Vaxneuvance Adverse Reactions

Clinical Trials Experience: Children 6 Weeks Through 17 Years of Age: Infants and Toddlers Receiving a Routine Vaccination Schedule: The safety of VAXNEUVANCE in healthy infants (from 6 weeks of age at first vaccination) and toddlers (11 months through 15 months of age) was assessed in 5 randomized, double-blind, active comparator-controlled clinical studies (Protocol 008, Protocol 025, Protocol 027, Protocol 029 and Protocol 031) of 7,229 participants conducted across the Americas, Europe, and Asia Pacific. In four of these studies (Protocol 008, Protocol 027, Protocol 029 and Protocol 031), the safety of VAXNEUVANCE was evaluated when administered as a 4-dose regimen given at 2, 4, 6 and 12 through 15 months of age. A fifth study (Protocol 025) evaluated the safety of VAXNEUVANCE when administered as a 3-dose regimen given at 2, 4 and 11 through 15 months of age. All 5 studies evaluated the safety of VAXNEUVANCE when administered concomitantly with other routine pediatric vaccinations [see Pharmacology: Clinical Studies under Actions]. Protocol 027 also evaluated the safety of mixed 4-dose regimens in participants who completed the regimen with VAXNEUVANCE after receiving one or more doses of Prevenar 13. Additionally, four of these studies evaluated safety in preterm infants (<37 weeks gestation at birth) [see Individuals at Increased Risk for Pneumococcal Disease under Precautions]. Across all 5 studies, 4,286 participants received a complete regimen of VAXNEUVANCE, 2,405 participants received a complete regimen of Prevenar 13 and 538 participants received a mixed regimen.
Safety was evaluated using a Vaccination Report Card for up to 14 days postvaccination. Injection-site adverse events and systemic adverse events were solicited on Day 1 through Day 14 postvaccination. Body temperature was solicited on Day 1 through Day 7 postvaccination. Unsolicited adverse events were reported on Day 1 through Day 14 postvaccination. The duration of the safety follow-up period following the last vaccination with VAXNEUVANCE was 1 month in Protocol 008 and 6 months in Protocol 025, Protocol 027, Protocol 029 and Protocol 031.
Solicited Adverse Reactions in Infants and Toddlers Receiving a Routine Vaccination Schedule: The percentage of infants (preterm and term) and toddlers with solicited adverse reactions that occurred within 14 days following administration of VAXNEUVANCE or Prevenar 13 based on pooled data from four studies (excluding mixed 4-dose regimens) are shown in Tables 9 and 10. 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 ≤1.3% of infants and toddlers following each dose, with the exception of irritability, which occurred in ≤5.2% of the participants. (See Tables 9 and 10.)

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Unsolicited Adverse Reactions in Infants and Toddlers Receiving a Routine Vaccination Schedule: Injection-site urticaria occurred in up to 0.3% of infants and toddlers following each dose of VAXNEUVANCE.
Safety with Concomitant Administration in Infants and Toddlers: The safety profile was similar when other routine pediatric vaccines were administered concomitantly with VAXNEUVANCE or Prevenar 13 [see Pharmacology: Clinical Studies under Actions].
Safety of a Mixed Dose Regimen of Different Pneumococcal Conjugate Vaccines: The safety profiles of mixed 4-dose regimens of VAXNEUVANCE and Prevenar 13 were generally comparable to those of complete 4-dose regimens of either VAXNEUVANCE or Prevenar 13 [see Pharmacology: Clinical Studies under Actions].
Infants, Children and Adolescents Receiving a Catch-Up Vaccination Schedule: The safety of VAXNEUVANCE in healthy infants, children and adolescents from 7 months through 17 years of age was assessed in a double-blind, active comparator-controlled clinical study (Protocol 024) in which 606 participants were randomized to receive 1 to 3 doses of VAXNEUVANCE or Prevenar 13, depending on age at enrollment. All infants and children less than 2 years of age were pneumococcal vaccine-naïve. Among children and adolescents from 2 through 17 years of age (N=352), 42.9% had a history of previous vaccination with a lower-valency pneumococcal conjugate vaccine. The safety assessment was consistent with that used in the studies evaluating a routine vaccination schedule. The duration of the safety follow-up period following the last study vaccination within each age cohort was 6 months.
Solicited Adverse Reactions in Infants, Children and Adolescents Receiving a Catch-Up Vaccination Schedule: The percentage of participants with solicited adverse reactions that occurred within 14 days following administration of VAXNEUVANCE or Prevenar 13 within each age cohort are shown in Tables 11, 12 and 13. 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 ≤1.6% of infants and children 7 months through 23 months of age following each dose, and ≤4.5% of children and adolescents 2 through 17 years of age. (See Tables 11, 12 and 13.)

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Adults 18 Years of Age and Older: The safety of VAXNEUVANCE in healthy and immunocompetent adults was assessed in 6 randomized, double-blind clinical studies (Protocol 007, Protocol 016, Protocol 017, Protocol 019, Protocol 020 and Protocol 021) conducted across the Americas, Europe and Asia Pacific, which included 7,136 adults ranging in age from 18 to 98 years. Each study enrolled adults with stable underlying medical conditions and/or risk factors that are known to increase the risk of pneumococcal disease.
VAXNEUVANCE was administered to 5,478 adults; 1,134 were 18 to 49 years of age, 1,874 were 50 to 64 years of age, and 2,470 were 65 years of age and older. Of those who received VAXNEUVANCE, 5,101 adults were pneumococcal vaccine-naïve and 377 adults were previously vaccinated with PNEUMOVAX 23 at least 1 year prior to enrollment.
The safety of VAXNEUVANCE in pneumococcal vaccine-naïve adults 50 years of age and older was evaluated in 3 active comparator-controlled clinical studies (Protocol 016, Protocol 019 and Protocol 020) in which 3,032 participants received VAXNEUVANCE and 1,154 participants received Prevenar 13 (PCV 13). A descriptive study (Protocol 017) evaluated the safety of VAXNEUVANCE in pneumococcal vaccine-naïve adults 18 to 49 years of age.
The safety of VAXNEUVANCE in adults 65 years of age and older who were previously vaccinated with PNEUMOVAX 23 (at least 1 year prior to study entry) was evaluated in an additional descriptive study (Protocol 007).
The safety of concomitant administration of VAXNEUVANCE with seasonal inactivated influenza vaccine was evaluated in 1,196 adults 50 years of age and older, including those with or without a history of prior vaccination with PNEUMOVAX 23 (Protocol 021).
Safety was evaluated using a Vaccination Report Card for up to 14 days postvaccination. Oral body temperature and injection-site adverse events were solicited on Day 1 through Day 5 postvaccination. Systemic adverse events were solicited on Day 1 through Day 14 postvaccination. Unsolicited adverse events were reported on Day 1 through Day 14 postvaccination. The duration of the safety follow-up period postvaccination with VAXNEUVANCE was 1 month in Protocol 007, 6 months in Protocol 019, Protocol 020, Protocol 017 and Protocol 021 and 12 months in Protocol 016.
Solicited Adverse Reactions: The percentage of participants with solicited adverse reactions that occurred within 5 or 14 days following administration of VAXNEUVANCE or Prevenar 13 in 5 studies are shown in Tables 14 and 15. All solicited adverse reactions occurred in ≥5% of participants with VAXNEUVANCE; older adults reported fewer solicited adverse reactions than younger adults, regardless of vaccination group. 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. (See Tables 14 and 15.)

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Unsolicited Adverse Reactions: Injection-site pruritus occurred in 1.0% to 2.8% of pneumococcal vaccine-naïve adults vaccinated with VAXNEUVANCE.
Safety with Concomitant Influenza Vaccine Administration: The safety profile of VAXNEUVANCE when administered concomitantly with inactivated influenza vaccine was generally consistent with the safety profile of VAXNEUVANCE.