Why can’t we have a rational discussion about the merits of pandemic flu vaccination?

[Guest guest]

Why can’t we have a rational discussion about the merits of pandemic

flu vaccination?

August 31, 2009 – 12:02 pm, by Croakey

http://blogs.crikey.com.au/croakey/2009/08/31/why-cant-we-have-a-rational-discus\

sion-about-the-merits-of-pandemic-flu-vaccination/

In some public health circles, it is seen as verging on cardinal sin

to raise questions in public about the safety or effectiveness of

vaccines. The fear is that even mentioning these issues risks lending

fuel to the anti-vaccination brigade.

One problem with this view is that is inhibits a discussion that we

need to have about the potential costs and benefits of the planned

pandemic influenza vaccine roll-out. One infectious diseases

specialist told me recently that it felt like the roll-out was

something of a juggernaut – relentlessly proceeding in the face of

quite widespread concerns about its merits.

The Australian Infection Control Association – critical players in any

vaccine roll out, not least because of their role in encouraging

vaccination of health care workers – has today come out opposing the

vaccination plans because of the potential risks of multidose vials.

Their concerns are reported in the Crikey bulletin.

Meanwhile, Professor Collignon, from the ANU Medical School, has

written this analysis for Croakey.

He writes:

“A pandemic H1N1 09 (swine flu) vaccine will be rolled out here very

soon as the start of a mass vaccination campaign. However, this will

be in multi-dose vials made by CSL. Spokespeople from Federal Health

and CSL have all been reassuring that this will be safe and that the

manufacturing and safety checking processes will be no different to

what happens with seasonal flu.

These reassurances fly in the face of reality. Multi-dose vials have

transmitted infectious organisms, resulting in deaths and serious

illnesses, repeatedly over decades.

In Australia we had the Bundaberg Disaster in 1928. Diphtheria vaccine

contaminated with Staphylococcus aureus from multi-dose vials caused

the deaths of 12 children and resulted in a Royal Commission.

In Geelong in the late 1960’s, two factory workers died from

Streptococcus pyogenes following workplace flu vaccinations from multi-

dose vial. The coroner subsequently recommended against the use of

multi dose vials. In NSW a multi-use vial was suspected as the cause

for HIV transmission in a surgeon’s office.

Infection Control guidelines and multiple international agencies such

as the World Health Organization (WHO), recommend as best practice

that single-dose vials be used where possible. Preservatives added to

multi-dose vials (such as thiomersal – a mercury containing compound)

reduce the survival of bacteria, but as WHO notes, they still remain

prone to bacterial contamination. Preservatives don’t kill viral

contaminants.

Multi-dose vials have frequently been the likely source of outbreaks

and some other examples are hepatitis B, hepatitis C and Pseudomonas

aeruginosa.

In a WHO document on best infection control practices for needle

injections, it noted that each year worldwide, poor injection

practices (that includes a contribution from contaminated multi-use

vials) cause millions of blood borne viral infections especially with

hepatitis B virus.

In Australia by August 28th there were 150 reported deaths associated

with H1N1 and 4,398 hospitalizations. Four deaths have been in

pregnant women.

NSW Health has the best updated and detailed data available. By August

26th in NSW there had been 1,164 hospitalizations, 181 ICU admissions

and 41 deaths. Infections peaked in mid July and now flu is at low

seasonal levels of activity. Only 2 deaths (12%) were in those below

the age of 40 years.

Surprisingly the age of the groups with the highest admission rates to

ICU were in 50 to 60 year olds. Of note the overall rate of hospital

admissions was 16.5 per 100,000 people compared with the rate in

Australia for seasonal flu of 15.3 per 100,000 (2003 to 2005).

The very young and those over 60 years have had fewer admissions to

hospital than normally seen.

We don’t know how many people have been infected in Australia, but in

NZ it was estimated to be 10% of the population (similar to most

winters with seasonal flu). The overall case fatality rate is less

than 0.005% and thus may be lower than what is usually seen in

seasonal influenza for most people.

In Australia each year we vaccinate about 8 million people against

seasonal flu with mainly single-dose pre-loaded syringes. It is thus

hard to see therefore why we should have to take this retrograde

infection control step given the obvious unnecessary hazards

associated with the use of multi-dose vials.

The only reasons to use multi-dose vials is to save money or else

because there is a rapidly evolving emergency with a high death rate

(as it is the easiest way to deliver a vaccine rapidly to a population).

Neither of these conditions are currently present in Australia. CSL

expects to make $300 million from sales of the swine flu vaccine this

financial year. Thus cost cutting should not be a factor.

We passed the peak of this epidemic in most states in Australia in mid

July. While some groups are over-represented with higher than expected

morbidity (pregnant women and Indigenous groups), overall this

epidemic has not been much worse as judged by overall hospital

admissions and deaths in comparison to seasonal flu over the last 10

years.

Even if we had to rush vaccine production, why not deliver them in

single use ampoules?

We are also very unlikely to see any second waves here till next

winter. Thus we have time here to do any vaccination program properly

and learn from what happens in the Northern hemisphere in their

upcoming winter.

We should not proceed in haste with a mass vaccination campaign using

multi-dose vials. We need to ensure all the appropriate and usual

steps associated with vaccine licensure have been followed. We know

that basic infection-control procedures are not always followed in

hospitals, clinics and general practice units in the community.

Although the risk may be judged to be slight, any failures will be

disastrous for any individuals infected and if linked back to the

vaccine roll out may also undermine confidence in the ongoing

implementation of Australian vaccination programmes in general.

In summary, we need careful reconsideration of the implementation of

this vaccination strategy.

• Multi-dose vials have a potential to transmit infectious

organisms and should not be used in a mass vaccination campaign.

• The proposed mass vaccination campaign should be delayed until a

safe formulation of the vaccine supplied in single dose vials becomes

available.

• All appropriate processes involved with vaccine licensure need to

be followed.

• We need to have an appropriate surveillance system in place that

can quickly detect any increase in rare or unexpected side effects

from the vaccine (eg Guillain-Barré syndrome - ascending paralysis,

that occurred in about 1 per 100,000 people in the US in 1970’s with

the last Swine flu mass vaccination program roll out).

References and further reading

1. Kellaway C, H., McCallum P, Tebbutta H. The fatalities at

Bundaberg. Report of the Royal Commission. Med J Aust 1928;ii(2):38.

2. Hutin Y, Hauri A, Chiarello L, et al. Best infection control

practices for intradermal, subcutaneous,and intramuscular needle

injections. Bulletin of the World Health Organization 2003;81(7):

491-500.

3. Katzenstein TL, nsen LB, Permin H, et al. Nosocomial HIV-

transmission in an outpatientclinic detected by epidemiological and

phylogenetic analyses. AIDS 1999;13(13):1737-1744.

4. Samandari T, Malakmadze N, Balter S, et al. A large outbreak of

hepatitis B virus infections associated with frequent injections at a

physician’s office. Infection Control & Hospital Epidemiology

2005;26(9):745-750.

5. Dumpis U, Kovalova Z, Jansons J, et al. An outbreak of HBV and HCV

infection in a paediatric oncology ward: epidemiological

investigations and prevention of further spread. Journal of Medical

Virology 2003;69(3):331-338.

6. Hutin YJ, Goldstein ST, Varma JK, et al. An outbreak of hospital-

acquired hepatitis B virus infection among patients receiving chronic

hemodialysis. Infection Control & Hospital Epidemiology 1999;20(11):

731-735.

7. Verbaan H, Molnegren V, Pentmo I, et al. Prospective study of

nosocomial transmission of hepatitis C in a Swedish gastroenterology

unit. Infection Control & Hospital Epidemiology 2008;29(1):83-85.

8. Germain JM, Carbonne A, Thiers V, et al. Patient-to-patient

transmission of hepatitis C virus through the use of multidose vials

during general anesthesia. Infection Control & Hospital Epidemiology

2005;26(9):789-792.

9. Kokubo S, Horii T, Yonekawa O, et al. A phylogenetic-tree analysis

elucidating nosocomial transmission of hepatitis C virus in a

haemodialysis unit. Journal of Viral Hepatitis 2002;9(6):450-454.

10. Silini E, Locasciulli A, Santoleri L, et al. Hepatitis C virus

infection in a hematology ward: evidence for nosocomial transmission

and impact on hematologic disease outcome. Haematologica 2002;87(11):

1200-1208.

11. Trasancos CC, Kainer MA, Desmond PV, H. Investigation of

potential iatrogenic transmission of hepatitis C in ,

Australia. Australian & New Zealand Journal of Public Health

2001;25(3):241-244.

12. Massari M, Petrosillo N, Ippolito G, et al. Transmission of

hepatitis C virus in a gynecological surgery setting. Journal of

Clinical Microbiology 2001;39(8):2860-2863.

13. Widell A, Christensson B, Wiebe T, et al. Epidemiologic and

molecular investigation of outbreaks of hepatitis C virus infection on

a pediatric oncology service. ls of Internal Medicine 1999;130(2):

130-134.

14. Stetler HC, Garbe PL, Dwyer DM, et al. Outbreaks of group A

streptococcal abscesses following diphtheria-tetanus toxoid-pertussis

vaccination. Pediatrics 1985;75(2):299-303.

15. Olson RK, Voorhees RE, Eitzen HE, et al. Cluster of postinjection

abscesses related to corticosteroid injections and use of benzalkonium

chloride. Western Journal of Medicine 1999;170(3):143-147.

16 Chant K. Lowe D, Rubin G, et al. (1993). Patient-to-patient

transmission of HIV in private surgical consulting rooms. Lancet.

342:1548-1549.

17 NSW Health. Weekly Influenza Epidemiology Report, NSW. Including

H1N1 influenza 09. [internet]. 2009. [Accessed 30/08/2009, 2009].

Available from:

http://www.emergency.health.nsw.gov.au/swineflu/resources/pdf/case_statistics_27\

0809.pdf

18. M G Baker, N , Q S Huang, S Paine et al. Pandemic influenza

A(H1N1)v in New Zealand: the experience from April to August 2009

Eurosurveillance, Volume 14, Issue 34, 27 August 2009. Rapid

communications

http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19319

19. Plueckhahn VD, Banks J. Fatal haemolytic streptococcasepticaemia

following mass inoculation with influenza vacine. Med J Aust. 1970 Feb

28;1(9):405-11.

20. The Geelong disaster. Med J Aust. 1970 Feb 28;1(9):401-2.

21. Lexi Metherell. CSL ‘maxed out’ on swine flu vaccine production

http://www.abc.net.au/news/stories/2009/08/19/2660597.htm?section=australia

August 19th 2009

22. Letter from Australasian Society of Infectious Diseases to

Professor Jim Bishop (Chief Health officer). Use of multi-dose vials

for H1N1 09 (“swine flu”) immunization. August 19th 2009.

23. Collignon P. Patient-to-patient transmission of HIV. Lancet. 1994

Feb 12;343(8894):415; author reply 415-6.