Adverse events after Fluzone® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011–2013

Moro, Pedro L.; Harrington, Theresa; Shimabukuro, Tom T.; Cano, Maria; Museru, Oidda I.; Menschik, David; Broder, Karen R.

doi:10.1016/j.vaccine.2013.08.001

Cited by 19 publications

(30 citation statements)

References 13 publications

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“…The most common ARs for the three vaccines were mild and transient injection-site reactions, headache, and fever, which are frequently reported for these and other influenza vaccines. 6,10,11 As reported elsewhere, 11 injection-site reactions were more frequent among participants receiving IIV3-ID, although the reported rate was lower than that listed in the SmPC. 12 An increased frequency of injection-site reactions is expected for intradermal vaccination compared to intramuscular injection, 13 probably due to higher, more localized antigen delivery and higher concentrations of immune cells in the skin.…”

Section: Discussionmentioning

confidence: 60%

Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season

Gandhi-Banga

Chabanon

Eymin

et al. 2019

Human Vaccines & Immunotherapeutics

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Safety surveillance is required for each season's influenza vaccines to rapidly detect and evaluate potential new safety concerns before the peak period of immunization. Here we report the results of an enhanced passive safety surveillance for a trivalent split-virion inactivated influenza vaccine (IIV3; Vaxigrip®), an intradermal version of this vaccine (IIV3-ID; Intanza® 15 µg), and a recently licensed quadrivalent version (IIV4; VaxigripTetra TM) during the 2017/18 influenza season in the UK and Republic of Ireland. The primary objective was to determine the rates of adverse reactions (ARs) occurring within 7 days following routine vaccination. Between September and November 2017, 979 safety report cards were distributed to vaccinees receiving IIV3-ID, 1005 to those receiving IIV3, and 957 to those receiving IIV4. At least one AR was reported by 28 participants (2.9%) vaccinated with IIV3-ID, 14 participants (1.4%) vaccinated with IIV3, and 20 participants (2.1%) vaccinated with IIV4. The most frequent ARs were injection-site reactions and headache. One participant vaccinated with IIV3-ID reported two suspected serious ARs (dyskinesia and a shock symptom), although these could not be confirmed as vaccine-related. Rates of ARs for IIV3 and IIV3-ID for 2017/18 did not differ from the 2016/17 rates. For IIV4, in its first season since licensure, AR frequencies were similar to those in the Summary of Product Characteristics. In conclusion, no change was found compared to the known or expected AR rates for IIV3, IIV3-ID, or IIV4 during the 2017/18 season.

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Section: Discussionmentioning

confidence: 60%

Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season

Gandhi-Banga

Chabanon

Eymin

et al. 2019

Human Vaccines & Immunotherapeutics

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“…A review of studies comparing intradermal and intramuscular IIV3 similarly noted higher rates of erythema, induration, swelling, and pruritus among adults aged 18-60 years within the first 7 days after receiving intradermal vaccine; local pain and ecchymosis and systemic reactions occurred with similar frequency (311). A review of VAERS reports covering the 2011-12 and 2012-13 seasons, the first two seasons that the intradermal IIV3 was available, revealed no new safety concerns (312). A randomized study comparing safety of the newer IIV4 with that of IIV3 revealed a similar adverse event profile (130).…”

Section: Adultsmentioning

confidence: 99%

Prevention and Control of Seasonal Influenza with Vaccines

Grohskopf

Sokolow²,

Broder³

et al. 2016

MMWR Recomm. Rep.

384

279

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“…[73][74][75][76] Immunogenicity has been explored also in immunocompromised patients: in transplanted patients, [77][78] in HIV-infected patients, 79 and in cancer patients. 80 Immunogenicity profiles of ID vaccines are not inferior to IM vaccines, as proven by some recently 89 Tsang and collaborators performed a randomized, controlled, multicenter, phase II study in older adults (≥65 years of age) who were randomly assigned to ID vaccine with 15μg (HA)/strain (n=636), ID vaccine with 21μg HA/strain (n=634), standard IM vaccine with 15μg HA/strain (n=319) and high-dose IM vaccine with 60μg HA/strain (n=320), respectively. Subjects immunized with ID vaccine were more likely to report more injection-site reactions.…”

Section: Cutaneous Drug and Vaccine Deliverymentioning

confidence: 92%

Fluzone® intra-dermal (Intanza®/Istivac® Intra-dermal): An updated overview

Bragazzi

Orsi

Ansaldi

et al. 2016

Human Vaccines & Immunotherapeutics

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Influenza is a highly contagious respiratory acute viral disease which imposes a very heavy burden both in terms of epidemiology and costs, in the developed countries as well as in the developing ones. It represents a serious public health concern and vaccination constitutes an important tool to reduce or at least mitigate its burden. Despite the existence of a broad armamentarium against influenza and despite all the efforts and recommendations of international organisms to broaden immunization, influenza vaccination coverage is still far from being optimal. This, taken together with logistic and technical difficulties that can result into vaccine shortage, makes intra-dermal (ID) vaccines, such as Fluzone® ID and Intanza®, particularly attractive. ID vaccines are comparable and, in some cases, superior to intra-muscular/sub-cutaneous vaccines in terms of immunogenicity, safety, reactogenicity, tolerability and cross-protection profiles, as well as in terms of patient preference, acceptance and vaccine selection. Further advances, such as Fluzone® ID with alternative B strains and Quadrivalent Fluzone® ID or the possibility of self-administering the vaccines, make influenza ID vaccines even more valuable.

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Adverse events after Fluzone® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011–2013

Cited by 19 publications

References 13 publications

Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season

Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season

Prevention and Control of Seasonal Influenza with Vaccines

Fluzone® intra-dermal (Intanza®/Istivac® Intra-dermal): An updated overview

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