Prevenar 20

/ Pfizer

The safety and efficacy of this medical product in infants below 6 weeks of age have not been established. No data are available.
No or only limited data are available for this medical product in preterm, older unvaccinated, or partially vaccinated infants and children.
Individuals 18 years of age and older
This medical product is to be administered as a single dose to individuals 18 years of age and older.
The need for revaccination with a subsequent dose of this medical product has not been established. No data on sequential vaccination with other pneumococcal vaccines or a booster dose are available for this medical product. Based on the clinical experience with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in this medical product), if the use of 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23 [PPSV23]) is considered appropriate, this medical product should be given first.
See prescribing information for full details.

Active immunisation for the prevention of pneumococcal disease caused by
Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B,
18C, 19A, 19F, 22F, 23F, and 33F in individuals from 6 weeks of age and less than 18 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

Hypersensitivity to the active substances, to any of the excipients or to diphtheria toxoid.

Hypersensitivity
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Concurrent illness
Vaccination should be postponed in individuals suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Thrombocytopenia and coagulation disorders
The vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
The risk of bleeding in patients with coagulation disorders needs to be carefully evaluated before intramuscular administration of any vaccine, and subcutaneous administration should be considered if the potential benefit clearly outweighs the risks.
Protection against pneumococcal disease
This medical product may only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia or otitis media (OM). As with any vaccine, this product may not protect all individuals receiving the vaccine from invasive pneumococcal disease (IPD), pneumonia or OM.
Immunocompromised individuals
Safety and immunogenicity data on this medical product are not available for individuals in immunocompromised groups. Vaccination should be considered on an individual basis.
Based on experience with pneumococcal vaccines, some individuals with altered immunocompetence may have reduced immune responses to this medical product.
Individuals with impaired immune response, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation. The clinical relevance of this is unknown.
Paediatric population
The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 h should be considered when administering the primary immunisation series to very premature infants (born less than or equal to 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 should not be withheld or delayed.
See prescribing information for full details.

Very common: Decreased appetite, Irritability, Drowsiness/increased sleep, Restless Sleep/decreased sleep, Headache, Joint pain, Muscle pain, pyrexia, Vaccination-site, pain/tenderness, Vaccination-site induration/swelling, Vaccination-site erythema, Fatigue.
Common: Diarrhoea, Vomiting, Rash, Vaccination-site induration/swelling, Vaccination-site erythema, Pyrexia
See prescribing information for full details.

See prescribing information for full details.

Pregnancy:
There are no data on the use of this medical product in pregnant women. Administration of this product in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Lactation:
It is unknown whether this medical product is excreted in human milk.

Overdose with this medical product is unlikely due to its presentation as a pre-filled syringe.