tetano
Editor, Senior Moderator
Vaccine. 2015 Oct 27. pii: S0264-410X(15)01527-3. doi: 10.1016/j.vaccine.2015.10.084. [Epub ahead of print]
[h=1]Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax?) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015.[/h] Moro PL[SUP]1[/SUP], Winiecki S[SUP]2[/SUP], Lewis P[SUP]3[/SUP], Shimabukuro TT[SUP]3[/SUP], Cano M[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax[SUP]?[/SUP], ccIIV3), was approved in the US for adults aged ≥18 years.
[h=4]OBJECTIVE:[/h] To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
[h=4]METHODS:[/h] We searched VAERS for US reports after ccIIV3 among persons vaccinated from July 1, 2013-March 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barr? syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category using MedDRA system organ classes (SOC) to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following ccIIV3.
[h=4]RESULTS:[/h] VAERS received 629 reports following ccIIV3 of which 313 were for administration of vaccine to persons <18 years. Among 309 reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for 'drug administered to patient of inappropriate age.'
[h=4]CONCLUSIONS:[/h] Review of VAERS reports did not identify any concerning pattern of AEs after ccIIV3. Injection site and systemic reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Reports following ccIIV3 in persons <18 years highlight the need for education of healthcare providers regarding approved ccIIV3 use.
Copyright ? 2015. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Adverse event; Cell culture; Surveillance; Trivalent inactivated influenza vaccine; Vaccine safety
PMID: 26518405 [PubMed - as supplied by publisher]
[h=1]Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax?) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015.[/h] Moro PL[SUP]1[/SUP], Winiecki S[SUP]2[/SUP], Lewis P[SUP]3[/SUP], Shimabukuro TT[SUP]3[/SUP], Cano M[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax[SUP]?[/SUP], ccIIV3), was approved in the US for adults aged ≥18 years.
[h=4]OBJECTIVE:[/h] To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
[h=4]METHODS:[/h] We searched VAERS for US reports after ccIIV3 among persons vaccinated from July 1, 2013-March 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barr? syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category using MedDRA system organ classes (SOC) to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following ccIIV3.
[h=4]RESULTS:[/h] VAERS received 629 reports following ccIIV3 of which 313 were for administration of vaccine to persons <18 years. Among 309 reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for 'drug administered to patient of inappropriate age.'
[h=4]CONCLUSIONS:[/h] Review of VAERS reports did not identify any concerning pattern of AEs after ccIIV3. Injection site and systemic reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Reports following ccIIV3 in persons <18 years highlight the need for education of healthcare providers regarding approved ccIIV3 use.
Copyright ? 2015. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Adverse event; Cell culture; Surveillance; Trivalent inactivated influenza vaccine; Vaccine safety
PMID: 26518405 [PubMed - as supplied by publisher]