Vaxneuvance Special Precautions

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE. [See Use with Immunosuppressive Therapies under Interactions and Use in Specific Populations as follows.]
The potential risk of apnea should be considered when administering any intramuscular vaccine to infants born prematurely. As the benefit of vaccination is high in this group of infants, vaccination generally should not be withheld or delayed.
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. The administration of the vaccine should be postponed in subjects suffering from acute severe febrile illness or acute infection.
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 hemophilia. Bleeding or bruising may occur following an intramuscular administration in these individuals.
Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization.
VAXNEUVANCE has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions. Adverse Reactions may temporarily affect the ability to drive or use machines.
As with any vaccine, VAXNEUVANCE may not protect all vaccine recipients.
Use in Specific Populations: Individuals at Increased Risk for Pneumococcal Disease: Infants Born Prematurely: The safety and immunogenicity of VAXNEUVANCE were evaluated in preterm infants (<37 weeks gestation at birth) enrolled within 4 double-blind, active comparator-controlled studies (Protocol 025, Protocol 027 [groups receiving a complete 4-dose regimen of either VAXNEUVANCE or Prevnar 13 [Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)]], Protocol 029 and Protocol 031). In these studies, 354 participants were randomized to receive VAXNEUVANCE or Prevnar 13 as a 4-dose regimen with the first dose administered at 2 months of age, followed by 2 additional doses at least 4 weeks apart and a fourth dose at 11 through 15 months of age. Serotype-specific immunoglobulin G (IgG) and opsonophagocytic activity (OPA) responses at 30 days following the primary series, prior to the toddler dose and at 30 days following the toddler dose were generally comparable between vaccination groups for the 13 shared serotypes and higher in VAXNEUVANCE for the two unique serotypes (22F and 33F). The safety profile and immune responses in preterm infants receiving 4 doses of VAXNEUVANCE were generally consistent with those observed in the overall healthy infant population in these studies (including preterm and term infants) [see Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Children with Sickle Cell Disease: In a double-blind, descriptive study (Protocol 023), the safety and immunogenicity of VAXNEUVANCE were evaluated in children 5 to 17 years of age with sickle cell disease. In this study, 104 participants were randomized 2:1 to receive a single dose of either VAXNEUVANCE or Prevnar 13. VAXNEUVANCE was immunogenic as assessed by serotype-specific IgG GMCs and OPA GMTs at 30 days postvaccination for all 15 serotypes contained in VAXNEUVANCE. Serotype-specific IgG GMCs and OPA GMTs were generally comparable between the two vaccination groups for the 13 shared serotypes and higher in VAXNEUVANCE for the two unique serotypes (22F and 33F). The safety profile of VAXNEUVANCE in children with sickle cell disease was generally consistent with the safety profile in healthy children [see Adverse Reactions].
Individuals Living with HIV: Children Living with HIV: In a double-blind, descriptive study (Protocol 030), the safety and immunogenicity of VAXNEUVANCE were evaluated in children 6 to 17 years of age living with HIV, with CD4+ T-cell count ≥200 cells per microliter and plasma HIV RNA value <50,000 copies/mL. In this study, 407 participants were randomized to receive a single dose of either VAXNEUVANCE or Prevnar 13, followed by PNEUMOVAX 23 [pneumococcal vaccine polyvalent] two months later. VAXNEUVANCE was immunogenic as assessed by serotype-specific IgG GMCs and OPA GMTs at 30 days postvaccination for all 15 serotypes contained in VAXNEUVANCE. Serotype-specific IgG GMCs and OPA GMTs were generally comparable for the 13 shared serotypes and higher for the 2 unique serotypes (22F and 33F). After sequential administration with PNEUMOVAX 23, IgG GMCs and OPA GMTs were generally comparable at 30 days postvaccination between the two vaccination groups for all 15 serotypes contained in VAXNEUVANCE. The safety profile of VAXNEUVANCE in children living with HIV was generally consistent with the safety profile in healthy children [see Adverse Reactions].
Adults Living with HIV: In a double-blind, descriptive study (Protocol 018), the safety and immunogenicity of VAXNEUVANCE were evaluated in pneumococcal vaccine-naïve adults ≥18 years of age living with HIV, with CD4+ T-cell count ≥50 cells per microliter and plasma HIV RNA value <50,000 copies/mL. In this study, 302 participants were randomized to receive either VAXNEUVANCE or Prevnar 13, followed by PNEUMOVAX 23 two months later.
VAXNEUVANCE was immunogenic as assessed by OPA GMTs and IgG GMCs at 30 days postvaccination for all 15 serotypes contained in VAXNEUVANCE. After sequential administration with PNEUMOVAX 23, OPA GMTs and IgG GMCs were generally comparable at 30 days postvaccination between the two vaccination groups for all 15 serotypes contained in VAXNEUVANCE. The safety profile of VAXNEUVANCE in adults living with HIV was generally consistent with the safety profile in immunocompetent pneumococcal vaccine-naïve adults [see Adverse Reactions].
Individuals with Hematopoietic Stem Cell Transplant: In a double-blind, descriptive study (Protocol 022), the safety and immunogenicity of VAXNEUVANCE were evaluated in children (≥3 years of age) and adults who received an allogeneic hematopoietic stem cell transplant (allo-HSCT) 3 to 6 months prior to enrollment. All participants had a history of stable engraftment and none had uncontrolled graft-versus-host disease. In this study, 277 participants were randomized to receive 3 doses of VAXNEUVANCE or Prevnar 13, administered one month apart. Twelve months after allo-HSCT, participants without chronic graft-versus-host disease (cGVHD) received a single dose of PNEUMOVAX 23 and those with cGVHD received a fourth dose of either VAXNEUVANCE or Prevnar 13. VAXNEUVANCE was immunogenic in recipients of allo-HSCT, as assessed by IgG GMCs and OPA GMTs at 30 days following the third dose of VAXNEUVANCE for all 15 serotypes contained in the vaccine. Serotype-specific IgG GMCs and OPA GMTs were generally comparable between the two vaccination groups for the 13 shared serotypes and higher in VAXNEUVANCE for the two unique serotypes (22F and 33F). Similarly, in participants who received either VAXNEUVANCE or Prevnar 13 twelve months after allo-HSCT, IgG GMCs and OPA GMTs at 30 days following vaccination were generally comparable between the two vaccination groups for the 13 shared serotypes and higher in VAXNEUVANCE for the two unique serotypes (22F and 33F). In participants who received PNEUMOVAX 23 twelve months after allo-HSCT, IgG GMCs and OPA GMTs at 30 days following vaccination were generally comparable between the two vaccination groups for all 15 serotypes contained in VAXNEUVANCE. The safety profile of VAXNEUVANCE in recipients of allo-HSCT was generally consistent with the known safety profile of VAXNEUVANCE.
Individuals 18 to 49 Years of Age with Chronic Conditions and Other Risk Factors: In a double-blind, descriptive study (Protocol 017), the safety and immunogenicity of VAXNEUVANCE were evaluated in immunocompetent adults 18 to 49 years of age, including individuals with one or more of the following risk factors for pneumococcal disease: diabetes mellitus, chronic heart disease including heart failure, chronic liver disease with compensated cirrhosis, chronic lung disease including persistent asthma and chronic obstructive pulmonary disease (COPD), current tobacco use and increased alcohol consumption. Participants were randomized 3:1 to receive either VAXNEUVANCE or Prevnar 13, followed by PNEUMOVAX 23 six months later. Of those who received VAXNEUVANCE, 54.7% (n=620) had 1 risk factor and 20.1% (n=228) had 2 or more risk factors. In both of these risk factor subgroups, VAXNEUVANCE elicited immune responses to all 15 serotypes contained in the vaccine as assessed by OPA GMTs and IgG GMCs at 30 days postvaccination, which were generally consistent with those observed in the overall study population [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. Sequential administration of VAXNEUVANCE followed by PNEUMOVAX 23 was also immunogenic for all 15 serotypes. The safety profile of VAXNEUVANCE in both of these risk factor subgroups was generally consistent with the safety profile in the overall study population [see Adverse Reactions].
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: The safety and effectiveness of VAXNEUVANCE in children younger than 6 weeks of age have not been established.
Use in the Elderly: Of the 4,344 individuals aged 50 years and older who received VAXNEUVANCE, 2,470 (56.9%) were 65 years and older, and 479 (11.0%) were 75 years and older [see Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies under Action].