Afluria is a flu vaccine primarily used in Australia. (CSL/Merck – Australia)
Afluria Quad Vaccine Package Insert
April 1, 2019 – Influenza: overview on prevention and therapy (full text) “Healthy children 6–59 months of age were enrolled. Children were excluded if they were febrile (axillary temperature ≥ 99.5 °F [≥37.5 °C]), acutely ill, immunocompromised, or allergic to egg proteins or any study vaccine component. Children were also excluded if they had a history of serious adverse reactions to any influenza vaccine; a known coagulation disorder; a history of seizures (with the exception of a single febrile seizure); or had received any influenza vaccine within the last 6 months, any immunoglobulin or blood product within the last 3 months, an investigational product within the last 28 days, or any licensed vaccine within the last 21 days.
Afluria Vaccine Package Insert (pdf)
December 12, 2012 – Afluria TN: BL 125254 Proper Name: Influenza Virus Vaccine Tradename: AFLURIA Manufacturer: CSL Limited, License No. 1764 Indication: For active immunization of persons ages 5 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
September 22, 2011 – Afluria Influenza Virus Vaccine CSLBiotherapies,Ltd (pdf) Pediatric Advisory Committee Meeting (pdf) – “Febrile seizure rate: – 1 in 298 subjects = 0.3%, 95% CI (-0.96, 2.96) – Prevalence of febrile seizures: 2-5% by age 5″
May 30, 2011 – Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine (full text) “In the meantime, the Australian government recommended use of vaccines other than the CSL products in children under 5 years of age for the remainder of 2010 and in 2011 and the US Advisory Committee on Immunization Practices has recommended that the CSL Biotherapies TIV marketed in the USA (Afluria) not be used in children aged from 6 months to 8 years.”
January 21, 2011 – 2010-2011 Influenza Season Vaccine Questions and Answers
September 3, 2010 – FDA Afluria Supporting Documents “In Australia and New Zealand, use of the 2010 Southern Hemisphere formulation of one influenza 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 13, 2010 – 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 “In Australia and New Zealand, use of 2010 Fluvax Junior (0.25 mL preparation) and Fluvax (0.5 mL preparation) was suspended in children aged <5 years because of reports of fever and febrile seizures occurring after receipt of these vaccines in children aged 6 months through 4 years”
August 5, 2010 – Summary* Recommendations: Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—(ACIP)—United States, 2013-14 “Age indication per package insert is ≥5 years; however, the ACIP recommends Afluria® not be used in children aged 6 months through 8 years because of increased risk of febrile reactions noted in this age group with CSL’s 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5–8 years who has a medical condition that increases the child’s risk for influenza complications, Afluria® can be used; however, providers should discuss with the parents or caregivers the benefits and risks of influenza vaccination with Afluria® before administering this vaccine. Afluria® may be used in persons aged ≥9 years.
August 3, 2010 – FDA approves 2010-2011 influenza vaccines; offers updates on Afluria “Current data indicate higher incidence of these adverse outcomes are only associated with the Southern Hemisphere’s formulation of Afluria, and the FDA is requiring CSL Limited to conduct a study of Afluria in children to further investigate the cause of these febrile events…”The FDA also announced that CSL Limited will not be providing the U.S. with the 0.25 mL single-dose, prefilled syringes that are used in very young children. However, the 0.5 mL single-dose, prefilled syringes and 5 mL multi-dose vials will be available.”
August 2, 2010 – Fevers, Febrile Seizures Higher After Afluria Vaccination in Children Below Equator (free registration)
July 30, 2010 – Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change – Risk of Fever and Febrile Seizure
June 28, 2010 – CSL Biotherapies FDA Letter current good manufacturing practice (CGMP) “During the inspection, FDA investigators documented deviations from current good manufacturing practice (CGMP) requirements in the manufacture of licensed biological vaccine products and monovalent influenza bulks. These products include Afluria and Influenza A (H1N1) Monovalent Vaccine.”…”You failed to assure that drug product containers or closures are not reactive and additive so as to alter the safety, identity strength, quality and purity of the drug beyond the official or established requirements [21 CFR 211.94(a)]. For example: Your firm was notified by its stopper supplier on December 17, 2009, that —-(b)(4)— rubber –(b)(4)– stoppers may react with thimerosal and therefore are not recommended for use with thimerosal containing products. To date your firm still utilizes these stoppers for MDV’s of vaccine containing thimerosal.”
September 11, 2009 – Statistical Review and Evaluation BLA Afluria (CSL Seasonal Flu Vaccine) (pdf) “Active immunization of persons ages 6 months to 18 years old against influenza disease caused by influenza virus subtypes A and type B present in the vaccine”
February 1, 2005 – Adverse Events After Inactivated Influenza Vaccination Among Children Less Than 2 Years of Age: Analysis of Reports From the Vaccine Adverse Event Reporting System, 1990–2003 “Nineteen of 28 seizure reports (68%) described fever with the seizure within 2 days after vaccination. Seizure was the most frequent coding term (N = 10, 7 with fever) among 23 serious reports. The annual number of TIV-related VAERS reports for children <2 years of age increased in the post-ACIP guideline period, probably at least in part because of an increase in the number of vaccinees after the ACIP announcement. The safety profiles in the pre-ACIP guideline and post-ACIP guideline periods were similar.”
November 2004 – Safety of the Trivalent Inactivated Influenza Vaccine Among Children “Results Study participants incurred 1165, 230, and 489 different diagnoses during the 14 days after vaccination according to the outpatient, emergency department, and inpatient data, respectively. Four diagnoses were positively associated with the vaccine in both groups 1 and 2: impetigo, dermatitis, uncomplicated diabetes mellitus, and ureteral disorder not otherwise specified. After medical record review, impetigo (9 cases) in children 6 to 23 months old remained significantly associated with vaccination.”