As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
As with other vaccines, the administration of PREVNAR 20 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.
PREVNAR 20 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease or pneumonia.
As with any vaccine, PREVNAR 20 may not protect all individuals receiving the vaccine from pneumococcal disease.
Driving and Operating Machinery
PREVNAR 20 has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines.
As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Safety and immunogenicity data on PREVNAR 20 are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Studies in individuals with HIV, sickle cell disease and bone marrow transplant have not been conducted with PREVNAR 20; however, safety and immunogenicity studies with PREVNAR 13 are relevant to PREVNAR 20, since the vaccines are manufactured similarly and contain 13 of the same polysaccharide conjugates (see 14 CLINICAL TRIALS).
Based on experience with pneumococcal vaccines, some individuals with altered immunocompetence may have reduced immune responses to PREVNAR 20. Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunization. The clinical relevance of this is unknown.
Reproductive Health: Female and Male Potential
No human data on the effect of PREVNAR 20 on fertility are available.
Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY).
7.1 Special Populations
7.1.1 Pregnant Women
Safety during pregnancy has not been established in humans.
Safety during lactation has not been established in humans.
It is not known whether vaccine antigens or antibodies are excreted in human milk.
As with all injectable pediatric vaccines, the potential risk of apnea should be considered when administering the primary immunization series to preterm infants. The need for monitoring for at least 48 hours after vaccination should be considered for every preterm infant born ≤28 weeks of gestation who remains hospitalized at the time of the recommended administration. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
The effectiveness of PREVNAR 20 for the prevention of pneumonia has not been established in individuals younger than 18 years of age.
The safety and effectiveness of PREVNAR 20 in children younger than 6 weeks of age have not been established.
Of the 4,263 adults in the three Phase 3 studies of the clinical development program who received PREVNAR 20, 668 (15.7%) were 65 through 69 years of age, 398 (9.3%) were 70 through 79 years of age, and 72 (1.7%) were 80 years of age and older. PREVNAR 20 has been shown to be safe and immunogenic in the geriatric population regardless of prior pneumococcal vaccination (see 14 CLINICAL TRIALS).