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 Peter Collignon, from the ANU Medical School, has written this analysis for Croakey.
“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, Jorgensen 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, Kelly H. Investigation of potential iatrogenic transmission of hepatitis C in Victoria, 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. Annals 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:
18. M G Baker, N Wilson, 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
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
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.