Mandatory influenza vaccination? First we need a better vaccine

Michael Gardam; Camille Lemieux

doi:10.1503/cmaj.122074

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Questionable Validity of Reported Physician Vaccination Rates
Thomas E. Ungar MD, M.Ed

Posted on: 08 August 2014
Yes to flu shots but no to making them mandatory
Michael A. Gardam

Posted on: 24 April 2013
Providing patients with the best safety strategies we have available is an ethical responsibility
Paul G Van Buynder

Posted on: 04 April 2013
Mandatory influenza vaccination? Protecting patients with the best available tools.
Keith F. Woeltje

Posted on: 02 April 2013

Posted on: (8 August 2014)

Questionable Validity of Reported Physician Vaccination Rates
Thomas E. Ungar MD, M.Ed, Recent Past Chair Medical Advisory Committee, Chief of Psychiatry
Reported rates of physician vaccination for seasonal influenza may be of questionable validity. At our community academic hospital the 2013-2014 official organizationally reported vaccination rates for our 505 active staff physicians was 57.3%, with a low of 44% at the main hospital, one of our three sites. These low rates were of concern. Some questioned the validity of reported rates. We undertook an audit to confirm...
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Reported rates of physician vaccination for seasonal influenza may be of questionable validity. At our community academic hospital the 2013-2014 official organizationally reported vaccination rates for our 505 active staff physicians was 57.3%, with a low of 44% at the main hospital, one of our three sites. These low rates were of concern. Some questioned the validity of reported rates. We undertook an audit to confirm the data. We reviewed 50 random physician occupational health records and contacted physicians by phone. We found that 90% of the physicians had voluntarily received their seasonal influenza vaccination. The discrepancy with reported rates appears to be due to the method of capturing the data. Immunization rates are collected by the hospital occupational health department. But physicians are not employees, and do not tend to use or report to occupational health. Of the physicians we contacted, many had obtained their vaccination outside the hospital and were unaware of hospital reporting requirements. Others claim to have reported, but this was not accurately reflected in the records.
Major policy discussion and debate on health care worker immunization is underway. These range from voluntary to mandatory vaccination of all health care workers, to "choice" policies of vaccinate or mask. We are encouraged that an overwhelming 90% majority of physicians in our audit voluntarily chose vaccination. It is important to critically reflect on the validity and quality of reported data on physician immunization rates to help inform policy and planners.
Conflict of Interest:
None declared
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Competing Interests: None declared.
Posted on: (24 April 2013)

Yes to flu shots but no to making them mandatory
Michael A. Gardam
We are in full agreement with the letters of Van Buynder et. al. and Woeltje and Babcock that, despite its shortcomings, the influenza vaccine is the best defence we have right now against influenza and that receiving the vaccine is certainly better than going without. We are strong supporters of immunization. Where we differ is on the issue of whether receipt of the influenza vaccine should be made a mandatory condition...
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We are in full agreement with the letters of Van Buynder et. al. and Woeltje and Babcock that, despite its shortcomings, the influenza vaccine is the best defence we have right now against influenza and that receiving the vaccine is certainly better than going without. We are strong supporters of immunization. Where we differ is on the issue of whether receipt of the influenza vaccine should be made a mandatory condition of employment for healthcare workers.
Both letters suggest through reductio ad absurdum logic that by questioning mandatory vaccination we are by extension not supportive of any public health intervention that is not 100% effective. This logic is not dissimilar to that used by the antivaccination lobby which, on identifying concerns with one vaccine, will extend its antivaccination sentiment to all vaccines. These suggestive inferences are not helpful and only serve to inflame and confuse the issue further.
In making important policy decisions, it is important to look at all of the possible downstream consequences. If we take a hard line with the influenza vaccine, which has a highly variable and limited effectiveness, we may alienate many who are currently vaccine proponents and embolden the antivaccine lobby. We note a recent paper suggesting that the spread of anti-vaccine sentiment is greater via Twitter than that of pro-vaccine messages (1).
We need to be honest with our audience. While seasonal all-cause mortality is traditionally used as a convenient surrogate for more influenza-specific causes of death, this highly sensitive outcome is also very non-specific. Other common high mortality conditions, such as myocardial infarction, C. difficile, and respiratory syncytial virus infection are also more common in the winter, and all contribute to a likely highly inflated estimate of influenza deaths when using all-cause mortality in place of more specific outcomes. The true impact of the influenza vaccine on mortality is overestimated by this approach and if we do not acknowledge this, we risk losing credibility.
We do not agree with Woeltje and Babcock's interpretation of influenza vaccine effectiveness. They suggest that 60% effectiveness means that most individuals will still be 100% protected, and that protection is durable for the entire influenza season. It is well known that breakthrough laboratory-confirmed influenza in immunized individuals can cause milder disease; that is, the vaccine can protect against more severe illness. In this circumstance one wonders whether immunized healthcare workers may mistake influenza symptoms for a more benign illness and continue to work. Further, three recent large European vaccine effectiveness studies demonstrated that effectiveness waned to near zero or zero within roughly three months after vaccination for the 2011-2012 season (2-4).
With any question that is difficult to answer and that raises debate, it is necessary to cite and critically analyze all of the evidence, even if it does not support a given position. As an example, the Vanderbilt study mentioned by Van Buynder et. al. did show a higher vaccine effectiveness in relation to influenza-related hospital admissions for the 2011-2012 season; however, the study had a very small sample size and very broad 95% confidence intervals around the protective effect of the vaccine (95% CI 17.1-94.9) (5). Furthermore, a much larger international study published only one day later calculated the overall adjusted vaccine effectiveness for the same season to be just 24.9% (95%CI 1.8-44.6) but this paper was not cited (6).
We have heard much about a small number of American facilities that have implemented mandatory vaccination and have seen their immunization rates increase to well over 95%. What we have not seen is evidence that these policies have brought about a significant reduction in both nosocomial influenza and influenza-related deaths. Vaccination rates on their own should not be the outcome we are interested in. As we have already noted both here and in the previous editorial, many existing studies of influenza mortality and of the impact of influenza vaccination have significant limitations.
We unreservedly support annual influenza vaccination. But we believe that 'it's the best we have right now' and 'it might help' are not sufficiently valid bases upon which to compel influenza immunization for healthcare workers. Taking such steps may paradoxically lead to a negative impact on overall vaccination rates, including those of much more effective vaccines.
References
1. Marcel Salathe, Duy Q Vu, Shashank Khandelwal, David R Hunter The Dynamics of Health Behavior Sentiments on a Large Online Social Network. EPJ Data Science 2013, 2:4 (4 April 2013). Available at: http://www.epjdatascience.com/content/pdf/epjds16.pdf. Accessed April 16, 2013.
2. J Castilla, I Martínez-Baz, V Martínez-Artola, G Reina, F Pozo, M García Cenoz, et. al. Decline in influenza vaccine effectiveness with time after vaccination, Navarre Spain, Season 2011/12 Eurosurveillance, Volume 18, Issue 5, 31 January 2013. Available at: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20388. Accessed April 16, 2013.
3. R G Pebody, N Andrews, J McMenamin, H Durnall, J Ellis, C I Thompson, C, et. al. Vaccine effectiveness of 2011/2012 trivalent seasonal influenza vaccine in preventing laboratory-confirmed influenza in primary care in the United Kingdom: Evidence of wanting intraseasonal protection. Eurosurveillance, Volume 18, Issue 5, 31 January 2013. Available at: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20389. Accessed April 16, 2013.
4. E Kissling, M Valenciano, A Larrauri, B Oroszi, J M Cohen, B Nunes, et. al. Eurosurveillance, Volume 18, Issue 5, 31 January 2013. Low and decreasing vaccine effectiveness against influenza A(H3) in 2011/12 among vaccination target groups in Europe: Results from the I-MOVE multicenter case-control study. Available at: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20390. Accessed April 16, 2013.
5. H. Keipp Talbot, Yuwei Zhu, Qingxia Chen, John V. Williams, Mark G. Thompson, and Marie R. Griffin. Effectiveness of Influenza Vaccine for Preventing Laboratory-Confirmed Influenza Hospitalizations in Adults, 2011 -2012 Influenza Season. Clin Infect Dis. first published online February 28, 2013 doi:10.1093/cid/cit124
6. Rondy M, Puig-Barbera J, Launay O, Duval X, Castilla J, et al. (2013) 2011-12 Seasonal Influenza Vaccines Effectiveness against Confirmed A(H3N2) Influenza Hospitalisation: Pooled Analysis from a European Network of Hospitals. A Pilot Study. PLoS ONE 8(4): e59681. doi:10.1371/journal.pone.0059681.
Conflict of Interest:
None declared
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Competing Interests: None declared.
Posted on: (4 April 2013)

Providing patients with the best safety strategies we have available is an ethical responsibility
Paul G Van Buynder, VP Public Health Fraser Health Authority
Other Contributors:
Justice Campbell in the SARS commission report, "Spring of Fear", stressed the most important lesson to be learned was the importance of the precautionary principle and that "we cannot wait for scientific certainty before we take reasonable steps to reduce risk" 1
Gardam and Lemieux recently questioned the merit of mandatory influenza vaccination policies for healthcare providers because of relatively poor vacci...
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Justice Campbell in the SARS commission report, "Spring of Fear", stressed the most important lesson to be learned was the importance of the precautionary principle and that "we cannot wait for scientific certainty before we take reasonable steps to reduce risk" 1
Gardam and Lemieux recently questioned the merit of mandatory influenza vaccination policies for healthcare providers because of relatively poor vaccine efficacy (approximately 60%) and what they consider inadequate evidence. 2 Our experience in British Columbia suggests that patients would not agree with them and the central issue under consideration here is patient safety.
In addition to hand hygiene, vaccination is one of the best tools in our armamentarium to prevent influenza and its complications. The vaccine is safe, and provides net health benefits to both health care workers and their patients. While we all want better vaccines, we use what is available. The seven valent pneumococcal vaccine was just over 60% effective when introduced, the quadrivalent HPV vaccine protects against about two thirds of cervical cancers, and there are legitimate concerns about both the effectiveness and duration of efficacy of acellular pertussis vaccines, all of which are in use.
Influenza vaccines are improving; the adjuvanted monovalent pandemic vaccine was over 90% effective3 and even the current widely available vaccine has good years with a Vanderbilt University study finding that flu vaccination reduced the risk of flu-related hospitalization by 71.4% among adults of all ages and by 76.8% in study participants 50 years of age and older during the 2011-2012 flu season.4 Gardam advocates for a better vaccine prior to supporting mandatory vaccination but doesn't clarify what level of effectiveness would be acceptable or how we would decide this before the arrival of the virus each year and prior to clarification of the virus-vaccine match.
While debate will continue over vaccine effectiveness each year Influenza vaccine is clearly 'good enough' to save many patient lives. Whether or not we need a better vaccine is fundamentally irrelevant to the argument about whether we should be using what we have now. While calling for more evidence is commonplace in academia, the threshold for not acting in the face of good evidence supporting patient safety should be high. As Gardam states, voluntary campaigns have clearly failed to achieve reasonable coverage rates and in a recent review of the ethical considerations Ottenberg and colleagues found overwhelming scientific, ethical, and legal justifications supporting mandating health care worker vaccination.5 They emphasised the professional obligations of health care workers to benefit individual patients and to do no harm and also to meet the shared obligations of health care institutions and professionals to protect the public health in the face of preventable infectious disease. Gardam suggests that not only may mandatory vaccination be legally challenged but there would be implications for other mandatory programs. No evidence is provided to support this contention and in fact, mandatory vaccination is increasingly widespread in the United States and institutions defending challenges on the basis of patient safety have won their cases. Pertussis vaccine was mandated in parts of British Columbia last year for staff in high risk areas during an outbreak without legal challenge, and the wearing of masks was mandated for all attending long term care facilities during peak influenza season without legal challenge.
If mandatory vaccination is a step too far for some of our colleagues, the British Columbia model is a well rehearsed alternative. Here, staff unwilling or unable to be vaccinated can opt to wear a mask all winter. Data exists to show that, while not as effective as being vaccinated, masks can reduce source transmission and, in a large number of facilities using this model in the United States, coverage rates of 95% have been achieved. In a commentary over a decade ago in this journal Rea and Upshur reminded us that "there is a special duty of care for us ... not simply to avoid transmission once infected, but to avoid infection in the first place whenever reasonable. Our patients come to us specifically for help in staying or getting well. We have not just the general obligation of any member of our community, but a particular trust: first do no harm.6
References:
1. Ontario, and Archie G. Campbell. Spring of Fear: The SARS Commission Final Report. Toronto: SARS Commission, 2006. www.ontla.on.ca/library/repository/mon/16000/268478.pdf
2. Gardam M and Lemieux C. Mandatory influrnza vaccination? First we need a better vaccine. CMAJ. 2013; DOI:10.1503/cmaj.122074
3. Skowronski DM, Janjua NZ, De Serres G et al. Effectiveness of AS03 adjuvanted pandemic H1N1 vaccine: case-control evaluation based on sentinel surveillance system in Canada, autumn 2009. BMJ. 2011;342c7297
4. Talbot HK, Zhu Y, Chen Q, Williams JV, Thompson Mg and Griffin MR. Effectiveness of influenza vaccine for preventing laboratory-confirmed influenza hospitalizations in adults, 2011-2012 influenza season. CID. 2013: doi: 10.1093/cid/cit124
5. Ottenburg AL, Wu JT, Poland GA, Jacobsen RM, Koenig KA, and Tilburt JC. Vaccinating Health Care Workers Against Influenza: The Ethical and Legal Rationale for a mandate. Am J Public Health. 2011; 101(2): 212-216
6. Rea E and Upshor R. Semmelweis revisited: the ethics of infection prevention among healthcare workers. CMAJ. 2001:164(10):1447-1448
Conflict of Interest:
None declared
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Competing Interests: None declared.
Posted on: (2 April 2013)

Mandatory influenza vaccination? Protecting patients with the best available tools.
Keith F. Woeltje, Professor
Other Contributors:
We read with interest the commentary by Gardam and Lemiux in the CMAJ, and agree completely with their concluding remark: "We need a better vaccine." The current vaccine does not have optimal efficacy, and improvements would clearly be welcome. In the interim, however, we disagree that the need for a better vaccine is sufficient reason not to maximize the use of the current influenza vaccine for healthcare workers.
Certa...
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We read with interest the commentary by Gardam and Lemiux in the CMAJ, and agree completely with their concluding remark: "We need a better vaccine." The current vaccine does not have optimal efficacy, and improvements would clearly be welcome. In the interim, however, we disagree that the need for a better vaccine is sufficient reason not to maximize the use of the current influenza vaccine for healthcare workers.
Certainly a protective efficacy as low as 55% to 70% is not as good as many other vaccinations, however this is still far better than the 0% efficacy of being unvaccinated. There is published literature to support the vaccination of one population to protect another more vulnerable group (2-5) . As Gardam and Lemiux have noted, a recent pooled analysis showed that vaccination of health care workers was associated with a significant reduction in nonspecific patient outcomes (influenza-like illness, all-cause mortality among patients > 60 yr)(6). We agree with that determining directly what deaths are attributable to influenza is difficult, especially given current and past variability in testing practices as well as sensitivity and specificity, therefore we believe that looking at measures like ILI and all cause mortality is appropriate because these measures are less likely to miss more links between influenza and mortality.
As recently noted by Talbot and Talbot (7), vaccination rates for influenza are still low, including for healthcare workers. This is due in part to a variety of myths, including the notion that "the vaccine doesn't work". While undoubtedly not their intent, we are concerned that commentaries such as that by Gardam and Lemiux only further that impression. The quoted efficacy rates are often misinterpreted. In a population of 100 healthcare workers all of whom receive the vaccine, 55 - 70 of them will be protected. If only 50 of them are vaccinated, only 27 - 35 are protected, leaving 65 - 73 vulnerable to getting influenza and potentially spreading it to their patients. Which of those HCW would you like to have providing care to your parent, child or spouse?
In 2008 BJC HealthCare became one of the first large health systems in the US to require seasonal influenza vaccination as a condition of employment (8). This was policy was implemented on the basis of evidence that vaccination of healthcare workers could help protect the vulnerable patients we care for and the fact that despite substantial efforts over more than a decade, more than a quarter of our healthcare workers were unvaccinated (9). Over the past five flu seasons, the policy continues to be very successful, with vaccination rates of employees sustained at about 98%, with only small numbers of exemptions allowed (e.g. for a history of allergic reaction to the vaccine). Concerns about the vaccine were addressed with town hall meetings, printed communications, and availability of Occupational Health nurses and physicians for individual conversations if desired.
Gardam and Lemiux seem concerned that mandating vaccination should be avoided because there may be legal challenges, and that such policies should be deferred until there is a better vaccine and overwhelming evidence of the benefit to patients. We would also love to have a better vaccine with increased efficacy and perhaps even less frequent dosing and fully support calls for rapid development. But as the saying goes, "perfect is the enemy of good". We are confident that in the future there will be better cleaning products against C. difficile in the environment, better gloves to protect patients and healthcare workers during surgery, and more rapidly effective antibiotics; but while waiting and working for those advancements we should not stop requiring thorough cleaning of our patients' rooms, wearing of gloves during surgical procedures, and carefully administering perioperative antibiotics.
While waiting for better tools, we should use all the tools currently available to protect our patients now.
Keith F. Woeltje
Hilary M. Babcock

CMAJ 2013. DOI:10.1503/cmaj.122074

Hayward AC, Harling R, Wetten S, et al. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ 2006;333:1241.

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Talbot TA, Talbot HK. Influenza prevention update: examining common arguments against influenza vaccination. JAMA. 2013;309:881-882.

Babcock HM, Gemeinhart N, Jones M, Dunagan WC, Woeltje KF. Mandatory influenza vaccination of health care workers: translating policy to practice. Clin Infect Dis. 2010;50:459-464.

Ajenjo MC, Woeltje KF, Babcock HM, Gemeinhart N, Jones M, Fraser VJ. Influenza vaccination among healthcare workers: ten-year experience of a large healthcare organization. Infect Control Hosp Epidemiol. 2010;31:233-240.

Conflict of Interest:
None declared
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Competing Interests: None declared.