NEWLY EXPANDED INDICATION

A PNEUMOCOCCAL CONJUGATE VACCINE NOW APPROVED FOR YOUR PEDIATRIC PATIENTS 6 WEEKS OF AGE AND OLDER

VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Logo

Newly Expanded Indication of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)

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Indication for VAXNEUVANCE

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

Select Safety Information for VAXNEUVANCE

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of VAXNEUVANCE.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%), and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection-site induration (6.8%).

In studies of infants and children who received a 4-dose series of VAXNEUVANCE, injection-site urticaria within 14 days following each dose of VAXNEUVANCE occurred in up to 0.6% of children. Serious adverse events up to 6 months following vaccination with the 4-dose series were reported by 9.6% of VAXNEUVANCE recipients and by 8.9% of PCV13 recipients. Participants in these studies may have received either US-licensed or non-US licensed concomitant vaccines according to the local recommended schedule.

Up to 30 days following completion of Doses 1 through 3, serious adverse events were reported by 4.8% of VAXNEUVANCE recipients and by 5.0% of PCV13 recipients. An adverse reaction of febrile seizure was reported in a 9-week-old female one day after receiving VAXNEUVANCE (Dose 1) and recommended infant vaccines. Up to 30 days following Dose 4, serious adverse events were reported by 1.0% of VAXNEUVANCE recipients and by 0.7% of PCV13 recipients.

There were no notable patterns or numerical imbalances between vaccination groups for specific categories of serious adverse events that would suggest a causal relationship to VAXNEUVANCE.

The safety and effectiveness of VAXNEUVANCE in individuals younger than 6 weeks of age have not been established.

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Indication for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

VAXNEUVANCE is indicated for active immunization for the prevention

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

Select Safety Information for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of VAXNEUVANCE.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%), and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection-site induration (6.8%).

In studies of infants and children who received a 4-dose series of VAXNEUVANCE, injection-site urticaria within 14 days following each dose of VAXNEUVANCE occurred in up to 0.6% of children. Serious adverse events up to 6 months following vaccination with the 4-dose series were reported by 9.6% of VAXNEUVANCE recipients and by 8.9% of PCV13 recipients. Participants in these studies may have received either US-licensed or non-US licensed concomitant vaccines according to the local recommended schedule.

Up to 30 days following completion of Doses 1 through 3, serious adverse events were reported by 4.8% of VAXNEUVANCE recipients and by 5.0% of PCV13 recipients. An adverse reaction of febrile seizure was reported in a 9-week-old female one day after receiving VAXNEUVANCE (Dose 1) and recommended infant vaccines. Up to 30 days following Dose 4, serious adverse events were reported by 1.0% of VAXNEUVANCE recipients and by 0.7% of PCV13 recipients.

There were no notable patterns or numerical imbalances between vaccination groups for specific categories of serious adverse events that would suggest a causal relationship to VAXNEUVANCE.

The safety and effectiveness of VAXNEUVANCE in individuals younger than 6 weeks of age have not been established.

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer VAXNEUVANCE to individuals with a severe allergic

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

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US-PVC-00243 06/22