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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.
Vaccine. 2015 Nov 27; 33(48):6684-8.V

Abstract

BACKGROUND

In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the US for adults aged ≥ 18 years.

OBJECTIVE

To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

METHODS

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-Barré 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.

RESULTS

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.'

CONCLUSIONS

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.

Authors+Show Affiliations

Immunization Safety Office, Centers for Disease Control and Prevention, United States. Electronic address: pmoro@cdc.gov.Center for Biologics Evaluation and Research, Food and Drug Administration, United States.Immunization Safety Office, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Centers for Disease Control and Prevention, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26518405

Citation

Moro, Pedro L., et al. "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." Vaccine, vol. 33, no. 48, 2015, pp. 6684-8.
Moro PL, Winiecki S, Lewis P, et al. 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. Vaccine. 2015;33(48):6684-8.
Moro, P. L., Winiecki, S., Lewis, P., Shimabukuro, T. T., & Cano, M. (2015). 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. Vaccine, 33(48), 6684-8. https://doi.org/10.1016/j.vaccine.2015.10.084
Moro PL, et al. 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. Vaccine. 2015 Nov 27;33(48):6684-8. PubMed PMID: 26518405.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Moro,Pedro L, AU - Winiecki,Scott, AU - Lewis,Paige, AU - Shimabukuro,Tom T, AU - Cano,Maria, Y1 - 2015/10/27/ PY - 2015/08/12/received PY - 2015/10/09/revised PY - 2015/10/18/accepted PY - 2015/11/1/entrez PY - 2015/11/1/pubmed PY - 2016/10/7/medline KW - Adverse event KW - Cell culture KW - Surveillance KW - Trivalent inactivated influenza vaccine KW - Vaccine safety SP - 6684 EP - 8 JF - Vaccine JO - Vaccine VL - 33 IS - 48 N2 - BACKGROUND: In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the US for adults aged ≥ 18 years. OBJECTIVE: To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS: 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-Barré 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. RESULTS: 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.' CONCLUSIONS: 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/26518405/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)01527-3 DB - PRIME DP - Unbound Medicine ER -