Gardasil 9 Adverse Reactions

A. Summary of the safety profile: In 7 clinical trials, individuals were administered Gardasil 9 on the day of enrolment and approximately 2 and 6 months thereafter. Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil 9. A total of 15,776 individuals (10,495 subjects aged 16 to 26 years and 5,281 adolescents aged 9 to 15 years at enrolment) received Gardasil 9. Few individuals (0.1%) discontinued due to adverse experiences.
In one of these clinical trials which enrolled 1,053 healthy adolescents aged 11 to 15 years, administration of the first dose of Gardasil 9 concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that more injection-site reactions (swelling, erythema), headache and pyrexia were reported. The differences observed were < 10 % and in the majority of subjects, the adverse events were reported as mild to moderate in intensity (see Interactions).
In a clinical trial that included 640 individuals aged 27 to 45 years and 570 individuals aged 16 to 26 years who received Gardasil 9, the safety profile of Gardasil 9 was comparable between the two age groups.
The most common adverse reactions observed with Gardasil 9 were injection-site adverse reactions (84.8% of vaccinees within 5 days following any vaccination visit) and headache (13.2% of the vaccinees within 15 days following any vaccination visit). These adverse reactions usually were mild or moderate in intensity.
B. Tabulated summary of adverse reactions: The adverse reactions are categorised by 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 the available data).
Clinical Trials: Table 3 presents adverse reactions considered as being at least possibly related to vaccination and observed in recipients of Gardasil 9 at a frequency of at least 1.0 % from 7 clinical trials (PN 001, 002, 003, 005, 006, 007 and 009, N=15,776 individuals) (see section 5.1 for description of the clinical trials).
Post-marketing experience: Table 3 also includes adverse events which have been spontaneously reported during the post-marketing use of Gardasil 9 worldwide. Their frequencies were estimated based on relevant clinical trials. (See Table 3.)

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qHPV vaccine: Table 4 includes adverse experiences that have been spontaneously reported during post-approval use of qHPV vaccine and may also be seen in post-marketing experience with Gardasil 9. The post-marketing safety experience with qHPV vaccine is relevant to Gardasil 9 since the vaccines contain L1 HPV proteins of 4 of the same HPV types.
Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure. (See Table 4.)

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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.