Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

Featured In: Regulatory News

By FDA MedWatch Friday, July 30, 2024

newsvine diigo google
slashdot
Share
Loading...
[Posted 07/30/2010]

AUDIENCE: Pediatrics, Family Practice

ISSUE: FDA updated the Warnings and Precautions sections of the Prescribing Information for Afluria to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.

BACKGROUND:  FDA announced the approved vaccines for the 2010-2011 influenza season in the United States. The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

The available data suggest that the increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of CSL’s vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure. FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.

RECOMMENDATION: Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectable (“shot”) forms. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year.  Therefore, it is important to get the influenza vaccine every year.

Various investigations into the cause(s) of the febrile seizures seen with Afluria vaccine are still ongoing. FDA is collaborating with Australia’s regulatory authority, other international regulatory counterparts, and CSL to obtain additional information, stay apprised and take part in the investigations. FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the Vaccine Adverse Events Reporting System, a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration.

SOURCE

Join the Discussion
Rate Article: Average 0 out of 5
register or log in to comment on this article!

0 Comments

Add Comment

Text Only 2000 character limit

Page 1 of 1

Research Exchange

New Frontiers: The Changing World of Biospecimen Collection and Management

Jul 30

The growth of biomarker research and personalized medicine requires more unified and large-scale software systems to track biological materials.

Optical Imaging in Stem Cell Research

Jun 1

Developing sensitive, non-invasive technologies to monitor engraftment in vivo is essential to accelerate the clinical implementation of cell therapies.

Standing Up in a Court of Law

Jun 1

Private forensic testing laboratory ensures data integrity with advanced calibration systems.

Simultaneous Measurement of Multiple Signaling Pathways in Human Leukemias Using Flow Cytometry

May 24

Next generation assays will need to be robust and standardized in order to make the transition from a research procedure to a routine clinical assay. Flow cytometry provides a unique and sensitive method to accomplish these requirements.

Step up to the MIQE

Mar 30

Over the years, polymerase chain reaction (PCR) has evolved into a readily automated, high throughput quantitative technology. Real-time quantitative PCR (qPCR) has become the industry standard for the detection and quantification of nucleic acids for multiple application, including quantification of RNA levels. But a lack of consensus among researchers on how to best perform and interpret qPCR experiments presents a major hurdle for advancement of the technology. This problem is exacerbated by insufficient experimental detail in published work, which impedes the ability of others to accurately evaluate or replicate reported results.

Fast Optimization of a Multiplex Influenza Identification Panel Using a Thermal Gradient

Mar 30

The year 2009 was marked by the emergence of a novel influenza A (H1N1) virus that infects humans. There is a need to identify the different strains of influenza virus for purposes of monitoring the H1N1 strain pandemic and for other epidemiological and scientific purposes.

Advantages of Monolithic Laser Combiner Technology in Confocal Microscopy Systems

Jan 6

Fluorescence microscopy techniques require a reliable light source at the desired wavelength or wavelengths, with minimal downtime for maintenance and alignment. Lasers are a popular light source, although the alignment and upkeep of laser combiners is a time-consuming prospect for many users.

Size-Exclusion Chromatography for Purification of Biomolecules

Dec 2 2009

Size-exclusion chromatography (SEC) is a popular method to separate biomolecules based on their size. Primarily, it is applied to the separation of biopolymers such as proteins and nucleic acids, i.e. water-soluble polymers.

Using the Tecan Genesis Workstation to Automate a Cytometric Bead Array (CBA) Immunoassay

Mar 11

The poster describe the process involved in automating a Cytometric Bead Array (CBA) immunoassay developed to measure relative concentrations of serum antibodies against Tetanus (TT), Sperm Whale Myoglobin (SWM) and Keyhole Limpet Hemocyanin (KLH) in KLH-immunized volunteers.

Ensuring Quality in Assays Performed with Automated Liquid Handlers

Feb 2

The focus of this presentation is to highlight the need of ensuring quality in important assays performed with automated liquid handlers. Nearly all assays performed within a laboratory are volume-dependent. In turn, all concentrations of biological and chemical components in these assays, as well as the associated dilution protocols, are volume-dependent. Because analyte concentration is volume-dependent, an assay’s results might be falsely interpreted if liquid handler variability and inaccuracies are unknown or if the system(s) go unchecked for a long period.

Inkjet System for Protein Crystallography

Feb 1

X-ray crystallography is used routinely by scientists to obtain the three dimensional structure of a biological molecule of interest.Such information can be used to determine how a pharmaceutical interacts with a protein target and what changes might improve functionality. However, the crystallization of macromolecules still remains a serious hindrance in structural determination despite impressive advances in screening methods and technologies.

Attention Deficit & Hyperactivity in a Drosophila Memory Mutant

Attention Deficit & Hyperactivity in a Drosophila Memory Mutant

Nov 9 2009

Action selection is modulated by external stimuli either directly or via memory retrieval. In a constantly changing environment, animals have evolved attention-like processes to effectively filter the incoming sensory stream. These attention-like processes, in turn, are modulated by memory. The neurobiological nature of how attention, action selection and memory are inter-connected is unknown. We describe here new phenotypes of the memory mutant radish in the fruit fly Drosophila.

Normal development of hindgut and anorectum in human embryo.

22 minutes ago

PURPOSE: The aim of the present analysis is to examine the morphological changes, the spatiotemporal distribution of apoptosis/proliferation in the human embryonic anorectum, to reveal the normal development of human anorectum, and investigate the possible roles...

Signet-ring cell carcinoma of colorectum-current perspectives and molecular biology.

23 minutes ago

PURPOSE: Colorectal signet-ring cell carcinoma (SRCC) is rare, and very little detailed information on the molecular biology of the disease is available. METHODS: The literature on the clinical, pathological and, in particular, the molecular biology of this rare...

Design of Potent Inhibitors of Human RAD51 Recombinase Based on BRC Motifs of BRCA2 Protein: Modeling and Experimental Validation of a Chimera Peptide.

23 minutes ago

We have previously shown that a 28-amino acid peptide derived from the BRC4 motif of BRCA2 tumor suppressor inhibits selectively human RAD51 recombinase (HsRad51). With the aim of designing better inhibitors for cancer treatment, we combined an in silico docking...

The relative influence of nutrients and habitat on stream metabolism in agricultural streams.

23 minutes ago

Stream metabolism was measured in 33 streams across a gradient of nutrient concentrations in four agricultural areas of the USA to determine the relative influence of nutrient concentrations and habitat on primary production (GPP) and respiration (CR-24). In conjunction with...

Prokariotic Cell Collection in Denmark

Nov 6 2009

I would like to know about a prokariotic cell collection in Denmark. Is there a cell bank in this country? I need a Lactobacillus strain for a fermentation assay and this information about the bank is very helpful for me.

Request for Entries

Oct 16 2009

Ask the Experts is your chance to get the answers to questions on applications, materials, methods, processes, and technologies. Email you question to bst_web@advantagemedia.com, and the editors of Bioscience Technology will find an appropriate expert to answer it. Watch this space in the future to see the questions your colleagues are posting.

STAY INFORMED: SUBSCRIBE TO

Magazine and E-mail Newsletters

Loading...
E-mail:   

MULTIMEDIA

Video:

Viewing SureFocus Slides

Jun 11

A demonstration of SureFocus Microscope Slides in the review of AFB Smears. SureFocus Slides are a patent-pending breakthrough in tuberculosis detection, as their fluorescent staining circle remains visible during review, Fluorescence Microscopy.

Podcasts:

Allen Institute for Brain Research

Allen Institute for Brain Research

Oct 14 2009

Discussed in this interview are both the mouse brain project and the human cortex project with an emphasis on the importance of these projects to neuroscience research.

Information: