Vaxigrip Adverse Reactions

Summary of the safety profile: The safety profile of Vaxigrip is based on data from 46 clinical studies in which approximately 17,900 participants from 6 months of age received Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated), and data from post-marketing surveillance.
Most of adverse reactions usually occurred within the first 3 days after vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of most these reactions was mild to moderate.
The most frequently reported adverse reaction after vaccination, in all populations including the whole group of children from 6 to 35 months of age, was injection site pain.
Tabulated list of adverse reactions: Adverse events are ranked under headings of frequency using the following convention: 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); Not known (cannot be estimated from available data).
Adult and elderly: The safety profile is based on data: from clinical studies in more than 8,000 adults (5,064 for Vaxigrip, 3,040 for Quadrivalent Influenza Vaccine (split virion, inactivated)) and more than 5,800 elderly over 60 years of age (4,468 for Vaxigrip, 1,392 for Quadrivalent Influenza Vaccine (split virion, inactivated)); from worldwide post-marketing surveillance in the overall population.
In adults, the most frequently reported adverse reactions after vaccination were injection site pain (52.8%), headache (27.8%), myalgia (23.0%), malaise (19.2%).
In the elderly, the most frequently reported adverse reactions after vaccination were injection site pain (25.8%), headache (15.6%), myalgia (13.9%). (See Table 8.)

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Paediatric population: The safety profile is based on data: from clinical studies in 1,247 children from 3 to 8 years of age (363 for Vaxigrip, 884 for Quadrivalent Influenza Vaccine (split virion, inactivated)) and in 725 children/adolescents from 9 to 17 years of age (296 for Vaxigrip, 429 for Quadrivalent Influenza Vaccine (split virion, inactivated)); from one clinical study in 1,981 children from 6 to 35 months of age (367 for Vaxigrip, 1,614 for Quadrivalent Influenza Vaccine (split virion, inactivated)); from worldwide post-marketing surveillance in the overall population.
Depending on immunization history, children from 6 months to 8 years of age received one or two doses of Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated). Children/adolescents from 9 to 17 years of age received one dose.
In children from 6 months to 8 years of age, the safety profile was similar after the first and the second injections with a trend of lower incidence of adverse reactions after the second injection compared to the first one in children from 6 to 35 months.
In children/adolescents from 9 to 17 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (65.3%), myalgia (29.1%), headache (28.6%), malaise (20.3%), shivering (13.0%), injection site erythema (11.7%) and injection site swelling (11.4%).
In children from 3 to 8 years of age, the most frequently reported adverse reactions after any vaccination were injection site pain (59.1%), malaise (30.7%), injection site erythema (30.3%), myalgia (28.5%), headache (25.7%), injection site swelling (22.1%), injection site induration (17.6%), and shivering (11.2%).
In children from 6 to 35 months of age, the most frequently reported adverse reactions after any vaccination were injection site pain/tenderness (29.4%), fever (20.4%) and injection site erythema (17.2%).
In subpopulation of children from 6 to 23 months of age, the most frequently reported adverse reactions after any vaccination were irritability (34.9%), crying abnormal (31.9%), appetite lost (28.9%), drowsiness (19.2%) and vomiting (17.0%).
In subpopulation of children from 24 to 35 months of age, the most frequently reported adverse reactions after any vaccination was malaise (26.8%). myalgia (14.5%), headache (11.9%). (See Table 9.)

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Other special populations: Although only a limited number of subjects with co-morbidities were enrolled, studies conducted in patients with co-morbidities such as renal transplant or asthmatic patients, showed no major differences in terms of safety profile of Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated) in these populations.
Pregnant women: In clinical studies conducted in pregnant women in South Africa and Mali with Vaxigrip (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions), frequencies of local and systemic solicited reactions reported within 7 days following administration of the vaccine, were consistent with those reported for the adult population during clinical studies. In the study conducted in South Africa, local reactions were more frequent in the Vaxigrip group than in the placebo group in both HIV-negative and HIV-positive cohorts. There were no other significant differences in solicited reactions between Vaxigrip and placebo groups in both cohorts.
In one clinical study conducted in pregnant women in Finland with Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated) (see Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions), frequencies of reported local and systemic solicited reactions were consistent with those reported for the non-pregnant adult population during clinical studies conducted with Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated) even though higher for some adverse reactions (injection site pain, injection site erythema, malaise, shivering, headache, myalgia).
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.