Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16

Abstract

Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 µg to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season. Among the Vaxigrip vaccinees (n = 1,012), 32 (3.2%) reported a total of 122 suspected ARs, including 110 suspected ARs that occurred within 7 days post vaccination. Among the Intanza 15 µg vaccinees (n = 1,017), 31 (3.0%) reported a total of 114 suspected ARs, including 99 that occurred within 7 days post-vaccination. These results were consistent with the known safety profile of the two vaccines and did not show any change in reactogenicity or safety concerns. This passive ESS showed improved data reporting and demonstrated its suitability to health authorities’ requirements; further fine tuning of the methodology is under discussion between all stakeholders.

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

“…Early influenza vaccine safety surveillance aims to identify potential new safety concerns as soon as possible, before the peak period of mass immunization. 2 As in previous EPSS studies, 8,9 no safety issues were observed during the NH 2017/ 18 influenza season in participants receiving IIV3-ID or IIV3. Similarly, for IIV4, the EPSS showed no difference between the reported rates of ARs and those expected based on clinical trial data.…”

“…ARs reported by each participant were collected using an Information Request Management System and were confirmed by a structured telephone interview as described previously. 8,9 All events reported spontaneously by participants or healthcare professionals were considered as suspected ARs (i.e., vaccinerelated) unless the participants specifically stated that they believed the events were unrelated or that a causal relationship could be excluded. No causality assessment was requested from the participants or healthcare professionals.…”

“…7 The results of EPSS have been previously published for these two vaccines during the Northern Hemisphere (NH) 2016/17 and 2015/16 influenza seasons. 8,9 Most recently, an intramuscularly administered quadrivalent split-virion influenza vaccine (IIV4; VaxigripTetra TM , Sanofi Pasteur) was licensed in Europe in 2016 for individuals aged 3 years and older. 10 Its indication has since been extended to children from 6 months of age in many countries.…”

“…Because it has only recently been licensed, IIV4 was not included in previous EPSS studies. 8,9 Here, we describe the EPSS results for these three vaccines during the NH 2017/18 influenza season and compare them with the NH 2016/17 season rates for IIV3 and IIV3-ID and with reference safety information for IIV4.…”

Engineering Microneedles for Therapy and Diagnosis: A Survey

“…Besides clinical trials, many commercial MN products have been developed for vaccination and are available nowadays. These commercial products, for example, Nanopatch TM [159], Fluzone Intradermal ® [160], and Intanza ® [161], have been published in journals, and contributed to public health against pestilence [162,163].…”