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FDA Warns Vaccine Company over Failure to Protect Children from Adverse Events

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The U.S. Food and Drug Administration has written a scathing warning letter to the vaccine company CSL Biotherapies about its Afluria and monovalent flu vaccines.

In 2010, the company’s vaccine, Fluvax, caused a much higher rate of fevers and convulsions in children than anticipated. It contained a strain of H1N1 flu that had never before been used on children. Afluria is almost the same vaccine, except that the strains of flu in it are different.

Officials found that Fluvax caused febrile convulsions in four out of every thousand children. In addition there were 1,000 reported adverse reactions.

In Western Australia, there were 23 children hospitalized after receiving Fluvax and experts said that children had a higher chance of being hospitalized after the vaccine than after the flu itself.

Most febrile convulsions are harmless and are caused by elevated body temperature, but sometimes they can lead to long term problems and brain damage.

Eleven-month-old Saba Button suffered seizures after her vaccine and was left with brain injury and liver, kidney and bone marrow failure. Saba’s parents have been told that she will never walk or talk and that she will require 'round the clock care for the rest of her life.

The vaccine was subsequently withdrawn and the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended that the similar vaccine, Afluria, not be used in children less than 9 years old.

A U.S. trial of the drug found that Afluria caused a higher incidence of fever in children aged 5 to 8 years old. Fever is a trigger for febrile convulsions.

The FDA criticized CSL for failing to find out the cause of the adverse reactions:
"You failed to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications, and failed to extend the investigation to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy," the FDA said.

The FDA also added that the company’s investigation of the adverse events was "inadequate" and that they hadn’t even documented their investigation.
CSL said the content level of the H1N1 virus may have been more potent than previous strains of flu used in vaccines but they initiated no testing on the vaccine to see if the content of the strains was different:

"The Quality Review Report indicates that the A/California/7/2009 (H1N1) strain appears to have a (b)(4) content, which could have contributed to the Adverse Events. You confirmed that A/California/7/2009 (H1N1) had a (b)(4) level of (b)(4), but have not initiated testing of the 2010 influenza vaccine lots to determine differences in (b)(4) content compared to 2009 strains," the FDA wrote.

They were also reprimanded for not investigating dark particles found in thimerosal-containing vials. The company argued that the dark particles were part of the product, but the FDA said they provided no proof of that:

"You concluded that the dark particles are not foreign to the product. However, dark particles have not been linked to bulk lots and product in syringes (using different stoppers) and no rationale is provided for your conclusion."

A meeting has been requested by the FDA to further discuss the safety of the vaccines.

FDA Warning Letter, Commonwealth Serum Laboratories, 15th June 2011 - http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm259888.htm
Vaccine Family Sue CSL over Flu Shots, Expert Briefings, 23rd June 2011 - http://www.expertbriefings.com/news/vaccine-family-to-sue-csl-over-flu-shots/
American Academy of Family Physicians, 12th August 2010 - http://www.aafp.org/online/en/home/publications/news/news-now/clinical-care-research/20100812afluria.html
Side effects worse than the disease, Sydney Morning Herald, 18th September 2010 - http://www.smh.com.au/lifestyle/wellbeing/side-effects-worse-than-the-disease-20100917-15gbm.html

Reviewed June 27, 2011
Edited by Alison Stanton

Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunisation,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.

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