IMMUNIZATION 2022 / MedUrgent

IMMUNIZATION

Definition

— Vacca: Latin = Cow

— Vaccinia: Cowpox virus

— Developed by Dr. Jenner in 1797

— Vaccination= Inoculation with the virus of vaccinia (cowpox) to protect against smallpox

Vaccine: 

—  A preparation of attenuated (weakened)or killed micro-organism, toxoid or genetically engineered antigenic material administered for the prevention of infectious disease

— EPI: Started in 1978

— Universal Immunization Program: Introduced in 1985

— Immunization: The act of rendering immune

— Active Immunity: Giving regular doses of vaccine

— Passive Immunity: Giving Antibodies

Cocooning Strategy of vaccination:

— Vaccinating Pregnant ladies, lactating mothers, Sibs, Fathers and Grand Parents (TdaP)

Live attenuated Vaccine:

— Weakened organism that produces antigenic response without serious infection

Killed Vaccine:

— Organism is killed or the antigen is inactivated by heat, phenol, formaldehyde or other methods

Conjugated vaccine:

— Polysaccharide vaccine (H. influenza) conjugated with DPT to stimulate T cells and thus eliciting immunological memory

Toxoid:

— Toxins rendered non-toxic (by formaldehyde) but antigenicity is maintained

Vaccine Handling & Storage

— Recommended temp.2- 8 °C

— OPV: <0°C (thawing and refreezing NOT more than 10 times)

— Varicella: <-15°C (reconstituted: use within ½ hr)

— MMR: Reconstituted: use within 8 hrs.

— Always: check the manufacturer package insert

— Revise the Cold Chain: shipment to customer

Personnel & Equipments

— One person responsible

— Working refrigerator and Electric Stabilizer

— Thermometer

— Frozen water bottles or ice packs

— Vaccines: in the central storage area

— NO food or other drugs

Vaccine administration

— ≤ 1 yr: Antero-lateral aspect of the thigh

— > 1 yr: Deltoid

• Buttocks: ↑subcutaneous fat + Sciatic nerve

• Deep i.m. (needle = 7/8 – 1 inch long)

• Same site for s.c. (Measles)

• Intra-dermal: On the volar surface of the forearm (25-27 gauge needle)

— Multiple vaccines: same (1-2 inches apart)or a different thigh

— NO mixing of vaccines in One syringe

— Gentle pressure: Relieves pain and stops bleeding

— Keep the child at his mother lap

— Local anesthetic may be used (ELMA cream or Vapo-coolant spray)

— Distracters or pacifiers

Complications

— Possible complications of i.m. vaccines:

-Nerve injury

-Infection

-Abscess

-Skin pigmentation

-Hemorrhage

-Cellulitis

-Tissue necrosis & gangrene

-Scars / cysts /local atrophy

-Periostitis

Special Considerations

— For patients with Bleeding tendency: Give the i.m. vaccine immediately after giving the replacement factor 

— Press for 2 min.

— Subcutaneous root is safer

— After giving IgG: Wait for 3-5 months to give live vaccines

— Wait for 2/52 after live vaccine to give IgG

— Pre-terms: Vaccination according to the chronological age

— A lapse : NO reinstitution, continue vaccination as scheduled

— No documentation: Start from zero

— Vaccine Adverse Events: Report to MOH

— Oral vaccine, spitted or vomited: Repeat

Remarks

— Injection sites: Lateral aspect of Thigh or Deltoid

— No vaccine should be given i.v.

— Fever : Analgesic

— Live vaccines: Not given to immuno-deficient children

— Pre-terms: Vaccinated at the proper chronological age

Precautions

— Convulsions within 72 hrs: No more pertussis vaccine

— Care with children brain damage and convulsions

— During epidemic: Measles vaccine can be given at age 6/12

— OPV, Yellow Fever & Cholera vaccines should not be given together

— Check the color of the square on the sticker on each vial

— Check the color of the vaccine solution:

                       -Colorless (MMR, PCV, Hib…)

                       -Turbid (DPT-aluminum conjugate, Toxoid)

Immuno-compromised patients

— Impaired host defense

— Frequent contact with medical environment

— CDC & IDSA Recommendations (Jan.2014):

             (Centers for Disease Control & Infectious Diseases Society of America)

  

— Live vaccines: Given 4/52 before immuno-suppression

— Influenza vaccine regularly every year i.m.(NOT the inactivated nasal spray vaccine). Age 6/12 – 49 yrs.

— Household contacts: Regular vaccination

— Complement deficiency: Normal vaccination 

— HIV: Normal vaccination (Not the nasal spray Influenza vac.) 

— Poor  uptake of vaccines during intensive chemotherapy or in patients on anti-B cell antibodies 

— Give vaccines 4/52 after immuno-therapy                    

— No vaccines during a course of IgG therapy

Vaccine Vial Monitoring

— Normal: inner square of the sticker is lighter than the outer circle

— Color of the square matches with or darker than the circle: discard

— Always: Check the Expiry Date 

— Always : check the color of the solution

— Always: Read the Insert 

NOT Contra-indications

— Mild URTI or Diarrhea

— Fever <38.5 C

— Allergy / Asthma

— Prematurity

— Malnutrition

— Breast feeding

— Family history of convulsions

— Antibiotics

— Chronic diseases e.g. CHD

— Cerebral palsy, Down’s Syndrome

Refrigerators

• Properly working

• Electric Stabilizer

• NO food, drinks or other drugs

• OPV: Freezer

• Other vaccines: Middle and lower compartments

• Thermometer

• Ice packs or frozen water bottles

• OPV : Freezer (Presence of sorbitol: does not freeze)

• Measles: Dried powder, under the freezer

• Thermometer

BCG

• Bacilli Calmette & Guerin

• Attenuated bovine mycobacterium

• Wheal: for 1/2 hr

• Nodule: After 3/52

• Ulceration & healing with a scar: 4-6/52

• Koch’s phenomenon: Accelerated reaction (10days)

• Complications: Erythema nodosum, abscess, ulceration, local lymphadenopathy and generalized T.B

• B.C.Giosis: Generalized T.B. secondary to vaccination

• No scar after 4/12: 

                                  - Repeat vaccine

                                  -Still no scar: repeat after ONE yr

• Intra-dermal

• At birth: (0.05ml)

• Older children: (0.1ml), Mantoux test first

• Efficacy: 0 – 86%

• Bacille Calmette & Guerin

• Live attenuated mycobacterium bovis

• Elder children: Mantoux test first

• Immunity wanes after 10-15 yrs

• Nodule (2-3/52), Ulcer (4-6/52), healing with a scar (2-3/12)

• Complications: erythema nodosum, deep ulceration, abscess, lymphadenopathy, generalized disease

OPV (Oral Polio) – Sabin

• Live attenuated type I, II, III

• Efficacy: 90 - 98%

• Protection is life long (within 1/52)

• Superior to IPV in antibody response

• Provides herd immunity 

• Not given to HIV, Immuno-compromized and immunosuppressant drugs users)

• Rarely: causes paralytic polio

• IPV: Less potent but no paralytic polio

Inactivated Polio vaccine(IPV)-Salk

— Given i.m./ s.c.

— Less immunogenic

— Does not cover the GIT 

— No herd immunity

— No spread to pregnant ladies

—

Pentavalent

• DPT + HiB + HepB

Diphtheria

— Anti-diphtheritic human Immunoglobulin:

                    *Prophylactic = 300 IU -i.m.

                    *Therapeutic  =1200 – 20000 IU –i.m.

— Antidiphtheritic Serum:

                    *Used when IgG is N.A.

                    *Horse serum: Test for allergy

                    *Prophylactic = 10000 IU –i.m.

                    *Therapeutic = 40000 – 120000 IU –i.m.

                

— Formaldehyde inactivated toxin & adsorbed onto aluminum salt to increase antigenicity

— Does not protect against the bacteria itself

— Efficacy:  >87%

— Dose: 0.5 ml – i.m.

— TD (for children when P is contraindicated) contains 10-20 Lf, causes severe reactions in adults

— Td (1-2 Lf) used for adults. 

Pertussis

— Whole cell vaccine or part of cell wall (aP)

— Efficacy:  ≈80%. Immunity wanes with time

— Dose: 0.5ml – i.m.

— Contraindications:

                       *Encephalopathy within 1/52 of a previous dose

                        *Anaphylactic reaction to the vaccine

— Side effects:

           *Fever > 40° C

           *Collapse / Shock

           *Seizures

           * Inconsolable crying

           * G-B Syndrome

           *Acute encephalopathy

           *Permanent neurological sequelae

Haemophilius Influenza type B

— Conjugated and combined with other vaccines

— Effective and very safe

— Dose: 0.5ml – i.m.

— Adults: one dose only

—

Tetanus Immunoglobulin (TIG)

• Prophylactic (250 IU – i.m.)

• Therapeutic (1000 – 10000 IU – i.m.)

• Protects for 30 days

Tetanus Toxoid (TT)

• Formaldehyde- inactivated tetanus toxin

• Stable (up to 37° C)

• Efficacy:  >95%

• Given even after clinical disease

• Very rarely: Anaphylaxis, G-B Syndrome & brachial neuritis

Tetanus Antitoxin (ATS)

• Protection for 7 -15 days

• Horse serum (do sensitivity test)

• Prophylactic : 

         1500 – 3000 IU – i.m.)

• Therapeutic: 

         40000 -60000 IU (half i.m. +half i.v.)

       

• Neonates:

       -10000 IU – s.c. around umbilicus

       -10000 IU – i.m.

       -10000 IU – i.v.       

Rota vaccine

• Rotarix: Monovalnt (RV1) attenuated 

• Rotarig: Pentavalent (RV5) v produced by reassorment)

• Oral:1.5 ml

• Given: 1st. Dose NOT later than age 100 days.

• 2nd. Dose NOT later than 8/12

• A 3RD. Dose of ROTARIG may be given at age 6/12 (NOT Rotarix)

• VAE: Intussusceptions (1/100000), allergy, Diarrhea& Vomiting 

• Contamination with Circovirus particles: Not harmlful

Pneumococcal

• Capsular antigen

• Available: 7,10,13,23 serotypes (>80 serotypes of pneumococci)

• Limited activity at age <2 yrs.

Pneumococcal Vaccine: PCV 23  

— Pneumococcal polysaccharide

— Polyvalent :23 serotypes

— Age: >2 yrs

— 3 doses

Pneumococcal Vaccine: Synflorix

— Polysaccharide 10 valent

— Contains small amounts of Hib, Tetanus toxoid and Diphtheria carrier proteins

— Age: <2 yrs

— Dose: 0.5 ml – i.m.

— 3 doses

Pneumococcal Vaccine: Prevenar 13

— Contains 13 serotypes

— Doses:

               -Age 7 – 11 months: 3 doses one month apart

               -Age 12 -24 months: 2 doses two months apart

               -Age > 2yrs – 5 yrs: One dose

                -Age > 50 yrs: One dose

Pneumococcal

• Dose 0.5ml i.m or s.c.

• Recommended for high risk patients: HSS, splenectomy, CRF, immuno-suppressed, HIV, CSF leak

Hepatitis B

• Inactive unit of the virus (not infectious)

• Efficacy: 80 -95%

• Given to infants born to HBsAg +ve mothers with HBIG (different sites)

• Exposed children: Check anti-HBs (level of antibodies to HBsAg), 

      * -ve: revaccinate

       *+ve: ( >10 mIU/ml), no need 

     

Hepatitis A

• Attenuated 

• Mostly during epidemics or for contacts, liver transplant and 

–ve. adolescents

• Dose: 0.5ml -720 (1 ml for adults - 1440)

• Children > 1 yr: two doses, 6/12 apart

• ??One booster after age 5yrs

Measles vac

• Live attenuated

• Efficacy: 85 -90%

• 0.5ml s.c.

• May cause fever, rash, convulsions and encephalitis

• Can be given 72 hr. post-exposure to measles 

• Can not be given to patients with allergy to neomycin, immuno-deficients and pregnant ladies, 

MMR (Measles, Mumps, Rubella)

• Live attenuated in lyopholized powder + diluent

• S.c./i.m.

• 1st.dose: 1 yr -  15/12

• 2nd.dose: 4 – 5 yrs

• Not given during pregnancy (Rubella)

• No pregnancy 2/12 after vaccination

• Leads to –ve Mantoux test: 

                             -Do the Mantoux test before the vaccine

                             -OR: do them simultaneously 

                             -OR do Mantoux test 6/52 after MMR

Combination Vaccines

   Why?

              -High immunogenicity

              -Less pricks

              -Less visits

              -Less cost

              -Increased compliance

  Examples:

               -DPT, Td, Pentavalent

               -Infanrix hexa (Pentavalent + IPV)

               -Priorix tetra (MMR + Varicella)

Immunization Schedule

— Varies: Why?

                         -Disease risk

                         -Age-specific immune response

                         -Vaccine availability

                         -Maternal vaccination

— High level of protection: Single dose vaccines e.g. Rubella

— Mostly give 85-98% coverage

Vaccination Schedule
EPI – Sudan

Age	Vaccine	Dose	Route
Birth	BCG+OPV	0.05ml – 2drops	Intradermal - Oral
6/52	Pentavalent + OPV+  PCV+ Rota + IPV	0.5ml+2drops + +1.5ml	i.m + Oral + Oral +im
10/52	Pentavalent + OPV +PCV+PCV	0.5ml+2drops	i.m + Oral
14/52	Pentavalent +OPV + PCV +Rota + IPV	0.5ml+2drops +   1.5ml	i.m + Oral + Oral
9/12	Measles +Meningitis + Yellow Fever	0.5ml	Subcutaneous + im+ im

Tetanus Vaccine for  pregnant ladies

Late Arrivals (≥ 7yrs.old)

Meningococcal

— Commonest serotypes of meningococci are A (epidemics), B (endemic, poor antigenicity), C, W-135 & Y.

— Short duration immunity (not for routine immunization)

— Important for children with splenectomy or hypo-complementaemia

— A: for age >3/12 (During epidemics -2doses )

— C: for age >2 yrs

— Not given before age 2yrs

— Efficacy: Wanes with time. Repeat every 5 yrs

— Dose: 0.5ml – s.c.

— Does not protect against B

Meningococcal Quadrivalent vaccine (A,C,W-135 & Y)

(Peter M  Dull–( Reuter, Health Information) – Jan. 2014

— Multinational study

— In USA, Infants <7/12 are more vulnerable to meningococcal infections than 14 – 24 yrs old

— Results support the expanded indication for infants as young as 2/12 of age

— Vaccine is well tolerated and highly immunogenic when given with the routine childhood vaccines

— Rate of Serious Adverse Events remained the same

Varicella

— Lyophilized powder of live attenuated virus (Oka stain)

— Age >1 yr

— Dose: 0.5ml – s.c. ( For adolescents:2 doses one month apart)

— Efficacy: 90 – 97%

— NO use of Salicylates for 6/52 following vaccination (Reye’s Syndrome)

— Contra-indicted during pregnancy

— Mild rash after vaccination

— For immuno-compromized patients:

                         -No vaccine for patients on Radiotherapy

                         -Stop chemotherapy One week before and One week after vaccination

                         -Others (HIV, malignancy, auto-immune diseases, CRF, collagen diseases, after transplant, steroid therapy..), Lymphocyte count should be above 1200/mm³

                          -Very rarely:  causes Herpes zoster and cerebellar ataxia

Typhoid

— Vi- antigen

— Dose: 0.5ml – i.m.

— Efficacy:<66%

— Start at age 2 yrs, then every 2 yrs

Cholera

— Efficacy of the injectable vaccine: Only 50%

— Dose: 0.2ml -0.5 ml – i.m.

— Boosters every 6/12

— Oral vaccine are more powerful:

                    1-Whole-cell-B subunit (also protects against Entero-toxigenic E.coli)

                    2-Live attenuated vibrio

Rabies

— Human Diploid Cell Vaccine (HDCV):

                  *Pre-exposure:

                          -Dose: 1 ml –s.c. or i.m.

                          -2 doses, one month apart, then a 3rd. Dose after 1 yr., then after 3- 4 yrs

                 *Post-exposure:

                         -Dose: 1 ml at days 0, 3, 7, 14 & 28

— Passive Immunization:

                  1- Human Rabies Immunoglobulin

                                     *Dose: 20 IU/kg – half i.m. and half around the wound

                  2- Rabies Anti-serum

                                      *Dose: 40 IU/kg – half i.m. and half around the wound

Vaccine Adverse Events

— Anaphylaxis (serum)

— Paralytic polio (OPV)

— Encephalomyelitis (Measles)

— Seizure (Pertussis)

— Inconsolable crying (DPT)

— Hypotension (DPT)

— Local reactions (Aluminum conjugate)

— Lymphadenitis (BCG)

Proposed Comprehensive Schedule

Other available vaccines

— Adenovirus

— Anthrax

— Influenza

— Japanese Encephalitis

— Lyme disease

— Pigbel (against Clostridium perfringens)

— Plague

— HPV (Human Papilloma Virus  causes cervical, penile and anal cancer ).

               - Given at age 9-18yrs for both sexes

               - Simultaneously with other childhood vaccines (TdaP, OPV, meningitis…..) 

— Covid 19 :  will be addressed separately

Vaccines under development

— Dengue

— E.coli

— Hepatitis C

— HIV

— Malaria

— Meningococcal B

— Para-influenza virus

— Respiratory Syncitial Virus

— Shigella

— Schistosomiasis

— Dengue

— E.coli

— Hepatitis C

— HIV

— Malaria

— Meningococcal B

— Para-influenza virus

— Respiratory Syncitial Virus

— Shigella

— Schistosomiasis