Statement that clinical studies had demonstrated bioCSL's seasonal influenza vaccines had acceptable safety profile in all age groups is not supported by the data

Author:

Effler Paul V.,Kelly Heath

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference5 articles.

1. New Wisdom to Defy an Old Enemy: summary from a scientific symposium at the 4th Influenza Vaccines for the World (IVW) 2012 congress, 11 October, Valencia, Spain;Poland;Vaccine,2013

2. Challenges in regulating influenza vaccines for children;Effler;Med J Aust,2013

3. Afluria Pediatric Safety and Utilization Review for the Pediatric Advisory Committee (PAC) Meeting. Michael Nguyen, MD, Medical Officer, Vaccine Safety Branch, Food and Drug Administration; 2011. p. 7. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM272238.pdf [accessed 05.06.13].

4. Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents;Lambert;Influenza Other Respi Viruses,2013

5. Afluria, Influenza Virus Vaccine, BLA Efficacy Supplement, Clinical Review. Cynthia Nolletti, MD, Clinical Reviewer, Clinical Trials Branch, Food and Drug Administration; 2011. p. 9. Available from: https://dl.dropboxusercontent.com/u/76256696/F13-1576%20Clinical%20Review%20FDA%202011%20CSL%20Afluria%20Fluvax%20Nolletti.pdf [accessed 05.06.13].

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