Immunisation. Table 1: The current Immunisation Schedule

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1 Immunisation 1. Immunisation schedule for Malaysia Immunisation Table 1: The current Immunisation Schedule Age (months) Age (Years) BCG* 1 if no scar Hep B DPT DT T OPV* Hib Measles* Sabah MMR* Vaccine/s available in KKM but not listed in the above schedule Pneumococcal vaccine : Pneumococcal polysaccharide vaccine - Protective efficacy ranges from 56-81%. Not recommended for children < 2 years old as vaccine is not effective in this group (conjugate vaccine is immunogenic in these infants but currently not widely available). Single dose. Booster 3-5 years only for high risk persons. Category A (specialist prescription) Meningococcal A, C, Y & W-135 (Does not cover B). Polysaccharide vaccine : Immunogenic in children 2 years or older. Single dose. Immunity up to 3 years. Category C (medical officers) Cholera : Killed whole cell vaccine : 2 doses 4 weeks apart (minimum 1 week). Booster every 6 months. Not highly effective & short duration of protection < 6 months. First dose given SC/IM; second dose and boosters given ID to reduce systemic side effects. Protects only 50% of vaccines (for 3 6 months). Vaccine is not recommended for infants < 6 months of age. Category B (MO) Japanese B encephalitis vaccine. 3 doses. Dose 1 and 2 at 2 4 weeks interval then Dose 3 at 1 year after that. This vaccine is given in Sarawak as part of the MOH vaccination program at 9, 10 and 18 months of age. A booster is then given at 4 year of age Rabies: IM/SC (available in KKM as HDC~ human diploid cell vaccine) Pre-exposure immunisation: 3 doses at Day 0, 7 and 28. Then boosters every 2-3 years. Post-exposure treatment: o Fully immunised: 2 doses at Day 0 and Day 3 or 7. Rabies specific Ig unnecessary. o Unimmunised: 6 doses at Day 0, 3, 7, 14 and 30. Rabies specific Ig (20 IU/kg given half around the wound and the rest IM). Category B

2 1.1.6 Typhoid: a) Vi polysaccharide vaccine : Single dose. Seroconversion in > 90% of vaccines and confers 60 80% protection commencing within 14 days from vaccination. Boosters every 3 years. Immunogenicity < 2 years of age has not been established. b)oral typhoid vaccine(ty21a vaccine)* (three doses two days apart) and whole cell typhoid vaccines are also available. Category B 1.2 Other Vaccines available in Malaysia but not yet in KKM s program: Varicella zoster * % effectiveness. From 12 months to 12 years: single dose. > 12 years old : 2 doses at least 28 days apart. Two vaccines are currently available in Malaysia: -Varivax (MSD) -Varilrix (GSK) Children who have not had chicken pox by 12 years of age are encouraged to receive the vaccine as the illness is more severe in older age groups. Considered for children with asymptomatic or mildly symptomatic HIV infection; two doses with a 3 month interval are recommended. Children with leukaemia & are in remission for at least 1 year, & have > 700/ml circulating lymphocytes may receive vaccination under supervision of the attending paediatrician Hepatitis A : 3 doses. Dose 1 and 2 at 2-4 weeks apart then Dose 3 at 6 12 months later. Adults need 2 doses 6 12 months apart. Seroconversion rate almost 100%. Booster every 10 years. Approved for children > 1-2 years of age Missed second dose: If a child misses the second dose at 2 4 weeks then: If > 1 month and < 5 months from 1st dose just give the second dose. If > 5 months have elapsed from 1st dose repeat whole course Influenza: Indications and recommended vaccine will vary between countries. Unprimed individuals will require a second dose 4 to 6 weeks after the first dose. Yearly revaccination with the latest recommended vaccine composition by WHO is required in countries at risk, e.g. temperate climate Recommendations: chronic decompensated disorders of respiratory or cardiovascular systems : e.g. cyanotic heart diseases, chronic lung diseases HIV infection. In advanced disease, vaccination may not induce protective antibody levels. * Live-vaccines usually only one dose is required to produce long term immunity (except Yellow Fever for travel purposes (vaccination may be obtained at IMR & respective state health departments. An International Certificate of Vaccination will be issued, valid for 10 years commencing from 10 days after vaccination) and oral poliovirus vaccine which contains 3 different components and more doses are required to ensure an adequate response to each component).

3 2 General Notes 2.1 Many vaccines (inactivated or life) can be given together simultaneously (does not impair antibody response or increase adverse effect). But they are to be given at different sites unless given in combined preparations. Many vaccines are now packaged in combinations so that the child is not subjected to multiple injections. 2.2 Site of administration Oral OPV Deep SC & IM injections. (ALL vaccines EXCEPT BCG and OPV) a) anterolateral aspect of thigh preferred site in children. b) upper arm preferred site in adults c) upper outer quadrant of buttock - is associated with reduced antibody level production Intradermal (ID) - BCG & rabies. Left deltoid area (proximal to insertion deltoid muscle) 2.3 A person who has been immunised using OPV can subsequently use IPV for booster and vice versa. 2.4 Repeat dose of OPV if child vomits soon after administration. 2.5 PRP-T (Act Hib) and PRP-OMP (Pedvax) (H. influenzae b vaccines) used in the primary series are interchangeable. Children partially immunized in the private sector with one particular type may be immunized with another type in the KKM schedule. 2.6 MMR can be given irrespective of previous history of measles, mumps or rubella infection. 3 Immunisation : Contraindications 3.1 Postponed during acute febrile illness. Minor infection without fever or systemic upset are NOT contraindication. Polio (OPV) postpone if severe diarrhoea and vomiting (to avoid decrease take). 3.2 A relative contraindication: do not give a vaccine within 2 weeks of an elective surgery. 3.3 Live vaccine: Absolute contraindication Immunosuppressed -malignancy; irradiation, leukaemia, lymphoma, primary immunodeficiency syndromes (but NOT asymptomatic HIV) On chemotherapy (< 6 months after last dose) High dose steroid: Prednisolone 2 mg/kg/day for > 7 days or low dose systemic > 2 wk.; (delay vaccination for 3 months). If tropical or inhaled steroids OR low dose systemic < 2 weeks or EOD for > 2 weeks can give live vaccine If another LIVE vaccine including BCG had been given < 3 wk. ago. (Either give live vaccines simultaneously or if cannot then separately with a 3 week interval) Within 3 months following IV Immunoglobulin. (except yellow fever or oral polio).

4 3 Weeks 3 Months Live Vaccine HNIG Live Vaccine Pregnancy (live vaccine theoretical risk to foetus) UNLESS there is significant exposure to serious conditions like polio or yellow fever in which case the importance of vaccination may outweigh the possible risk to the foetus. 3.4 Killed vaccines are generally safe. The only Absolute contraindications are SEVERE local (induration involving > 2/3 of the limbs) or severe generalised reaction in the previous dose (i.e. Temp > 39 C, anaphylaxis, persistent screaming, convulsions). 3.5 Specific Contraindications BCG - Not to be given to symptomatic HIV infected children Hep B vaccine Severe hypersensitivity to aluminium or thiomersal. (Not needed for HBsAg or Ab positive) Pertussis Progressive neurological diseases like infantile spasm, tuberous sclerosis. Severe reaction to previous dose i.e. a. Anaphylaxis b. Collapse or shock-like states c. Hyporesponsive states d. Fits and fever within 72 hr e. Fever > 40.5 C within 48 hours e. Encephalitis within 7 days f. Severe local reaction involving 2/3 of limbs. Static neurological diseases, developmental delay, personal or family history of fits are NOT contraindications. Severe hypersensitivity to aluminium and thiomersal. And point 3.4 as above Diphtheria & Tetanus: Severe hypersensitivity to aluminium and thiomersal. And point 3.4 as above Polio Diarrhoea & vomiting. Hypersensitivity to penicillin, neomycin, streptomycin or polymycin. Within 3 week from a proposed tonsillectomy (remote risk of vaccine induced bulbar polio). Polio (IPV) is to be used for immunocompromised children, their siblings and household contacts. OPV if given to immunosuppressed or HIV positive children tend to cause prolonged excretion of the OPV and be hazardous to care givers.

5 3.5.6 Rubella - Contraindicated in pregnancy (even though no reported cases of congenital rubella syndrome due to vaccine) Measles - If < 9 months old presence of maternal Ab may decrease immunogenecity. Avoid in persons hypersensitive to neomycin, polymyxin OR anaphylaxis to egg ingestion MMR and Influenza severe reaction to hen s eggs or neomycin Pneumococcal children less than 2 years old; revaccination within 3 years has high risk of adverse reaction; avoid during chemotherapy or radiotherapy and less than 10 days prior to commencement of such therapy antibody response is poor. Pregnancy Hepatitis A: Severe hypersentivity to aluminium hydroxide, phenoxyethanol or neomycin Typhoid (whole-cell) and Cholera: patients with chronic illness such as multiple sclerosis, rheumatoid arthritis, diabetes and compensated cardiac conditions may suffer a relapse Meningococcus A, C, Y & W-135: polysaccharide vaccine : Not useful in children < 2 years old Japanese B: contraindicated in immunodeficiency and malignancy, diabetes, acute exacerbation of cardiac, hepatic and renal conditions. 3.6 The following are NOT contraindications to vaccination in Children Mild illness without fever e.g. mild diarrhoea, cough, running nose Asthma, eczema, hay fever, impetigo, heat rash, etc.(avoid injection in area of skin lesion) Treatment with antibiotics or locally acting steroids Child's mother is pregnant Breast fed child (does not affect polio uptake) Neonatal jaundice Underweight or malnourished Over the recommended age Past history of pertussis, measles or rubella (unless confirmed medically) Non progressive, stable neurological conditions like Cerebral palsy, Down s syndrome, simple febrile convulsions, controlled epilepsy. mental retardation Family history of convulsions History of heart disease, acquired or congenital Prematurity (give immunisation according to schedule irrespective of gestational age).

6 4 Vaccination: Possible Side Effects 4.1 Diphtheria and Tetanus vaccine. Swelling, redness and pain A small painless nodule may at injection site harmless. Transient fever, headaches, malaise, rarely anaphylactic reaction. Neurological reactions rare. 4.2 DPT Local swelling and redness within hours lasting 1 2 weeks. Acute encephalopathy ( per million) Shock and unusual shock-like state (3.5 to 250 cases per ) Anaphylaxis (2 per doses) Protracted crying (0.1 to 6%) 4.3 OPV Vaccine associated paralytic polio (VAPP) risk at 1 case/ 5.3 million doses highest risk after 1 st dose estimated at 1 case / 1 million contacts of first dose recipients. risk for subsequent doses is greatly reduced. It is important that contacts of children receiving OPV are themselves fully immunized. 4.4 IPV No serious side effects have been documented, apart from local reaction. Indicated for children with severe immunocompromised conditions e.g. immunodeficiency states (1 o and 2 o such HIV infection, malignancy & organ transplantation) 4.5 HiB (Haemophilus influenzae b) vaccine Local swelling, redness and pain soon after vaccination and last up to 24 hours in 10% of vaccines Malaise, headaches, fever, irritability, inconsolable crying. Very rarely seizures. 4.6 Measles: Transient rash in 5% of cases. Fever between D5 and D12 post vaccination lasting for 1-3 days (5 to 15% of doses of vaccines). URTI symptoms. Febrile convulsions (D6 to D14) in 1 in doses of vaccine. (Natural infection 1:200) Encephalopathy within 30 days in 1 in 1,000,000 doses of vaccines. (Natural infection 1: ) SSPE may occur in 1 in 1,000,000 doses. (Incidence in natural infection is 6 to 22 per 1,000,000). 4.7 Mumps Rarely transient rash, pruritis and purpura. Parotitis in 1% of vaccines, 3 or more weeks after vaccination. Orchitis and retro bulbar neuritis very rare. Meningoencephalitis is mild and rarely occur. (1 in 800,000 doses). (Natural infection 1 in 400).

7 4.8 Rubella May have rash, fever, lymphadenopathy, thrombocytopenia, transient peripheral neuritis. Arthritis and arthralgia occurs in up to 3% of children and 20% of adults who receive the vaccine. Rarely polyneuropathy (like Guillain-Barre syndrome can occur). 4.9 BCG Local reaction :a papule at site of vaccination occurs within 2 to 6 weeks. This grows and flattens with scaling and crusting. Occasionally a discharging ulcer may occur. This heals leaving a BCG scar of at least 4 mm in successful vaccination. BCG adenitis may occur Influenza and Rabies Transient swelling, redness, pain and induration locally. Myalgia, malaise and fever for 1 2 days starting within a few hours post vaccination. Very rarely neurological or anaphylactic reaction occurs Pneumococcal Local reaction. Fever and myalgia in less than 1% of vaccines. Rarely neurological disorder (Guillain-Barre), glomerulonephritis, ITP or anaphylaxis Hepatitis A Local reaction. Flu-like symptoms lasting 2 days in 10% of vaccines Hepatitis B Local reaction. Fever and flu-like symptoms in 1 st 48 hours. Rarely erythema multiforme or urticaria Typhoid (Typhim Vi): Local reaction. Myalgia, malaise, nausea, headaches and fever in 3% of recipients Cholera Local reaction. Headache, fever and malaise for 1 2 days. Rarely anaphylactic reaction, neurological symptoms including cerebral and meningeal irritation may occur. Repeated vaccination over a few years can result in hypersensitivity to the protein components Meningococcus A, C, Y & W-135 Local reaction. Irritability, fever and rigors for 1 2 days. Very rarely anaphylaxis.

8 5 Vaccination : Special Circumstances 5.1 What to do if a measles case is admitted to the Paediatric Ward? Protect all immunocompromised children with immunoglobulin (HNIG) 0.2 mls/kg (32 mg/kg). (Measles is the major cause of mortality in leukaemia in remission.) Check the status of the other children with regards with measles immunisation. If they are not immunised then give the measles monocomponent vaccine within 24 hours of exposure. Vaccination within 72 hours can abort clinical measles in 75% of contacts Discharge uncomplicated measles case. 5.2 Immunisation in HIV infected children With or without symptoms should receive : live vaccines (WHO recommends BCG for asymptomatic cases) Inactivated vaccines Give immunoglobulin if exposed to measles or chicken pox IPV is to be used. 5.3 In patients with past history or family history of fits, neurological or developmental abnormalities that would predispose to febrile fits : Febrile fits can occur 5 10 days after measles (or MMR) vaccination or within the first 72 hours following pertussis immunisation Give Paracetamol (120 mg or ¼ tablet) prophylaxis after immunisation (esp. DPT) 4 hourly for 48 hours regardless of whether the child is febrile or not. This can reduce the incidence of high fever, febrile convulsions, fretfulness, crying, anorexia and local inflammation Rectal Diazepam may need to be given on stand by. 5.4 Maternal Chicken Pox during perinatal period. Rash appearing within 5 days before and 2 days after delivery Isolate mother from baby and other patients. Isolate baby Immunoglobulin to be given :- Human immunoglobulin (400u/kg) OR ZIG (125µ/kg) within 48 hours Because severe varicella may develop in new-borns despite ZIG, some investigators recommend Acyclovir prophylaxis. Neonates with VZ infection should be treated with IV Acyclovir 10 mg/kg every 8 hrs for 10 days.

9 5.5 Close contacts of immuno-deficient children and adults must be immunized, particularly against measles and polio (use IPV). 5.6 In cases of contact with a patient with invasive Haemophilus influenzae B disease: Close contacts in a household, nursery or kindergarden under the age of 4 years should be immunised Rifampicin prophylaxis should be given to all household contacts at 20 mg/kg once daily (Maximum 600 mg) for 4 days (except pregnant women - one IM dose of ceftriaxone ) Index case should be immunised irrespective of age. 5.7 Asplenia (Elective or emergency splenectomy; asplenic syndromes; sickle cell anaemia) susceptible to encapsulated bacteria and malaria Pneumococcal, Meningococcal A, C, Y & W-135 and Haemophilus influenza b vaccines should be given For elective splenectomy (and also chemotherapy or radiotherapy); it is preferable to give the vaccines 2 or more weeks before the procedure. However they can be given even after the procedure Penicillin prophylaxis should continue even after vaccination. Ideally for life. If not until 16 years old for children or 5 years post splenectomy in adults. 5.8 Babies born to mothers who are HbeAg OR HbsAg positive should be given Hepatitis B immunoglobulin (200 IU) and vaccinated with the Hepatitis B vaccine at within 12 hours and not later than 48 hours. Given in different syringes and at different sites.

10 6. Recommended Immunisation Schedule for Infants and Children Not Immunised at the Recommended Time Time of Immunisation 1st visit Age at first visit Between 6 weeks and 9 9 months and older months BCG, DPT-Hib1, OPV1 & HBV1 BCG, DPT1-Hib, OPV1 measles in Sabah at 9 months of age MMR at 12 months of age 2nd visit (1 month later) DPT-Hib2, OPV2, HBV2 or DPT2, OPV2, HBV1 3rd visit (1 month later) DPT-Hib3, OPV3, HBV2 DPT3, OPV3, HBV2 1 month later HBV3 HBV3 2-8 months later DPT & OPV (booster) measles in Sabah at 9 months of age MMR at 12 months of age DPT & OPV (booster) Subsequent booster doses: follow "Recommended Immunisation Schedule for Infants & Children For infants aged less than 6 weeks, use "Recommended Immunisation Schedule for Infants & Children". Note that measles vaccine should be given only after 9 months. Omit pertussis vaccine if child is aged 7 years or older at first contact. In this situation, adult dtap (lowered antigen) may be considered. For special groups of children with no regular contact with Health Services and with no immunisation records, BCG, OPV, DPT, HBV and measles can be given simultaneously at different sites at first contact. It is not necessary to restart a primary course of immunisation irrespective of the period that has elapsed since the last dose was given. Only the subsequent course that has been missed need be given. (Example. An infant who has been given OPV1 and then 9 months later comes for follow-up, the OPV1 need not be repeated. Go on to OPV2.). Except Hepatitis A. Reference: 1. Ministry Of Health Malaysia 2. Immunization Precautions and Contraindications (2 nd Edition) George C. Kassianos. Blackwell Scientific Publications Health Technology Assessment Expert Committee report on immunisation (MOH Malaysia). 4. Malaysian Immunisation Manual. College of Paediatrics, Academy of Medicine of Malaysia Canadian Immunization Guide.(6 th Edition) Cholera vaccines. WHO position paper ; Weekly Epidemiol Rec 2001;76: Typhoid vaccines. WHO position paper ; Weekly Epidemiol Rec. 2000;32:

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