CSL: Report On Febrile Reactions To FluVax

Photo Credit PHIL

 

# 6395

 

 

A year after the 2009 pandemic started, vaccine manufacturers began delivering a seasonal trivalent influenza vaccine (TIV) with this newly emergent H1N1 strain included.

 

Australia was among the first to receive this new formulation in the spring of 2010.

 

Within weeks it became apparent that a significant number of young Australian children receiving a specific brand of flu shot - FluVax or FluVax Junior (CSL) - developed adverse reactions. Most of the side effects were mild and related to fever, but some children experienced potentially serious febrile convulsions.

 

Other symptoms included nausea and vomiting, or injection site inflammation (see Australia Investigating Adverse Vaccine Reactions).

 

For a while, Australia placed a moratorium on dispensing flu shots to children under the age of 5, but that was lifted after investigations found the problem was only linked to one manufacturer (see Australia Lifts Ban On Flu Vax For Under Five’s).

 

Since then, Australia, the United States, and Great Britain have recommended that CSL’s vaccine not be used in children under the age of 5 (see FDA Approves 2010-2011 Flu Vaccines) and cautioned for those aged 5 to 9, and investigations into the cause of these adverse reactions have continued.

 

Fast forward two years, and today we have a report from CSL Biotherapies that describes, at least in general terms, what appears to have gone wrong.

 

The details are presented in a press release and a series of supporting documents, including an Investigation summary.  Some excerpts (in blue) from that summary follow:

 

After ruling out bacterial or chemical contamination as the cause, the focus moved to CSL’s manufacturing process, and there they found (in animal models and in vitro systems):

 

• CSL’s influenza vaccines, as a class, trigger a greater immune gene response and induce higher levels of immune-stimulating hormones (cytokines) compared to other manufacturer’s influenza vaccines
• Fluvax^® 2010 induces higher levels of immune-stimulating hormones (cytokines) compared to previous season’s formulations of CSL’s influenza vaccine
• The B strain followed by the H1N1 strain used in Fluvax^® 2010 induces the strongest activity in the paediatric blood samples.

 

 

The reasons for these differences, CSL believes, include but may not be limited to:

 

CSL’s method of manufacture preserves more short gene fragments and lipids from the virus than other manufacturers.

 

The particular characteristics of the gene fragments and/or lipids from the swine flu strain and the B strain used in Fluvax^® 2010 may have led it to being more reactive in some young children in 2010 compared to CSL’s vaccines in previous seasons.

The gene fragments and lipids appear to be from split virus, but residual whole virus or clusters of both may have also contributed, and are under further investigation.

 

Increasing the amount of splitting agent (TDOC) reduces the amount of short gene fragments and lipids in the CSL vaccine, and also reduces the reactivity of the CSL vaccine (in vitro).

 

The scientific studies indicate that the root cause of the severe febrile response seen in some young children after vaccination with Fluvax^® in 2010 is complex and multi-factorial.

 

CSL continues their investigation, and is looking at ways to remedy the problem. Until they do, they plan no immediate changes to their manufacturing process, and recommend their vaccines for children over the age of nine.

 

While there are a number of news stories on the wires this morning, the always excellent Jason Gale, writing for Bloomberg News has some of the most complete coverage that I’ve seen.

 

Convulsion Risk From CSL Flu Vaccine Linked to Components

By Jason Gale on June 20, 2012

Convulsions in children immunized with a CSL Ltd. (CSL) flu shot probably were caused by an excessive immune response to viral components in the vaccine, according to preliminary findings of a two-year study.

 

(Continue . . . )

 

It is worth noting that In the summer of 2011, the Medical Journal of Australia (MJA) published a letter that looked at early flu-season testing of several non-CSL TIVs (Trivalent Influenza Vaccines) given to thousands of children under the age of 5. 

 

Ensuring safety of the 2011 trivalent influenza vaccine in young children

Christopher C Blyth, Tracy Y Markus, Paul V Effler and Peter C Richmond

 

 

As expected, a small number of febrile reactions were observed, but none proved serious, and none required professional medical attention.

 

Their reassuring finding was that the pediatric flu shots manufactured by both Sanofi Pasteur and Solvay proved to be very safe when administered to young children, with no repeat of the significant number of adverse reactions reported in 2010.

 

While no vaccine (or drug) can be said to be 100% safe – and rare but sometimes serious adverse effects have been reported - the preponderance of evidence continues to support the scientific consensus that flu vaccines are very safe and most years, reasonably effective.

 

Given that influenza-related illnesses claims thousands of lives each year in the United States (cite Estimating Seasonal Influenza-Associated Deaths in the United States), the smart money is on getting the vaccine every year.

 

For more on flu shot safety and benefits, you may wish to revisit:

 

BMJ: H1N1 Vaccination & Fetal Death Rates

Harvard Study Reaffirms Safety Of Flu Vaccine

»» Read More

Australia: Panvax Investigated For Febrile Convulsions

 

 

 

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Late last week Australia’s Therapeutic Goods Administration (TGA) issued an advisory on recent reports of a higher-than-expected number of pediatric febrile convulsions following administration of CSL’s monovalent Panvax  (pandemic) H1N1 flu vaccine

 

CSL’s trivalent seasonal flu shot came under scrutiny last April with similar adverse reactions.

 

The total number of reports were small (several hundred) out of tens of thousands of shots given, but significantly higher than normal.

 

Most of the side effects were related to fever, with some children experiencing febrile convulsions. Others experienced nausea and vomiting, or injection site inflammation (see Australia Investigating Adverse Vaccine Reactions).

 

This latest announcement regarding the Panvax vaccine suggests that the incidence of side effects for this monovalent shot -  while higher than usual – was a fraction of that seen with CSL’s seasonal vaccine.

 

Thus far, we’ve not seen excessive reports like these from other countries or from other manufacturer’s vaccines.

 

Two reports. 

 

First, excerpts from the TGA’s advisory, then a news report from The Sydney Morning Herald that suggests that these side effects may not prove as common as originally stated.

 

 

Suspected adverse reactions to Panvax® reported to the TGA 30 September 2009 to 17 September 2010

22 September 2010

 

The national immunisation program with Panvax® began on 30 September 2009. The TGA has been closely monitoring any side effects from the use of the vaccine.

 

As at 17 September 2010 a total of 1960 suspected side effects had been reported to the TGA following vaccination with Panvax® in Australia. The great majority of reported side effects have been mild and common problems such as headache, gastrointestinal upset, and soreness, swelling, or redness at the injection site. Most of the side effects that have been reported are well recognised and listed in the Panvax® Product Information. Of the suspected side effects reported, only 190 related to Panvax Junior®, and the majority of these reports were of fever (151) and/or vomiting (98).

The TGA's assessment remains that Panvax® is a safe, effective vaccine for prevention of the H1N1 influenza.

As at 17 September 2010 the TGA had received 48 reports of febrile convulsions in children following Panvax/Panvax Jr administration. Nine of these had occurred in children who had also been given other vaccines at the same time as they received Panvax.

 

(Continue . . .)

 

 

 

 

Swine flu jab for children may not be so harmful

Mark Metherell

September 28, 2010

The Commonwealth chief medical officer, Jim Bishop, has sought to play down concerns following the revelation that a second influenza vaccine, Panvax, has been linked to febrile convulsions in infant recipients of the vaccine.

(Continue . . . )

 

 

While often dramatic, febrile convulsions in young children are not uncommon with a fever, and only rarely prove serious.

 

Febrile Seizures Fact Sheet

»» Read More

Australia: No Clear Answers On Child’s Death

 

 

# 4889

 

 

 

Last April we began hearing reports of an unexpected number of adverse side effects among young children in Australia who had received CSL Ltd.’s  Fluvax seasonal flu vaccine.

 

The total number of reports were small (several hundred) out of tens of thousands of shots given, but significantly higher than normal.

 

Most of the side effects were related to fever, with some children experiencing febrile convulsions. Others experienced nausea and vomiting, or injection site inflammation (see Australia Investigating Adverse Vaccine Reactions).

 

Of most concern was the death of a 2 year old girl named Ashley, who died the day after receiving the shot (see Australian Vaccine Investigation Widens).

 

Obviously a suspicious timeline, but as we’ve seen many times in the past, correlation doesn’t always imply causation.

 

In June the Coroner investigating the case announced that autopsy results had failed to establish a cause of death (see Australian Coroner: No Link To Vaccine In Childs Death).

 

To be absolutely fair, saying `they’ve found no evidence to link the death to the vaccine’ isn’t quite the same as saying they have `proof that the vaccine didn’t cause the death’.

 

But that sort of definitive proof is often impossible to come by, particularly when no cause of death can be established.

 

Fast forward to today, and the Coroner has closed the investigation, with essentially no new developments. 

 

The coroner stated that while a link between her death and the vaccine cannot `absolutely be excluded’ that he found nothing to causally connect Ashley’s death to the flu vaccine.

 

Which, judging from the Australian newspaper headlines this morning, isn’t being taken as particularly reassuring.

 

Flu shot not ruled out in toddler's death

 

While technically accurate, this isn’t the headline I would have chosen. But then, it isn’t my job to sell newspapers.

 

With the investigation at a close, we will probably never know the true cause of Ashley’s tragic death. 

 

While it can’t be stated with 100% certainty that the vaccine didn’t in some way contribute to Ashley’s death, absolutely no link to the vaccine has been established.

 

 

Which would seem to me to be pretty good news and the real story here.

 

Unfortunately, inconclusive answers and headlines like the one above help to foster the public’s anxieties over the safety of vaccines.   

 

And it doesn’t seem to matter how many positive reports we get about the overall safety and overwhelming benefits of vaccination.

 

All it takes is one sensational story like this to undermine them.

»» Read More

UK: DOH Advises CSL/Pfizer Flu Vax Not For Under Five’s

 

 

# 4771

 

 

CSL, Ltd produces influenza vaccines for Australia, and for export to other countries.  In some cases those vaccines are marketed - and re-labeled – by other companies.

 

The UK is among the importers of CSL’s flu vaccine, which earlier this year was been linked to a higher than normal incidence of febrile side effects in children under the age of five.  

 

Pfizer markets the CSL vaccine under the name Enzira while CSL Biotherapies sells it as a generic influenza vaccine.

 

Doctors in the UK are being urged by the DOH to use the CSL/Pfizer vaccines for those over the age of five.

 

Healthcare Republic has the story at the link below.  

 

Flu jabs from CSL and Pfizer not for under fives, DoH warns

Tom Moberly, healthcarerepublic.com, 29 July 2010, 10:49am

 

 

You’ll I posted another story on the CSL vaccine earlier today in  Australia Lifts Ban On Flu Vax For Under Five’s.

»» Read More