MJA
MJA InSight
MJA Careers
Perspectives

Challenges in regulating influenza vaccines for children

Paul V Effler and Heath A Kelly
Med J Aust 2013; 198 (7): 360-362.
doi:
10.5694/mja12.10857

Lessons need to be drawn from the assessment and licensing of influenza vaccines in previous years

Paul V Effler, MD, MPH, FAFPHM, Public Health Physician1
Heath A Kelly, MB BS, MPH, Adjunct Professor2
1 Prevention and Control, Western Australia Department of Health, Perth, WA.
2 National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT.
Article References: 
Reference Text: 
Australian Technical Advisory Group on Immunisation. Clinical advice for immunisation providers on resumption of the use of 2010 trivalent seasonal vaccines in children less than 5 years of age: July 2010. http://www.health. gov.au/internet/immunise/Publishing.nsf/content/B4A8DC125C08290ACA 25776D001DA89B/$File/atagi-statement-tiv.pdf (accessed Feb 2013).
Reference Order: 
1
Reference Text: 
Therapeutic Goods Administration. Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination. http://www.tga.gov.au/pdf/alerts-medicine-seasonal-flu-100702.pdf (accessed Feb 2013).
Reference Order: 
2
Reference Text: 
Armstrong PK, Dowse GK, Effler PV, et al. Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open 2011; 1: e000016. http://bmjopen.bmj.com/content/1/1/e000016.full?sid=91662646-fe5f-410a-85b9-d0074d033782 (accessed Feb 2013).
Reference Order: 
3
PubMed ID: 
22021725
Reference Text: 
Hambidge SJ, Glanz JM, France EK, et al; Vaccine Safety Datalink Team. Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. JAMA 2006; 296: 1990-1997.
Reference Order: 
4
PubMed ID: 
17062862
Reference Text: 
Gross PA, Ennis FA, Gaerlan PF, et al. A controlled double-blind comparison of reactogenicity, immunogenicity, and protective efficacy of whole-virus and split-product influenza vaccines in children. J Infect Dis 1977; 136: 623-632.
Reference Order: 
5
PubMed ID: 
335000
Reference Text: 
Food and Drug Administration. Afluria, influenza virus vaccine. Prior approval supplement: pediatric indication. Clinical review. BLA supplement 125254/132. 7 November 2009. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM229905.pdf (accessed Feb 2013).
Reference Order: 
6
Reference Text: 
Medical Products Agency, Sweden. Afluria, suspension for injection. Influenza vaccine (split virion, inactivated). Public assessment report, scientific discussion. Mutual recognition procedure SE/H/0485/01/E01. 28 June 2007. http://www.lakemedelsverket.se/SPC_PIL/Pdf/par/Afluria,%20suspension %20for%20injection.pdf (accessed Feb 2013).
Reference Order: 
7
Reference Text: 
Food and Drug Administration. Biologics license application for Afluria, manufactured by CSL Limited. No. 125254. September 19, 2007. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Approved Products/ucm127190.pdf (accessed Feb 2013).
Reference Order: 
8
Reference Text: 
Nolan T, Richmond PC, McVernon J, et al. Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in infants and children. Influenza Other Respi Viruses 2009; 3: 315-325.
Reference Order: 
9
PubMed ID: 
19903213
Reference Text: 
World Health Organization. Recommendations for influenza vaccine composition. http://www.who.int/influenza/vaccines/vaccinerecommendations1/en/index.html (accessed Feb 2013).
Reference Order: 
10
Reference Text: 
Food and Drug Administration. Statistical review and evaluation. Biologics license application/supplement number 125254/132. Afluria (CSL seasonal flu vaccine). 11 September 2009. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM229865.pdf (accessed Feb 2013).
Reference Order: 
11
Reference Text: 
CSL Limited. Afluria, influenza virus vaccine, suspension for intramuscular injection, 2008-2009 formula [package insert]. http://fedgeno.com/documents/2008-2009-afluria-vaccine-package-insert.pdf (accessed Feb 2013).
Reference Order: 
12
Reference Text: 
Tabor E. FDA requirements for clinical studies in pediatric patients. Regulatory Focus 2009; 14: 16-21.
Reference Order: 
13
Reference Text: 
US National Institutes of Health, ClinicalTrials.gov. A study to determine the immunogenicity and safety profile of CSL Limited’s influenza virus vaccine compared to a US licensed comparatory influenza virus vaccine in a pediatric population. Study identifier CSLCT-USF-07-36. http://clinicaltrials.gov/ct2/show/NCT00959049?term=CSLCT-USF-07-36&rank=1 (accessed Feb 2013).
Reference Order: 
14
Reference Text: 
Centers for Disease Control and Prevention. Update: recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding use of CSL seasonal influenza vaccine (Afluria) in the United States during 2010-11. MMWR Morb Mortal Wkly Rep 2010; 59: 989-992. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5931a4.htm (accessed Feb 2013).
Reference Order: 
15
PubMed ID: 
20703207
Reference Text: 
Salisbury DM. Risk of febrile convulsions in children aged under five years and seasonal influenza vaccines marketed by Pfizer Vaccines (Enzira and CSL Biotherapies generic influenza vaccine). Dear colleague letter dated 28 July 2010. London: Department of Health, 2010. http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_117984 (accessed Feb 2013).
Reference Order: 
16
Reference Text: 
Maraskovsky E, Rockman S, Dyson A, et al. Scientific investigations into febrile reactions observed in the paediatric population following vaccination with a 2010 Southern Hemisphere Trivalent Influenza Vaccine. Vaccine 2012; 30: 7400-7406.
Reference Order: 
17
PubMed ID: 
23063831
Reference Text: 
Kelly HA, Skowronski DM, De Serres G, Effler PV. Adverse events associated with 2010 CSL and other inactivated influenza vaccines. Med J Aust 2011; 195: 318-320.
Reference Order: 
18
Reference Text: 
Joint Australian Technical Advisory Group on Immunisation (ATAGI) and Therapeutic Goods Administration (TGA) Seasonal Influenza Vaccine Safety Ad Hoc Working Group. Review of data on the safety of seasonal influenza vaccines, particularly Fluvax (CSL Biotherapies) in adults and children >10 years. Working group report. 10 February 2012. http://www.immunise.health .gov.au/internet/immunise/publishing.nsf/Content/96E2FDB094859 CA0CA2579960083A5D0/$File/Final%20Report.pdf (accessed Feb 2013).
Reference Order: 
19
Reference Text: 
Kelly H, Carcione D, Dowse G, Effler P. Quantifying benefits and risks of vaccinating Australian children aged six months to four years with trivalent inactivated seasonal influenza vaccine in 2010. Euro Surveill 2010; 15: 19661.
Reference Order: 
20
PubMed ID: 
20929647
Reference Text: 
Gold MS, Effler P, Kelly H, et al. Febrile convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccine safety surveillance in Australia. Med J Aust 2010; 193: 492-493.
Reference Order: 
21

The full contents of this page are only available to subscribers.