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In the Phase 3 trials, 4,263 participants received Apexxnar. This, included 1,798 participants 18 through 49 years of age, 334 participants 50 through 59 years of age, and 2,131 participants 60 years of age and older (1,138 were 65 years of age and older). Of the participants who received Apexxnar in the Phase 3 trials, 3,639 were naïve to pneumococcal vaccines, 253 had previously received Pneumovax 23 (pneumococcal polysaccharide vaccine [23-valent]; PPSV23) (≥1 to ≤5 years prior to enrollment), 246 had previously received Prevenar 13 only (≥6 months prior to enrollment), and 125 had previously received Prevenar 13 followed by PPSV23 (the dose of PPSV23 ≥1-year prior to enrollment).
Participants in the Phase 3 trial B7471007 (Pivotal Study 1007) were evaluated for adverse events for 1 month after vaccination, and serious adverse events through 6 months after vaccination. This study included 447 participants 18 to 49 years of age, 445 participants 50 to 59 years of age, 1,985 participants 60 to 64 years of age, 624 participants 65 to 69 years of age, 319 participants 70 to 79 years of age, and 69 participants ≥80 years of age.
In participants 18 to 49 years of age in Studies 1007 and a Phase 3 trial B7471008 (Lot Consistency Study 1008), the most frequently reported adverse reactions were pain at injection site (79.2%), muscle pain (62.9%), fatigue (46.7%), headache (36.7%), and joint pain (16.2%). In participants 50 to 59 years of age in Study 1007, the most frequently reported adverse reactions were pain at injection site (72.5%), muscle pain (49.8%), fatigue (39.3%), headache (32.3%), and joint pain (15.4%). In participants ≥60 years of age in Study 1007, the most frequently reported adverse reactions were pain at injection site (55.4%), muscle pain (39.1%), fatigue (30.2%), headache (21.5%), and joint pain (12.6%). These were usually mild or moderate in intensity and resolved within a few days after vaccination.
Phase 3 Study B7471006 (Study 1006) evaluated Apexxnar in participants ≥65 years of age with varying prior pneumococcal status (prior PPSV23, prior Prevenar 13 or prior Prevenar 13 followed by PPSV23). In this study, the most frequently reported adverse reactions for participants were similar in frequency to those described for participants ≥60 years of age in Study 1007, with slightly higher injection site pain (61.2%) in participants with prior Prevenar 13, and joint pain (16.8%) in participants with prior Prevenar 13 followed by PPSV23.
Tabulated list of adverse reactions: Tabulated lists of adverse reactions from the Phase 3 clinical trials and postmarketing experience are presented as follows.
Adverse reactions from clinical trials: As Apexxnar contains the same 13 serotype-specific capsular polysaccharide conjugates and the same vaccine excipients as Prevenar 13, the adverse reactions already identified for Prevenar 13 have been adopted for Apexxnar. Table 4 presents adverse reactions reported in Phase 3 trials of Apexxnar, based on the highest frequency among adverse reactions, local reactions, or systemic events after vaccination in any Apexxnar group. In clinical trials, the safety profile of Apexxnar was similar to that of Prevenar 13. No new adverse reactions were identified as compared to Prevenar 13.
Adverse reactions are listed by 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 available data). (See Table 4.)
Click on icon to see table/diagram/imageSafety with concomitant vaccine administration in adults: The safety profile was similar when Apexxnar was administered with or without influenza vaccine, adjuvanted (Fluad Quadrivalent [QIV]).
Apexxnar administered together with COVID 19 mRNA vaccine (nucleoside modified) was observed to have a tolerability profile similar to COVID 19 mRNA vaccine (nucleoside modified) administered alone, and an overall safety profile consistent with Apexxnar or COVID-19 mRNA vaccine (nucleoside modified) given alone.
Adverse reactions from postmarketing experience: Table 5 includes adverse experiences that have been spontaneously reported during the postmarketing use of Prevenar 13, which may also occur with Apexxnar. The postmarketing safety experience with Prevenar 13 is relevant to Apexxnar, as Apexxnar contains all components (polysaccharide conjugates and excipients) of Prevenar 13. These events were reported voluntarily from a population of uncertain size. Therefore, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure. (See Table 5.)
Click on icon to see table/diagram/imageAdditional information in special populations in studies with Prevenar 13: Participants ≥18 years of age with HIV infection have similar frequencies of adverse reactions in Table 4, except for pyrexia (5% to 18%) and vomiting (8% to 12%) which were very common and nausea (<1% to 3%) which was common.
Participants ≥18 years of age with an HSCT have similar frequencies of adverse reactions in Table 4, except for pyrexia (4% to 15%), vomiting (6% to 21%), and diarrhoea (25% to 36%) which were very common.
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