Changes

January 2025 — minor update. Information relating to people aged over 10 years who are unvaccinated or partially vaccinated vaccination has been updated in line with the updated UK Health Security Agency (UKHSA) publication Immunisation against infectious disease (The Green Book) Chapter 25: Pneumococcal.

Update

Goals

To support primary healthcare professionals to:

• Ensure children aged under 2 years are vaccinated against pneumococcal infection as part of the Childhood Immunization Programme.
• Ensure adults aged over 65 years are vaccinated against pneumococcal infection.
• Ensure children and adults at clinical risk of pneumococcal disease or its complications are vaccinated against pneumococcal infection.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

QOF indicators

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE quality standards

No NICE quality standards were found during the review of this topic.

What is it?

• Pneumococcal disease is the term used to describe infections caused by the encapsulated Gram-positive bacterium Streptococcus pneumoniae (also called pneumococcus) — over 90 different capsular types have been characterized. 
  • Non-invasive infection with Streptococcus pneumoniae can cause sinusitis, otitis media, non-invasive pneumococcal pneumonia, or bronchitis.
  • Systemic (invasive) infection can cause bacteraemic pneumonia, bacteraemia, and meningitis.
    • Invasive pneumococcal disease is defined as the isolation of S. pneumoniae from blood or another normally sterile site.
• Transmission of S. pneumoniae is by aerosol, droplets, or direct contact with respiratory secretions of a person carrying the bacterium, and usually requires either frequent or prolonged close contact. 
  • The incubation period for pneumococcal disease is not clearly defined, but it may be as short as 1–3 days.

[WHO, 2016; PHE, 2020a]

How common is it?

• Pneumococcal disease is a major cause of morbidity and mortality.
• Non-invasive pneumococcal disease in adults mainly causes community-acquired pneumonia [Drijkoningen, 2014]. 
  • The annual incidence of community-acquired pneumonia is 5–11 per 1000 adult population, and it accounts for 5–12% of all lower respiratory tract infections managed by GPs in the community [NICE, 2019].
  • In 2016, Streptococcus pneumoniae was the leading cause of lower respiratory infection (pneumonia or bronchiolitis) morbidity and mortality globally, contributing to over 1.1 million deaths — more than all other aetiologies combined [GBD, 2016].
• Between July 2016 and June 2017, the overall annual incidence of invasive pneumococcal disease (IPD) in England and Wales was 9.87 per 100,000 [PHE, 2020b]. 
  • The incidence has increased from a record low in 2013/14 of 7.12 cases per 100,000 — however it is still 37% lower than before the introduction of the 7-valent pneumococcal conjugate vaccine (PCV7) and 7% lower than before the introduction of the 13-valent vaccine (PCV13). 
  • This recent increase is largely due to a considerable rise in IPD due to non-PCV13 serotypes, especially in adults aged 45 years and older. 
    • Eight of the 10 most prevalent serotypes currently causing IPD are included in the 23-valent vaccine (PPV23).
•  IPD disproportionately affects young children and the elderly with rates higher than the overall rate [PHE, 2020b]: 
  • 13.9 cases per 100,000 in children aged under 2 years.
    • On average, about 75% of cases of invasive pneumococcal disease, and 83% of cases of pneumococcal meningitis, occur in children aged under 2 years [WHO, 2019].
  • 28.9 cases per 100,000 in adults aged over 65 years.
• There is seasonal variation in IPD, with the highest incidence reported in winter. 

What are the risk factors?

• Pneumococcal disease or its complications more frequently affect the following groups of people, who therefore require immunization: 
  • People aged 65 years and over. 
  • Children aged under 2 years. 
  • People with asplenia or dysfunction of the spleen, including conditions that may lead to splenic dysfunction such as: 
    • Homozygous sickle cell disease.
    • Coeliac disease.
  • People with chronic respiratory disease, including: 
    • Chronic obstructive pulmonary disease. 
    • Bronchiectasis.
    • Cystic fibrosis.
    • Interstitial lung fibrosis.
    • Pneumoconiosis.
    • Bronchopulmonary dysplasia.
    • Children with respiratory conditions caused by aspiration, or neuromuscular diseases with a risk of aspiration (for example cerebral palsy).
    • Asthma is not an indication for vaccination unless it requires the use of oral corticosteroids for more than a month at an equivalent dose of 20 mg prednisolone or more per day (or 1 mg/kg/day for children under 20 kg).
  • People with chronic heart disease, including: 
    • Ischaemic heart disease.
    • Congenital heart disease.
    • Hypertension with cardiac complications.
    • Chronic heart failure.
  • People with chronic kidney disease, including: 
    • Nephrotic syndrome.
    • Chronic kidney disease at stages 4 and 5.
    • Conditions requiring kidney dialysis.
    • Kidney transplantation.
  • People with chronic liver disease, including: 
    • Cirrhosis.
    • Biliary atresia.
    • Chronic hepatitis.
  • People with diabetes mellitus requiring insulin or oral hypoglycaemic drugs. 
  • People with immunosuppression including: 
    • Receipt of chemotherapy that leads to immunosuppression.
    • Bone marrow transplant.
    • Complement disorder.
    • HIV infection (any stage).
    • Multiple myeloma.
    • Genetic disorders affecting the immune system (such as IRAK-4, NEMO).
    • Use of systemic corticosteroids, for more than a month, at an equivalent dose of 20 mg prednisolone or more per day (any age), or for children under 20 kg, a dose of 1 mg/kg per day.
  • People with cochlear implants. 
  • People with cerebrospinal fluid leaks (including following trauma or major neurosurgery). 
  • People with occupational risks, for example welders exposed to metal fume are at increased risk of lobar pneumonia. 

[WHO, 2019; PHE, 2020c]

What pneumococcal vaccines are available?

• Pneumococcal vaccines use purified capsular polysaccharide from several strains of Streptococcus pneumoniae to achieve active immunity.
• There are several types of pneumococcal vaccine available in the UK:
  • Prevenar 13^® is a 13-valent pneumococcal conjugate vaccine (PCV13) mainly suitable for children aged under 2 years as part of the Childhood Immunization Programme, or for some people at risk of infection.
    • Conjugating the polysaccharide to other proteins improves the antibody response in children.
    • The PCV vaccine also contributes to 'herd immunity' by preventing pneumococcal carriage and onward transmission to others. 
  • Vaxneuvance^® is a 15-valent pneumococcal conjugate vaccine (PCV15) licensed for use from the age 6 weeks.
    • It protects against the PCV13 pneumococcal serotypes as well as two additional serotypes (22F and 33F).   
  • Pneumovax^® is a 23-valent pneumococcal polysaccharide vaccine (PPV23), suitable for children aged 2 years and over, and adults.
    • PPV23 contains purified capsular polysaccharide from each of the 23 common capsular types of pneumococcus. 
    • PPV23 has moderate short-term effectiveness of 41% against invasive pneumococcal disease (IPD) caused by the vaccine serotypes in adults aged 65 years and over during the first 2 years after vaccination, with vaccine effectiveness higher among healthy individuals compared with those with underlying medical conditions.
    • The length of protection offered by PPV23 in risk groups and in older adults is variable and serotype-dependent. Post-immunization antibody levels usually begin to wane after about 5 years but may decline more rapidly in asplenic patients and children with nephrotic syndrome. 
    • There is some evidence that PPV23 offers protection against non-bacteraemic pneumococcal pneumonia. 
    • Children younger than 2 years of age show poor antibody responses to immunization with PPV23 and there is no evidence of effectiveness of PPV23 in this age group. 

[PHE, 2020a]

Scenario: Routine pneumococcal vaccination of infants, and adults aged 65 years or over

From age 2 months onwards.

Scenario: Children diagnosed at clinical risk aged under 1 year

From age 2 months to 12 months.

Scenario: Children diagnosed at clinical risk aged 1 year to under 2 years

From age 12 months to 24 months.

Scenario: Children diagnosed at clinical risk aged 2 years to under 10 years

From age 24 months to 10 years.

Scenario: Children aged over 10 years, and adults diagnosed at clinical risk

From age 10 years onwards.

Scenario: Administration and advice

From age 2 months onwards.

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of immunizations - pneumococcal.

Search dates

July 2016 - March 2021

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

• Pneumococcal Infections / epidemiology
• Streptococcus pneumoniae  or pneumococcus / immunology/
• Pneumococcal Vaccines/
• Immunization/
• exp Vaccines/ or Vaccination/
• ("Pneumococcal disease" or "infection$ or vaccin$").ti,ab.
• Pneumococcal$ and meningitis.tw/
• vaccin$.tw. immuni?ation$.tw.

Sources of guidelines

• National Institute for Health and Care Excellence (NICE)
• Scottish Intercollegiate Guidelines Network (SIGN)
• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• NICE Evidence
• World Health Organization
• Guidelines International Network
• TRIP database
• Agency for Healthcare Research and Quality
• National Health and Medical Research Council (Australia)
• Royal Australian College of General Practitioners
• British Columbia Medical Association
• Canadian Medical Association
• Alberta Medical Association
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• RefHELP NHS Lothian Referral Guidelines
• Medline (with guideline filter)
• Driver and Vehicle Licensing Agency
• NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

• The Cochrane Library:
  • Systematic reviews
  • Protocols
  • Database of Abstracts of Reviews of Effects
• Medline (with systematic review filter)
• EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

• NIHR Health Technology Assessment programme
• The Cochrane Library:
  • NHS Economic Evaluations
  • Health Technology Assessments
• Canadian Agency for Drugs and Technologies in Health
• International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

• The Cochrane Library:
  • Central Register of Controlled Trials
• Medline (with randomized controlled trial filter)
• EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

• Drug and Therapeutics Bulletin
• TRIP database
• Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

• Department of Health
• Health Management Information Consortium (HMIC)

Patient experiences

• Healthtalk
• BMJ - Patient Journeys

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

• British National Formulary (BNF)
• electronic Medicines Compendium (eMC)
• European Medicines Agency (EMEA)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• REPROTOX
• Scottish Medicines Consortium
• Stockley's Drug Interactions
• TERIS
• TOXBASE
• Micromedex
• UK Medicines Information

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

• Clinical accuracy.
• Consistency with other providers of clinical knowledge for primary care.
• Accuracy of implementation of national guidance (in particular NICE guidelines).
• Usability.

Principles of the consultation process

• The process is inclusive and any individual may participate.
• To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
• Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
• Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
• External reviewers are not paid for commenting on the draft topics.
• Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
• All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
• All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

• Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
• Stakeholders identified from the following groups are invited to review draft topics:
  • Experts in the topic area.
  • Professional organizations and societies (for example, Royal Colleges).
  • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
  • Guideline development groups where the topic is an implementation of a guideline.
  • The British National Formulary team.
  • The editorial team that develop MeReC Publications.
• Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

• Topic selection
• Scoping of topic
• Selection of clinical scenarios
• First draft internal review
• Second draft internal review
• External review
• Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

• Animal studies
• Original research is not written in English

Possible exclusions for reviewed literature:

• Sample size too small or study underpowered
• Bias evident or promotional literature
• Population not relevant
• Intervention/treatment not relevant
• Outcomes not relevant
• Outcomes have no clear evidence of clinical effectiveness
• Setting not relevant
• Not relevant to UK
• Incorrect study type
• Review article
• Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

• Feasibility
  • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
• Organizational and Financial Impact Analysis
• Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
  • Eligible population
  • Current interventions
  • Likely uptake of new intervention or recommendation
  • Cost of the current or new intervention mix
  • Impact on other costs
  • Condition-related costs
  • In-direct costs and service impacts
  • Time dependencies
• Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

• Personal financial interests
• Personal family interest
• Personal non-financial interest
• Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.