Please note that all guidance is currently under review and some may be out of date. We recommend that you also refer to more contemporaneous evidence in the interim.
Preterm infants should be immunised according to the recommended schedule, without correction for prematurity, provided that they are well and that there are no contraindications.1,2 Recent changes have seen the timing of the first dose of scheduled vaccines to occur at 6 weeks of life (Day 42).
Rotavirus immunisation must be given within a strict timeframe, with the 1st dose before 15 weeks of age and the 2nd dose before turning 25 weeks of age. The interval between dosing should be at least 4 weeks. Preterm infants are recommended to receive rotavirus immunisation starting at the chronological age of 6 weeks.3
Additional immunisations recommended in preterm infants:
<28 weeks gestation
- An extra Pneumococcal conjugate immunisation (Prevanar 13) should be given at 6months of age (total of 4 doses)
- Pneumococcal polysaccharide immunisation (Pneumovax 23) should be given at 4 years of age
<32 weeks gestation and/or <2000g birth weight
- Hepatitis B immunisation should be given at 12 months
In Victoria all preterm infants are recommended to receive influenza immunisation every year, starting at ≥6 months of age. Two vaccine doses, at least 4 weeks apart, are required in the first year that influenza immunisation is received.
Preterm infants have a special need for protection against infectious agents such as pertussis.4
- Immunisation commenced before discharge ensures the development of some degree of protection from infectious agents prevalent within the community.
- Preterm infants generally do not have a higher incidence of adverse reactions following immunisation and despite their immunological immaturity they respond satisfactorily to vaccines.
- Preterm infants with a history of apnoea of prematurity do have a slightly increased risk of apnoea following their 6 week immunisation.
- Babies whose mothers are hepatitis B surface antigen positive (HbsAg +ve,) should receive hepatitis B immunisation on the day of birth. They should also be given hepatitis B immunoglobulin (HBIG 100 units, 0.5 mL intramuscularly) within 12 hours of birth.
Adverse events following immunisation
Surveillance for adverse events following immunisation is an integral part of the national immunisation program. An adverse event is a serious, uncommon or unexpected event following immunisation. Such an event may be caused by the vaccine or may occur by chance after immunisation.
Any event that is considered serious or unexpected and possibly related to the immunisation should be reported to the Melbourne Vaccine Education Centre (SAEFVIC) on phone 1300 882 924 (option 1) or online at www.aefican.org.au
Common minor adverse events
The following adverse events are common but not serious although they can be distressing for parents. These adverse events do not contraindicate further immunisation and do not need to be reported. Transient minor events include:
- soreness, redness or pain at the injection site (5-15 per cent)
- fever (approx. 30 per cent - usually low grade)5
- sleepier or more irritable than usual.6
Cardiorespiratory monitoring after immunisation
There is an increased incidence of cardiorespiratory instability following immunisation of preterm infants.
Immunisation has been associated with an increased risk of apnoea in preterm infants immunised in hospital, and appears to be influenced by the severity of underlying neonatal conditions,7 previous sepsis8 and/or with an existing history of apnoea.9 In addition, extremely preterm infants immunised in hospital may require increased respiratory support (oxygen or non-invasive respiratory support) after their first immunisation.
It is recommended that the cardiorespiratory function of hospitalised preterm infants is monitored for 24-48 hours post immunisation.
If there is a history of apnoea following immunisation, consideration must be given to administering future immunisations under medical supervision including after discharge from hospital.
Observation after immunisation
Recipients of vaccines should remain under observation for a minimum of 15 minutes. Most life-threatening adverse events will begin within 15 minutes of immunisation.
The most serious immediate reaction to immunisation is anaphylaxis.
Anaphylaxis following immunisation
Anaphylaxis following immunisation is very rare.
Anaphylaxis is a life-threatening adverse event of rapid onset, characterised by skin features plus respiratory and/or circulatory and/or severe gastrointestinal symptoms.10
Signs of anaphylaxis include:
- circulatory collapse
- pallor, loss of consciousness, weak pulse
- rapid development of urticarial lesions (elevated red lumps with raised edges and pale centres)
- signs of upper airway obstruction
- stridor, weak cry
- wheeze or persistent cough.
Management of anaphylaxis
- Call for help.
- Administer oxygen.
- Commence positive pressure ventilation if the respirations are slow or stop.
- Administer intramuscular adrenaline and repeat every 5 minutes if the infant is not improving.
- Commence cardiopulmonary resuscitation (CPR) if the heart rate is < 60 beats per minute.
|Dose||0.05 to 0.1 ml (0.01 ml/kg)|
|Route of administration||IM|
|Frequency||Every five minutes until cardiac output is established|
Use of adrenaline
The use of 1:1,000 adrenaline is recommended because it is universally available. Adrenaline 1:1,000 (one in one thousand) contains 1 mg of adrenaline per mL of solution in a 1 mL glass vial. Adrenaline 1 in 10,000 is no longer recommended for the treatment of anaphylaxis.
A 1 mL syringe should be used to improve the accuracy of measurement when drawing up small doses of adrenaline. The recommended dose of 1:1,000 adrenaline is 0.01 mL/kg body weight (equivalent to 0.01 mg/kg) given by deep IM injection preferably in the anterolateral (upper outer) thigh. The anterolateral thigh is the preferred site because there is a more predictable dispersal of adrenaline from this site. Administration of adrenaline in the anterolateral thigh is also in accordance with recommendations from various emergency medicine, anaesthetic and immunology professional bodies.
Note: Adrenaline 1: 1,000 must not be given intravenously.
Storage of vaccines
The 'cold-chain' is the system of transporting and storing vaccines within the safe temperature range (2-8°C) from the place of manufacture until administration.
Maintenance of the cold chain is essential to maintaining the effectiveness of the vaccines.
Cold chain breach is the exposure of vaccines to temperatures outside the recommended range of 2°C to 8°C, excluding fluctuations up to 12°C lasting less than 15 minutes when restocking, cleaning the fridge or stock taking.
In most cases, cold chain breaches must be reported to the Immunisation Section at the department as soon as possible using the Cold Chain Breach Report form. This form is also used to report light exposure breaches for light-sensitive vaccines.
Areas of uncertainty in clinical practice
Rotavirus immunisation for preterm infants with Chronic Lung Disease receiving postnatal corticosteroids.
- According to the DART regime,12 a 10 day tapering regimen with a total dose of 890micrograms/kg, there is no contraindication for live vaccines as the steroid dose does not reach a level of concern for immunocompromise. Immunisations, including rotavirus, can be administered at any time.
- According to the Cumming’s regime,13 a 42 day tapering regimen commencing at 500micrograms/kg of dexamethasone, timing of immunisation for rotavirus needs to be considered. It is safe to consider rotavirus immunisation once on <1mg/kg/day prednisolone equivalent dosing of steroid, and >2 weeks since being on >2mg/kg/day prednisolone equivalent dosing (or from day 25 of 42 day protocol onward, on dose of 70 micrograms/kg dexamethasone BD).
- For further advice about the safe use of vaccines for preterm babies contact the Victorian vaccine safety service (SAEFVIC) on telephone 1300 882 924 (option 1).
- Omeñaca F, Vázquez L, Garcia-Corbeira P, Mesaros N, Hanssens L, Dolhain J, Gómez IP, Liese J, Knuf M. Immunization of preterm infants with GSK’s hexavalent combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine: A review of safety and immunogenicity. Vaccine. 2018 Feb 8;36(7):986-96. DOI:10.1016/j.vaccine.2018.01.005
- Faldella G, Alessandroni R, Magini GM, Perrone A, Sabatini MR, Vancini A, Salvioli GP. The preterm infant's antibody response to a combined diphtheria, tetanus, acellular pertussis and hepatitis B vaccine. Vaccine. 1998 Oct 1;16(17):1646-9. DOI:10.1016/S0264-410X(98)00060-7
- Australian Technical Advisory Group on Immunisation (ATAGI). Australian Immunisation Handbook, Australian Government Department of Health, Canberra, 2018, immunisationhandbook.health.gov.au.
- Gagneur A, Pinquier D, Quach C. Immunization of preterm infants. Human vaccines & immunotherapeutics. 2015 Nov 2;11(11):2556-63.DOI:10.1080/21645515.2015.1074358
- Ellison VJ, Davis PG, Doyle LW. Adverse reactions to immunization with newer vaccines in the very preterm infant. Journal of paediatrics and child health. 2005 Aug;41(8):441-3. DOI:10.1111/j.1440-1754.2005.00663.x
- Martinón-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omeñaca F, Iturbe EB, Gamero DB, Concheiro-Guisán A, Gimenez-Sanchez F, Szenborn L. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr 1;135(4):e876-86. DOI:10.1542/peds.2014-2941
- Cooper PA, Madhi SA, Huebner RE, Mbelle N, Karim SS, Kleinschmidt I, Forrest BD, Klugman KP. Apnea and its possible relationship to immunization in ex-premature infants. Vaccine. 2008 Jun 25;26(27-28):3410-3. DOI:10.1016/j.vaccine.2008.04.037
- Hacking DF, Davis PG, Wong E, Wheeler K, McVernon J. Frequency of respiratory deterioration after immunisation in preterm infants. Journal of paediatrics and child health. 2010 Dec;46(12):742-8. DOI:10.1111/j.1440-1754.2010.01832.x
- Klein NP, Massolo ML, Greene J, Dekker CL, Black S, Escobar GJ. Risk factors for developing apnea after immunization in the neonatal intensive care unit. Pediatrics. 2008 Mar 1;121(3):463-9.
- Australasian Society of Clinical Immunology and Allergy (ASCIA). Acute management of anaphylaxis guidelines [Internet]. 2018 [updated 2019 August; cited 2019 August]. Available from: https://www.allergy.org.au/hp/papers/acute-management-of-anaphylaxis-guidelines
- Australian Government Department of Health. National vaccine storage guidelines-strive for 5. 3rd edition. 2019 Available from: https://www.health.gov.au/sites/default/files/national-vaccine-storage-guidelines-strive-for-5_0.pdf
- Doyle LW, Davis PG, Morley CJ, McPhee A, Carlin JB. Low-dose dexamethasone facilitates extubation among chronically ventilator-dependent infants: a multicenter, international, randomized, controlled trial. Pediatrics. 2006 Jan 1;117(1):75-83. DOI: 10.1542/peds.2004-2843
- Cummings JJ, D'Eugenio DB, Gross SJ. A controlled trial of dexamethasone in preterm infants at high risk for bronchopulmonary dysplasia. New England Journal of Medicine. 1989 Jun 8;320(23):1505-10. DOI: 10.1056/NEJM198906083202301
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First published: August 2017
Last web updated: November 2019
Review by: August 2020
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Page last updated: 17 Feb 2021