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Overview

This Guidelines summary is based on the Green Book chapter 25. It provides information on the pneumococcal disease, the pneumococcal vaccination, and recommendations for vaccination, including in children and clinical risk groups. For information on contraindications, precautions (including in pregnancy and during breast feeding, premature infants, immunosuppression and HIV infection), adverse reactions, and management of cases, refer to the full guideline.

This summary provides recommendations for infants born on or after 1 January 2020. For infants born up to and including 31 December 2019, refer to the full guideline and the PHE document, Changes to the infant pneumococcal conjugate vaccine schedule.

This summary has been abridged for print. View the full summary at guidelines.co.uk/454701.article.

The disease

Pneumococcal disease is the term used to describe infections caused by the bacterium Streptococcus pneumoniae (also known as the pneumococcus). S. pneumoniae is an encapsulated Gram-positive coccus. The capsule is the most important virulence factor of S. pneumoniae; pneumococci that lack the capsule are normally not virulent.

Over 90 different capsular types have been characterised. Prior to the routine conjugate vaccination programme, around 69% of invasive pneumococcal infections were caused by the 10 (14, 9V, 1, 8, 23F, 4, 3, 6B, 19F, 7F) most prevalent serotypes. Some serotypes of the pneumococcus may be carried in the nasopharynx without symptoms, with disease occurring in a small proportion of infected individuals. Other serotypes are rarely identified in the nasopharynx but are associated with invasive disease.

The incubation period for pneumococcal disease is not clearly defined but it may be as short as one to three days. The organism may spread locally into the sinuses or middle ear cavity, causing sinusitis or otitis media. It may also affect the lungs to cause pneumonia or cause systemic (invasive) infections including bacteraemic pneumonia, bacteraemia and meningitis.

Invasive pneumococcal disease is a major cause of morbidity and mortality. It particularly affects the very young, the elderly, those with an absent or non-functioning spleen and those with other causes of impaired immunity. Recurrent infections may occur in association with skull defects, cerebrospinal fluid leaks, cochlear implants or fractures of the skull.

Transmission is by aerosol, droplets or direct contact with respiratory secretions of someone carrying the organism. Transmission usually requires either frequent or prolonged close contact. There is a seasonal variation in pneumococcal disease, with peak levels in the winter months.

The vaccination

There are three types of pneumococcal vaccine licensed in the UK that provide protection against different serotypes, detailed in Table 1. The vaccines are inactivated, do not contain thiomersal and do not contain live organisms so cannot cause the diseases against which they protect.

Table 1: Pneumococcal vaccines available in the UK

Vaccine typeLicenced vaccineStereotypes covered

Pneumococcal  polysaccharide vaccine (PPV23)

Pneumococcal  Polysaccharide Vaccine®

1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A,  12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F

Pneumococcal  conjugate vaccine (PCV13)

Prevenar13®

1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,  23F

Pneumococcal  conjugate vaccine (PCV10)

Synflorix®

1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F

Pneumococcal polysaccharide vaccine (PPV)

PPV23 contains purified capsular polysaccharide from each of 23 common capsular types of pneumococcus. Most healthy adults develop a good antibody response to a single dose of PPV23 by the third week following immunisation. Children younger than two years of age show poor antibody responses to immunisation with PPV23 and there is no evidence of effectiveness of PPV23 in this age group.

In the UK, PPV23 has been recommended for risk groups since 1992 and for all people aged 65 and over since 2003.

Pneumococcal conjugate vaccines (PCVs)

PCVs have been developed containing polysaccharides from the most common capsular types. Conjugating the polysaccharide to proteins, using similar manufacturing technology to that used successfully for Haemophilus influenzae type b (Hib) and meningococcal conjugate vaccines, improves the antibody response in young children.

Pneumococcal conjugate vaccines are known to be highly immunogenic in children from two months of age.

PCV10 does not contain serotypes 3, 6A or 19A and is not currently used in the UK immunisation programme.

In 2020, as the maximum direct and indirect benefit from the PCV13 programme was likely to have been achieved, the UK schedule changed from a 2+1 to a 1+1 schedule, with doses given at 12 weeks and one year of age.

Storage

See Green Book chapter 3: Storage, distribution and disposal for information on storage.

Presentation

Information on the presentation of PCV10, PCV13 and PPV23 can be found in the Summary of Product Characteristics (SPCs).

PCV10 and PCV13

Storage can cause the vaccine to separate into a white deposit and clear supernatant. The vaccine should be shaken well to obtain a white homogeneous suspension and should not be used if there is any residual particulate matter after shaking.

PPV23

The polysaccharide vaccine should be inspected before being given to check that it is clear and colourless.

Vaccines must not be given intravenously.

Dosage and schedule

PCV13

For children and adults in risk groups, refer to Table 2 and the ‘Risk groups’ section.

Routine immunisation for infants under one year of age:

  • a single priming dose of 0.5ml of PCV13 at 12 weeks of age
  • a booster dose of 0.5ml of PCV13 at one year of age (on or after their first birthday) given at the same time as the Hib/MenC, 4CMenB and MMR vaccines (see Green Book chapter 11: UK immunisation schedule).

Additional PCV13 doses are not recommended for routine immunisation but may be indicated for some risk groups (see Tables 2 and 3).

For further guidance on changes to the infant schedule, for infants born on/after 01 January 2020 and for infants born on/before 31 December 2019, view the PHE document, Changes to the infant pneumococcal conjugate vaccine schedule.

PPV23

Adults aged 65 years and over, and clinical risk groups aged 2 years or over:

  • a single dose of 0.5ml of PPV23.

Antibody levels are likely to decline rapidly in individuals with asplenia, splenic dysfunction or chronic renal disease and, therefore, re-immunisation with PPV23 is recommended every five years in these groups. Testing of antibody levels prior to vaccination is not required. Revaccination with PPV23 is currently not recommended for any other clinical risk groups or age groups.

PCV10

Not currently recommended in the UK National Immunisation Programme. See the SPC for potential dosing schedules.

Administration

For guidance on administering vaccines please refer to the Green Book chapter 4: Immunisation procedures.

Pneumococcal vaccines can be given at the same time as other vaccines such as DTaP/IPV/Hib/HepB, 4CMenB, MMR, MenACWY, Hib/MenC, rotavirus and influenza. The vaccines should be given at separate sites, preferably in different limbs. If given in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine was given should be noted in the individual’s records.

Disposal

Equipment used for vaccination, including used vials, ampoules or syringes should be disposed of by placing it in a proper, puncture-resistant ‘sharps’ box according to local authority regulations and guidance in the technical memorandum 07-01. For further information, see Green Book chapter 3 Storage, distribution and disposal.

Individuals with unknown or incomplete vaccination histories

Unless there is a reliable history of previous immunisation, individuals should be assumed to be unimmunised. The full UK recommendations should be followed.

Unimmunised or partially immunised children who present late for vaccination before the age of one year should receive a single priming dose of PCV13, followed by a PCV13 booster at one year of age (on or after their first birthday). If the first PCV13 dose is given very late (such as at 11 months), then a minimum interval of four weeks should be observed before the booster dose to ensure appropriate boosting of the immune response.

An unimmunised or partially immunised child aged between one and under two years of age should have a single dose of PCV13.

Routine immunisation with PCV is not offered after the second birthday.

Any child eligible for PCV vaccination, who has received one or more doses of PCV10 vaccine in another country should be offered an additional dose of PCV13 at least 4 weeks later. This ensures that the infants are protected against the same pneumococcal serotypes as those vaccinated according to the UK national immunisation schedule. These infants should receive one PCV13 dose from 12 weeks of age and a booster at one year of age (on or after their first birthday), allowing an 8-week (ideal) or 4-week (minimum) interval between the two PCV13 doses.

Risk groups

Children and adults in clinical risk groups (Table 2) will require additional pneumococcal vaccination depending on their age at presentation (diagnosis), vaccination status and underlying condition (see Table 3).

Primary care staff should identify patients for whom vaccine is recommended and use all opportunities to ensure that they are appropriately immunised, for example, when immunising against influenza or at other routine consultations, especially on discharge after hospital admission.

Table 2: Clinical risk groups who should receive the pneumococcal immunisation

Clinical risk groupsExamples (decision based on clinical judgement)

Asplenia or  dysfunction of the spleen

Also includes conditions that may lead to splenic dysfunction such as homozygous sickle cell disease and coeliac syndrome

Chronic respiratory  disease (chronic respiratory disease refers to chronic lower respiratory tract disease)

Includes chronic obstructive pulmonary disease, including chronic bronchitis and emphysema; and such conditions as bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia. Children with respiratory conditions caused by aspiration, or a neurological disease (such as cerebral palsy) with a risk of aspiration. Asthma is not an indication, unless so severe as to require continuous or frequently repeated use of systemic steroids (as defined in Immunosuppression)

Chronic heart disease

Includes those requiring regular medication and/or follow-up for  ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure

Chronic kidney disease

Nephrotic syndrome, chronic kidney disease at stages 4 and 5 and those on kidney dialysis or with kidney transplantation

Chronic liver disease

Includes cirrhosis, biliary atresia and chronic hepatitis

Diabetes

Diabetes mellitus requiring insulin or anti-diabetic medication. This does not include diabetes that is diet controlled

Immunosuppression

Due to disease or treatment, including patients undergoing chemotherapy leading to immunosuppression, bone marrow transplant, asplenia or splenic dysfunction, complement disorder, HIV infection at all stages, multiple myeloma or genetic disorders affecting the immune system (such as IRAK-4, NEMO)

Individuals on or likely to be on systemic steroids for more than a month at a dose equivalent to prednisolone at 20 mg or more per day (any age), or for children under 20 kg, a dose of 1 mg or more per kg per day

Individuals with  cochlear implants

It is important that immunisation does not delay the cochlear implantation

Individuals with  cerebrospinal fluid leaks

This includes leakage of cerebrospinal fluid such as following trauma or major skull surgery (does not include cerebral spinal fluid shunts).

Occupational risk

See later

Table 3: Summary of vaccine doses for at-risk patients

Patient’s age when presenting or first diagnosed with a clinical risk conditionAt clinical risk (excluding those with asplenia, splenic dysfunction, complement disorder or severe immunocompromise)[A]Asplenia, splenic dysfunction, complement disorder or severe immunocompromise[A]
 

PCV13

PPV23

PCV13

PPV23

Infants from birth  to one year of age

Routine PCV13 at 12 weeks and one year (on or after first birthday)

PPV23 at 2 years, at least 8 weeks after last PCV dose

Two PCV13 doses at least 8 weeks apart (commencing no earlier  than 6 weeks of age)

PCV13 booster at one year (on or after the first  birthday)

Additional PCV13 dose at least 8 weeks later

PPV23 at 2 years, at l east 8 weeks after last PCV dose

One year to two years of age

Routine PCV13 booster at one year (on or after first birthday)

PPV23 at 2 years,  at least 8 weeks after last PCV dose

Routine PCV13 booster at  one year (on or after first birthday)

Additional PCV13 dose at  least 8 weeks later

PPV23 at 2 years, at  least 8 weeks after last PCV dose

Two years to under 10 years of age

No further PCV13  required (if unimmunised or partially immunised, give one PCV13 dose)

PPV23 at 2 years,  at least 8 weeks after last PCV dose

Asplenia, splenic  dysfunction or complement disorder:

No further PCV13  required (if unimmunised or partially immunised, give one PCV13 dose)

Severely  immunocompromised

One PCV13 dose (even if unimmunised)

PPV23 at 2 years, at least 8 weeks after last PCV dose

Children aged over 10 years and adults

No further PCV13  required, irrespective of PCV vaccination history

One PPV23 dose

Asplenia, splenic  dysfunction or complement disorder:

No further PCV13  required

Severely  immunocompromised:

One PCV13 dose[B]

One PPV23 dose, at  least 8 weeks after last PCV dose[B]

Footnotes:

[A] Examples of severe immunocompromise include bone marrow transplant patients, patients with acute and chronic leukaemia, multiple myeloma or genetic disorders affecting the immune system (such as IRAK-4, NEMO)

[B] PCV13 or additional PPV23 not needed if individual received PPV23 in the previous 2 years because of a theoretical risk of pneumococcal serotype-specific hypo-responsiveness with re-vaccination.

Timing of vaccination for those requiring splenectomy or commencing immunosuppressive treatment 

Because of the high risk of overwhelming infection, particularly for pneumococcal disease, vaccination is recommended for all individuals with asplenia, splenic dysfunction and conditions which may lead to splenic dysfunction, including haemoglobinopathies such as sickle cell disease and coeliac syndrome. See Green Book chapter 7: Immunisation of individuals with underlying medical conditions for a complete schedule including other vaccines indicated for this group.

Those requiring splenectomy or commencing immunosuppressive treatment should be vaccinated according to the age-specific advice above. Ideally, the vaccines should be given 4-6 weeks before elective splenectomy or initiation of treatment such as chemotherapy or radiotherapy. Where this is not possible, it can be given up to two weeks before treatment.

If it is not possible to vaccinate beforehand, splenectomy, chemotherapy or radiotherapy should never be delayed.

If it is not practicable to vaccinate two weeks before splenectomy, immunisation should be delayed until at least two weeks after the operation because functional antibody responses may be better from this time. If it is not practicable to vaccinate two weeks before starting chemotherapy/radiotherapy, immunisation should be delayed until at least three months after completion of therapy to maximise vaccine response. Immunisation of these patients should not be delayed if this is likely to result in a failure to vaccinate.

For leukaemia patients, PCV13 should be given from six months after completion of chemotherapy, and for bone marrow transplant patients, PCV13 should be offered nine to 12 months following transplantation.

Individuals at occupational risk

There is an association between exposure to metal fume and pneumonia, particularly lobar pneumonia, and between welding and invasive pneumococcal disease. PPV23 (single 0.5 ml dose in those who have not received PPV23 previously) should be considered for those at risk of frequent or continuous occupational exposure to metal fume (such as welders) taking into account the exposure control measures in place.

Vaccination may reduce the risk of pneumococcal disease but should not replace the need for measures to prevent or reduce exposure.

Full guideline: gov.uk/government/publications/pneumococcal-the-green-book-chapter-25Pneumococcal: the green book, chapter 25 (for infants born on or after 1 January 2020). January 2020.

Contains public sector information licensed under the Open Government Licence v3.0.

Published date: January 2020.