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

Details

• Alternative Title:
  Vaccine
• Personal Author:
  Moro, Pedro L. ; Winiecki, Scott ; Lewis, Paige ; Shimabukuro, Tom T. ; Cano, Maria
• Description:
  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.
  
  
• Subjects:
  Adolescent Adult Aged Aged, 80 And Over Cell Culture Techniques Child Child, Preschool Drug-Related Side Effects And Adverse Reactions Female Humans Infant Influenza Vaccines Male Middle Aged Product Surveillance, Postmarketing Technology, Pharmaceutical United States Vaccines, Inactivated Young Adult

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• Keywords:
  Adverse Event Cell Culture Surveillance Trivalent Inactivated Influenza Vaccine Vaccine Safety
• Source:
  Vaccine. 33(48):6684-6688
• Pubmed ID:
  26518405
• Pubmed Central ID:
  PMC6500456
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHSUnited States/
• Volume:
  33
• Issue:
  48
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:10953d1c7a1ec36a1f7542f0ec38bb9f4dc39e484404481b183eb4d6ebd8ff75250fb6f358636d57bab49ede515e7a02d536231f6270d700915ed95c65174147
• Download URL:
  https://stacks.cdc.gov/view/cdc/78347/cdc_78347_DS1.pdf
• File Type:
  [PDF - 66.44 KB ]