Enhanced passive safety surveillance of a trivalent and a quadrivalent influenza vaccine in Denmark and Finland during the 2018/2019 season

Serradell, Laurence; Wagué, Sophie; Moureau, Annick; Nissilä, M; Chabanon, Anne-Laure

doi:10.1080/21645515.2020.1804247

Cited by 9 publications

(16 citation statements)

References 16 publications

(27 reference statements)

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“…Annual seasonal influenza vaccination is the primary strategy used globally to limit the burden of seasonal influenza [ 2 , 3 ]. Annual vaccination is recommended by the World Health Organization (WHO) for high-risk groups including pregnant women, children aged < 5 years, the elderly, and individuals with chronic health conditions [ 4 , 5 ]. However, current influenza vaccines generally induce strain-specific immunity.…”

Section: Introductionmentioning

confidence: 99%

“…The introduction of a combination of a paper reporting method, using a pre-paid envelope, and phone reporting to replace email reporting, during the 2019/20 EPSS for individuals vaccinated with IIV4 provided better quality reporting. This was demonstrated by the higher than expected rates of spontaneous reporting (6.0%) in comparison to the method of email reporting alone that was used during the northern hemisphere 2018/19 EPSS for IIV4 [ 4 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

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Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21

et al. 2022

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Background The European Medicines Agency (EMA) requires enhanced safety surveillance to be conducted for annual seasonal influenza vaccines with the aim of rapidly detecting any potential new safety concerns before the peak immunisation period of the vaccine in any given year. The aim of this study was to detect any clinically significant change in the frequency or severity of expected reactogenicity of the quadrivalent inactivated split-virion influenza vaccine (IIV4) during routine immunisation in Finland for the 2020/21 season. The primary objective was to investigate the frequency of suspected adverse drug reactions (ADRs) occurring within 7 days following vaccination. Methods Enhanced passive safety surveillance of individuals vaccinated with IIV4 was conducted from October 9, 2020 to November 30, 2020 across seven sites in Finland. The vaccinee reporting rate and ADR reporting rate were calculated and compared with known or expected safety data in order to identify any clinically significant changes. Results Data were collected from 1008 individuals with 29 vaccinees reporting 82 suspected ADRs. Of these, 28 people reported 79 suspected ADRs within 7 days following vaccination, corresponding to a vaccinee reporting rate of 2.78% (95% CI: 1.85, 3.99) (ADR reporting rate, 7.84% [95% CI: 6.25, 9.67%]). The most frequently reported ADRs were injection site reactions (vaccination site pain, vaccination site erythema and vaccination site swelling) (n = 46, 2.28%), myalgia (n = 9, 0.89%) and headache (n = 8, 0.79%). No serious suspected adverse events were reported at any point post-vaccination and ADR reporting rates were in general lower compared to those reported for IIV4 in the 2019/20 surveillance study. Conclusion No clinically significant changes in what is known or expected for IIV4 were reported for the 2020/21 season which supports the safety profile of this vaccine and will help maintain public confidence in influenza vaccination.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21

et al. 2022

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“…All vaccines were maintained under a cold-chain protocol, carefully temperature-monitored, and administered by trained nurses working under the supervision of a JiVitA physician. The vaccine contained four inactivated influenza virus strains: A/Michigan/2015 (H1N1), A/Singapore/2016 (H3N2), B/Maryland/2016, and B/Phuket/2013 [38]. Sociodemographic characteristics, including age, education, socioeconomic status, household size (number of people), and house size (number of rooms excluding the kitchen and storerooms), were similar between pregnant women who enrolled (n=784) and pregnant women who did not enroll in the PAIR Study (n=1,519, after excluding women who were missing sociodemographic information [n=313]) (Table 1).…”

Section: Enrollment and Vaccinationmentioning

confidence: 99%

“…While weekly telephone surveillance was prespecified to end at three months postpartum, for some women and infants it continued for longer. The median (interquartile range [IQR]) number of weeks with complete calls was 35 (23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42) for women and 17 (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) for infants.…”

Section: Weekly Telephone Surveillancementioning

confidence: 99%

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Cohort profile: The Pregnancy, Arsenic, and Immune Response (PAIR) Study, a longitudinal pregnancy and birth cohort in rural northern Bangladesh

Avolio

Smith

Navas‐Acien

et al. 2022

Preprint

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PurposeArsenic exposure and micronutrient deficiencies may alter immune reactivity to influenza vaccination in pregnant women, transplacental transfer of maternal antibodies to the fetus, and maternal and infant acute morbidity. The Pregnancy, Arsenic, and Immune Response (PAIR) Study is a longitudinal pregnancy and birth cohort designed to assess whether arsenic exposure and micronutrient deficiencies alter maternal or newborn immunity and acute morbidity following maternal seasonal influenza vaccination during pregnancy.ParticipantsWe enrolled 784 pregnant women in rural Gaibandha District in northern Bangladesh between October 2018 and March 2019. Women received a quadrivalent seasonal inactivated influenza vaccine at enrollment in the late first or early second trimester between 11 and 17 weeks of gestational age. Follow-up included up to 13 visits between enrollment and three months postpartum as well as weekly telephone surveillance to ascertain influenza-like illness and other acute morbidity symptoms in women and infants. Tube well drinking water and urine specimens were collected to assess arsenic exposure. Of 784 women who enrolled, 736 (93.9%) delivered live births and 551 (70.3%) completed follow-up visit to three months postpartum.Findings to DateArsenic was ≥0.02 µg/L in 97.9% of water specimens collected from participants at enrollment. The medians (interquartile ranges) of water and urinary arsenic were 5.1 (0.5-25.1) µg/L and 33.1 (19.6-56.5) µg/L, respectively. Water and urinary arsenic were strongly correlated (Spearman’s ρ=0.72) among women with water arsenic ≥ median but weakly correlated (ρ=0.18) among women with water arsenic < median.Future PlansThe PAIR Study is well positioned to examine the effects of low-moderate arsenic exposure and micronutrient deficiencies on immune outcomes in women and infants.RegistrationNCT03930017

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Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea

Lim

Li²,

Syrkina

et al. 2022

Infect Dis Ther

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Introduction In 2017, a quadrivalent inactivated split-virion influenza vaccine (QIV; Vaxigrip Tetra ® , Sanofi) was licensed in South Korea for active immunization against influenza A and influenza B viruses in individuals aged 3 years or older, which was subsequently extended to individuals aged 6 months or older in 2018. Post-marketing surveillance trials are mandatory in South Korea to retain drug licensure. Here, we assessed the safety of QIV in routine clinical practice in South Korea. Methods This was an open, multicenter, observational, active safety surveillance study conducted between 20 June 2017 and 19 June 2021 at 10 study sites in South Korea in individuals aged 3 years or older who received a single dose of QIV during a routine healthcare visit. The participants or their legally acceptable representatives were instructed to record any adverse reactions (solicited events) and unsolicited non-serious adverse events (AE) in diary cards, and notify study investigators in case of serious adverse events (SAE). Results Overall, 663 participants were included in this study. There were no AEs leading to study termination, and no SAEs reported. Injection site pain (278 [41.9%]) was the most frequent solicited injection site reaction, with myalgia (250 [37.7%]) and malaise (236 [35.6%]) the most frequent solicited systemic reactions. Grade 3 solicited injection site and systemic reactions were reported by 8 (1.2%) and 13 (2.0%) participants, respectively; most participants with solicited reactions recovered without the need for further action. Overall, 39 (5.9%) participants experienced 49 unsolicited non-serious AEs with the most frequently reported being nasopharyngitis (19 [2.9%]). Grade 3 unsolicited non-serious adverse events were reported in 1 (0.2%) participant. None of the unsolicited non-serious AEs were considered to be related to QIV. Conclusion This post-marketing surveillance study confirms that QIV is well tolerated and has an acceptable safety profile in routine practice in South Korea. No unexpected safety concerns were identified. Trial Registration ClinicalTrials.gov identifier NCT05406180.

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Enhanced passive safety surveillance of a trivalent and a quadrivalent influenza vaccine in Denmark and Finland during the 2018/2019 season

Cited by 9 publications

References 16 publications

Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21

Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21

Cohort profile: The Pregnancy, Arsenic, and Immune Response (PAIR) Study, a longitudinal pregnancy and birth cohort in rural northern Bangladesh

Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea

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