VACCINE-PREVENTION

VACCINES USED UNDER THENATIONAL IMMUNIZATION PROGRAMME

• VACCINE = antigenic product obtained from a specific pathogenic agent or one very close related to it, which can induce, in a receptive person, an immune response that protect against the pathogenic agent.

• RECEPTIVES = people who interact with a source of pathogenic agent and did not have an effective specific or non-specific resistance.

• ANATOXIN (TOXOID) = bacterial exotoxin partially detoxified, but which keeps it immunogenicity

OBSERVATIONS

• 5 classes of Ig: IgM, IgG, IgA, IgD, IgE

• Normal serum (non-immune serum) – Ig without Ab activity

• Maternal Ig – cross the placenta (IIIrd trim.) → at birth, in n.b. circulation – especially maternal IgG – ensure the n.b. protection in the first 6-9 months, if the mother has a protective level of Ab and just against the Ag with which the mother interacts

OBSERVATIONS

• foetus – very low level of IgM (10th week) and IgG (12th week of intrauterine life)

• after birth – level of IgM grows quickly, IgG production - start since 4th week of extrauterine life

• cellular immunity = able from birth → BCG

IMMUNE RESPONSE• Primary immune response (PIR):

- after the first contact with an Ag- latency period = 10-15 days- IgM

• Secondary immune response (SIR):- after the secondary contact, repeated with the same Ag- initiate by the very low doses- IgG

• PIR/SIR – appear after natural or artificial active immunization

IMMUNE RESPONSE• humoral:

- Ab → Ly B- primary vaccination → immune response → level of Ab decreases in short time under the protecting limit- secondary vaccination → repeated administration of Ag at an appropriate intervals → increases the level of Ab, extends the synthesis duration = keeping the immunologic memory

• cellular:- Ly T- a single administration / at long distances in time → immunologic memory for the entire life (theoretically)

VACCINE-PREVENTION

= the operation of giving the necessary doses of

Ag to the persons or groups receptive to a

pathogenic agent, in order to give them

protection

VACCINE-PREVENTION

Objective: specific protection → knowing the factors conditioning the immune response :

- age- immune deficiencies- genetic factors- vaccination scheme- vaccination indications- vaccination contraindications- the necessary technical conditions

MINIMAL OPTIMAL AGE FOR VACCINATION

1. Stages of immune system maturation:

a. Cellular immunity – efficient from birth → BCG

b. Local intestinal immunity (IgA) – efficient till 6-8 weeks of life → substituted after that by VPOT

c. Humoral immunity (circulating Ab) – efficient before the age of 2-3 months → DTP

MINIMAL OPTIMAL AGE FOR VACCINATION

2. Protection - inherited from mother (protective level of Ab) – efficient till 6-9 months → measles vaccine (live attenuated vaccine) = after 9 months

3. Epidemiological context – according to the incidence and severity of transmissible diseases in the area, available vaccines, economic resources

• IMMUNE DEFICIENCIES → reduces the IR

• GENETIC FACTORS :- strong IR, good quality

- IR with unprotected levels - IR humoral – weak; cellular - strong

• SCHEDULE VACCINE :- specify the population groups

- methods and routes of administration - number and size of doses

- the interval between doses and the interval between different vaccines

INDICATIONS1. Vaccines administrated under the National

Immunization Program - according to age group: BCG, IPV, DTPa, MMR, HepB, Hib, pneumococcal vaccine (PCV)

2. Vaccines administrated in special epidemiological situations – for risk groups: HepA vaccine, influenza vaccine, rabies vaccine, leptospirosis, HPV vaccine, meningococcal vaccine; chickenpox vaccine (varicella); rotavirus vaccine; yellow fever vaccine

Whooping cough —pertussis —

is a highly contagious

respiratory tract infection.

Although it initially resembles

an ordinary cold, whooping

cough may eventually turn

more serious, particularly in

infants. The best way to

prevent it is through

vaccinations. The childhood

vaccine is called DTaP. The

whooping cough booster

vaccine for adolescents and

adults is called Tdap. Both DTaP

and Tdap protect against

whooping cough, tetanus, and

diphtheria.

Polio is an infectious disease caused by a virus that lives in the throat and

intestinal tract. It is most often spread through person-to-person

contact with the stool of an infected person and may also be spread

through oral/nasal secretions. Polio used to be very common in the

United States and caused severe illness in thousands of people each

year before polio vaccine was introduced in 1955. Most people

infected with the polio virus have no symptoms; however, for the less than 1% who develop paralysis it

may result in permanent disability and even death.

INDICATIONS 3. Vaccines administered in relation with certain diseases

- anatomic / functional asplenia: pneumococcal vaccine, influenza vaccine, Hib vaccine, meningococcal vaccine

- hemodialysis, recipients of transplants: Hib vaccine, influenza vaccine, pneumococcal vaccine

- chronic alcoholism

GENERAL CONTRAINDICATIONS

• TEMPORARY– must be recovered- fever due to mild infection- incubation period of some infectious diseases- infectious disease in progress and in convalescence- recent administration of standard Ig → after 4-6 weeks- immunosuppressive therapy with corticosteroids → high

doses, extended scheme

- pregnancy

- diabetes mellitus - active TB

- prematurity - IIIrd degree dystrophy

GENERAL CONTRAINDICATIONS

• DEFINITIVE:- progressive neurological disorders

- organic diseases - decompensated

- immunodeficiency status (including HIV positive persons)

- major allergy to egg proteins

- skin diseases

SIDE EFFECTS /ADVERSE EVENTS

• Side Effects After Vaccination (SEAV)

= medical incidents occurring after vaccination, which are considered to be due to its

- SEAV produced by vaccines with live attenuated agents → of infectious nature and with late onset

- SEAV produced by vaccines with killed / inactivated agents → immediate / early onset and are based on hypersensitivity mechanisms

SIDE EFFECTS /ADVERSE EVENTS

1. Local side effects after vaccination :

• Early (the first 3 days) ~ localised pain, redness, swelling at injection site (vaccines with killed / inactivated agents).

• Late (3-12 weeks) ~ suppurated lesions (TB vaccine)

2. Febrile episodes :• Early (the first 1-3 days) → anatoxin, pertussis vaccine,

influenza vaccine, Hep B vaccine.

• Late (5-15 days) → vaccines with live attenuated virus (measles vaccine, yellow fever vaccine).

SIDE EFFECTS /ADVERSE EVENTS

3. Seizures (hyperthermic to young children) → pertussis vaccine, measles vaccine.

4. Exanthema

• Allergic (early) - vaccines with inactivated agents • Infectious (late) – measles vaccine

5. Arthralgia (adults) - rubella vaccine, Hep B vaccine .

SIDE EFFECTS /ADVERSE EVENTS

Severe side effects:

• shock, persistent seizures, encephalopathy ~ after pertussis vaccine ;

• ~ paralysis after poliomyelitis vaccine – live attenuated virus (returning to initial neuro virulence);

• generalized tuberculosis ~ after TB vaccine administered to a person with congenital immunodeficiency, undetectable at birth.

VACCINES USED UNDER THE NATIONAL IMMUNIZATION PROGRAM

- Morbidity structure - Morbidity trendfor transmissible diseases

ROMANIAN NATIONAL IMMUNIZATION PROGRAM - Vaccination against- tuberculosis (BCG) - Vaccination against- poliomyelitis (IPV) - Vaccination against- viral hepatitis B (HepB) - Vaccination against- diphtheria-tetanus-pertussis (DTPa, dT) - Vaccination against- measles-mumps-rubella(MMR)

- Vaccination against- Hemophilus influenzae b infection (Hib)

- Pneumococcal conjugate vaccine (PCV)

Schedule in use (2014-2015)The

recommended ageVaccines Observations

First 24 hours

2-7 days 2 months

4 months

6 months

12 months

14 months

4 years

6 years

7 years (in Ist grade)

6 and 8 years

14 years

Hep B

BCG

DTPa-IPV-Hib-Hep B, PCVDTPa-IPV-Hib, PCV

DTPa-IPV-Hib-Hep B

DTPa-IPV-Hib, MMR

PCV, Hep B

DTPa (until the end of the existing doses)

DTPa-IPV (since 2015)

MMR

IPV (until 2014)

dT

dT

In Maternity

In Maternity

Family doctor

Family doctor

Family doctor

Family doctor

Family doctor

Family doctor

Family doctorSchool campaigns

School campaigns

School campaigns

Tuberculosis Vaccination (BCG)

INDICATIONS

- 4-7 days from birth (Wbirth > 2500 g)

- until 3 months (babies not vaccinated in the maternity hospital)

- at 6 months – reading of postvaccinal scar (those without a scar or with a scar Ø < 3 mm – are receiving a vaccine dose without a previous tuberculin test)

ADMINISTRATION TECHNIQUE

- lyophilized product- powder non-adhering to the walls of the ampoule – 1 vial = 20 mg bacterial mass

- open the ampoule after protection with a sheet of cellophane that comes with the vaccine

- for reconstitution : Sauton medium (2ml sol/ampoule)

- Injection site: deltoid muscle of the left arm

- dose: 0,1 ml vaccine- route of administration: strictly intradermal

- correct vaccination: papule with Ø = 5-6 mm which disappears in 30 minutes

CONTRAINDICATIONS- persons with positive tuberculin skin test

- HIV infection

- underweight newborns (Wbirth< 2500 g)

- malignancies

- treatment with corticosteroids

- acute dermatological diseases

- pregnancy

- convalescents after infectious diseases

ADVERSE EVENTS

- persistent ulcerations (over 3 months)

- abscess at the inoculation site

- locoregional lymph nodes

- inflammatory nodules

- osteitis, osteomyelitis

- disseminated BCG infection – Mycobacterium bovis strain

Poliomyelitis vaccination

INDICATIONS

- first-vaccination (primary immunisation): at the age of 2, 4, 6 months (IPV)

- Ist revaccination: at 12 months (6 months from first-vaccination) (IPV)

- IInd revaccination: at 6 years (IPV)

- IIIrd revaccination: at 9 years (IPV)

ADMINISTRATION TECHNIQUE

- IPV (injectable poliomyelitis vaccine) prepared from inactivated agent

- i.m. administration

- dose: 0,5 ml

ADMINISTRATION TECHNIQUE

For small babies

Infants < 12 months of age

ADMINISTRATION TECHNIQUE

Children > 3 years: deltoid muscle

CONTRAINDICATIONS

- infectious diseases during the acute period and in convalescence

- contact with sick persons (rubella, measles, chicken pox, mumps)

- immunosuppressive treatments

- Ig administration less than six weeks before

- administration of other vaccines with less than 30 days before - convalescents after infectious diseases

- allergic reaction to neomycin, streptomycin or polymyxin B

ADVERSE EVENTS

• local: pain, redness, swelling

• medium fever

Hepatitis B vaccination

INDICATIONS

- Ist Dose : in the first 24h from birth (maximum 7 days)

- IInd Dose: at 2 months

- IIIrd Dose: at 6 months

INDICATIONS

• active medical staff

• familial / sexual contacts

• intravenous drug users

• hemodialysis, haemophilia, recipients of blood and derivatives, candidates for organ transplants

• population in areas where VHB is hyperendemic • institutionalized persons

PARTICULAR CASES1. Newborns from mothers with positive HBsAg:

- specific Ig against-HBV (HBIg) +

- concurrent vaccination (in other anatomic site) in the first 12h after birth - with one of the schemes : 0, 1, 2 months or 0, 1, 6 months

2. Accidental exposure:- before exposure: vaccination (scheme 0,1,6 months) ± IVth dose after 1 year and Vth dose after 5 years (for high risk sectors)- post exposure - dermal exposure or percutaneous :

- person with complete vaccination scheme → check the level of Ab → protective level (> 10mUI/ml) → not require additional doses

- unvaccinated person or with an incomplete vaccination scheme → HBIg + vaccination (Ist dose) → level of

Ab – the vaccination is stopped or we continue with the quick scheme

ADMINISTRATION TECHNIQUE

• Slightly opaque white suspension • Administration: deep i.m.

- before 3 years age (infant and toddler): at the thigh level, at the union of upper 1/3 with the inferior 2/3 - in older children and adults : deltoid muscle

• Dose: - infant and toddler = 0,5 ml suspension /10 µg HBsAg - older children and adults = 1 ml suspension /20 µg HBsAg - immunosuppressed adults = 2 ml suspension /40 µg HBsAg

CONTRAINDICATIONS

- Subjects with high sensibility to one of the vaccine components (yeast or others)

- Subjects with sensibility at previous administration

ADVERSE REACTIONS

1. Most frequently – local:

- pain

- rash

- induration

2. Rarely – transitory:

- subfebrility, fatigue, headache, vertigo, malaise

- abdominal pain, nausea, vomiting

- pruritus, urticaria

- arthralgia

Vaccination against – diphtheria-tetanus-pertussis

(DTPa, dT)

Infanrix hexa = DTPa-hepB-IPV-Hib - GlaxoSmithKline

Infanrix -IPV= DTPa-IPV – GlaxoSmithKline

Infanrix Penta = DTPa-hepB-IPV – GlaxoSmithKline

Adacel – Sanofi Pasteur = dTpa

Adacel Polio – Sanofi Pasteur = dTpa-IPV

INDICATIONS

- The first vaccination: 3 doses at age 2, 4, 6 months – with DTPa product (tetra-vaccine DTPa-IPV or penta-vaccine DTPa-IPV-Hib)

- Ist Revaccination : 12 months (at 6 months from the first vaccination) with DTPa-IPV or DTPa-IPV-Hib

- IInd Revaccination : 4 years with DTPa

- IIIrd Revaccination : 6 years with DTPa-IPV

- IVrd Revaccination : 14 years with dT

- Vth Revaccination : 24 years with dT

- After 24 years age: revaccination at every 10 years with dT

ADMINISTRATION TECHNIQUE

• Milky white liquid

• Administration - deep intramuscular injection:

- infants and young children: at the union of superior 1/3 with the inferior 2/3, 2-3 cm lateral to the midline

- children after 3 years of age and adults: the deltoid muscle

• Dose: 0.5 ml

CONTRAINDICATIONS- Temporary:

- recent Ig administration- incubation period of infectious diseases - immunosuppressive treatments

- Definitive:- kidney diseases, decompensated cardiovascular diseases- autoimmune diseases, hematological diseases - cancers

- Related to pertussis: - fever (> 40,5˚C), persistent crying (> 3 hours), seizure

syndrome (within 3 days after vaccination) occurred after a previous vaccination

- onset of encephalopathy within 7 days after a previous dose of DTP

SIDE EFFECTS /ADVERSE EVENTS

1. Local:

- pain

- swelling

- induration at the injection site

2. General: febrile reaction for 1-2 days

3. Neurological:

- Guillain-Barré syndrome, brachial neuritis (correlated with – ATPA)

- encephalopathy, episodes of hypotonia-areflexia , persistent crying (correlated with pertussis component)

Measles – mumps - rubella(MMR) vaccination

INDICATIONS

- First dose: at 12 months

- Revaccination: 7 years

ADMINISTRATION TECHNIQUE

• Trivaccine MMR

• White lyophilised powder/red pill with a vial of solvent

• Use as soon as possible after opening – it is extremely sensitive

• i.m. / s.c. administration - deltoid region

• Dose: 0.5 ml

CONTRAINDICATIONS

- Acute febrile illness

- Allergic reactions to egg proteins

- Recent administration of standard Ig

- Immunosuppression

- Allergies to kanamycin / neomycin

- Pregnancy

- Individuals with HIV infection - are not contraindicated (before monthly dose of Ig)

SIDE EFFECTS/ADVERSE EVENTS

Minor:

- low-grade fever

- coryza

- nasopharyngitis

Causes of measles among vaccinated people

• thermal lability of the vaccine

• immunological inertia (5%)

• the reduction of post-vaccination level of Ab

• population or medical negligence • blocking of the immunogenicity (Ab from mother/ Ig /

IFN production in viral infections

• groups which are not included in the vaccination programme

• religious motivations

• population migration

Haemophilus influenzae b vaccine (Hib)

INDICATIONS(Infanrinx hexa)

- Primary immunisation: 3 dosesat 2, 4 and 6 months

- Revaccination: 12 months of age

• Children >2 years of age who have received all doses of Hib vaccine do not require a booster dose after splenectomy

• A single dose of Hib vaccine is recommended for other splenectomised individuals who were not vaccinated in infancy or are incompletely vaccinated.

ADMINISTRATION TECHNIQUE

• the vaccine consists of both a pre-filled syringe containing diphtheria toxoid, tetanus toxoid; pertussis toxoid (PT); AgHBs; polioviruses type 1, 2 and 3; traces of formaldehyde, polymyxin and neomycin AND a vial containing a lyophilised pellet of Hib

• i.m.

• Dose: 0.5 ml

CONTRAINDICATIONS

• anaphylaxis following a previous dose of any of the vaccines, or

• •anaphylaxis following any component of the vaccine.

SIDE EFFECTS/ADVERSE EVENTS

• Swelling and redness at the injection site after the first dose

• Fever

• These adverse events usually appear within 3 to 4 hours and resolve completely within 24 hours

• The incidence of these adverse events declines with subsequent doses

Pneumococcal conjugate vaccinePneumococcal conjugate vaccine

• people over 60 years with or without chronic lung disease, chronic renal disease, chronic heart disease, low physical activity and poor nutritional status

• institutionalized persons → health care facilities, hospitals, prisons

• people suffering from chronic diseases regardless of age (alcoholism, cirrhosis, etc.)

• anatomical / functional asplenia - pneumococcal infection has a rapid development and a high mortality (75%)

• immunosuppression of various causes (including HIV-positive)

INDICATIONS

• children under the age of 2 years

• strong postvaccination reaction to a previous administration

• previous vaccination less than 5 years

• pregnancy

CONTRAINDICATIONS

• hypersensitivity

• pain, tiredness, induration, mild fever

• rare: asthenia

SIDE EFFECTS (ADVERSE EVENTS)

VACCINE-PREVENTION

- is mandatory

- is free of charge

- reporting is necessary for the evaluation of transmissible diseases at national and international level – reporting to the WHO