ROTAVIRUS DISEASE AND VACCINATION

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ROTAVIRUS DISEASE AND VACCINATION

• TRAINING PROGRAM FOR AUTHORISED REGISTERED NURSES
  
• Prepared by Sonya Nicholl
• NSW Department of Health
• June 2007

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Virology and Rotavirus Classification

• Rotaviruses are RNA viruses that have a
  characteristic wheel-like appearance when viewed
  under a microscope.
• There are a number of different strains of
  rotavirus, which are classified by the G and
  P outer protein of the virus.
• Five strains G1 G2 G3 G4 and G9 have accounted
  for around 90 of the serotypes worldwide and
  Australia.

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Epidemiology Rotavirus Disease

• Leading cause of severe acute gastroenteritis in
  infants and young children.
• Almost every child in the world will suffer at
  least one infection by the time they are 3 years
  old.
• Estimated 600,000 children worldwide die each
  year from rotavirus gastroenteritis- Almost 2
  million children are hospitalized each year.
• In Australia, it is estimated that 10,000
  hospitalisations each year in children less than
  5 years of age are due to rotavirus.
• An estimated 115,000 children under 5 years of
  age visit a GP and 22,000 require a visit to an
  Emergency Department.
• On average there is one death due to rotavirus
  each year in Australia.
• In temperate Australia, rotavirus infections peak
  in mid to late winter.

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Clinical Manifestations

• Children can be infected with rotavirus several
  times during their lives.
• Incubation period 24-72 hours.
• Faecal-oral route of transmission.
• Ranges from mild, watery diarrhoea of limited
  duration (usually 3-9 days), to severe,
  dehydrating diarrhoea with vomiting and fever,
  which can result in death if untreated.
• Faecal shedding of virus exclusion from
  childcare etc.
• Confirmation of rotavirus infection can only be
  made by laboratory testing of faecal specimens.

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Rotavirus - Age Distribution

• Virtually all children will be infected by 5
  years of age.
• Mainly in children 3 to 35 months.
• Infected Adults mild disease.

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Rotavirus Immunity

• Can be infected more than once due to strain
  variation.
• Immunity after infection is incomplete.
• Repeat infections less severe than original
  infections.

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ROTAVIRUS VACCINES
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Rotavirus Vaccine History

• The use of the rotavirus vaccine was suspended
  due to an increase in number of children
  developing intussusception.
• Vaccine voluntarily withdrawn from the market in
  1999.
• Investigation calculation that 1 per 10,000
  children vaccinated developed intussusception 3
  x higher than unvaccinated children.

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ROTAVIRUS VACCINES

• Two rotavirus vaccines registered for use in
  Australia
• ROTARIX - GlaxoSmithKline
• RotaTeq - Merck Sharp Dhome (Distributor
  CSL)
• Both are oral vaccines containing live attenuated
  rotavirus strains.
• Both are registered for use in infants only.
• ROTARIX has been approved for inclusion in NSW
  Immunisation Schedule from 1 July 2007 for
  children born on/after 1 May 2007.

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ROTARIX
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Rotarix
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Rotarix - Efficacy

• After 2 doses
•  95.8 protection against severe
  gastro-enteritis.
•  87.1 against any rotavirus gastro-enteritis.
• 100 protection against hospitalisation due to
  rotavirus gastro-enteritis.
•  91.8 protection against gastroenteritis
  requiring medical attention.

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Rotarix - Presentation

• Upon storage of the syringe containing the
  solvent, a white deposit and clear fluid
  (supernatant) is observed.
• The content of the syringe should be inspected
  visually both before and after shaking for any
  foreign particulate matter and/or abnormal
  physical appearance prior to administration.
• The vaccine is for single use only.
• Any unused vaccine or waste material should be
  discarded.
• The reconstituted vaccine should also be
  inspected visually for any foreign particulate
  matter and/or abnormal physical appearance prior
  to administration. In the event of either being
  observed, discard the vaccine.
• This vaccine must not be mixed with other
  medicinal products.

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Rotarix - Reconstitution

• Remove the plastic cover from the vial containing
  the powder. Connect the transfer adapter onto the
  vial by pushing it downwards until the transfer
  adapter is properly and solidly placed.
• With the stopper still attached, shake the
  syringe containing the suspension vigorously. The
  shaken suspension will appear as a cloudy liquid
  with a slow settling white deposit.
• Remove the stopper from the syringe. Connect the
  syringe onto the transfer adapter by pushing it
  firmly on this device.
• Inject the entire contents of the syringe into
  the vial containing the powder.
•  With the syringe still attached, shake the vial
  and examine for complete suspension of the
  powder.
• The reconstituted vaccine will appear more cloudy
  than the diluent alone. This appearance is
  normal.

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Rotarix - Reconstitution

• Withdraw the entire mixture back into the
  syringe. Remove the syringe from the transfer
  adapter.
• This vaccine is for oral administration only. The
  child should be seated in a reclining position.
  Administer the entire content of the syringe
  ORALLY (on the inside of the cheek).
• If the reconstituted vaccine is to be stored
  temporarily before administration,( for example
  large clinic) replace the stopper on the tip of
  the syringe. The syringe containing the
  reconstituted vaccine should be shaken gently
  again before ORAL administration.
• Do not inject.

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Rotarix - Storage

• Rotavirus vaccines must be stored in accordance
  with the general vaccine storage guidelines as
  specified by the NHMRC in the current edition of
  the Australian Immunisation Handbook.
• Rotavirus vaccines should be stored at 2o C to 8o
  C and protected from light.

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Rotarix Upper Age Limit Dosing
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Recommendations Rotavirus Vaccination

• Routine infant vaccination
• All infants by 6 months of age.
• Vaccination of older infants is not recommended.
• Theoretical concerns regarding use in the older
  age groups.
• Rotarix vaccination should occur at 2 and 4
  months of age.
• Catch-up
• Routine catch-up or primary vaccination of older
  children is NOT recommended.
• Commence the course of rotavirus vaccination
  within the recommended age limits for the first
  dose.
• Doses must not be given beyond the upper age
  limits for the final dose of the vaccine course.

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Recommendations

• Infant feeding
• No restrictions on food or liquid, including
  breast milk, either before or after vaccination.
• Efficacy appears similar among breastfed and
  non-breastfed infants.
•  Pre-mature infants
• Pre-term infant vaccination indicated at a
  chronological age of at least 6 weeks if
  clinically stable.
• Premature infants (lt37 weeks gestation) appear to
  be at increased risk of hospitalisation from
  viral gastroenteritis.
• Administration to hospitalised pre-term infants
  carries a low risk for transmission of vaccine
  viruses -use standard infection control
  precautions.

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Contraindications

• Rotavirus vaccine should not be given to any
  infant who has
• hypersensitivity to any of the vaccine
  components.
• had an anaphylactic reaction to a previous dose
  of either vaccine.
• any moderate to severe febrile illness.
•  

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Precautions

• Acute gastroenteritis
• Moderate to severe illness
• Underlying conditions predisposing to severe
  rotavirus gastroenteritis
• Infants with impaired immunity
• Infants living in households with persons with
  impaired immunity
• Recent administration of antibody-containing
  blood products
• Hospitalised infants-use Standard Infection
  Control Precautions
• Exposure of pregnant women to vaccinated infants
• Regurgitation of vaccine dose

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Safety and Side effects

• In clinical trials - Rotarix first dose limited
  to infants under 3 months of age and did not give
  subsequent doses to children past 6 months.
• Infants may have a slightly increased risk (1-3)
  of developing diarrhoea or vomiting in the first
  week post vaccination.
•  

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Conflicts with Product Information

• Rotarix PI advises that rotarix should not be
  administered to infants with any history of
  chronic GI disease.
• NHMRC - pre-existing chronic GI disease is not
  considered a contraindication to rotavirus
  vaccination see Precautions in Rotavirus
  Training Program for Authorised Registered
  Nurses.
• Rotarix PI advises that in the unlikely event
  that an infant spits out or regurgitates most of
  the vaccine dose, a single replacement dose may
  be given at the same vaccination visit.
• NHMRC advise that Re-administration of a dose of
  rotavirus vaccine is not recommended if infants
  have regurgitated or spat out the vaccine after
  administration.

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Interchangeability of Rotavirus Vaccines

• NO Studies to address the interchangeability of
  Rotarix and Rota Teq vaccines.
• Completion of a vaccination course should be with
  a rotavirus vaccine from the same manufacturer
  whenever possible.
• Should a 2nd or 3rd dose be given with a vaccine
  from a different manufacturer
• If a 2nd dose of Rotarix is given following a
  first dose of Rota Teq, give 3rd dose of Rota
  Teq.
• If a 2nd dose of Rota Teq is given following a
  first dose of Rotarix, give 3rd dose Rota Teq

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Special Considerations

• Vaccine rotaviruses can be shed in the stool
  post-vaccination, particularly after the first
  dose.
• Infants living in the same households as
  immunodeficient or impaired immune status
  individuals can be vaccinated.
• Infants living in households with pregnant women
  can be vaccinated.

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Authority to Administer Rotavirus vaccine

• A Special Authority has been granted under NSW
  Poisons and Therapeutic Goods Act 1966 for
  Authorised Registered Nurses who have completed
  the NSW Department of Health Training Program to
  administer Rotavirus vaccine without a doctors
  order.

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ADVERSE EVENTS FOLLOWING IMMUNISATION
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AEFI Use of Adrenaline

• Mainstay of Rx.
• Prompt use can be lifesaving.
• Withholding due to misplaced concerns of possible
  adverse effects can result in deterioration
  death.
• Must be used at first suspicion.
• It is safe effective.

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Administration of Adrenaline

• Dose 11,000 (one in one thousand) 0.01mg/kg
  body weight
• Deep intra muscular injection
• Less than 1 year 0.05mL 0.1mL
• Repeat every 5 mins if no improvement

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Reporting AEFIs

• Adverse Events Following Immunisation (AEFI) are
  to be notified to the Public Health Unit.
• Public Health Units will assess each AEFI and
  enter on to the Notifiable Diseases Database
  (NDD) as appropriate.

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Ordering Rotavirus Vaccine

• Rotarix vaccine order form for June to August
  only.
• After 31 August order Rotarix vaccine as per
  routine childhood vaccine orders. A new vaccine
  order form will be provided as part of an
  Information Kit to providers in August.
• Allow 3 working days for delivery.
• Photocopy the form use for future orders.
• Telephone vaccine distribution company 1300 656
  132 if order has not been received after 3
  working days DO NOT refax order.

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