Immunisation guideline for neonates

*babies with asplenia, splenic dysfunction, complement disorder or who are severely immunocompromised will require additional doses of  Pneumococcal (PCV) - see Green book for full details.

• DTaP/IPV/Hib/HepB (Infanrix hexa ®)
• Pneumococcal conjugate vaccine (Prevenar 13 ®)
• Meningitis B vaccine (Bexsero ®)

Schedule

• Three doses of DTaP/IPV/Hib/Hep B vaccine at 8, 12 and 16 weeks of age
• One dose of Pneumococcal vaccine* at 12 weeks of age
• Two doses of Meningitis B vaccine at 8 weeks and 16 weeks

Preterm babies follow the same protocol with no correction for their prematurity.
Meningitis B vaccine should be administered into the left thigh by preference. Other vaccines given at the same time should be administered into different limbs for optimal immune response (or at least 2.5cm apart if the same limb must be used).

* Only the conjugate vaccine Prevenar 13 ® should be used, as the pneumococcal polysaccharide vaccine (Pneumovax) is not suitable for the under twos.  If the infant remains at high risk for pneumococcal disease beyond 2yrs of age they should receive the 23-valent polysaccharide pneumococcal vaccine (Pneumovax).  Refer to the “Green Book” for at-risk conditions

Contraindications

Contraindications for preterm babies are as for term babies – refer to the “Green book”.

Babies currently or recently treated with high dose systemic steroids or intravenous immunoglobulin (IVIG) may have impaired response to immunisation.   There is no requirement to delay vaccination but consideration should be given to the need for a booster dose once immunity returns to normal.  (Immune responses return to normal by 3 months after the cessation of therapy)

Caution in Very Premature Infants

Very premature infants (born ≤ 28 weeks of gestation) who are in hospital should have respiratory monitoring for 48-72 hrs following their first immunisation, particularly those with a previous history of respiratory immaturity. If the child has apnoea, bradycardia or desaturations after the first immunisation, the second immunisation should also be given in hospital, with respiratory monitoring for 48-72 hrs

Paracetamol for febrile reactions

Fever is a common reaction following vaccination, particularly following vaccination with Bexsero for Meningitis B.  The JCVI recommends the administration of three doses of Paracetamol following vaccination.  One dose should be given at the time of administration, and two further doses at 6 hly intervals (refer to the paracetemol monograph for doses). 

Recent systematic review (Das et al 2014) has concluded that previous concerns regarding the effect of anti-pyretics on the immunogenicity of childhood vaccines are no longer felt to be clinically significant.  In order to avoid confusion, this guideline will recommend prophylactic paracetemol is given with each of the routine vaccinations given to inpatients in the neonatal unit.

Documentation

A record of the vaccinations given along with the batch numbers and the site of each injection should be entered in the infant’s notes.  The same information should be reported to SIRS (Scottish Immunisation Recall System) either by using an ‘unscheduled attendance form’ or other local proforma

Local arrangements for reporting vaccination to SIRS – GG&C
A copy of the inpatient prescription form (Appendix) should be sent by email to public health

Patient information

• "Protect Your Child Against Serious Diseases" Leaflet  (N.B website also has easy to read versions and other language versions):
• Vaccination consent form – See Appendix

Schedule

Two doses of Rotarix ® oral vaccine normally given at the time of the first and second primary vaccinations, at 8 and 12 weeks of age with no correction for prematurity.
If there are any contraindications to rotavirus vaccination at the normal vaccination age the doses may be given at a later date. However, due to a small risk of intussusception when the rotavirus vaccination is administered at later ages the vaccine doses must be given by the following chronological ages.

• The first dose should be given ideally by 12 weeks of age and must not be given if the baby is 15 weeks and 0 days of age or older (more than 14weeks and 6 days)
• The second dose should be given ideally by 16 weeks of age with a minimum interval of 4 weeks and must not be given if the baby is 24 weeks of age or older (more than 23 weeks and 6 days). If the course is interrupted, it should be resumed, but not repeated, in line with the restrictions on timings above.
• The vaccine can be given at the same time as any other vaccination including BCG.

Administration

Rotarix is an oral vaccine and should be administered using the applicator provided.  The full dose (1.5 ml) should be given into the mouth towards the cheek. If the dose is spat out or vomited an additional dose may be used immediately after the failed dose.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in SPC.
• Hypersensitivity after previous administration of rotavirus vaccines.
• Rotarix is a live vaccine and is contraindicated in babies with severe combined immune deficiency (SCID). In other immune deficient states it is advised that the benefits of protection outweigh the risks and the vaccine should be offered (including babies born to HIV positive mothers, before the baby’s HIV status is known and babies who have received multiple courses of steroids).
• Infants with a history of intussusception or who have a malformation of the GI tract which would predispose them to intussusceptions. (See cautions below).
• Infants with the following inherited disorders - fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency.
• Infants who are 24weeks and 0 days or older

Cautions

• Vaccination should be delayed in following circumstances
• infants with a febrile illness or who have vomiting or diarrhoea of any cause
• Patients having undergone recent intestinal surgery should be discussed with the surgical team on an individual case basis
• Infants who have  a confirmed diagnosis of NEC in the preceding 2-3 weeks
• Where a mother has received immunosuppressant biological agents during pregnancy, the infant may receive Rotavirus vaccine following a risk vs benefit discussion.(see also Live Vaccine section above)

NB - Where vaccination is delayed the schedule should be resumed within the timescales outlined above. 

• Infants born at ≤28 weeks gestation should be monitored for apnoea for 48 - 72hours after administration of the first dose.  If apnoea is noted after the first dose then the babies should be monitored similarly after the second dose
• Rotarix is a live vaccine, although highly attenuated.  The vaccine virus is excreted in the faeces for 2-3 weeks after administration.  If transmitted to an immuno-compromised contact the virus could result in minor gastrointestinal symptoms.   Normal hygiene precautions should be used to prevent transmission
• Intussusception has been reported in 2:100,000 cases. 

"Protect Your Child Against Serious Diseases" booklet (N.B website also has easy to read versions and other language versions)

Indications for accelerated Hepatitis B vaccination

• All babies whose mothers have a history of past or present hepatitis B. Some will also require Hepatitis B immunoglobulin
  see next section for indications for Hepatitis B immunoglobulin.
  
  NB babies born to a mother who is negative for hepatitis B but who will subsequently be living with another individual who is positive for Hepatitis B should get a single dose of monovalent Hepatitis B vaccine at birth but should otherwise follow the routine childhood vaccination schedule

Monovalent Preparation - Only Engerix B (0.5ml) or HBVaxPRO (0.5ml) to be used.

Schedule – Two doses of monovalent Hepatitis B vaccine should be given, at birth and at 4 weeks of age. The first dose is to be given as soon as possible after birth (within 24 hrs of delivery at the latest). Subsequent to this, infants born on, or after, the 1^st Aug 2017 should be offered Infanrix Hexa vaccine according to the normal childhood schedule outlined above.  This will involve 3 doses of the Hexavalent vaccination at 8, 12 and 16 weeks of age.

A booster, using the monovalent vaccine, will be given at 1yr of age at the same time as the Hib /MenC booster vaccination.

Preterm babies follow the same schedules with no correction for their prematurity.

For infants born to mothers infected with Hepatitis B, serology is required at 1yr of age, on the day of the booster vaccinations, to determine whether vaccination has successfully prevented infection with Hepatitis B. 

Hepatitis B in the Immunisation schedule for routine childhood and selective neonatal hepatitis B programmes following the introduction of the Infanrix hexa®

Local arrangements for serology – GG&C
This is arranged by the GP, with a reminder to them from public health if the postnatal notification form (see appendix) has been completed and returned.

Reporting - Women who are surface antigen positive on antenatal screening will have been reported to Public Health prior to delivery who will in turn inform the Obstetricians. All immunised infants, low or high risk, must be reported to the Community Screening Department to ensure adequate follow-up. Notification forms (see appendix) should be scanned and emailed to the Community Screening Department, and the original stored in the baby’s notes, as soon as possible after vaccination/immunoglobulin administration.  Please note that where there is uncertainty about a baby’s final discharge address or carer (i.e. when there is consideration of foster care etc) at the time of vaccination then it is better to send the form with the current maternal details in place to Public Health.  Delaying sending the form until such details are complete can cause delays and confusion- the CHI number allows effective tracking of the baby through public health systems.

Antenatal testing process.

Please refer to the obstetric guidelines page for full details.

In summary hepatitis B testing is offered as part of routine booking bloods to all pregnant women.  In the event of a positive result the Regional Virus Laboratory will inform the patient’s obstetrician and a named link obstetrician by letter.  This letter will give recommendations for vaccination +/- immunoglobulin administration depending on the maternal serology (predominantly based on e antigen and antibody status at this point).  The named obstetrician will also record these recommendations on the neonatal alert section of the maternal notes.

At 26 weeks gestation all of those that had tested positive on booking bloods will have further bloods taken by their obstetrician for HBV DNA levels.  Following this the recommendation for neonatal treatment of the baby may change (if the HBV DNA level is ≥200,000 IU/mL (≥ log 5.3) but initial serology was anti-HBe positive).  The named link obstetrician will amend the initial virology letter and the neonatal alert sheet with this information ensuring that up to date and accurate information is available to the neonatal team at delivery.

Notes - In viral infections the presence of virus indicates ongoing infection and the detection of specific antibody indicates previous infection.  Following hepatitis B infection, 90% of individuals clear the virus, become immune and are not infectious to others.  These patients do not have detectable circulating virus (hepatitis B surface antigen (HBsAg) negative) but have antibody against hepatitis B core antigen (anti HB core positive).  Note that immunisation stimulates antibody against HBsAg (anti HBs) but not against HBcore antigen (anti HB core negative).  A small minority of those infected by hepatitis B virus remain carriers of the virus and are HBsAg positive.  If the hepatitis B e-antigen (HBe antigen) is positive, this means that the patient has viral protein associated with a high rate of transmission.  Babies of women who are infectious carriers may be infected at delivery (or rarely during pregnancy).  Perinatal infection has a much higher risk of carrier status, more common among people born in endemic areas such as South East Asia.

Hepatitis B virus can also be transmitted through intravenous drug use or sexual intercourse.  These transmission routes are less likely to result in carrier status.  Babies of non-infectious women are not at risk of vertical transmission but other members of the family may be carriers and the mother’s immunity may indicate a high-risk environment in which the baby may be infected at a later date.

The risk of perinatal transmission can be reduced by administration of hepatitis B immunoglobulin (HBIg) at birth together with a course of active immunisation (HB vaccine).  Environmental infection can be avoided by active immunisation commenced at birth, but in this situation, HBIg is not required.  (See indications for Hep B Immunoglobulin – next section)

Schedule

A single dose of 200 IU should be administered as soon as possible after birth to babies who are at high risk of perinatal transmission.  The volume is variable dependent on the strength of each individual batch however the volume of this preparation will always be such that the dose must be split and injected into two separate sites.

Indications

Hepatitis B immunoglobulin is indicated in the following situations:-

1. Mothers who are persistent carriers of hepatitis B surface antigen (HBsAg), where hepatitis e antigen (HbeAg) is detectable or its antibody (Anti-Hbe) is not (see Notes).
2. Mothers who are HbsAg positive as a result of recent acute infection (see Notes).
3. HBsAg positive, where e-markers have not been determined (often late booking mothers)
4. Mothers who are HbsAg positive and the baby’s birth weight is 1500g or less regardless of e-antigen status of mother.
5. Woman is HBsAg seropositive and known to have an HBV DNA level above 200,000 IU/mL (≥log 5.3)** in an antenatal sample (regardless of HBeAg and anti-HBe status)

Summary of indications for Hepatitis B Immunisation & Immunoglobulin

** Note, the ‘Green Book’ (Immunisation against Infectious Disease, Public Health England, 2013) states ‘equal or above 1x10⁶IUs/ml’.

References

Guidance on the use of Hepatitis B immunoglobulin - UK Health Security Agency

Green Book chapter 18 Hepatitis B

National Neonatal Network Guideline: Hepatitis B virus - prevention of perinatal transmission

Schedule

A single dose of 250 mg, given as soon as possible after birth (or after contact), to babies at risk.

Indications

• Infants whose mothers develop chickenpox (but not herpes zoster) in the period 7 days before to 7 days after delivery. VZIG can be given without antibody testing of the infant. VZIG should be given even if the mother received VZIG herself. N.B. Consider prophylactic iv aciclovir in addition to VZIG where mother has developed chickenpox between 4 days before and 2 days after delivery as these infants are at the highest risk of fatal outcome despite VZIG.
• Infants of VZ antibody-negative mothers*, exposed to chickenpox or herpes zoster (other than in the mother) in the first 7 days of life.
• Infants up to 28 days of age who are VZ antibody-negative exposed to chickenpox or herpes zoster  AND Were born before 28 weeks gestation OR weighed <1kg at birth OR have severe congenital or underlying condition that requires prolonged intensive or special care.

These infants should be tested as maternal antibody may not be present despite a positive maternal history of chickenpox or positive maternal VZ antibody test.

N.B.babies older than 4weeks of age should be given oral aciclovir starting 7 days after exposure unless contraindicated-see aciclovir monograph

*Mothers who have a positive history of chickenpox may be assumed to be VZ antibody positive.  In the absence of a definite history maternal antibody status can normally be established quickly by liaising with the virus lab.

Exposure to chicken pox can be said to have occurred where there has been direct, indoor contact with someone who has active chicken pox (or who develops vesicles within a few days of such exposure). Sufficient exposure to place a susceptible individual at risk may be brief if the exposure was face to face e.g. someone cuddling, feeding or changing the baby. If the contact is not face to face, sufficient exposure will only occur after a more prolonged period (> 15 mins). Where a contact has shared a hospital room with a case of chicken pox, but where there has been no direct contact, much longer periods are required to give sufficient exposure.

N.B. The baby should be isolated for 21 days and the contact excluded from the unit until all lesions have crusted over. If the contact is a parent they may attend the unit but remain in strict isolation with their baby for this period. (This is not necessary if the parent has shingles in an area of the body which is completely covered with clothing).  The baby should be cared for only by members of staff who are immune to chicken pox.  

References

Guidance on the use of Zoster Immunoglobulin - UK Health Security Agency

Guidelines on VZ post exposure prophylaxis Jan 23 -UK Health Security Agency

Patient information

Chicken Pox in Pregnancy: What you need to know - RCOG

Please carefully read the monograph if you are unfamiliar with the use of this preparation

Protect your baby against TB - Parental Leaflet - Public Health Scotland

Schedule

1. A single dose, administered in the neonatal period or at the time of the first vaccinations at 8 weeks, should be offered to high risk groups as detailed below.
2. Infants born to mothers with sputum positive TB should be treated prophylactically for three months.  Following this they should have a Mantoux test.  See “The Mantoux test: Administration, reading and interpreting a tuberculin skin test”.   If the Mantoux test is negative they should receive their BCG vaccination. It is not necessary to use isoniazid resistant BCG. Prophylactic treatment will include Isoniazid with or without the addition of Rifampicin – the respiratory team at RHC should be consulted.  All babies should receive Pyridoxine whilst on Isoniazid prophylaxis.
3. Infants born to mothers who have completed a course of TB therapy during pregnancy and are considered cured, or where they have positive skin tests without evidence of disease may be given BCG at birth IF household screening has been carried out. If the rest of the household has not been screened, then the baby should receive prophylaxis as above until there is no chance of contact with potentially contagious individuals. The baby should then have a Mantoux test at 6 weeks and receive BCG vaccine at this time if negative.

Indications

• Infants from families where the parents or grandparents were born in a ‘high risk’ country – i.e. a country with a TB incidence of more than 40 cases / 100,000 population
   - High Risk’ Country list - derived from UK Health Security Agency
  OR – visit the WHO site TB Incidence for up to date information
• Any child likely to spend more than 3 months in the above countries in the next 5 years
• Where there is a current or past history (within previous 5 years ) of TB in the household or in a frequent visitor e.g. grandparents

Infants born in, or moving to, an area of the UK where the incidence of TB is more than 40 cases /100,000 population - TB incidence and epidemiology in England, 2021 - GOV.UK (www.gov.uk)

N.B. - No NHS boards in Scotland fall into this category

Contraindications

Babies born to mothers who are HIV +ve should not be given BCG vaccination until the baby has tested -ve for evidence of HIV particles at 3 months. All mothers of infants eligible for BCG should be informed that HIV is a contraindication to BCG vaccination. If they believe they may be at risk of HIV and have not been tested in pregnancy (HIV screening is now offered to all pregnant women) then they should be offered screening before their baby is immunised.

BCG should also be delayed if the infant has recently been treated with systemic corticosteroids

BCG vaccination should not be given until 6 months of age if the mother has had treatment with immunosuppressive biologic agent or 12months of age if mother on Infliximab during pregnancy or while breastfeeding unless infant levels are undetectable (see Live Vaccine section above)

Administration

The dose must be given intradermally. It is given at the insertion of the Deltoid muscle in the Left upper arm. Do not give if you are unfamiliar with the technique of intradermal injection. N.B post - administration skin testing is unnecessary

Documentation

The administration of the vaccine should be recorded in the notes along with the batch number.   A public health notification slip should be completed (see appendix) and all three parts returned to public health.  N.B. please include the GP details and the name that the child will be known as after discharge.

Reference

NICE TB Guidelines

JCVI recommendations for treatment with Synagis ® are as follows:

1. Preterm infants with CLD (defined as oxygen dependency or respiratory support until at least 36 weeks corrected gestational age) at the chronological ages at the start of the RSV season and gestational ages at birth covered within the shaded area in Table 1.

NB – Infants of any gestation who have chronic respiratory disease requiring O2 therapy or long-term ventilation, at the start of the RSV season, are also eligible

2. Pre-term infants with haemodynamically significant, acyanotic CHD
OR - infants with cyanotic or acyanotic CHD plus  significant comorbidities at the chronological ages at the start of the RSV season and gestational ages covered within the shaded area in Table 2.

3. Infants with Severe Combined Immunodeficiency are also eligible.

A Calculator to help identify eligible cases can be found here  - DoH Palivizumab Calculator

Where clinical judgement of other individual patient circumstances strongly suggests that prophylaxis would prevent serious RSV infection in infants who are at particular risk of complications from RSV, use of Synagis® could be considered during the RSV season.

Dosage and administration

Synagis® should be given as a maximum of five doses (15mg/kg/dose) given one month apart from the beginning of the RSV season (beginning of calendar week 40 i.e. beginning of October). However, where the course of treatment begins later in the RSV season (e.g. where infants are born within the RSV season) up to five doses should be given one month apart until the end of calendar week 8 (i.e. the end of February). As the risk of acquiring RSV infection while in the neonatal unit is extremely low, infants in neonatal units who are in the appropriate risk groups should only begin Synagis® treatment 24 to 48 hours before being discharged from hospital. An exception is twins; where one twin is ready for discharge, but the other remains in the NNU, consideration should be given to immunising the hospitalised twin to ensure that follow up doses for both twins will be due simultaneously. Those infants that have begun a course of Synagis® treatment but are subsequently hospitalised should continue to receive Synagis® whilst they remain in hospital.

Protecting children at increased risk of Flu - information from NHS immunisation information site

Schedule

Two doses of 0.25 ml at 4 weekly intervals, starting at 6 months. In subsequent seasons only a single dose will be required.

Indications

This vaccine should be recommended in their first winter season for all babies who received prolonged respiratory support or oxygen therapy. It may be recommended in subsequent winter seasons for those infants who had severe chronic lung disease.  NB - If the patient is too young for influenza immunisation (< 6 months) then the GP may be asked to offer Influenza vaccination to any other members of the immediate family who do not otherwise qualify for vaccination.

Vaccine consent form (pdf)

Inpatient prescription form (pdf)

Prevention of Hepatitis B Transmission in Newborn Babies (pdf)

BCG Vaccination Reporting Sheet (pdf)