Fluarix is a flu shot created by GSK.
Fluarix Quadrivalent Package Insert
Fluarix Quadrivalent Supporting Documents
September 27, 2018 – 2018-2019 Recommendations for influenza prevention and treatment in children : an update for pediatric providers ”
2018 – Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults (open access) “During the entire study period, there were 59 (14.4%) and 52 (12.7%) MAEs (most commonly upper respiratory tract infection, bronchitis, pharyngitis, and nasopharyngitis) in the IIV4-I and IIV4 groups, respectively (Additional file 3). Only 1 SAE, viral meningitis was observed in the IIV4-I group but it was not considered by the investigator to be vaccine-related.
Volume 21 Number 2, 2012 – Childhood Stroke after Influenza Vaccination (pdf)
- A 10-year-old girl of Chinese-Thai descent presented with acute-onset vertiginous giddiness, blurred vision, headache and non-bilious vomiting. She had new-onset vertiginous giddiness six hours prior to admission, associated with mild frontal headache, which was worse on sitting up. She also complained of a sudden inability to balance herself and had vomited more than 10 times prior to admission. There were no associated symptoms of tinnitus, hearing loss, focal numbness or weakness, and there was no history of head trauma. However, she did receive the influenza vaccine (FluarixTM, GlaxoSmithKline Pte Ltd) one day prior to the onset of symptoms.
- “To our knowledge, childhood stroke has not been previously reported in association with the influenza vaccination. A review of literature revealed two recent reports of stroke temporally associated with influenza vaccination in adults; however both reported cases had underlying co-morbidities that substantially increased their predisposition to developing a stroke. The first report was of a 55-year-old Caucasian female with a history of osteoporosis and non-erosive knee arthritis. The patient developed a left middle cerebral artery ischaemic infarct four days after the influenza vaccination.”
- The second report occurred in a 64-year-old Caucasian male who had a history of atrial fibrillation on warfarin for stroke prophylaxis5 . He passed away following a large left temporal, parietal and occipital haemorrhagic infarct 4½ weeks after receiving an inactivated influenza vaccine; at the time of the stroke, he was documented to have a greatly increased INR that had increased from two at the time of vaccination (and stable INR over the previous six months) to >15.
October 18, 2011 – Statistical Review and Evaluation – Fluarix “Over 40% of subjects were excluded from the ATP immunogenicity cohort. This may reflect poor execution of this study. However, among the subjects excluded from the immunogenicity analysis, I did not find any significant imbalance between the two groups with respect to important baseline variables. The applicant is seeking an indication based on post-hoc subgroup analysis. Even though the 3-5 year age group was used as a randomization stratum, it was not pre-specified for separate immunogenicity analysis. The post-doc nature of any analysis increases the likelihood that a positive finding is spurious.
October 6, 2011 – Stability of seasonal influenza vaccines investigated by spectroscopy and microscopy methods “The split vaccine Fluarix (GlaxoSmithKline) was affected only by storage at 25°C. The virosomal vaccine Inflexal V (Berna Biotech) was stable after the temperature stresses but aggregated after one freeze-thaw cycle. This study provides new insights into commercial vaccines of low antigen concentration and highlights the importance of using multiple techniques to assess vaccine stability.”
September 22, 2011 – FDA FLUARIX Influenza virus vaccine GlaxoSmithKline Biologicals Review of Pre-Licensure Safety Data (pdf) “FLUARIX first licensed in U.S. in adults ≥ 18 years on August 31, 2005 – under accelerated approval regulations“…”FLUARIX use expanded to individuals ≥ 3 years on October 19, 2009
July 15, 2011 – FDA Pediatric Safety and Utilization Review: FLUARIX® (Influenza Virus Vaccine) (pdf) “In Australia and New Zealand, use of the 2010 Southern Hemisphere formulation of one trivalent inactivated influenza virus vaccine, manufactured by CSL Limited, has been associated with an increased incidence of fever and febrile seizure among young children, mainly among those less than 5 years of age. Therefore, the Warnings and Precautions section of the Prescribing Information for Afluria, the U.S. licensed Northern Hemisphere formulation made by CSL Limited, has been changed to include a statement to inform healthcare providers about the occurrence of these events.”
August 20, 2010 – Inactivated split-virion seasonal influenza vaccine (Fluarix): a review of its use in the prevention of seasonal influenza in adults and the elderly. “The most common adverse reactions in recipients of Fluarix® were pain, redness or swelling at the injection site, muscle aches, fatigue, headache and arthralgia.”
July 10, 2010 – Mining of vaccine-associated IFN-g gene interaction networks using the Vaccine Ontology (full text) “Our method also allows the generation of the networks of gene-vaccine and vaccine-vaccine associations, leading to better understanding of vaccine-induced immune mechanisms.”
October 19, 2009 – FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use “The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.”
February 19, 2009 – Vaccines and Related Biological Products Advisory Committee Meeting (pdf) “In terms of fever, there was actually more fever among Fluarix recipients”
January 15, 2009 – The Rationale for Initiating Pediatric Clinical Development of GlaxoSmithKline Biologicals’ Candidate H5N1 Vaccine Produced in Quebec (pdf) “The overall safety profie of the D-Pan vaccine containing a 1.9 iig dose of viral HA and AS03B was acceptable as established preliminarily in 102 children when compared with that of the control, Fluarix”
March 26, 2006 – How fast can a new vaccine for an emerging respiratory virus be developed and available for use? (pdf) “If product can be made, core data can be generated rapidly – example GSK Fluarix: 1 month/900 patients”