Questions and Answers About Smallpox Contraindications and Screening

Who should NOT get the vaccine in a non-emergency situation?
At this time the vaccine is not recommended for the general public. It is only recommended for laboratorians who work with orthopox viruses, and public health and health care response team members who have no contraindications to receiving the vaccine (http://emergency.cdc.gov/agent/smallpox/vaccination/contraindications-clinic.asp). People who should not get the vaccine in a non-emergency situation include:

• anyone who is allergic to the vaccine or any of its components;
• women who are pregnant or planning to become pregnant within 4 weeks after vaccination;
• women who are breastfeeding;
• anyone under 12 months of age;
• people who have, or have had certain skin conditions (especially eczema and atopic dermatitis);
• people with weakened immune systems, such as those who have received a transplant, are HIV positive, are receiving treatment for cancer, or are taking medications (like steroids) that suppress the immune system; and,
• people who have been diagnosed as having a heart condition, or 3 or more known major cardiac risk factors.

The Advisory Committee on Immunization Practices [ACIP] advises against non-emergency use of smallpox vaccine in anyone under 18 years of age. These people should not receive the vaccine unless they have been exposed to smallpox. It is unlikely that health care response team members are under the age of 18, but can be older than 65. Vaccination of persons older than 65 years of age is not recommended in a non-emergency situation, unless they are smallpox response team members with no contraindications to receiving the vaccine. The vaccine’s package insert notes that there are no published data that supports the use of smallpox vaccine in a geriatric population and does not recommend its use in this group in a non-emergency situation. The definition of "geriatric" commonly used in vaccination programs is 65 years of age and older.

How can a questionnaire effectively screen out the presence of contraindications (such as HIV, eczema or atopic dermatitis) in the household?
We expect that the questionnaire will identify most people with contraindications, but we also recognize that some people will not remember or will be unaware of conditions (e.g. HIV infections) that put them at risk from the smallpox vaccine. For this reason, we encourage them to get additional tests or not be vaccinated, if they are unsure about having risk factors.

Are children under the age of 1 year in a household a contraindication for the administration of a licensed to vaccine to household members?
No, the presence of a child under the age of 1 year in the household is not a contraindication to vaccination according to the Advisory Committee on Immunization Practices (ACIP) recommendations published 4/4/03 in the MMWR. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5207a1.htm. However, vaccinated parents of young children need to be careful not to inadvertently spread the virus to their children. They should follow site care instructions that are essential to minimizing the risk of contact transmission of vaccinia. These precautions include covering the vaccination site, wearing a sleeved shirt, and careful hand washing anytime after touching the vaccination site or anything that might be contaminated with virus from the vaccination site. If these precautions are followed, the risk for children is very low. Individuals who do not believe that they can adhere to such instructions should err on the side of caution and not be vaccinated at this time.

What if I have doubts or concerns about whether or not I might have a contraindication to being vaccinated for smallpox?
While the CDC has responded (and will respond) to numerous questions about specific contraindications to vaccination, it is difficult to address all possible questions about real or hypothetical conditions, situations, or combinations of factors that do or could exist. It is important to remember that at the present time, there is no smallpox disease to content with. If individuals eligible for smallpox vaccination are unsure whether their particular set of circumstances place them at greater risk for a bad reaction to vaccination, they should consult with their primary health care provider. If there are reservations or uncertainties, do not get vaccinated at this time. There is no reason at the moment to get vaccinated for smallpox if there are any questions or doubts about contraindications.

What are the contraindications to revaccination or booster shots if there is an equivocal or negative "take"? e.g., erythema multiforme with or without urticaria to the primary or most recent vaccination?
The same contraindications that apply to primary vaccinations also apply to revaccinations following equivocal or negative takes.

What is the risk to sexual partners of vaccinees?
Anytime there is prolonged, intimate contact such that a person can come into physical contact with a vaccinee’s uncovered vaccination site or fluid from a vaccination site there is the possibility of transmission of vaccinia virus to the contact. Should the contact have risk factors such as a history of eczema or immunosuppression, then there is an increased risk that a severe or life threatening adverse event could result from such contact.

Why is aspirin not to be used to treat robust reactions (takes) from smallpox vaccine?
FDA has concern about the use of aspirin with the varicella vaccine and offers the following warning from the Varivax package insert: "Reye's Syndrome has occurred in children and adolescents following natural varicella infection, the majority of whom had received salicylates. In clinical studies in healthy children and adolescents in the United States, physician advised varicella vaccine recipients not to use salicylates for six weeks after vaccination. There were no reports of Reye's Syndrome in varicella vaccine recipients during these studies." Therefore, CDC recommends following this well established approach, given the rare appearance of Reye's Syndrome reported in adults. Vaccinees should elect to take NSAIDs to treat the robust reactions whenever possible. However, chronic aspirin use for non-vascular indications such as arthritis, should not be deemed a contraindication.

If a person has an asthma attack after receiving the vaccine, can they receive steroid treatments?
Yes, if an individual has an asthma attack after being vaccinated, they can receive steroid treatments, with their primary health care provider’s consultation and approval, if necessary.

Diseases

What diseases are contraindicated for vaccination?
Few diseases, per se, are contraindicated unless the therapy used to treat the disease causes immunosuppression. The FOLLOWING LIST of diseases, WHILE NOT ALL INCLUSIVE, ARE NOT CONTRAINDICATIONS for vaccination. However, WHEN IN DOUBT, potential vaccinees being treated for the following diseases should CONSULT WITH THEIR PRIMARY HEALTH CARE PROVIDER.

• Fibromyalgia
• Hepatitis B & C
• Multiple Sclerosis (MS
• Rheumatois Arthritis
• Diabetes
• Bilateral Pterygium
• Erythema Multiforma
• Guillian-barre Syndrome
• Seizures
• Vitiligo
• Agent Orange Exposure
• Panhypopituitarism

We need clear definition of what is considered "moderate" illness. This is listed as a "contraindication" for vaccination. Are there examples?
The Advisory Committee on Immunization Practices (ACIP) has not functionally defined a “moderate or severe illness" for routine vaccination. They have not done so for smallpox vaccine either. This is a clinical judgment that must be made by the screener or vaccinator at the time of vaccination. A reasonable approach is that if in the opinion of the person giving the vaccine the vaccinee should be seen by a doctor or sent to an ER, then deferral of vaccination was acceptable. But if a smallpox mass vaccination program was underway, this would mean that a smallpox outbreak was in progress. ACIP has stated, most recently in the April 4, 2003 MMWR, that in a post-event situation there are no absolute contraindications to smallpox vaccination, and the risk must be weighed against the benefit. We interpret this to mean that vaccination would be deferred for only the most severe concurrent illness, and that if the ill person had been actually exposed to smallpox, they should be vaccinated regardless of concurrent illness.

Is autoimmune disease in the absence of immune-suppressing medication a contraindication for receiving smallpox vaccine?
There are no data on an increased rate of complications from smallpox vaccination of individuals with severe immune diseases such as ulcerative colitis, Lupus, Hashimoto's disease (chronic lymphoid thyroiditis), Crohn’s disease and juvenile rheumatoid arthritis in the absence of immunosuppressive therapy. The Advisory Committee on Immunization Practices (ACIP) does state in the MMWR dated 4/4/03 that "Patients with severe clinical manifestations of certain autoimmune disease (e.g., systemic lupus erythematosis) might have a degree of immunocompromise as a component of the disease." http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5207a1.htm Together, patients with underlying medical conditions and physicians familiar with their disease status should consider weighing the risks and benefits of smallpox vaccination in a pre-event setting.

Should you get the smallpox vaccine if you have a weakened immune system (e.g., you are immunocompromised)?
No, people with weakened immune systems, for whatever reason, should not be vaccinated at this time. Vaccination can cause death in people with weakened immune systems. Thus, there is no need to take the risks associated with smallpox vaccination unless you have been directly exposed to smallpox—and even then, you should first consult a physician or health care provider. In the event of a smallpox outbreak, recommendations on who should be vaccinated will change.

Is cancer itself a contraindication to vaccination, or is it the treatment of chemotherapy and radiation?
Both cancer in and of itself and the treatments often applied to cancer are contraindication to vaccination. Both can suppress the immune system. For more information on immune suppression as it applies to smallpox vaccination, visit http://emergency.cdc.gov/agent/smallpox/vaccination/immune-contra.asp.

Skin Diseases

What skin conditions are contraindicated for vaccination?
See "Skin Conditions that Mean You Should Not Get Vaccinated" at http://emergency.cdc.gov/agent/smallpox/vaccination/skin-contra.asp. Many skin conditions are NOT CONTRAINDICATED as long as they are not active and the person does not have any breaks in the skin. SOME of these conditions are listed below but this LIST IS NOT ALL INCLUSIVE. When in doubt, CONSULT YOUR PRIMARY HEALTH CARE PROVIDER about whether or not to receive smallpox vaccination.

• Cradle Cap
• Asteatotic Eczema (chapped fissured feet)
• Herpes Zoster (shingles)
• Herpes Simplex virus
• Varicella Zoster (chicken pox)
• Poison Ivy or Poison Oak
• Seborrheic Dermatitis
• Nail Psoriasis

Is an urticarial rash that develops after a previous smallpox vaccination a contraindication to subsequent smallpox vaccine?
Generalized urticaria is a contraindication to smallpox vaccination if it occurs within a few hours of vaccination (because it could be the result of an allergy). If it occurs days after vaccination, it is not a contraindication. Urticarial rashes are common and the majority of them are self-limiting. Often the urticaria is a manifestation of an allergic IgE mediated reaction. Urticaria frequently occurs during an anaphylactic response although other signs that would be present include flushing, hypotension, syncope, respiratory blockage and abdominal symptoms. Persons with a history of urticaria but no other sign of anaphylaxis after a previous smallpox vaccination could probably be re-vaccinated without severe consequences. If there are questions or concerns about the history or the risks versus the benefits of vaccination in a pre-event setting, a referral to an allergist may be prudent.

How is contact dermatitis defined? Can a person be vaccinated if he has a history of contact dermatitis, but not an active condition?
A person with a history of contact dermatitis can be vaccinated, but a person with an active case cannot be vaccinated. Contact dermatitis is usually an acute condition that resolves once exposure to the skin irritant ends. A person who truly has this condition, as diagnosed by a physician, can be vaccinated once the skin has healed. A history of contact dermatitis, without active disease, is not a contraindication to vaccination.

If I have a significant rash, I should not be vaccinated right away. What is a significant rash?
Individuals with breaks in their skin should not be vaccinated until the skin is fully healed. (Also individuals in close physical contact with someone else who has breaks in their skin should not be vaccinated until the skin is fully healed.)

The definition of eczema as "a red, itchy spot that lasts two weeks and then comes and goes" is too broad and could cause a number of unnecessary claims of a contraindication to vaccine.
The definition of eczema was established by an experienced group of dermatologists on the American Academy of Dermatology’s Bioterrorism Taskforce. They reviewed the available literature and proposed the above definition of eczema to the Advisory Committee on Immunization Practices (ACIP). The ACIP understood that this definition is highly sensitive but elected to be cautious in a non-emergency situation. Persons meeting this definition, without a previous diagnosis of eczema, should consult their treating physician to assess their risk for adverse reactions before they are vaccinated.

Is dyshidrotic eczema a contraindication to smallpox vaccine?
Inactive dyshidrotic eczema (unless accompanied by a diagnosis of atopic dermatitis) is not a contraindication to vaccination. However, someone with active dyshidrotic eczema, should not be vaccinated until the disease becomes inactive. D. Eczema is a contraindication ONLY while active ---- however you must probe the history to ensure that the potential vaccinee also does not have a history of atopic dermatitis (sometimes dyshidrotic eczema is the only manifestation of atopic dermatitis in adults, but they usually give you a pretty clear history of atopic dermatitis in childhood) Eczema is considered a contraindication to vaccination when active because of loss of integrity of the skin and when inactive because it often is confused with atopic dermatitis. Atopic dermatitis is a risk factor for development of eczema vaccinatum. It is felt that an immune deficiency that occurs with atopic dermatitis is the reason it is a risk for developing eczema vaccinatum.

Is a health care worker more at risk of side effects if there is a family history of eczema, but the worker has not experienced the condition themselves?
A family history of eczema would not constitute a contraindication to smallpox vaccination. However, if the potential vaccine currently lives with, or is in similar close physical contact with someone with any history of eczema or atopic dermatitis, he or she should not be vaccinated because of the risk it poses to that close contact.

Is having Stevens-Johnson syndrome in the past a contraindication to getting the smallpox vaccine?
Having Stevens-Johnson syndrome (SJS) in the past is not a contraindication from smallpox vaccine receipt, if there are no other contraindications presently to the antibiotics in the vaccine (polymyxin B sulfate, streptomycin sulfate, neomycin sulfate). SJS is an idiosyncratic vesicular mucocutaneous eruption, which may be triggered by medications or infectious agents. Erythema multiforme (E. multiforme) is a mild form of SJS that can range from spots to sores. With SJS a patient has a rash of sores over much of the body and feels sick. E. multiforme usually occurs as a reaction to: infections, such as infections caused by the herpes simplex virus, some medicines, such as sulfa drugs and the seizure medicine phenytoin (Dilantin).

How should we evaluate the advisability and risk associated with Smallpox vaccinations and Pityriasis rubra pilaris (PRP)?
PRP is a contraindication to receiving the smallpox vaccine. A rare disease, PRP causes widespread derangement of the epidermis. In many ways, it is like psoriasis clinically except that psoriasis is often mild and localized. PRP is almost always widespread. Control is often with oral retinoids (first cousins to Accutane), which the American Academy of Dermatolgists (AAD) noted might pose a contraindication to vaccination (not because of immunosuppression but because retinoids can disturb the epidermis as well).

Is basal cell carcinoma a contraindication to vaccination?
Yes, basal cell carcinoma would be a contraindication for smallpox vaccination either resulting from the disease itself, or treatment being administered to combat the disease. If an individual is cured and is not being treated, they may be vaccinated for smallpox if their primary health care provider agrees there is no remaining suppression of the immune system.

Is rosacea a contraindication to smallpox vaccination?
Severe inflammatory acne rosacea falls into the category of an exfoliative skin condition. Therefore a patient with severe inflammatory acne rosacea may only be vaccinated when their skin condition is resolved and there is no evidence of disrupted dermis. However, the typical telangectatic rosacea or mild acne rosacea is NOT considered to be an exfoliative skin condition and therefore the individual may be vaccinated even in the presence of the rash.

Is Grover's disease a contraindication to getting a smallpox vaccination?
Although Grover's disease (Transient acantholytic dermatosis) is not listed as a specific contraindication to receipt of smallpox vaccine, any person with acute, chronic, or exfoliative skin conditions is at higher risk for clinically significant inadvertent inoculation, and should not be vaccinated until the condition resolves. Patients should ask their dermatologists whether their skin condition is resolved or controlled enough for them to be vaccinated. Grover's disease is a skin condition affecting the chest and back; although frequently itchy, it may cause no symptoms. Sometimes Grover's disease can be complicated by the development of dermatitis. In this case there are larger itchy patches with a dry surface, and the rash may spread to affect other areas of the body. Most cases of Grover's disease last 6-12 months. Occasionally it may persist for longer. Reference- http://www.dermnetnz.org/index.html http://www.aad.org/BioInfo/Presidents%20Message_statement2_10_03.pdf

Other Medical Contitions

Is asplenia a contraindication for receiving smallpox vaccine?
It depends on the current state of the patient’s recovery and treatment, and the reason for spleen removal. If no severe conditions or side effects are present, then this condition is not inherently a contraindication. Have this person consult with their health care provider. (Feb 7, 2003)

If a patient has an ileostomy and has daily contact with the hygiene and care of his stoma, should he receive the smallpox vaccination?
Having an ileostomy is not a contraindication for receipt of smallpox vaccination. Observing the proper infection control procedures should be sufficient in preventing accidental inoculation of the stoma. However, if the patient had the ileostomy due to current cancer (for example), and is still on immunosuppressive medication, then he should not get the smallpox vaccination until he is in remission and off the treatment. Immunosuppression is a contraindication to smallpox vaccination.

Is stem cell transplant a contraindication to receiving smallpox vaccine?
Persons with hematopoietic stem cell transplants should not receive the smallpox vaccine if they <24 months post-transplant or if they are >24 months post-transplant but have graft-versus-host disease or disease relapse. [Refer to the Vaccinia (Smallpox) Vaccine ACIP Recommendations, 06/22/2001.] http://www.cdc.gov/mmwr/PDF/rr/rr5010.pdf

Is cirrhosis a contraindication to vaccination?
Yes, end stage liver disease produces a relative immunodeficiency that would be a contraindication to smallpox vaccination.

If someone in my household is at risk for or has HIV infection, should I be vaccinated?
If you or someone in your household is at risk for HIV infection, you should get an HIV test before being vaccinated. If you live with or otherwise have close physical contact with (i.e.-sexual partner) someone who is HIV positive, you should not get the vaccine at this time.

Will dialysis patients be added to the list of those who should not be vaccinated?
Persons on dialysis with uremia have a variety of immunologic abnormalities that can place them at risk for severe adverse events. These persons probably already meet the criteria for a contraindication due to immunosuppression or acquired deficiencies of the immune system.

What about pacemaker leads? Granted this signifies an underlying cardiac problem in itself, however if leads are present will this predispose an individual to endocarditis?
Indeed the acute problem is myocarditis, or rarely pericarditis, rather than endocarditis. However, sometimes the clinical manifestations of myocarditis are mild or mistaken for other causes by the patient, or even forgotten. A few such patients then go on to develop ideopathic dilated cardiomyopathy months later. Post-vaccination infection of the endocardium does not seem to occur. For whatever reason, the endocardium seems to be spared. Any untreated infection of the heart should be a cause for exclusion. However, for the sake of argument, if a patient had infected pacemaker leads, and was adequately treated with resolution of symptoms and had no residual problems related to it, that person could in the past get smallpox vaccination. However, the existence of a pacemaker signifies existing heart disease (congenital or acquired), and therefore is a reason for excluding this patient from being vaccinated.

Is chronic fatigue syndrome a contraindication for pre-event vaccination?
Persons with chronic fatigue syndrome (CFS) do not have an immunosuppression detectable in laboratory tests and CFS in itself is not a contraindication. However, persons with CFS sometimes suffer exacerbations of their symptoms following viral infections. While there are no prior data, it is possible that disease symptoms in a person with CFS could increase after smallpox vaccination. Persons with CFS may want to discuss their individual situation with their treating physician before vaccination.

Should persons with a history of latex allergy be advised not to volunteer?
The package insert notes that the vial contains dry, natural rubber and may cause a hypersensitivity reaction when administered to persons with known or possible latex sensitivity. The ACIP’s General Recommendations for Immunization advises that persons who have a severe (anaphylactic) allergy to latex should not be given vaccinations supplied in a vial that contains natural rubber. However, vaccines supplied in vials or syringes with natural rubber can be administered to persons with less hypersensitivity (such as contact allergy to latex gloves).

I am allergic to eggs. Can I still get vaccinated against smallpox?
An egg allergy is not a contraindication to smallpox vaccination. Egg is not used in the manufacture of the vaccine.

Medications

Is there a listing of ALL meds contraindicated for being vaccinated against smallpox? There is not a list of medications which is all inclusive. However, there is a list of immunosuppressive medications on the Web site at http://emergency.cdc.gov/agent/smallpox/vaccination/immuno_suppress_meds.asp.

What medications are not contraindicated for vaccination?
Certain antibiotics and immunosuppressing drugs are contraindicated. However, many medicines are not contraindicated. The following list of medications, while NOT ALL INCLUSIVE, are NOT CONTRAINDICATIONS for vaccination. However, when in doubt, potential vaccinees being treated with the following medications should CONSULT WITH THEIR PRIMARY HEALTH CARE PROVIDER.

• Hydrocortisone for hormone replacement therapy
• Seizure medications
• Penicillin
• Sulfa [Note: Sulfa (as in trimethoprim sulfa) and sulfites (used as stabilizers/preservatives in drugs) are two different things.]
• Mesalamine
• Coumadin
• Anti-viral drugs that are not specific for orthopox viruses* (i.e. Acyclovir, Zovirax)

*It should be noted that some people taking antiviral drugs are most likely immunosuppressed for other reasons and would, thus, be contraindicated for the vaccine due to their medical condition.

ANTIBIOTICS AND ANTIVIRALS

"Previous allergic reaction to vaccine" is listed as a contraindication to receiving a smallpox vaccination. Does this apply to reactions to other vaccines as well as the smallpox vaccine?
No, this only applies to smallpox vaccine or any of the smallpox vaccine’s components including polymyxin B sulfate, dihydrostreptomycin sulfate, and neomycin sulfate.

Which antibiotics might be similar in structure and potentially cross react to the 3 antibiotics in ACAM2000 (e.g. other aminoglycosides). Is there a list of antibiotic allergies we should keep in mind?
Dryvax smallpox vaccine contains polymyxin B sulfate, dihydrostreptomycin sulfate, and neomycin sulfate in trace amounts. For the purposes of screening for antibiotic allergy, people should be asked about severe (i.e., anaphylactic) allergy to drugs. People who report severe allergy to polymyxin B, streptomycin, or neomycin should not be vaccinated in the current pre-event vaccination program. If a person reports a severe allergy to a drug in the same class, it is prudent to defer vaccination until the person can be evaluated by an allergist to sensitivity to the antibiotic contained in the vaccine. People who report only contact-type allergy without signs or symptoms of anaphylaxis may be vaccinated.

Is the use of antiviral drugs a contraindication?
There are many classes of antiviral drugs and some may have activity against the vaccinia virus, namely Cidofovir (Vistide®). However, some people taking antiviral drugs that are not specific for orthopoxviruses are most likely immunosuppressed for other reasons and would, thus, be contraindicated for the vaccine due to their medical condition.

OTHER DRUGS AND PRODUCTS

Is the recent receipt of immune globulin or other blood product a contraindication to vaccination?
Receipt of blood products prior to smallpox vaccination would not be expected to interfere with the vaccination, and blood product recipients may be vaccinated as usual. However, if someone who has recently received a blood product (within 1 month) has an unsuccessful vaccination, the individual should wait an additional 1-2 months before the re-administration of vaccine in order to further reduce the chance of an unsuccessful vaccination due to the recent blood product transfusion.

Many people take an aspirin a day for the treatment of a variety of ailments. Should they be advised to stop taking aspirin when receiving smallpox vaccination?
No, low dose aspirin therapy is not a contraindication to smallpox vaccination. People who have a medical indication for the use of aspirin, both for treatment and prophylactic purposes, should be advised to continue to take aspirin following vaccination, as prescribed by their physician. However, CDC has received reports of cardiac events following smallpox vaccinations. Although it is unclear whether or not there is any association between smallpox vaccination and these events, CDC recommends, as a precautionary measure, that individuals who have been diagnosed by a doctor as having a heart condition with or without symptoms, who are under the care of a doctor, should not receive smallpox vaccine at this time.

Is there any particular risk for adverse reactions from people who wear contact lenses?
Vaccinia infection of the eye is a potentially serious complication of vaccination and can lead to altered vision. Therefore, all vaccinees need to be very careful to not inoculate the vaccinia into the eye. You should do several things to ensure you do not inoculate virus into your eye. Covering the vaccine site with gauze, tape, and a sleeved shirt or similar clothing, and careful handwashing decreases the chance of inadvertently getting vaccinia virus on your hands and possibly into your eye. Additionally, you should take extra care to wash your hands before handling your contact lenses.

Is use of Interferon a contraindication to vaccination?
Yes, using Interferon is a contraindication for smallpox vaccination because it suppresses the immune system. Concurrent administration of exogenous interferon products may inhibit viral replication and thus reduce antibody response to the vaccine. The same rule shou ld be applied to Interferon as is valid for the use of high-dose steroids, individuals would need to be completely off the drug for three months before vaccination.

Is cancer itself a contraindication to vaccination, or is it the treatment of chemotherapy and radiation?
Both cancer in and of itself and the treatments often applied to cancer are contraindication to vaccination. Both can suppress the immune system. For more information on immune suppression as it applies to smallpox vaccination, visit http://emergency.cdc.gov/agent/smallpox/vaccination/immune-contra.asp.

STEROIDS

How much time needs to elapse after treatment with steroids before it is considered safe to vaccinate an individual?
If the dose of steroids has been given long enough to cause significant immune suppression, “Vaccination providers should wait = 1 month after discontinuation of therapy before administering a live-virus vaccine to patients who have received high systematically absorbed doses of corticosteroids for = 2 weeks” (per the Advisory Committee on Immunization Practices general recommendations on immunization). http://www.cdc.gov/mmwr/preview/mmwrhtml/m2d226.htm

What are the recommendations regarding persons who regularly use inhaled or topical steroids? Is this a contraindication for administration of the vaccine?
The Advisory Committee on Immunization Practices in the General Recommendations on Immunization has stated: "The exact amount of systemically absorbed corticosteroids and the duration of administration needed to suppress the immune system of an otherwise immunocompetent person are not well-defined. The majority of experts agree that corticosteroid therapy usually is not a contraindication to administering live-virus vaccine when it is short-term (i.e., <2 weeks); a low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes) or by intra-articular, bursal, or tendon injection. Although of theoretical concern, no evidence of increased severity of reactions to live vaccines has been reported among persons receiving corticosteroid therapy by aerosol, and such therapy is not a reason to delay vaccination."

Most dosages would not cause immunosuppression. Use of high-dose corticosteroid therapy [i.e., greater than or equal to 2 mg/kg body weight or 20 mg/day of prednisone for greater than or equal to 2 weeks] is contraindicated. Patients should contact their physician to find out whether their dosage would cause immunosuppression. Currently only asthmatic individuals who take daily steroids by mouth at 20 mg/day (or higher levels) are contraindicated from vaccination for smallpox. For more information about immunosuppressive medications, visit http://emergency.cdc.gov/agent/smallpox/vaccination/immune-contra.asp

On the pre-event information worksheet, in item 16, page 5 of 7, current use of steroid eye drops is a contraindication to receipt of immunization. What is the rationale behind this contraindication?
Persons with inflammatory eye diseases may be at increased risk for inadvertent inoculation due to touching or rubbing of the eye. Therefore it may be prudent to defer vaccination of persons with inflammatory eye diseases requiring steroid treatment until the condition resolves and the course of therapy is complete. See ACIP guidelines: http://emergency.cdc.gov/agent/smallpox/vaccination/pdf/acip-guidelines.pdf

HOW LONG AFTER…?

How long after receiving Hepatitis A Immune Globulin should a person wait before receiving smallpox vaccination?
Patients should wait 3 months before receiving the smallpox vaccination. (Apr 10, 2003)

How much time needs to elapse after treatment with steroids before it is considered safe to vaccinate an individual?
If the dose of steroids has been given long enough to cause significant immune suppression, “Vaccination providers should wait = 1 month after discontinuation of therapy before administering a live-virus vaccine to patients who have received high systematically absorbed doses of corticosteroids for = 2 weeks” (per the Advisory Committee on Immunization Practices general recommendations on immunization). http://www.cdc.gov/mmwr/preview/mmwrhtml/m2d226.htm

How should the timing of PPD testing be coordinated with smallpox vaccinations?
As with other live vaccines, tuberculin skin testing can be done before or on the same day as smallpox vaccination, but PPD testing should be deferred at least 4 weeks after smallpox vaccination. In other words you can give the PPD before or on the same day, but if you have already given the smallpox vaccine, you have to wait 4-6 weeks to give the PPD.

How long should smallpox vaccinees wait to get their allergy shots, or if they have just received their allergy shots, how long should they wait to get vaccinated?
There is no recommended interval between receipts of allergy shots and smallpox vaccination. An allergy shot can cause a localized reaction similar to eczema, and so if vaccine and allergy shot are received at or close to the same time, a different arm should be used. In general, since at this time the smallpox vaccination program is a voluntary program, it may be prudent for the person to wait until the desensitization is complete and the areas of skin inflammation, if any, have resolved.

A patient with rheumatoid arthritis wishes to be vaccinated, and has been on no medication other than NSAIDs. The physician wants to start Humira for treatment of the rheumatoid arthritis. How long should the physician wait after the smallpox vaccination to begin this drug? Humira (Adalimumab) is a monoclonal antibody that works by blocking tumor Necrosis Factor (TNF) alpha. It is an immunosuppressive agent and the patient should allow at least 3 months between receipt of smallpox vaccine and this agent, plus ensure that their health condition is stable (and off other immunosuppressive agents).