Better regulation needed for kids' flu vaccine

April 15, 2013 by Carley Tonoli, The Conversation
CSL TIV is no longer recommended for children less than five years of age in Australia. Credit:

Flu vaccines given to children should be more rigorously tested before before being allowed onto the market, researchers say, to prevent a repeat of the 2010 vaccine release, which caused a spate of high fevers and febrile convulsions in young children.

The paper, published in the Medical Journal of Australia, reviews the regulatory history of CSL Fluvax trivalent (TIV) in Australia and overseas and recommends a tougher to protect .

Australian estimate that the risk of febrile convulsions in young children after vaccination with CSL TIV ranged from three to ten per 1,000 children vaccinated in Australia, before the program was suspended in April 2010.

As a result, CSL TIV is no longer recommended for children less than five years of age in Australia, the United States and the United Kingdom.

The paper reports that in 2002 thiomersal-free CSL TIV was approved for use in Australia in people aged six months and older, even though no controlled clinical studies had been conducted in children.

"Ideally, adequately powered, controlled paediatric studies should be conducted before a is licensed for children," study authors Health Kelly and Nicholas Kelley say in the paper.

The first and only randomised to date commenced in 2005 and was reported on in 2009, seven years after the vaccine was licensed for children in Australia.

The paper re-examined the data from that trial, which involved 298 children, aged less than nine years, who each received two doses of the 2005 formulation of TIV and a "booster" of the 2006 formulation, which had different virus antigens.

"The study results, published in 2009, showed a marked difference between the risk of reported fever, depending on the annual formulation of the CSL TIV administered," the new paper said.

Once a is licensed for use in Australia, the manufacturer is able to alter the formulation of the vaccine each year to protect against new flu strains that may be circulating.

Professor Robert Booy, Professor and Head of Clinical Research, National Centre for Immunisation Research and Surveillance (NCIRS) at University of Sydney said this was an important paper that deserved recognition.

"More research is needed before flu vaccines are introduced," he said.

"At NCIRS we have been conducting a systematic review of all relevant literature, published or not.

"We hope the various pharmaceutical companies will cooperate with us in providing anonymised individual level data."

Professor Booy said he agreed with the authors that thorough post-marketing monitoring for adverse events after all paediatric flu vaccines was essential and proposed an integrated yearly study involving at least 1,000 per year for the next three years.

Professor Anton Middelberg, Deputy Director of The Australian Institute for Bioengineering and Nanotechnology at the The University of Queensland said the study served as a reminder of the need to strictly control vaccine manufacture processes.

"Vaccine quality, and adverse effects, have on occasion been linked to variations in batch-to-batch manufacture," Professor Middelberg said.

"Subtle changes in process conditions can magnify in a chaotic fashion to compromise product quality, if not fundamentally understood and strictly controlled," he said.

"The problems become more acute when old technology is pushed to operate more quickly than it is designed to do, for example, when we are faced with a pandemic.

"There is a clear need for new, quicker and better-understood vaccine manufacture technology."

Explore further: Any prime-boost mix of injected or spray flu vaccine shields toddlers

More information: … es-control-influenza

Related Stories

Any prime-boost mix of injected or spray flu vaccine shields toddlers

August 16, 2011
Children younger than 3 years old receive the same protective antibody response from the recommended two doses of licensed seasonal influenza vaccines regardless of whether the two doses are injected by needle, inhaled through ...

FDA approves flu vaccine for coming season

August 14, 2012
(HealthDay) -- The formulation for the vaccine that will help protect against the flu this coming season was approved by the U.S. Food and Drug Administration on Monday.

Recommended for you

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

Price tag on gene therapy for rare form of blindness: $850K

January 3, 2018
A first-of-its kind genetic treatment for blindness will cost $850,000 per patient, making it one of the most expensive medicines in the world and raising questions about the affordability of a coming wave of similar gene-targeting ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.