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General 2_20 All infants should be immunized except in these three rare situations: 1. Anaphylaxis or a severe hypersensitivity reaction is an absolute contraindication to subsequent doses of a vaccine. Persons with a known allergy to a vaccine component should not be vaccinated. 2. Do not give BCG or yellow fever vaccine to an infant that exhibits the signs and symptoms of AIDS. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 24 2_21 The following are not contraindications. Infants with these conditions should be immunized: allergy or asthma (except if there is a known allergy to a specific component of the vaccine mentioned above); any minor illness, such as respiratory tract infections or diarrhoea with temperature below 38.5 C; family history of adverse events following immunization; family history of convulsions, seizures, or fits; treatment with antibiotics; known or suspected HIV infection with no signs and symptoms of AIDS; signs and symptoms of AIDS, except as noted above (see 2_20); child being breastfed; chronic illnesses such as chronic diseases of the heart, lung, kidney, or liver stable neurological conditions, such as cerebral palsy or Down s Syndrome; premature or low-birthweight (vaccination should not be postponed); recent or imminent surgery; malnutrition; and history of jaundice at birth. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 25 14 February 2008 Page 1 of 17

2_22 If a reaction does occur, health workers should report the problem to supervisors immediately. Children who have a severe reaction to a vaccine should not receive additional doses of that vaccine. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 25 6_11 All infants should be immunized except in these three rare situations: 1. Anaphylaxis or a severe hypersensitivity reaction is an absolute contraindication to subsequent doses of a vaccine. Persons with a known allergy to a vaccine component should not be vaccinated. 2. Do not give BCG or yellow fever vaccine to an infant who exhibits the signs and symptoms of AIDS (see Appendix 6_11A). Other vaccines should be given. 3. If a parent strongly objects to an immunization for a sick infant, do not give it. Ask the mother to come back when the infant is well. The following are not contraindications. Infants with these conditions should be immunized (see Appendix 6_11B) Immunization in practice: a practical resource guide for Health workers update Module 6: Holding an immunization session Page 12 6_12 Children who have a severe reaction to a vaccine should not receive additional doses of that vaccine. Immunization in practice: a practical resource guide for Health workers update Module 6: Holding an immunization session Page 13 BCG 2_20 All infants should be immunized except in these three rare situations: 1. Anaphylaxis or a severe hypersensitivity reaction is an absolute contraindication to subsequent doses of a vaccine. Persons with a known allergy to a vaccine component should not be vaccinated. 2. Do not give BCG or yellow fever vaccine to an infant that exhibits the signs and symptoms of AIDS. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 24 14 February 2008 Page 2 of 17

6_11 All infants should be immunized except in these three rare situations: 1. Anaphylaxis or a severe hypersensitivity reaction is an absolute contraindication to subsequent doses of a vaccine. Persons with a known allergy to a vaccine component should not be vaccinated. 2. Do not give BCG or yellow fever vaccine to an infant who exhibits the signs and symptoms of AIDS (see Appendix 6_11A). Other vaccines should be given. 3. If a parent strongly objects to an immunization for a sick infant, do not give it. Ask the mother to come back when the infant is well. The following are not contraindications. Infants with these conditions should be immunized (see Appendix 6_11B) Immunization in practice: a practical resource guide for Health workers update Module 6: Holding an immunization session Page 12 50_3 Infants and children with symptomatic human immunodeficiency virus (HIV) or those known to have other immunodeficiency states should not be BCGvaccinated. BCG vaccine (WHO position paper) Weekly Epid. Record (, 79: 27-38) Page 28 50_13 BCG vaccination is indicated for all infants living in areas where TB is highly endemic (concerning HIV, see below); for infants and children at particular risk of TB exposure in otherwise low-endemic areas; for persons exposed to multidrug-resistant Mtb (impact not established.) BCG vaccination is contraindicated for persons with impaired immunity (symptomatic HIV infection, known or suspected congenital immunodeficiency, leukaemia, lymphoma or generalized malignant disease); for patients under immunosupressive treatment (corticosteroids, alkylating agents, antimetabolites, radiation); in pregnancy. BCG vaccine (WHO position paper) Weekly Epid. Record (, 79: 27-38) Page 36 14 February 2008 Page 3 of 17

50_14 HIV-positive infants may receive BCG vaccine only when asymptomatic and living in areas where TB is highly endemic. Long-term follow-up of such children following vaccination is desirable. HIV-positive, asymptomatic infants in low-burden areas should not be BCG-vaccinated. Indications for vaccination of groups likely to contract HIV should always be considered carefully. The efficacy of BCG vaccination in HIV-infected infants is not known. BCG vaccine (WHO position paper) Weekly Epid. Record (, 79: 27-38) Page 36 50_15 Given the high risk of acquiring TB and the low risk of serious adverse events following BCG vaccination of HIV-exposed neonates, WHO maintains that, in HIVinfected areas, all neonates be given BCG. Older infants or children suspected of being HIV-infected should not be vaccinated if they have symptomatic disease or other evidence of immunosuppression. BCG vaccine (WHO position paper) Weekly Epid. Record (, 79: 27-38) Page 38 79_5 There are few population-based data on the effectiveness, or otherwise, of BCG vaccine in preventing severe tuberculosis in HIV-positive infants. Given the high prevalence of HIV and tuberculosis in certain countries and of the current development of new tuberculosis vaccines, some of which are based on BCG, GACVS advises no change in the current recommendations for BCG immunization of infants in countries with a high prevalence of tuberculosis and that population-based studies should be undertaken to determine the efficacy and safety of BCG and related vaccines in HIV-negative and HIV-positive children in countries with a high endemic rate of tuberculosis. Global Advisory Committee on Vaccine Safety, 3 4 December 2003 Weekly Epid. Record (, 79: 16-20) Page 19 14 February 2008 Page 4 of 17

Diptheria 2_7 Because it contains high levels of diphtheria toxoid, (DT) should not be given to children older than six years old or adults. Td, or tetanus-diphtheria toxoids adult dose vaccine, is the same vaccine as DT, but with a lower diphtheria toxoid dose. It is suitable for children older than six years old and adults, including pregnant women. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 12 Hepatitis A 54_6 2000 Contraindications to hepatitis A vaccination include a known allergy to any of the vaccine components. Hepatitis A vaccines (WHO position paper ) Weekly Epid. Record (2000, 75: 38-44) Page 42 Hepatitis B 55_18 Hepatitis B vaccine is contraindicated for individuals with a history of allergic reactions to any of the vaccine s components. Neither pregnancy nor lactation is a contraindication for use of this vaccine. Hepatitis B vaccines (WHO position paper) Weekly Epid. Record (, 79: 255-263) Page 261 14 February 2008 Page 5 of 17

36_8 2001 A child with a history of a severe allergic reaction (e.g. generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypertension, shock) to a previous dose of hepatitis B vaccine should not receive another dose. The following are NOT contraindications: minor illness, such as respiratory tract infection or diarrhoea with temperature below 38.5 C; allergy or asthma; family history of convulsions; treatment with antibiotics; infection with HIV; breastfeeding; history of seizures (convulsions, fits); chronic illnesses such as chronic diseases of the heart, lung, kidney or liver; stable neurological conditions such as cerebral palsy and Down syndrome; prematurity or low birth weight; history of jaundice at birth. Introduction of hepatitis B vaccine into childhood immunization services. Management guidelines, including information for health worker s and parents WHO/V&B/01.31 Page 12 HIB 15_4 2000 There are no contra-indications to Hib immunization, except a history of hypersensitivity to any of the components in the vaccine (for example, tetanus or diphtheria toxoids). Introduction of Haemophilus influenzae type b vaccine into immunization programmes WHO/V&B/00.05 Page 6 14 February 2008 Page 6 of 17

Influenza 56_6 2005 Except for anaphylactic allergic reactions to egg or other components of the (trivalent, inactivated influenza) vaccines, there are no contraindications to the use of these vaccines in age groups >6 months. Influenza vaccines (WHO position paper) Weekly Epid. Record (2005, 80: 279-287) Page 284 56_9 2005 Following nasal administration, (t)ransmission of the (influenza) vaccine virus to exposed non-immune people appears to be very rare. However, as a precaution the vaccine should not be given to highly immunosuppressed individuals or their close contacts. Contraindications for use (of CAIV-T influenza vaccine) include anaphylactic reactions to eggs, a history of Guillain-Barré syndrome, patients aged <18 years on longterm aspirin therapy, pregnancy during the first trimester, and various states of immunosuppression. Influenza vaccines (WHO position paper) Weekly Epid. Record (2005, 80: 279-287) Page 285 56_10 2005 (Inactivated) influenza vaccination in pregnancy is considered safe and is recommended for all pregnant women during the influenza season. This recommendation is motivated not only by the potential severe course of influenza during pregnancy, but also in order to protect infants against influenza during their vulnerable first months of life. Influenza vaccines (WHO position paper) Weekly Epid. Record (2005, 80: 279-287) Page 286 14 February 2008 Page 7 of 17

Measles 80_43 2006 There are no contraindications for measles vaccination. During SIAs, health workers or volunteers may encounter children who have had a dose of measles vaccine less than four weeks previously. This is not a contraindication to measles vaccination and these children should receive a dose of measles during SIAs. Children aged 9 months to 14 years who are admitted to hospital while SIAs are in progress should receive measles vaccination. Global field guide for planning and implementing measles supplementary immunization activities WHO/IVB/04.24 Page 27 58_20 Mild, concurrent infections are not considered a contraindication, and there is no evidence that measles vaccination exacerbates tuberculosis. However, vaccination should be avoided if there is high fever or other signs of serious disease. On theoretical grounds, measles vaccine should also be avoided in pregnancy. Measles vaccines (WHO position paper) Weekly Epid. Record (, 79: 130-142) Page 140 58_21 Persons with a history of an anaphylactic reaction to neomycin, gelatin or other components the vaccine should not be vaccinated (with measles vaccine.) Furthermore, measles vaccine is contraindicated in persons who are severely immunocompromised as a result of congenital disease, HIV infection, advanced leukaemia or lymphoma, serious malignant disease, or treatment with high-dose steroids, alkylating agents or antimetabolites, or in persons who are receiving immunosuppressive therapeutic radiation. Measles vaccines (WHO position paper) Weekly Epid. Record (, 79: 130-142) Page 140 14 February 2008 Page 8 of 17

Mumps 60_8 2001 There are few contraindications to mumps vaccination. As with all live attenuated vaccines, mumps vaccine should not be administered to individuals with advanced immune deficiency or immunosuppression. Fetal damage has not been documented when mumps vaccines have been given to pregnant women. Allergy to vaccine components such as neomycin and gelatin is a contraindication to administration of the vaccine. Mumps virus vaccines (WHO position paper) Weekly Epid. Record (2001, 76: 345-356) Page 353 Pertussis 61_4 2005 While in terms of severe adverse events, ap (acellular pertussis) and wp (whole cell pertussis) vaccines appear to have the same high level of safety, mild to moderate adverse reactions are more commonly associated with wp vaccine; wp vaccines are not recommended for use in adolescents and adults. Pertussis vaccines (WHO position paper) Weekly Epid. Record (2005, 80: 31-39) Page 32 61_14 2005 Except for an anaphylactic reaction following prior administration of the vaccine, there are no strict contraindications to this vaccination. There are no data to support the perception that previous encephalitis may be a contraindication for pertussis vaccination. Pertussis vaccines (WHO position paper) Weekly Epid. Record (2005, 80: 31-39) Page 35 14 February 2008 Page 9 of 17

Pneumococcal 92_14 2007 The only contraindication to PCV-7 immunization is a severe hypersensitivity reaction to a previous dose of the vaccine. Pneumococcal conjugate vaccine for childhood immunization (WHO position paper) Weekly Epid. Record (2006, 82: 93-104) Page 102 62_9 2003 There are no absolute contraindications to vaccination with pneumococcal polysaccharide vaccine except for an anaphylactic reaction to the previous dose. Pneumococcal vaccines (WHO position paper) Weekly Epid. Record (2003, 78: 110-119) Page 116 Rabies 93_6 2007 Because rabies is a lethal disease, no contraindications to post-exposure prophylaxis following high-risk exposure exist. This also pertains to post-exposure rabies prophylaxis in infancy and pregnancy. Weekly epidemiological record No. 49/50, 2007, 82, 425-436 Page 431 93_7 2007 For pre-exposure immunization, previous severe reaction to any of the vaccine components is a contraindication to further use of the same vaccine. Weekly epidemiological record No. 49/50, 2007, 82, 425-436 Page 431 14 February 2008 Page 10 of 17

93_8 2007 In immunocompromised individuals, including patients with HIV/AIDS, comprehensive wound management and local infi ltration with RIG, in combination with a complete intramuscular CCV series, are of utmost importance for the successful prevention of rabies. In these situations, the VNA response should be determined 2 4 weeks following vaccination to assess the possible need for an additional dose of the vaccine. Weekly epidemiological record No. 49/50, 2007, 82, 425-436 Page 431 93_9 2007 People taking chloroquine for treatment or malaria prophylaxis can have a reduced response to ID rabies vaccination. These patients should receive the vaccine by the IM route. Weekly epidemiological record No. 49/50, 2007, 82, 425-436 Page 432 64_6 2002 There are no contraindications to any of these (cell-derived rabies) vaccines being used for post-exposure treatment. Should an allergic reaction occur, the modern vaccines of different cell substrate origin may replace each other. Pregnancy is not a contraindication to post-exposure treatment. Rabies vaccines (WHO position paper) Weekly Epid. Record (2002, 77: 109-119) Page 115 14 February 2008 Page 11 of 17

Rubella 66_10 2000 Rubella vaccination should be avoided in pregnancy because of the theoretical, but never demonstrated, teratogenic risk. No cases of CRS have been reported in more than 1 000 susceptible pregnant women who inadvertently received a rubella vaccine in early pregnancy. Consequently, there is no need to screen women for pregnancy before rubella vaccination. If pregnancy is being planned, then an interval of 1 month should be observed after rubella immunization. Rubella vaccination during pregnancy is not an indication for abortion. Rubella vaccines (WHO position paper) Weekly Epid. Record (2000, 75: 161-169) Page 166 Tetanus 83_13 2006 (I)mmunodeficiency including HIV infection is not a contraindication to (the use of TT or dt.) Tetanus vaccine (WHO position paper) Weekly Epid. Record (2006, 81: 198-208) Page 204 2_7 Because it contains high levels of diphtheria toxoid, (DT) should not be given to children older than six years old or adults. Td, or tetanus-diphtheria toxoids adult dose vaccine, is the same vaccine as DT, but with a lower diphtheria toxoid dose. It is suitable for children older than six years old and adults, including pregnant women. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 12 14 February 2008 Page 12 of 17

Typhoid 67_10 2000 It is not known whether this live attenuated vaccine (Ty21a typhoid vaccine) can cause fetal harm when administered to pregnant women. Ty21a can be administered to HIV-positive, asymptomatic individuals without risk as long as the T-cell count (CD4) is above 200/mm3. Typhoid vaccines (WHO position paper) Weekly Epid. Record (2000, 75: 257-264) Page 262 67_15 2000 There are no contraindications (to the Vi polysaccharide typhoid vaccine) other than prior severe reaction to vaccine components. Although the vaccine is safe for HIVinfected persons, the induction of protective antibodies is directly correlated to the levels of CD4 positive T-cells. Typhoid vaccines (WHO position paper) Weekly Epid. Record (2000, 75: 257-264) Page 262 Varicella 68_7 1998 In immunocompromised persons, including patients with advanced HIV infection, varicella vaccination is currently contraindicated for fear of disseminated vaccine induced disease. Varicella vaccines (WHO position paper) Weekly Epid. Record (1998, 73: 241-248) Page 246 14 February 2008 Page 13 of 17

68_8 1998 Contraindications for varicella vaccination include a history of anaphylactic reactions to any component of the vaccine (including neomycin), pregnancy (due to theoretical risk to the fetus; pregnancy should be avoided for 4 weeks following vaccination), ongoing severe illness, and advanced immune disorders of any type. Except for patients with acute lymphatic leukaemia in stable remission, ongoing treatment with systemic steroids (for adults >20 mg/day, for children >1mg/kg/day) is considered a contraindication for varicella vaccination. A history of congenital immune disorders in close family members is a relative contraindication. Varicella vaccines (WHO position paper) Weekly Epid. Record (1998, 73: 241-248) Page 246 68_15 1998 Recommendations on possible use of (varicella) vaccine for persons in certain states of immunodeficiency are beyond the scope of this article. Advice is provided by several expert panels such as the Advisory Committee on Immunization Practices (ACIP) in the United States. Varicella vaccines (WHO position paper) Weekly Epid. Record (1998, 73: 241-248) Page 248 Vitamin A 80_37 2006 Additionally, vitamin A supplements are not given to any mother or females of childbearing age during SIAs because of the risks involved if pregnant and the difficulty of careful screening. Global field guide for planning and implementing measles supplementary immunization activities WHO/IVB/04.24 Page 12 14 February 2008 Page 14 of 17

Yellow Fever 39_18 2005 Yellow fever vaccine is contraindicated for infants less than 6 months of age, immune-deficient persons and persons with egg allergy. The risk of disease should be weighed against the risk of vaccination in pregnant women and in persons with symptomatic HIV infection. These are important factors to consider before planning a mass preventive vaccination campaign. Vaccine introduction guidelines. Adding a vaccine to a national immunization programme: decision and implementation WHO/IVB/05.18 Page 46 77_4 2005 GACVS reiterates that particular care should be taken that the (17D yellow fever) vaccine is received only by those travellers who are truly at risk of exposure to yellow fever. In addition, vaccine providers should give careful consideration to the risks and benefits for elderly travellers and should routinely enquire about a history of thymus disorder, irrespective of the age of the subject. Where a history of thymus disorder is reported, alternative prevention measures should be considered. Global Advisory Committee on Vaccine Safety, 2 3 December Weekly Epid. Record (2005, 80: 3-7) Page 7 2_20 All infants should be immunized except in these three rare situations: 1. Anaphylaxis or a severe hypersensitivity reaction is an absolute contraindication to subsequent doses of a vaccine. Persons with a known allergy to a vaccine component should not be vaccinated. 2. Do not give BCG or yellow fever vaccine to an infant that exhibits the signs and symptoms of AIDS. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 24 2_29 Those who have a severe reaction (to yellow fever vaccine) should not receive additional doses. Immunization in practice: a practical resource guide for Health workers update Module 2: The vaccines Page 23 14 February 2008 Page 15 of 17

6_11 All infants should be immunized except in these three rare situations: 1. Anaphylaxis or a severe hypersensitivity reaction is an absolute contraindication to subsequent doses of a vaccine. Persons with a known allergy to a vaccine component should not be vaccinated. 2. Do not give BCG or yellow fever vaccine to an infant who exhibits the signs and symptoms of AIDS (see Appendix 6_11A). Other vaccines should be given. 3. If a parent strongly objects to an immunization for a sick infant, do not give it. Ask the mother to come back when the infant is well. The following are not contraindications. Infants with these conditions should be immunized (see Appendix 6_11B) Immunization in practice: a practical resource guide for Health workers update Module 6: Holding an immunization session Page 12 79_4 (GACVS stated that) particular care should be taken that the (yellow fever) vaccine is received only by those travellers truly at risk for yellow fever exposure. Furthermore, care should be taken that routine yellow fever vaccination programmes are not jeopardized by risk benefit ratios that may be inapplicable to the target populations in endemic countries. Global Advisory Committee on Vaccine Safety, 3 4 December 2003 Weekly Epid. Record (, 79: 16-20) Page 19 79_7 A critical and unresolved issue is the safety and efficacy of yellow fever vaccine in human subjects infected with immunodeficiency virus (HIV). It remains to be determined whether HIV-positive status materially affects seroconversion, the risk of invasion of the nervous system and of encephalopathy, the stage of HIV disease at which yellow fever vaccination should be contraindicated, and whether there are differences in the incidence of minor and major adverse effects in HIV-positive subjects. Global Advisory Committee on Vaccine Safety, 3 4 December 2003 Weekly Epid. Record (, 79: 16-20) Page 19 69_13 2003 The (yellow fever) vaccine is contraindicated in children aged under 6 months and is not recommended for those aged 6-8 months, except during epidemics when the risk of YF virus transmission may be very high. It is also contraindicated for persons with severe allergy to egg and for severely immunocompromised persons. On theoretical grounds, the 17D vaccine is not recommended during pregnancy. However, pregnant women may be vaccinated during epidemics when the risk of YFV transmission may be very high. Yellow fever vaccine (WHO position paper) Weekly Epid. Record (2003, 78: 349-359) Page 356 14 February 2008 Page 16 of 17

69_17 2003 Contraindications against YF vaccination include age less than 6 months, severe hypersensitivity to egg antigens and severe immunodeficiency. Whereas it is relatively easy to avoid immunization of the first two categories, the principal contraindications against immunization during pregnancy and in severe immunodeficiency cause significant practical problems. Fortunately, the few published cases of congenital infection caused by 17D have not been associated with fetal abnormalities. Similarly, no adverse events occurred in a small study of HIV-infected children with low CD4+ counts who received the vaccine. These observations are important considering the likelihood that many pregnant women and HIV-positive individuals, including children, will be immunized inadvertently during large-scale immunization activities in at risk countries. For international travellers, where laboratory and other resources are available, YF (yellow fever) vaccination may be offered to asymptomatic HIV-infected persons with CD4+ counts above 200 cells/mm3 who require vaccination for unavoidable travel. Individual expert assessments are required before YF vaccination may be offered to persons taking highdose corticosteroids or antineoplastic drugs. If possible, tests should be performed to ensure that protective levels of neutralizing antibodies have been achieved, as primary vaccination failure is common in immunodeficient individuals. Yellow fever vaccine (WHO position paper) Weekly Epid. Record (2003, 78: 349-359) Page 357 69_19 2003 Given the very rare, but potentially severe, adverse effects, YF (yellow fever) vaccine for travellers should be administered on strict indications only, particularly in the elderly. Restriction of YF vaccination to authorized centres is likely to promote the appropriate use of YF vaccine. Yellow fever vaccine (WHO position paper) Weekly Epid. Record (2003, 78: 349-359) Page 358 14 February 2008 Page 17 of 17