Prevenar 13, manufactured by Pfizer was introduced in 2010 to vaccinate against pneumococcal disease. The HSE recommend three doses for babies at 2, 6 and 13 months of age. The previous pneumococcal vaccine, PCV7, was first introduced to the infant schedule in 2008. The number refers to the number of serotypes of pneumococcal disease it targets.
This article provides an overview of the potential risks associated with both the vaccine and the diseases it targets, helping you make an informed decision.
Disease versus Vaccine Risk Summary
Risk from pneumococcal disease
|
Risk of getting pneumococcal disease Post PCV7: approx 1 in 12,000 (0.008%) for all ages (2008 to 2017) Post PCV7: approx 1 in 9,000 (0.01%) for under 5s (2008 to 2017) Risk of death from pneumococcal disease Post vaccine: approx 1 in 161,000 (0.0006%) for all ages (2008 to 2017) Approx 1 in 213,000 (0.0005%) for under 5s (2008 to 2017) |
Risks from each dose of pneumococcal vaccine Prevnar 13
3 doses recommended, at 2, 6 and 13 months
As per Prevnar 13 patient information leaflet March 2024
| Observed side effects post administration of Prevnar (post marketing) | Severe allergic reaction including shock (cardiovascular collapse), Angioedema (swelling of lips, face or throat); hives (urticaria), redness, itching (dermatitis); enlarged lymph nodes; rash |
| Up to 1 in 1,000 (0.1%) | Collapse or shock-like state (hypotonic-hyporesponsive episode); allergic reaction with swelling of face/lips, difficulty in breathing |
| Up to 1 in 100 (1%) | Seizures (including febrile seizures); hives (urticaria); redness/swelling/hardness at vaccination site >7 cm; crying |
| Up to 1 in 10 (1% to 10%) | Vomiting; diarrhoea; fever >39°C; injection site tenderness affecting movement; rash |
| More than 1 in 10 (10%) | Decreased appetite; fever; irritability; pain, tenderness, redness, swelling at injection site; drowsiness; restless sleep |
WHO Vigibase Adverse Events Reporting System
As of August 2024, 292,333 adverse events have been reported for all pneumococcal vaccines.
What is pneumococcal disease?
Disease caused by any streptococcus pneumoniae (‘pneumococcus’) serotype is called pneumococcal disease. There are over 90 different types of streptococcus pneumoniae bacteria and can cause a wide range of infections, from mild to severe. Invasive Pneumococcal Disease (IPD) refers to cases where the bacteria infects parts of the body that are normally sterile, such as the blood. The elderly and those with underlying health conditions are at highest risk. The bacteria is commonly carried in the upper respiratory tract, particularly in children, and can be spread through respiratory droplets.
- Milder Infections
- Middle ear infection: often follows viral respiratory infection and very common in children.
- Sinusitis & conjunctivitis: these infections are usually self-limiting.
- Severe Infections – less frequent and can include both invasive (IPD) and non invasive infections.
- Pneumococcal pneumonia: Leading cause of community-acquired bacterial pneumonia, particularly affecting the elderly. Symptoms often start abruptly with fever, chills, productive cough, and chest pain. Most children can fight pneumonia with their natural defences although some may require intravenous penicillin. Therapeutic vitamin C supplementation may also be considered as a low cost low risk intervention.
- Meningitis: most common bacterial cause in adults.
- Bacteraemia & Sepsis: bloodstream infections, often originating from pneumonia.
What is the risk of getting pneumococcal disease in Ireland?
The risk of getting invasive pneumococcal disease in Ireland for all ages between the years 2014 and 2023 was approximately 1 in 12,000 (0.007%) and approximately 1 in 9,000 for children under 5. Adults aged 65+ account for the highest proportion of cases. Not all these cases were confirmed. For example, in 2014, only 349 out of 680 cases were confirmed. The years between 2019 to 2022 may have been affected by pandemic measures.
What is the risk of death from invasive pneumococcal disease in Ireland?
Between the years 2008 and 2017, the risk for all ages of dying from invasive pneumococcal disease was approximately 1 in 161,000 (0.0006%) while the risk for under 5s was approximately 1 in 213,000 (0.0005%).
Does vaccination guarantee protection against pneumococcal disease?
No. Your baby can still get pneumococcal disease after vaccination. The vaccination targets 13 out of 90 serotypes of s. pneumoniae bacteria.
- In 2014, of the 39 cases of pneumococcal meningitis, 12 were vaccinated, 12 unvaccinated and 15 unknown.
- In 2016, the HPSC reported that 76% of infections were due to serotypes/strains not covered by the vaccine.
- The European Centre for Disease Control (ECDC) report from 2018 (their latest report) stated that for all the cases under five years of age, 75% were caused by a serotype not included in any pneumococcal conjugate vaccine (PCV) [5]
Additional vaccine safety data
Like all medicines, vaccines come with side effects, sometimes very serious. Parents need to research every vaccine and ensure benefits outweigh the risks.
- See disease/vaccine risk table at the top of this page for list of possible side effects
- “Severe allergic reactions can occur to any vaccine but they are very rare and are usually seen in less than 1 in 10,000 people who are vaccinated” [Menitorix PIL, 11/2016]
- There is up to a 1 in 1,000 risk of collapse or shock-like state (hypotonic-hyporesponsive episode) or allergic reaction.
- As of June, 2024, 288,895 adverse events (including 2251 deaths) have been reported on the World Health Organisation Vigiaccess database for pneumococcal vaccines including Prevenar 13.
What are the vaccine ingredients?
| Vaccine | Ingredients as listed on patient information leaflets |
|---|---|
| Prevenar 13 |
Active substances: 13 types of Streptococcus pneumoniae bacteria adsorbed on aluminium phosphate
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