (i.e., one or more of the conditionslisted as indications for vaccination) was approximately 560 influenza-associated hospitalizations per 100,000 persons compared with

approximately 190 per 100,000 healthy persons aged 65 years. Personsaged 50--64 years who have underlying medical conditions also were atsubstantially increased risk for hospitalizations during influenza seasoncompared with healthy adults aged 50--64 years (MMWR 2010; 59(rr08):1-62)http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5908a1.htm?s_cid=rr5908a1_e.

What is the efficacy of zoster vaccine? Emphasize the severity ofzoster and that a greater than 50% reduction in the chance that youwill get zoster is significant.

The vaccine reduced the risk for developing zoster by 51.3% (95% CI =44.2--57.6; p


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ResidentsThese findings were recently reproduced in a large observational study of75,800 vaccinees (Tseng , JAMA 2011 ; ). In this study vaccine effectivenessat preventing zoster was 55% and effectiveness at preventing zoster-linked

hospitalization was 65%.http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm?s_cid=rr5705a1_e.

Question 3: How can you address other concerns seniors might haveabout immunization?

What can you say to address the concern that the vaccine schedule is amoney-fueledconspiracy?

Remind patients that immunization recommendations are developed

and endorsed by physicians and public health officials, not thecompanies Challenge them by saying, Do you really think all the physicians in the

country are conspiring to promote a schedule that we dont think issafe and the best for you?

Question 4: Where do people with concerns about vaccines get theirinformation?

Answer: Likely sources include Web sites (mostly anti-vaccine), blogs,television, popular magazines, community discussions and relatives

Exercise: Type Vaccines into Google and review the first 20 sitesquickly. How many could be classified as anti-vaccine sites. Readand discuss some of the theories put forth on these sites.

Discussion:How can you point out in a respectful way that the information they arereading is not scientifically based and is incorrect?

Ask them why they are taking medical advice from an celebrity,friend, relative or magazine instead of from their childs doctor

Point out some of the inconsistencies you find on these sites Emphasize the lack of scientific studies and reiterate the basic tenet

of science-an observation needs to be repeated by independentgroups before we can really have confidence that it is correct. Noneof the claims about serious problems from vaccines has beenreproduced.

What are the characteristics of a Web site, specific article or author that

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Residentsgives it/them credibility?

The source of the information is reliable/stable (e.g. AmericanAcademy of Pediatrics, World Health Organization, National Library of

Medicine, NIH) The individuals/groups posting the information are identified and

provide contact information? People with a scientific/medical background contribute the material or

at least review it The information is dated and current - vaccine science changes quickly The scientific evidence is referenced with a citation, not just

statements like studies show or it has been shown that.. There is no obvious conflict of interest (e.g. selling a book) The site doesnt rely on anecdotes (e.g. My child got a vaccine and

then got XXX) The purpose of the site is to provide accurate information. The

purpose is not to sell something

Where can patients find credible information about vaccine safety, especiallyinformation about autism?

NNII (www.immunizationinfo.org)VEC (www.vaccine.chop.edu)IAC (www.immunize.org)CDC/NIP (www.cdc.gov/nip)AAP (www.aap.org)AAFP (www.aafp.org/)IVS (www.vaccinesafety.edu)Vaccine Page (www.vaccines.org)Every Child by Two (www.ecbt.org)

Documents

Small Group Guide