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

Abstract

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.

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database

“…The recent passive surveillance and cohort studies have failed to show an increased risk of facial paralysis [18][19][20][21][22]. Apart from the study by Zhou et al [13], the VAERS database has not been specifically studied for facial paralysis possibly due to influenza vaccine, although the adverse effects of influenza vaccine, in general, have been studied [28].…”

“…However, based on the findings of two subsequent wellconducted studies, the Institute of Medicine's Committee to Review Adverse Effects of Vaccines concluded that there was no causal relationship of inactivated influenza vaccine with Bell's palsy [14]. Subsequent studies have shown conflicting results [15,16], with most of the recent follow-up studies showing no increased risk [17][18][19][20][21][22].…”

Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives

“…4,11,12 Four complete influenza seasons have elapsed since the release of the EMA interim and updated guidance on ESS and several groups (i.e., academic groups, public health representatives, and manufacturers) have reported the outcome of their ESS investigations for the following seasons; 2014/15 (two studies), 2015/16 (three studies), 2016/17 (three studies); and 2017/18 (three studies) ( Table 1). Most studies are published [13][14][15][16][17][18][19][20] (or accepted for publication 21 ), and one additional study evaluating GSKs Fluarix Tetra for the 2017/18 (NCT03278067) season is also completed. 22 The vaccines studied were Sanofi Pasteur's Intanza (9 and 15 µg), Vaxigrip and Vaxigrip Tetra, GSK's Fluarix Tetra/ Alpharix Tetra and AstraZeneca's Fluenz Tetra.…”

“…Of 11 studies reported here, 9 employed the EPS methodology,1 was set up as a non-interventional voluntary PASS, and 1 was a passive surveillance using a population-based description study design (Table 1). To facilitate passive reporting of AEIs, five of the EPS studies used a combination of Adverse Event Reporting Cards (AERCs) and data from patients' EHR,; 15,17,19,21,22 one study used daily diaries and patient interviews, 13 one used a webbased questionnaire with daily reminders via text message, 18 one used telephone interview 20 , and another principally used telephone interview although a minority used web-based questionnaire. 16 The PASS study employed a web-based questionnaire issued 14 days after vaccination.…”

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

“…6 Both IIV3 and IIV4 are intramuscularly administered, split-virion vaccines and are indicated in Europe for individuals aged 6 months and older. The results from EPSS in previous seasons have been published for IIV3 [7][8][9] and for IIV4. 9 Here, we describe the EPSS results for IIV3 and IIV4 in the Northern Hemisphere for the 2018/19 influenza season and compare them with the 2017/18 season results.…”