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.
Highlights
Influenza is an acute viral respiratory infection that affects 5% to 20% of the global population annually [1]
The recommendation is based on extensive surveillance of influenza strains through the World Health Organization (WHO) Global Influenza Surveillance network as the influenza strains continue to evolve, causing an antigenic mismatch between the virus strains in the vaccine and the circulating viruses in the subsequent influenza season [3,4]
The passive Enhanced safety surveillance (ESS) relied on enhanced reporting of suspected adverse reactions (ARs) by increasing the awareness of vaccinees, through trained healthcare professionals (HCPs), regarding the importance of reporting suspected ARs post vaccination and by distributing safety report cards (SRCs) that allowed vaccinees to report suspected ARs through a dedicated toll-free telephone number
Summary
Influenza is an acute viral respiratory infection that affects 5% to 20% of the global population annually [1]. This rate amounts to ca 25 to 100 million persons each influenza season in Europe. As recommended by the World Health Organization (WHO), the current trivalent or quadrivalent marketed influenza vaccines are composed of antigens from two influenza A strains and one or two influenza B virus strain [1]. The recommendation is based on extensive surveillance of influenza strains through the WHO Global Influenza Surveillance network as the influenza strains continue to evolve, causing an antigenic mismatch between the virus strains in the vaccine and the circulating viruses in the subsequent influenza season [3,4]. The strain composition of the influenza vaccine is adapted to the epidemiological situation to provide optimal protection for the population
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