Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season

Abstract

Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15 µg. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15 µg (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15 µg only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.

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].…”