Vaxneuvance Adverse Reactions

Summary of the safety profile: Paediatric population: Infants and children aged 6 weeks to less than 2 years: The safety of Vaxneuvance in healthy infants, including preterm infants (from 6 weeks of age at first vaccination) and children (11 through 15 months of age) was assessed as a 3-dose or 4-dose regimen in 5 clinical studies with a total of 7,229 participants.
All 5 studies evaluated the safety of Vaxneuvance when administered concomitantly with other routine paediatric vaccines. In these studies, 4,286 participants received a complete regimen of Vaxneuvance, 2,405 participants received a complete regimen of the 13-valent pneumococcal conjugate vaccine (PCV) and 538 participants received Vaxneuvance when used to complete a regimen initiated with the 13-valent PCV (mixed dose regimen).
The most frequent adverse reactions were pyrexia ≥38°C (75.2%), irritability (74.5%), somnolence (55.0%), injection-site pain (44.4%), injection-site erythema (41.7%), decreased appetite (38.2%), injection-site induration (28.3%) and injection-site swelling (28.2%) based on results in 3,589 participants (Table 8), excluding participants who received a mixed dose regimen. The majority of solicited adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤3 days). Severe reactions (defined as being extremely distressed or unable to do usual activities or size >7.6 cm) occurred in ≤3.5% of infants and children following any dose, with the exception of irritability which occurred in 11.4% of participants.
Children and adolescents 2 to less than 18 years of age: The safety of Vaxneuvance in healthy children and adolescents was assessed in a study that included 352 participants 2 to less than 18 years of age, of whom 177 received a single dose of Vaxneuvance. In this age cohort, 42.9% of all participants had a history of previous vaccination with a lower valency pneumococcal conjugate vaccine.
The most frequent adverse reactions 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%), injection-site induration (6.8%), and pyrexia ≥38°C (5.6%) (Table 8). The majority of solicited adverse reactions were mild to moderate (based on intensity or size) and of short duration (≤3 days); severe reactions (defined as being extremely distressed or unable to do usual activities or size >7.6 cm) occurred in ≤4.5% of children and adolescents.
Adults 18 years of age and older: The safety of Vaxneuvance in healthy and immunocompetent adults was assessed in 6 clinical studies in 7,136 adults ≥18 years of age. An additional clinical study assessed 302 adults ≥18 years of age living with HIV. Vaxneuvance was administered to 5,630 adults; 1,241 were 18 to 49 years of age, 1,911 were 50 to 64 years of age, and 2,478 were 65 years of age and older. Of those who received Vaxneuvance, 1,134 were immunocompetent adults 18 to 49 years of age who had no (n=285), 1 (n=620) or ≥2 (n=229) risk factors for pneumococcal disease and 152 were adults ≥18 years of age living with HIV. In addition, 5,253 adults were pneumococcal vaccine-naïve and 377 adults were previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPV23) at least 1 year prior to enrolment.
The most frequently reported adverse reactions following vaccination with Vaxneuvance were solicited. In the pooled analysis of the 7 studies, the most frequent adverse reactions were injection-site pain (64.6%), fatigue (23.4%), myalgia (20.7%), headache (17.3%), injection-site swelling (16.1%), injection-site erythema (11.3%) and arthralgia (7.9%) (Table 8). The majority of solicited adverse reactions were mild (based on intensity or size) and of short duration (≤3 days); severe reactions (defined as an event that prevents normal daily activity or size >10 cm) occurred in ≤1.5% of adults across the clinical program.
Older adults reported fewer adverse reactions than younger adults.
Tabulated list of adverse reactions: In clinical studies of adults, local and systemic adverse reactions were solicited daily after vaccination for 5 and 14 days, respectively, and in infants, children and adolescents up to 14 days after vaccination. In all populations, unsolicited adverse reactions were reported for 14 days after vaccination.
Adverse reactions reported for all age groups are listed per system organ class, in decreasing order of frequency and seriousness. 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). (See Table 8.)

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Additional information for other dosing regimens, vaccination schedules and special populations: Mixed dose regimen of different pneumococcal conjugate vaccines: The safety profiles of mixed 4-dose regimens of Vaxneuvance and the 13-valent PCV in healthy infants and children were generally comparable to those of complete 4-dose regimens of either Vaxneuvance or the 13-valent PCV (see Pharmacology: Pharmacodynamics under Actions).
Catch-up vaccination schedule: Safety was also assessed as a catch-up vaccination schedule in 126 healthy infants and children from 7 months to less than 2 years of age who received 2 or 3 doses of Vaxneuvance based on age at enrollment. The safety profile of the catch-up vaccination schedule was generally consistent with the safety profile of the routine vaccination schedule initiated from 6 to 12 weeks of age (see Pharmacology: Pharmacodynamics under Actions).
Children and adolescents with sickle cell disease or living with HIV: Safety was also assessed in 69 children and adolescents 5 to less than 18 years of age with sickle cell disease and in 203 children and adolescents 6 to less than 18 years of age living with HIV, all of whom received a single dose of Vaxneuvance. The safety profile of Vaxneuvance in children with these conditions was generally consistent with the safety profile in healthy children (see Pharmacology: Pharmacodynamics under Actions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.