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Adverse event reporting can be found at the bottom of the page
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The content of this site is based on the Prescribing Information for Prevenar 20®▼ (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)) for United Kingdom. The Prescribing Information for United Kingdom can be found here. Prescribing Information for Prevenar 13® (pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)) can be found here.
Example
There has been an update to the pneumococcal National Immunisation Programme1,2.
From early 2026, Prevenar 20 will replace PPV23 on the pneumococcal National Immunisation Programme for adults aged 65 years and over, and clinical risk groups aged 2 years and over1,2,3.
PPV23, 23 valent Pneumococcal Polysaccharide Vaccine
Below are the UKHSA and NHSE decisions regarding the delivery of the pneumococcal programme and the complete routine immunisation schedule:
UKHSA, United Kingdom Health Security Agency
The table below shows the estimated mean seasonal respiratory admissions attributable to each pathogen between August 2010 and July 2017:
The highest rate of admissions in 65 years and over was attributable to pneumococcus
HMPV - Human Metapneumovirus
Pneumococcal disease refers to infections caused by the bacterium Streptococcus pneumoniae. These infections are classified as invasive and non-invasive.8,9
Invasive pneumonia is a type of pneumococcal pneumonia where Streptococcus pneumoniae bacteria spread beyond the lungs into normally sterile areas of the body, such as the bloodstream (causing bacteraemia) or the fluid around the brain and spinal cord (causing meningitis).8,9
When this happens, the infection is classified as invasive pneumococcal disease (IPD), which is more severe because it means that bacteria have invaded parts ot the body that are usually protected from infection.8,9
Non-invasive pneumococcal infections refer to lung infectons caused by Streptococcus pneumoniae that remain confined to the lungs, without the bacteria entering normally sterile parts of the body (such as blood or cerebrospinal fluid).8,9
In these cases, an infection of the lungs occurs without bacteraemia, distinguishing it from invasive (bacteraemic) pneumonia.8,9
Prevenar 20 is built on the foundation of PREVENAR 13 (Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)).10
Prevenar 20 helps protect against some of the most prevalent serotypes causing pneumococcal pneumonia in adults.11,12
Polysaccharide vaccines elicit a T-cell independent response, which produces antibodies that are short-lived and cannot be boosted.13-16
Conjugate vaccines, on the other hand, elicit a T-cell dependent response, resulting in higher affinity antibodies and provides long lasting protection compared to polysaccharide vaccines.13-16
Prevenar 20, as a conjugate pneumococcal vaccine, induces serum antibody protection and immunologic memory against the 20 serotypes contained in the vaccine. By eliciting a T-cell-dependent response, it promotes the generation of memory B cells, which enable a strong booster response upon re-exposure to pneumococcal bacteria.13-16
The information below is general vaccine information and not all information is specific to pneumococcal vaccines.
Prevenar 20 is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae in individuals from 6 weeks and older.4 Prevenar 20 should be used in accordance with official recommendations.
Given the elevated burden of pneumocccal disease in older adults and individuals with underlying clinical risk coniditons, the pneumococcal National Immunisation Programme targets these groups for pneumococcal vaccination.
Among adults aged ≥ 18 years hospitalised with pneumococcal lower respiratory infection in the UK, around 71% were 65 years and older and around 94% were at increased risk.11
This study, sponsored and funded by Pfizer, included 280 adults aged ≥18 years admitted to two large hospitals in Bristol, UK with pneumococcal community-acquired pneumonia detected by any of the following methods: sterile site culture, pneumococcal urinary antigen test (PUAT, BinaxNow S. pneumoniae) or Pfizer’s serotype specific urinary antigen detection test (UAD1 or UAD2).
†At-risk included adults without immunocompromising conditions who had asthma, congestive heart failure, liver disease, chronic obstructive pulmonary disease, diabetes mellitus, alcohol abuse, or who were currently smoking.
‡High-risk included adults with chronic kidney disease, organ transplantation, immunodeficiency, hematological or solid tumor malignancy, AIDS, HIV, or were treated with immunosuppressive drug therapy; all other patients were classified as low risk.
UK=United Kingdom.
Individuals with clinical risk factors face elevated risk of pneumococcal disease compared to healthy adults.18
Those at clinical risk according to the Green Book include:3
While these groups are not directly covered by the NIP, some individuals may be eligible for vaccination due to underlying clinical conditions. Others may seek private pneumococcal vaccination due to their elevated risk.
One dose (0.5mL) of Prevenar 20 should be administered intramuscularly, preferably in the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in children and adults, with care to avoid injection into or near nerves and blood vessels.4
Prevenar 20 has a 24-month shelf life and should be stored in a refrigerator (2 C to 8 C). Do not freeze.4
Once removed from the refrigerator, Prevenar 20 should be used immediately.4
Refer to the Prevenar 20 Summary of Product Characteristics for more information.
Paedriatic population
In infants and children, 6 weeks to less than 5 years of age, Prevenar 20 can be administered concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular pertussis, hepatitis B, Haemophilus influenzae type b, inactivated poliomyelitis, measles, mumps, rubella, and varicella vaccines. The vaccine has been safely administered with influenza and rotavirus vaccines.4
Individuals 18 years of age and older
Prevenar 20 can be administered concomitantly with seasonal influenza vaccine (surface antigen, inactivated, adjuvanted). In subjects with underlying conditions associated with a high risk of developing life-threatening pneumococcal disease, consideration may be given to separating administrations of seasonal influenza vaccine and Prevenar 20 (e.g., by approximately 4 weeks).4
In a double-blind, randomised study (B7471004) in adults 65 years of age and older, the immune response was formally non-inferior, however numerically lower titres were observed for all pneumococcal serotypes included in Prevenar 20 when given concomitantly with a quadrivalent seasonal influenza vaccine (surface antigen, inactivated, adjuvanted) compared to when Prevenar 20 was given alone. The clinical relevance of this finding is unknown.4
Prevenar 20 can be administered concomitantly with COVID-19 mRNA vaccine (nucleoside modified).
There are no data on the concomitant administration of Prevenar 20 with other vaccines.4
As Prevenar 20 contains the same 13 serotype-specific capsular polysaccharide conjugates and the same vaccine excipients as Prevenar 13, the adverse reactions already identified for Prevenar 13 have been adopted for Prevenar 20.4
Table 1 shows adverse reactions from clinical trials, based on the highest frequency reported after vaccination with Prevenar 20 or in the integrated dataset. Data for infants reflect Prevenar 20 given alongside routine childhood vaccines. For reactions seen in Prevenar 13 trials but not in Prevenar 20 trials, the frequency shown is from Prevenar 13.4
| Table 1: Tabulated Adverse Reactions From Prevenar 20 Clinical Trials | ||||
| System Organ Class | Adverse Reactions | Frequency | ||
| Infants/Children/Adolescents | Adults | |||
| 6 weeks to less than 5 years of age | 5 years to less than 18 years of age | - | ||
| Immune System Disorders | Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm | Rarea | - | Uncommon |
| Metabolism and Nutrition Disorders | Decreased appetite | Very common | Very commona | Very commona |
| Psychiatric Disorders | Irritability | Very common | Very commona | - |
| Crying | Uncommona | - | - | |
| Nervous System Disorders | Drowsiness/increased sleep | Very common | Very commona | - |
| Seizures (including febrile seizures) | Uncommon | - | - | |
| Hypotonic-hyporesponsive episode | Rarea | - | - | |
| Restless sleep/decreased sleep | Very commona | Very commona | - | |
| Headache | - | Very common | Very common | |
| Gastrointestinal Disorders | Diarrhoea | Common | Commona | Uncommonb |
| Nausea | - | - | Uncommon | |
| Vomiting | Common | Commona | Uncommonb | |
| Skin and Subcutaneous Tissue Disorders | Rash | Common | Commona | Uncommonb |
| Angioedema | - | - | Uncommon | |
| Urticaria or urticaria-like rash | Uncommon | Uncommon | - | |
| Musculoskeletal and connective tissue Disorders | Muscle pain | - | Very common | Very common |
| Joint pain | - | Common | Very common | |
| General Disorders and Administration Site Conditions | Fever (pyrexia) | Very common | Uncommon | Common |
| Fever greater than 38.9 C | Common | - | - | |
| Fatigue | - | Very common | Very common | |
| Vaccination-site erythema | Very common | Very common | Commonb | |
| Vaccination-site induration/swelling | Very common | Very common | Commonb | |
| Vaccination-site erythema or induration/swelling (>2.0-7.0cm) | Very common (after toddler dose and in older children [age 2 to < 5 years]) | - | - | |
| Common (after infant series) | - | - | ||
| Vaccination-site erythema or induration/swelling (>7.0 cm) | Uncommon | - | - | |
| Vaccination-site pain/tenderness | Very common | Very common | Very common | |
| Vaccination-site pain/tenderness causing limitation of limb movement | Common | Common | Very commona | |
| Vaccination-site pruritus | - | - | Uncommon | |
| Lymphadenopathy | - | - | Uncommon | |
| Vaccination-site urticaria | - | - | Uncommon | |
| Chills | - | - | Uncommonb | |
| Vaccination-site hypersensitivity | Rarec | - | - | |
a. These frequencies are based on adverse reactions (ARs) reported in clinical trials with Prevenar 13 as these ARs were not reported in Prevenar 20 trials. b. Event reported with very common frequency (≥ 1/10) in clinical trials with Prevenar 13. c. AR not reported for Prevenar 13, although injection-site urticaria, injection-site pruritus, and injection-site dermatitis were reported in Prevenar 13 postmarketing experience. | ||||
Prevenar 20’s safety profile was similar to Prevenar 13, with no new adverse reactions identified.
Adverse reactions are listed by system organ class in decreasing order of frequency and seriousness. Frequency definitions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated).
Table 2 lists adverse events spontaneously reported during postmarketing use of Prevenar 13 in paediatric and adult populations, which may also occur with Prevenar 20. As Prevenar 20 contains all components of Prevenar 13, its postmarketing safety experience is relevant. These events were reported voluntarily from an unknown population size, so their frequency cannot be reliably estimated, nor can a causal relationship be confirmed for all events.4
| Table 2: Adverse Reactions From Prevenar 13 Postmarketing Experience | |
| System Organ Class | Frequency Not Known |
| Blood and lymphatic system disorders | Lymphadenopathy localised to the region of the vaccination site |
| Immune system disorders | Anaphylactic/anaphylactoid reaction, including shock |
| Skin and subcutaneous tissue disorders | Angioedema, erythema multiforme |
| General disorders and administration site conditions | Vaccination-site dermatitis, vaccination-site urticaria, vaccination-site pruritus |
References:
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PP-UNP-GBR-13971. December 2025