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.
Background: In 2007, an electronic repository called the Ontario Laboratories Information System (OLIS) was introduced to allow health care providers timely access to laboratory test results. Since not all laboratories began submitting their data to OLIS simultaneously, we sought to create a date-dependent table of geographic regions (forward sortation areas [FSAs]) from which people would likely present to a hospital linked to OLIS. Methods: In this descriptive study, we used administrative data to capture adults in Ontario who presented to the emergency department for any reason from 2007 to 2017. To assess changes over time, we classified all emergency department visits into fiscal quarters. The primary outcome measure was the proportion of people in a given FSA presenting to an emergency department at an OLIS-linked hospital (v. a hospital not linked to OLIS). To be included in the catchment area, at least 90% of all emergency department visits in a given quarter from a given FSA must have occurred at an OLIS-linked hospital. Results: By Dec. 31, 2017, 323 (61.4%) of 526 Ontario FSAs were in the catchment area (a population of about 8.5 million). There were no differences in selected demographic characteristics or comorbidities between people residing within the catchment area of OLIS-linked hospitals and those residing in the catchment area of unlinked hospitals on Dec. 31, 2017. We used the FSA information to construct a date-dependent table of geographic areas likely to have hospital laboratory data available in OLIS for future studies. Interpretation: We identified relevant Ontario geographic regions from which people would likely present to a hospital linked to OLIS. These geographic regions constitute a catchment area that may be used in future studies to capture adults who present to an OLIS-linked hospital with laboratory-defined conditions such as acute kidney injury, hyperkalemia and hyponatremia.
Background: Enhanced passive safety surveillance (EPSS) was conducted for quadrivalent inactivated split-virion influenza vaccines (IIV4) in Germany (high dose [HD], aged ≥60 years) and in Finland (standard dose [SD], aged ≥6 months) at the beginning of the northern hemisphere 2021/22 influenza season. The primary objective was to assess adverse drug reactions (ADRs) occurring ≤7 days post-vaccination.Methods: Vaccinees were issued vaccination cards (VC) and were encouraged to report ADRs via an electronic data collection system or by telephone. ADRs were assessed by frequency, time to onset, intensity and by age group. The vaccinee reporting rate (RR) was calculated as the number of vaccinees reporting ≥1 ADR divided by total vaccinees. Reactogenicity was compared with previous experiences with each vaccine.Results: Among 903 HD-IIV4 vaccinees in Germany, 17 reported ≥1 ADR within ≤7 days post-vaccination: RR, 1.88% (95% CI: 1.10, 3.00). Time to onset was known for 53/65 ADRs, all of which occurred ≤7 days post-vaccination. In Germany, seven ADRs were reported that were not listed previously. Among the 1000 SD-IIV4 vaccinees in Finland, 49 reported ≥1 ADR within ≤7 days post-vaccination: RR, 4.90% (95% CI: 3.65, 6.43). Time to onset was known for 126/134 ADRs, of which 125 occurred ≤7 days post-vaccination. In Finland, 21 ADRs were reported that were not listed previously. No ADRs reported during follow-up were serious. Conclusions:The EPSS for HD-IIV4 and for SD-IIV4 in the 2021/22 influenza season did not suggest any clinically relevant changes in safety beyond what is known/ expected for IIV4s.
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