Excellent response in the BMJ to the suspension of flu vaccines in Australia

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Sweet

Australia suspends seasonal flu vaccination of young children

BMJ 2010; 340: c2419

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Adverse events following influenza vaccination in Australia--should we be surprised?

Collignon, Doshi, Tom Jefferson

(7 May 2010)

Adverse events following influenza vaccination in Australia--should we be surprised?

7 May 2010

Collignon, Infectious Diseases Physician and Microbiologist Canberra Clinical School. Australian National University, Doshi, Tom Jefferson

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Re: Adverse events following influenza vaccination in Australia--should we be surprised?

There have been large numbers of major adverse reactions to this year's

seasonal influenza vaccine in Australia, and the vaccine has been

suspended for use in children aged five and under [1,2]. These

reactions have occurred across the country and involved multiple

batches of vaccine [2]. In the state of Western Australia where

the problem was first detected, reports suggest that of the 20,000 to

30,000 children vaccinated, more than 250 had adverse reactions and 55

had febrile convulsions before vaccination was suspended in young

children [2]. Assuming all convulsions were in children, about

one child in every 500 vaccinated had a febrile convulsion.

Across Australia, media accounts indicate that more than 400 adverse

reactions [3] including 77 cases of febrile convulsion [1] have been

reported by regulators. While attention remains focused on

reactions in very young children, reports suggest only one-third of the

reactions may have occurred in children under five [4].

Although this situation has triggered considerable controversy in

Australia, the story has attracted little to no media attention in the

US and Europe. Similarly, the media has paid little attention to

a US H1N1 federal vaccine safety advisory committee which recently

reported detecting signals for Guillain-Barre syndrome (GBS), Bell's

palsy, and thrombocytopenia in the monovalent H1N1 (swine flu) vaccine

[5]. The same monovalent H1N1 antigen component under review in the US

is scheduled to be added to the US trivalent seasonal vaccine and is

contained in the Australian trivalent seasonal vaccine and will be

given to children, pregnant women and adults [6].

Data from a previous Australian study of H1N1 vaccine show that a large

percentage of children developed fevers following vaccination--in

children less than 3 years, between three and six in every ten

vaccinated, depending on dose [7,8]. The data also show a dose response

effect -- the larger the vaccine dose, the more severe the harms. There

was also an age relationship: children under the age of three developed

fevers at more than twice the rate of older children [7,8]. The study

was however underpowered to detect febrile convulsions at the current

rates in Australia, with only 162 children below the age of three. The

size problem was further aggravated by stratification by age group and

antigen dose.

Presumably the vaccine manufacturer CSL, which sponsored the trial, and

Australia’s regulatory body, the Therapeutic Goods Administration

(TGA), which used this data in approving the vaccine for children, were

aware of these important findings. But authors of the study

published earlier this year did not discuss the high incidence of fever

associated with vaccination [7]; data were instead only reported in

online-only supplementary tables [8].

Overall, the percentages of children under three who developed a fever

after vaccination appear very high; thirty five per cent with the 15 ug

dose and 62% after a 30 ug dose [7,8]. Of those that received a 7.5 ug

dose in the seasonal influenza vaccine, 23% develop a fever of >38

degrees Celsius [6].

The large number of children suffering harms--and subsequent suspension

of the vaccine--challenges the assumption that regulators are ensuring

the safety and efficacy of all marketed therapeutics. Should we

be surprised that these problems have occurred with influenza vaccine,

a vaccine used for over 60 years, said to have "an established record

of safety in all age groups"? [9] There are actually relatively

little data on the effects of vaccinating young children against

influenza [10]. Some manufacturers have even withheld data from public

scrutiny amidst general indifference [10,11]. Evidence from all

comparative influenza vaccine studies shows that harms, when they are

investigated, are not reported consistently and systematically [10,11].

As pandemic vaccines are provided to governments and not individuals

and manufacturers are indemnified for damages caused to users [12-14],

there seem to be few incentives for investigation of harms.

Last winter, the likelihood that a child without risk factors would die

from swine flu was less than one in a million [15]. When such a high

proportion of children develop moderate to severe febrile reactions to

the influenza vaccine, it's likely that more harm than good will occur

by vaccinating the entire population.

If such a large proportion of children develop high fevers, it is also

likely that a substantial number will develop febrile convulsions as a

result of vaccination. It is thus surprising the vaccine was approved

for this age group. It is also surprising that more explicit warnings

about the high risk of adverse reactions were not given to parents when

their children were being vaccinated. Passive surveillance (as in

Australia and elsewhere) is a relatively weak mechanism to detect and

evaluate post-vaccination adverse events [16].

Unlike most drugs, vaccines are used on a population basis triggered by

public health policy. As such, evidence of their safety and

efficacy needs to be extraordinarily rigorous and evaluation methods

and data should be open to independent scrutiny. We need much better

and larger studies on both safety and efficacy before we roll out

influenza vaccine programs to all populations, especially to children

who appear to have much higher rates of adverse reactions. Finally,

decisions to use a vaccine in a population must consider its safety

profile, but principally its effectiveness. There is poor evidence on

how well influenza vaccines prevent any influenza complications in

children [10] and other age groups. There is good evidence that

influenza vaccines study reports cherry pick results and achieve

spurious notoriety [17]. Exposing human beings to uncertain effects is

a risky business.

References

1. Sweet M. Australia suspends seasonal flu

vaccination of young children. BMJ. 2010 May

4;340(may04_2):c2419. http://www.bmj.com/cgi/content/extract/340/may04_2/c2419

2. J. Flu reactions cause still unclear

[internet]. 6minutes. 2010 Apr 27 [cited 2010 May 5];Available from: http://www.6minutes.com.au/articles/z1/view.asp?id=516097

3. Bita N. Suspended flu jab caused fits in 67 kids

[internet]. The Australian. 2010 Apr 30 [cited 2010 May 5];Available

from: http://www.theaustralian.com.au/news/health-science/suspended-flu-jab-caused-fits-in-67-kids/story-e6frg8y6-1225860374357

4. A. Flu jab scare sparks call for

surveillance system [internet]. 2010 23T16:38:00+10:00 4 [cited 2010

Apr 24];Available from: http://www.abc.net.au/news/stories/2010/04/23/2881522.htm

5. U.S. National Vaccine Advisory Committee. Report

on 2009 H1N1 Vaccine Safety Risk Assessment [internet]. 2010 Apr 28

[cited 2010 Apr 30];Available from: http://www.hhs.gov/nvpo/nvac/reports/vsrawg_report_apr2010.html

6. CSL. Fluvax Inactivated Influenza Vaccine (Split

Virion). Product information [internet]. 2009 Nov [cited 2010 May

5];Available from: http://www.csl.com.au/s1/cs/auhq/1217017237558/Web_Product_C/1196562642777/ProductDetail.htm

7. Nolan T, McVernon J, Skeljo M, Richmond P, Wadia

U, Lambert S, et al. Immunogenicity of a Monovalent 2009 Influenza

A(H1N1) Vaccine in Infants and Children: A Randomized Trial. JAMA. 2010

Jan 6;303(1):37-46. http://jama.ama-assn.org/cgi/content/full/303/1/37

8. Nolan T, McVernon J, Skeljo M, Richmond P, Wadia

U, Lambert S, et al. Immunogenicity of a Monovalent 2009 Influenza

A(H1N1) Vaccine in Infants and Children: A Randomized Trial. JAMA. 2010

Jan 6;303(1):Supplementary online content. http://jama.ama-assn.org/cgi/content/full/2009.1911/DC1

9. World Health Organization. Safety of pandemic

vaccines [internet]. 2009 Aug 6 [cited 2009 Aug 14];Available from: http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html

10. Jefferson T, Rivetti A, Harnden A, Di Pietrantonj

C, Demicheli V. Vaccines for preventing influenza in healthy children.

Cochrane Database Syst Rev. 2008;(2):CD004879. http://www3.interscience.wiley.com/homepages/106568753/CD004879_standard.pdf

11. Jefferson T, S, Demicheli V, Harnden A,

Rivetti A. Safety of influenza vaccines in children. Lancet. 2005 Sep

3;366(9488):803-804.

12. Sebelius K. Pandemic Influenza

Vaccines--Amendment [internet]. 2009 Jun 25;Available from: http://edocket.access.gpo.gov/2009/pdf/E9-14948.pdf

13. Lakhani N. Swine flu in Britain: The guessing

game [internet]. 2009 Jul 19 [cited 2009 Aug 11];Available from: http://www.independent.co.uk/life-style/health-and-families/health-news/swine-flu-in-britain-the-guessing-game-1752302.html

14. Legal immunity set for swine flu vaccine makers -

Swine flu [internet]. [cited 2010 May 6];Available from: http://www.msnbc.msn.com/id/31971355/

Other vaccine contracts between the French, German, and Italian

government and manufacturers are available at http://attentiallebufale.it/uncategorized/contract-fishing/

15. New South Wales public health network.

Progression and impact of the first winter wave of the 2009 pandemic

H1N1 influenza in New South Wales, Australia. Euro Surveill [internet].

2009 Oct 22 [cited 2010 May 5];Available from: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19365

16. Rosenthal S, Chen R. The reporting sensitivities

of two passive surveillance systems for vaccine adverse events. Am J

Public Health. 1995 Dec 1;85(12):1706-1709. http://ajph.aphapublications.org/cgi/reprint/85/12/1706

17. Jefferson T, Di Pietrantonj C, Debalini MG,

Rivetti A, Demicheli V. Relation of study quality, concordance, take

home message, funding, and impact in studies of influenza vaccines:

systematic review. BMJ. 2009;338:b354. http://www.bmj.com/cgi/content/full/338/feb12_2/b354

Competing interests: TJ is author of the relevant Cochrane reviews.

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