Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study

<p><b>Background:</b> ​​The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines.</p> <p><b>Objective</b>: We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium.</p> <p><b>Methods</b>: One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited.</p> <p><b>Results</b>: Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction.</p> <p><b>Conclusion</b>: Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials.</p

Estimated number and mean annual incidence rates of MA-NGE in relation to health care setting and age group in Japan.

<p>Estimated number and mean annual incidence rates of MA-NGE in relation to health care setting and age group in Japan.</p

Monthly mean rates of MA-NGE associated with outpatient visits or hospitalizations for all ages and different age groups.

<p>Overall and age-group specific mean monthly incidence rates of MA-NGE were estimated from the JMDC database using the indirect regression model and adjusted for year-specific age distributions in the Japan census population in the period 2007–2014.</p

Mean annual incidence rates of MA-AGE associated with outpatient care or hospitalization according to age groups.

<p>Mean annual incidence rates of MA-AGE associated with outpatient care or hospitalization according to age groups.</p

Mean annual number and incidence rates of cause-specified and unspecified MA-AGE episodes associated with outpatient care or hospitalization.

<p>Mean annual number and incidence rates of cause-specified and unspecified MA-AGE episodes associated with outpatient care or hospitalization.</p

Proportion of the total population found to be free of any chronic medical condition, to have any of the chronic medical conditions included, to have only one chronic medical condition (per group of conditions) and more than one chronic medical condition in the MarketScan population between 2002 and 2013, per age group and overall.

<p>Proportion of the total population found to be free of any chronic medical condition, to have any of the chronic medical conditions included, to have only one chronic medical condition (per group of conditions) and more than one chronic medical condition in the MarketScan population between 2002 and 2013, per age group and overall.</p

Incidence rate ratio of NGE hospitalizations among eight risk groups, compared to the healthy population (mean incidence, 2002–2013).

<p>CV = cardiovascular, Resp = respiratory, ImmunoC = Immunocompromising, GI = gastrointestinal, H&P = Hepatic and pancreatic, Neuro = neurological conditions, ≥ 2 = having 2 or more chronic conditions.</p

Seasonality of cause-unspecified MA-AGE by age group associated with outpatient care and or hospitalizations.

<p>3-monthly mean incidence rates of cause-unspecified MA-AGE episodes in the JMDC database for the period July 2007 –June 2015 were calculated for different age groups.</p

Mean annual rate (per 10,000 person-years with 95% confidence intervals) of norovirus gastroenteritis (NGE)-attributable emergency department (ED) visits, hospitalizations and outpatient visits by age (2002–2013 MarketScan database).

<p>Mean annual rate (per 10,000 person-years with 95% confidence intervals) of norovirus gastroenteritis (NGE)-attributable emergency department (ED) visits, hospitalizations and outpatient visits by age (2002–2013 MarketScan database).</p

Seasonality of norovirus gastroenteritis healthcare utilization: mean annual incidence (per 100,000 population) by age (2002–2013).

<p>Seasonality of norovirus gastroenteritis healthcare utilization: mean annual incidence (per 100,000 population) by age (2002–2013).</p