Oculo-respiratory syndrome after influenza vaccination: trends over four influenza seasons

Serres, Gaston De; Toth, Eveline; Ménard, Suzanne; Grenier, Jean Luc; Roussel, Renée; Tremblay, Mireille; Landry, Monique; Robert, Y.; Rochette, Louis; Skowronski, Danuta M.

doi:10.1016/j.vaccine.2005.01.154

Cited by 20 publications

(11 citation statements)

References 9 publications

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“…Arm soreness, arm redness, and muscle aches were all significantly associated with receipt of the inactivated vaccine; trouble breathing and red eyes, reported in other studies as ocular respiratory syndrome [10], were also associated with receipt of the inactivated vaccine, but smaller risk differences were measured. Sore throat and runny nose or congestion were the only reactions significantly associated with receipt of the live attenuated vaccine.…”

Section: Resultsmentioning

confidence: 86%

Prevention of Symptomatic Seasonal Influenza in 2005–2006 by Inactivated and Live Attenuated Vaccines

et al. 2008

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Background The efficacy of influenza vaccines may vary annually. In 2004–2005, when antigenically drifted viruses were circulating, a randomized, placebo-controlled trial involving healthy adults showed that inactivated vaccine appeared to be efficacious, whereas live attenuated vaccine appeared to be less so. Methods In 2005–2006, we continued our trial, examining the absolute and relative efficacies of the live attenuated and inactivated vaccines in preventing laboratory-confirmed symptomatic influenza. Results A total of 2058 persons were vaccinated in October and November 2005. Studywide influenza activity was prolonged but of low intensity; type A (H3N2) virus was circulating, which was antigenically similar to the vaccine strain. The absolute efficacy of the inactivated vaccine was 16% (95% confidence interval [CI], −171% to 70%) for the virus identification end point (virus isolation in cell culture or identification through polymerase chain reaction) and 54% (95% CI, 4%–77%) for the primary end point (virus isolation or increase in serum antibody titer). The absolute efficacies of the live attenuated vaccine for these end points were 8% (95% CI, −194% to 67%) and 43% (95% CI, −15% to 71%), respectively. Conclusions With serologic end points included, efficacy was demonstrated for the inactivated vaccine in a year with low influenza attack rates. The efficacy of the live attenuated vaccine was slightly less than that of the inactivated vaccine, but not statistically greater than that of the placebo. Trial registration ClinicalTrials.gov identifier: NCT00133523.

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Section: Resultsmentioning

confidence: 86%

Prevention of Symptomatic Seasonal Influenza in 2005–2006 by Inactivated and Live Attenuated Vaccines

et al. 2008

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“…These symptoms reflect many conditions (e.g., hypersensitivity reactions, GBS, pneumonitis) and may also be more common due to confounding by indication, i.e., persons with chronic respiratory conditions are advised to receive TIV. An "oculorespiratory syndrome", defined as respiratory symptoms or facial edema or red eyes within 24 h following receipt of TIV, has been described in Canada [37][38][39][40][41]. However these symptoms have high background rates (3.4% among placebo recipients in one study [41]), and it is difficult to assess their possible association with vaccination from spontaneous reporting.…”

Section: Discussionmentioning

confidence: 99%

Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring

Vellozzi

Burwen

Dobardzic

et al. 2009

Vaccine

171

122

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a b s t r a c tIn preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barré syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.Published by Elsevier Ltd. BackgroundInfluenza vaccines are the primary method for the control of influenza and its complications and the most widely used type of vaccine for adults in the United States (US). The US and much of the world is preparing for the use of pandemic influenza vaccines [1]. However, even with extensive planning, limited safety data will be available for these vaccines prior to use. Safety profile highlights of the seasonal trivalent inactivated influenza vaccines (TIV) can provide a background for interpretation of adverse events that can be anticipated if pandemic influenza vaccines must be employed in the future. In addition, special importance for TIV safety monitoring stems from the 1976-1977 influenza season, when a mass vaccination effort in the US against swine influenza was halted after the vaccines appeared to be associated with an elevated risk of Guillain-Barré syndrome (GBS) [2].Placebo-controlled trials among older and healthy young adults have demonstrated that TIV administration is not associated with an increased risk of systemic symptoms (e.g., fever, malaise, myalgia); the most frequent adverse effect following vaccination is pain at the injection site [3] including anaphylaxis can occur [3], but the latter is rare [4]. A pre-licensure study of the recently licensed H5N1 vaccine identified headache, malaise, and myalgia as the most frequent systemic symptoms but also identified these at similar rates among placebo recipients [5]. Clinical trials are generally not large enough to detect rare adverse events. Post-licensure safety data provide examples of adverse event experiences among a larger and more diverse population, and reporting of adverse events following receipt of seasonal TIV to the US Vaccine Adverse Event Reporting System (VAERS) is an important source of this information. We examined 15 years of VAERS data among adults aged ≥18 years to describe patterns of adverse events after seasonal vaccines and to identify possible safety concerns that might merit intensified monitoring or evaluation. Although pandemic influenza vaccines will differ fr...

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“…While we did not observe efficient replication of these human viruses in vivo or in vitro, ocular symptoms occur sporadically following influenza infection with seasonal viruses (37). Seasonal influenza vaccination has been associated rarely with the onset of oculo-respiratory syndrome in individuals with no prior history of ocular disease, and there have been sporadic reports of individuals rejecting corneal transplants following vaccination (12,34,35,49). These adverse effects demonstrate the importance of studying the ocular environment in the context of both avian and human influenza virus infection and vaccination.…”

Section: Discussionmentioning

confidence: 99%

Ocular Infection of Mice with Influenza A (H7) Viruses: a Site of Primary Replication and Spread to the Respiratory Tract

Belser

Wadford

et al. 2009

J Virol

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Avian H7 influenza viruses have been responsible for poultry outbreaks worldwide and have resulted in numerous cases of human infection in recent years. The high rate of conjunctivitis associated with avian H7 subtype virus infections may represent a portal of entry for avian influenza viruses and highlights the need to better understand the apparent ocular tropism observed in humans. To study this, mice were inoculated by the ocular route with viruses of multiple subtypes and degrees of virulence. We found that in contrast to human (H3N2 and H1N1) viruses, H7N7 viruses isolated from The Netherlands in 2003 and H7N3 viruses isolated from British Columbia, Canada, in 2004, two subtypes that were highly virulent for poultry, replicated to a significant titer in the mouse eye. Remarkably, an H7N7 virus, as well as some avian H5N1 viruses, spread systemically following ocular inoculation, including to the brain, resulting in morbidity and mortality of mice. This correlated with efficient replication of highly pathogenic H7 and H5 subtypes in murine corneal epithelial sheets (ex vivo) and primary human corneal epithelial cells (in vitro). Influenza viruses were labeled to identify the virus attachment site in the mouse cornea. Although we found abundant H7 virus attachment to corneal epithelial tissue, this did not account for the differences in virus replication as multiple subtypes were able to attach to these cells. These findings demonstrate that avian influenza viruses within H7 and H5 subtypes are capable of using the eye as a portal of entry.

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Oculo-respiratory syndrome after influenza vaccination: trends over four influenza seasons

Cited by 20 publications

References 9 publications

Prevention of Symptomatic Seasonal Influenza in 2005–2006 by Inactivated and Live Attenuated Vaccines

Prevention of Symptomatic Seasonal Influenza in 2005–2006 by Inactivated and Live Attenuated Vaccines

Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring

Ocular Infection of Mice with Influenza A (H7) Viruses: a Site of Primary Replication and Spread to the Respiratory Tract

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