About VAXNEUVANCE
VAXNEUVANCE®▼ (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed))
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
VAXNEUVANCE is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.1,2
VAXNEUVANCE is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.1,2
Please refer to the VAXNEUVANCE SmPC for further information before making any prescribing decisions. The use of VAXNEUVANCE should be in accordance with official recommendations.1,2
VAXNEUVANCE:
Posology and method of administration1,2
Posology
Routine vaccination schedule in infants and children aged 6 weeks to less than 2 years
| Two-dose primary series followed by a booster dose | The recommended immunisation regimen consists of 3 doses of Vaxneuvance, each of 0.5 mL. The first dose is given as early as 6 weeks of age, with a second dose administered 8 weeks later. The third (booster) dose is recommended between 11 through 15 months of age. |
| Three-dose primary series followed by a booster dose | An immunisation regimen consisting of 4 doses of Vaxneuvance, each of 0.5 mL, may be given. This primary series consists of 3 doses, with the first dose given as early as 6 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series. The fourth (booster) dose is recommended between 11 through 15 months of age and at least 2 months after the third dose. |
| Preterm infants (<37 weeks gestation at birth) | The recommended immunisation regimen consists of a three-dose primary series of Vaxneuvance followed by a fourth (booster) dose, each of 0.5 mL, as per three-dose primary series followed by a booster dose posology (see sections 4.4 and 5.1 of the SmPC). |
| Prior vaccination with another pneumococcal conjugate vaccine | Infants and children who have begun immunisation with another pneumococcal conjugate vaccine may switch to Vaxneuvance at any point in the schedule (see section 5.1 of the SmPC). |
Catch-up vaccination schedule for children 7 months to less than 18 years of age
| Unvaccinated infants 7 to less than 12 months of age | 3 doses, each of 0.5 mL, with the first two doses given at least 4 weeks apart. A third (booster) dose is recommended after 12 months of age, separated from the second dose by at least 2 months. |
| Unvaccinated children 12 months to less than 2 years of age | 2 doses, each of 0.5 mL, with an interval of 2 months between doses. |
| Unvaccinated or not fully vaccinated children and adolescents 2 to less than 18 years of age | 1 dose (0.5 mL). If a previous pneumococcal conjugate vaccine was administered, at least 2 months should elapse before administering Vaxneuvance. |
Vaccination schedule for individuals 18 years of age and older
| Individuals 18 years of age and older | 1 dose (0.5 mL). The need for revaccination with a subsequent dose of Vaxneuvance has not been established. |
Table adapted from VAXNEUVANCE SmPC.
Special populations
One or more doses of Vaxneuvance may be given to individuals who have one or more underlying conditions predisposing them to an increased risk of pneumococcal disease (such as individuals with sickle cell disease or living with human immunodeficiency virus (HIV) infection or recipients of haematopoietic stem cell transplant (HSCT) or immunocompetent individuals 18 to 49 years of age with risk factors for pneumococcal disease; see section 5.1 of the SmPC).
Method of administration
The vaccine should be administered by intramuscular injection. The preferred site is the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children and adults.
No data are available for administration via the intradermal route.
For instructions on the handling of the vaccine before administration, see section 6.6 of the SmPC.
Contraindications and special warnings1,2
Contraindications
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 of the SmPC, or to any diphtheria toxoid-containing vaccine.
Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Precaution related to route of administration
Vaxneuvance must not be administered intravascularly.
Anaphylaxis
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Concurrent illness
Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders
As with other intramuscular injections, the vaccine should be given with caution to individuals receiving anticoagulant therapy, or to those with thrombocytopenia or any coagulation disorder such as haemophilia. Bleeding or bruising may occur following an intramuscular administration in these individuals. Vaxneuvance may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1 of the SmPC).
Apnoea in premature infants
The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination generally should not be withheld or delayed.
Immunocompromised individuals
Immunocompromised individuals, whether due to the use of immuno-suppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
Safety and immunogenicity data for Vaxneuvance are available for individuals with sickle cell disease or living with HIV infection or with a haematopoietic stem cell transplant (see section 5.1 of the SmPC). Safety and immunogenicity data for Vaxneuvance are not available for individuals in other specific immunocompromised groups and vaccination should be considered on an individual basis.
Protection
As with any vaccine, vaccination with Vaxneuvance may not protect all vaccine recipients. Vaxneuvance will only protect against Streptococcus pneumoniae serotypes included in the vaccine (see sections 2 and 5.1 of the SmPC).
Sodium
This medicinal product contains less than 1 mmol sodium (23 milligrams) per dose, i.e. essentially ‘sodium-free’.
Interactions1,2
Different injectable vaccines should always be administered at different injection sites.
Immunosuppressive therapies may reduce the immune responses to vaccines.
Infants and children aged 6 weeks to less than 2 years
Vaxneuvance can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, pertussis, poliomyelitis (serotypes 1, 2 and 3), hepatitis A, hepatitis B, Haemophilus influenzae type b, measles, mumps, rubella, varicella and rotavirus vaccine.
Children and adolescents 2 to less than 18 years of age
There are no data on the concomitant administration of Vaxneuvance with other vaccines.
Data from a post-marketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to other pneumococcal vaccines suggest that administration of antipyretics concomitantly or within the same day of vaccination may reduce the immune response after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown.
Adults
Vaxneuvance can be administered concomitantly with seasonal quadrivalent influenza vaccine (split virion, inactivated). There are no data on the concomitant administration of Vaxneuvance with other vaccines.
Shelf life1,2
3 years
Adverse events1,2
The frequency is defined as follows:
– 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 from the available data)
| Frequency | ||||
| Infants/Children/Adolescents | Infants/Children/Adolescents | Adults | ||
| System Organ Class | Adverse Reactions | 6W to <2Y | 2 to <18Y§ | |
| Metabolism and nutrition disorders | Decreased appetite | Very common | Common | – |
| Psychiatric disorders | Irritability | Very common | Common | – |
| Immune system disorders | Hypersensitivity reaction including tongue oedema, flushing, and throat tightness | – | – | Rare |
| Nervous system disorders | Somnolence | Very common | Common | – |
| Headache | – | Very common | Very common | |
| Dizziness | – | – | Uncommon† | |
| Skin and subcutaneous tissue disorders | Urticaria | Common | Common | Rare |
| Rash | Common | Not known‡ | Uncommon | |
| Gastrointestinal disorders | Nausea | – | Common | Uncommon† |
| Vomiting | Common | Uncommon | Uncommon | |
| Musculoskeletal and connective tissue disorders | Myalgia | – | Very common | Very common |
| Arthralgia | – | – | Common* | |
| General disorders and administration site conditions | Pyrexia¶ | Very common | Common | Uncommon† |
| ≥39°C | Very common | – | – | |
| ≥40°C | Common | – | – | |
| Injection-site pain | Very common | Very common | Very common | |
| Injection-site erythema | Very common | Very common | Very common | |
| Injection-site swelling | Very common | Very common | Very common | |
| Injection-site induration | Very common | Common | – | |
| Injection-site urticaria | Uncommon | – | – | |
| Fatigue | – | Very common | Very common | |
| Injection-site pruritus | – | – | Common | |
| Injection-site warmth | – | – | Uncommon | |
| Injection-site bruising/haematoma | Common | Common | Uncommon | |
| Chills | – | – | Uncommon† |
Table adapted from VAXNEUVANCE SmPC.
§ Different systemic adverse events were solicited for participants 2 to <3 years of age, than for participants ≥3 to less than 18 years of age. For participants <3 years of age (VAXNEUVANCE N=32, 13-valent PCV N=28), decreased appetite, irritability, somnolence and urticaria were solicited from Day 1 through Day 14 following vaccination. For participants ≥3 to less than 18 years of age, fatigue, headache, myalgia, and urticaria were solicited from Day 1 through Day 14 following vaccination.
† common in adults 18 to 49 years of age
‡ In clinical trials, no events were observed following VAXNEUVANCE in healthy children and adolescents and two events were observed in special populations (sickle cell disease and HIV).
*very common in adults 18 to 49 years of age
¶defined as temperature ≥38°C
References
- VAXNEUVANCE Summary of Product Characteristics for GB.
- VAXNEUVANCE Summary of Product Characteristics for NI.
- Martinon-Torres F, et al. A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1) Vaccine. 2023; 1(21):3387-3398.
- Wilck M, et al. A phase 3 randomized, double-blind, comparator-controlled study to evaluate safety, tolerability and immunogenicity of V114 pneumococcal vaccine in hematopoietic cell transplant recipients (PNEU-STEM). Hemasphere. 2022 Jun 23;(6 Suppl):1457-1458.
- Banniettis N, et al. A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN). Vaccine. 2022 Oct 19;40(44):6315-6325.
- Quinn CT, et al. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv. 2023 Feb 14;7(3):414-421.
- Benfield T, et al. Safety, tolerability, and immunogenicity of V114 pneumococcal vaccine compared with PCV13 in a 2+1 regimen in healthy infants: A phase III study (PNEU-PED-EU-2). Vaccine. 2023. 41(15):2456-2465.
- Mohapi L, et al. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV: a randomised phase 3 study. AIDS. 2022 Mar 1;36(3):373–382.
- Hammit L, et al. Immunogenicity, safety, and tolerability of V114, a 15-valent pneumococcal conjugate vaccine, in immunocompetent adults aged 18–49 years with or without risk factors for pneumococcal disease: a randomised phase 3 trial (PNEU-DAY). Open Forum Infectious Diseases. 2022;9(3), of ab605, https://doi.org/10.1093/ofid/ofab605.
Supporting documentation
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website.