CDC: Flu Shots Reduce Hospitalizations In The Elderly

Photo Credit - CDC PHIL

 

 

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Although the elderly (> 65) are considered to be the most endangered by influenza infection, they are also the group least likely to be protected by the seasonal flu vaccine (see PLoS One: Limited Effectiveness Of Flu Vaccines In The Elderly & Flu Shots And The Elderly).

 

That isn’t to say the flu vaccine is worthless, or not worth bothering with – only that the amount of protection for the elderly is generally less than for other age cohorts.

 

In 2011,  NFID - the National Foundation for Infectious Diseases - convened a group of experts to address the issues of influenza and the elderly. From that panel a 5-page brief has emerged, called: Understanding the Challenges and Opportunities in Protecting Older Adults from Influenza.

This report pointed out that although the elderly generally see less protection from the flu vaccine, older individuals may still mount a robust immune response. In populations 65 and older, the brief points out that:

• Hospitalization rates for influenza and pneumonia are lower in community-dwelling adults who received the seasonal influenza vaccine.
• Immunization is associated with reduced hospitalization of older patients for cardiac, respiratory, and cerebrovascular diseases.

While the goal of vaccinating the younger population is to prevent infection, the authors point out that:

• . . . the goal in older adults is to prevent severe illness, including exacerbation of underlying conditions, hospitalization, and mortality.

Similarly, over the past couple of years, we’ve seen studies suggesting the flu vaccine may reduce the risk of heart attack and stroke (see JAMA: Flu Vaccine and Cardiovascular Outcomes & Study: Flu Vaccine May Reduce Heart Attack).  .

 

Yesterday, the CDC announced the results of a study published in Clinical Infectious Diseases.  First a link to the study, then some excerpts from the CDC statement.

 

Modeling the effect of different vaccine effectiveness estimates on the number of vaccine prevented influenza associated hospitalizations in older adults

Alicia M. Fry1, Inkyu K. Kim1,2, Carrie Reed1, Mark Thompson1, Sandra S. Chaves1, Lyn Finelli1, and Joseph Bresee1

Abstract

We compared influenza vaccine-prevented hospitalizations in adults aged>65 years for a range of hypothetical effectiveness estimates. During 2012-13, a vaccine with 10% effectiveness (66% coverage)would have averted ∼13,000 hospitalizations and a vaccine with 40% effectiveness would have averted ∼60,000 hospitalizations.Annual vaccination is merited in this vulnerable population.

(Continue . . . )

 

This from the http://www.cdc.gov/flu website.

 

CDC Study Concludes Flu Vaccination Prevents Hospitalizations in Older People

Hospitalizations averted even when vaccine effectiveness is lower

May 9, 2014 – A new CDC study shows that flu vaccines prevent flu-associated hospitalizations in people 65 years and older, even during seasons when vaccine effectiveness is low. The study reinforces CDC’s existing recommendation for annual vaccination of adults 65 years and older who are at high risk for serious flu-related complications and often most impacted by serious flu disease each year resulting in hospitalization or death.

The study, published in Clinical Infectious Diseases online on May 6, 2014, used statistical modeling to estimate flu-vaccine-prevented hospitalizations in adults aged 65 years and older for estimates of vaccine effectiveness against medically attended influenza illness ranging from 10% to 70%. Researchers used CDC flu surveillance data collected during the 2011-12 and 2012-13 seasons. The 2011-12 season was considered to be a mild flu season, whereas the 2012-13 season was characterized as moderate to severe. Using data from these two seasons, researchers were able to determine the varying impact that flu vaccination had in terms of hospitalizations prevented.

Findings showed that during the more severe 2012-13 flu season, a flu vaccine with 10% effectiveness (and 66% coverage) would avert about 13,000 hospitalizations, whereas a vaccine with 40% effectiveness would avert about 60,000 hospitalizations. In contrast, during the more mild 2011-12 season, a flu vaccine with the same two effectiveness estimates would avert about 2,000 and 11,000 hospitalizations, respectively.

(Continue . . .)

 

Despite disappointing VE (Vaccine Effectiveness) numbers (see CIDRAP: A Comprehensive Flu Vaccine Effectiveness Meta-Analysis) - particularly among the elderly (see BMC Infectious Diseases: Waning Flu Vaccine Protection In the Elderly) - we continue to see evidence of benefit from the shot, even if full protection isn’t conveyed to the recipient.

 

As addressed back in 2012 by CIDRAP: The Need For `Game Changing’ Flu Vaccines, there is obviously a great need for better, more effective, and faster to the market flu vaccines.  But even with their current limitations -  I certainly get one each year -  and I urge others to do the same.

 

Not because it is guaranteed protection . . . .

 

But because – like wearing a seatbelt during a motor vehicle crash  – it substantially improves your odds of a good outcome.

Research: Low Vaccination Rates Among 2013-2014 ICU Flu Admissions

Yearly Flu Hospitalizations by Age Cohort – CDC FluView

Showing 2009-10 & 2013-14 Hitting ages 18-64 unusually hard

 

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Despite reduced VE (Vaccine Effectiveness) estimates in recent years, and a production schedule that requires predicting – 6 months in advance – what flu strains will dominate in the upcoming flu season, we continue to see evidence that most years the seasonal flu shot manages to convey a fairly decent level of protection against influenza.

 

Despite the mantra of the CDC, and other public health organizations, urging people to get the yearly jab, only just over 1/3rd of adults (aged 18-64) got the flu shot last year (see TFAH Report Finds Low Uptake Of Flu Shots Among Young Adults). 

 

This year, we are seeing the pH1N1 strain dominate for the first time since 2010, and as it did in 2009, it appears to be targeting younger adults harder than usual. As a result, we’ve seen reports of an uptick in ICU hospitalizations, and deaths, among younger adults across the nation this winter.

Which brings us to a research letter, published yesterday in the American Journal of Respiratory and Critical Care Medicine, that finds – between November 2013 and January 8th, 2014 – a `high number of otherwise healthy individuals with critical illness requiring care in the ICU. Most patients who required ICU level care were not previously vaccinated.’

 

High ICU admission rate for 2013-2014 Influenza is associated with a low rate of vaccination

Jelena Catania, Loretta G Que, Joseph A Govert, John W Hollingsworth, and Cameron R Wolfe

 

While most of this letter is behind a pay wall, we have a press release from Duke University, with some of the details. First an excerpt, after which I’ll return with more.

 

Duke University Medical Center

Young, unvaccinated adults account for severest flu cases

DURHAM, N.C. – A snapshot of patients who required care at Duke University Hospital during this year's flu season shows that those who had not been vaccinated had severe cases and needed the most intensive treatment.

In an analysis of the first 55 patients treated for flu at the academic medical center from November 2013 through Jan. 8, 2014, Duke Medicine researchers found that only two of the 22 patients who required intensive care had been vaccinated prior to getting sick.

The findings were published online in Monday, Feb. 10, 2014, in the American Journal of Respiratory and Critical Care Medicine.

"Our observations are important because they reinforce a growing body of evidence that the influenza vaccine provides protection from severe illness requiring hospitalizations," said lead author Cameron Wolfe, M.D., assistant professor of medicine at Duke. "The public health implications are important, because not only could a potentially deadly infection be avoided with a $30 shot, but costly hospitalizations could also be reduced."

Wolfe said this year's flu season was marked by hospitalizations of previously healthy young people, with a median age of 28.5 years. Among those who were hospitalized at Duke, 48 of the 55 were infected with the H1N1 virus that caused the 2009 pandemic. That outbreak also hit young adults particularly hard.

(Continue . . .)

This research also found a high rate of failure of the rapid flu test (something we’ve discussed before in MMWR: Evaluating RIDTs and No Doesn’t Always Mean No) which has led to delays in starting antiviral treatment for some patients.

The authors conclude:

Together, our observations during this influenza season support a high prevalence of the H1N1 virus affecting young adults and requiring ICU care, high false negative rates of rapid flu tests, and delay in starting antiviral treatment," Wolfe said. "Added to the finding of very low vaccination rates among both hospitalized and ICU admissions, our observations support previous findings that vaccination reduces the severity of disease and vaccinations should be encouraged as recommended by the U.S. Centers for Disease Control and Prevention."

 

While the effectiveness of the seasonal flu shot has often been oversold, I certainly get one every year, and urge others to do the same.  

 

Not because it is guaranteed protection, but because – like wearing a seatbelt in a vehicle – it improves your odds of a good outcome.

 

And despite disappointing VE numbers (see CIDRAP: A Comprehensive Flu Vaccine Effectiveness Meta-Analysis) - particularly among the elderly ( see PLoS One: Limited Effectiveness Of Flu Vaccines In The Elderly & BMC Infectious Diseases: Waning Flu Vaccine Protection In the Elderly) - we continue to see evidence of benefit from the shot, even if full protection isn’t conveyed to the recipient.

 

In  2011,  NFID - the National Foundation for Infectious Diseases - convened a group of experts to address the issues of influenza and the elderly. From that panel a 5-page brief has emerged, called: Understanding the Challenges and Opportunities in Protecting Older Adults from Influenza.

Although the elderly generally see less protection from the flu vaccine, older individuals may still mount a robust immune response. In populations 65 and older, the brief points out that:

• Hospitalization rates for influenza and pneumonia are lower in community-dwelling adults who received the seasonal influenza vaccine.
• Immunization is associated with reduced hospitalization of older patients for cardiac, respiratory, and cerebrovascular diseases.

While the goal of vaccinating the younger population is to prevent infection, the authors point out that:

• . . . the goal in older adults is to prevent severe illness, including exacerbation of underlying conditions, hospitalization, and mortality.

 

Similarly, over the past couple of years, we’ve seen studies suggesting the flu vaccine may reduce the risk of heart attack and stroke (see JAMA: Flu Vaccine and Cardiovascular Outcomes & Study: Flu Vaccine May Reduce Heart Attack).  Not a slam dunk, but intriguing nonetheless.

 

There is obviously a great need for better, and faster to market, flu vaccines.  A topic that was well addressed back in 2012 by CIDRAP: The Need For `Game Changing’ Flu Vaccines.

 

But until they can be developed - the flu shots we have –  when coupled with good `flu hygiene’ (washing hands, covering coughs, staying home when ill)  remain the best preventative actions you can take against the flu.

 

And this year’s flu season shows that being young, and healthy, is no reason to avoid getting the shot.

Study: Flu Vaccine May Reduce Heart Attack Risk

 

 

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In a perfect world, the conclusions drawn from medical research would always be unequivocal and we would be able to automatically accept their results as being the final word on the subject.

 

But as we’ve seen often in the past (When Studies Collide & When Studies Collide (Revisited)), no research methodology is perfect, all studies are subject to limitations, and it isn’t unusual to end up with conflicting results from different research teams.

 

While we would all like medicine to be based on treatments, drugs, and procedures proved – beyond a shadow of a doubt – to be safe and effective  . . . sometimes we must accept a lower burden of proof -the preponderance of evidence – instead.

 

All of which brings us to a new study out of Australia – published yesterday in the BMJ Journal Heart, that finds compelling – but not exactly conclusive – evidence that flu shots may reduce the risk of heart attacks.

 

If all of this sounds vaguely familiar, it’s because we’ve trod this ground before.

 

In 2010 we saw a study in the CMAJ: Flu Vaccinations Reduce Heart Attack Risk that found that those over the age of 40 who get a seasonal flu vaccine each year may reduce their risk of a heart attack by as much as 19%.

 

Almost immediately questions were raised over the way this study was conducted (see Vaccine/Heart Attack Study Questioned). The primary concern was these researchers only looked at heart attacks during `flu season’, without the control of looking at AMI risks year-round.

 

Last year, in Study: Influenza And Heart Attacks, we looked at a study appearing in the Journal of Infectious Diseases that suggested Influenza - and other acute respiratory infections - can act as a trigger for heart attacks.  There was an accompanying editorial called Increasing Evidence That Influenza Is a Trigger for Cardiovascular Disease published in the same issue.

 

In February of this year, in Another Study Links Heart Attacks & Influenza, we looked at a study from the University of Iowa that appeared in the January issue of the journal of Epidemiology and Infection linking spikes in AMIs (acute myocardial infarction) to influenza during the winter months, and also finds a similar spike in AMIs during the H1N1 pandemic wave of the fall of 2009.

 

Today’s study, which looked 559 patients over three flu seasons in Sydney, Australia, finds a 45% reduction in AMI risk among those who had received a flu vaccine.

 

They also found that those who had reported a recent respiratory infection were twice as likely to have a heart attack.  But the link between Influenza infection and an AMI was more tenuous.

 

Ischaemic heart disease, influenza and influenza vaccination: a prospective case control study

C Raina MacIntyre, Anita E Heywood, Pramesh Kovoor, Iman Ridda, Holly Seale, Timothy Tan, Zhanhai Gao, Anthea L Katelaris, Ho Wai Derrick Siu, Vincent Lo, Richard Lindley, Dominic E Dwyer

Published Online First 21 August 2013

Abstract

Background Abundant, indirect epidemiological evidence indicates that influenza contributes to all-cause mortality and cardiovascular hospitalisations with studies showing increases in acute myocardial infarction (AMI) and death during the influenza season.

Objective To investigate whether influenza is a significant and unrecognised underlying precipitant of AMI.

Design Case-control study.

Setting Tertiary referral hospital in Sydney, Australia, during 2008 to 2010.

Patients Cases were inpatients with AMI and controls were outpatients without AMI at a hospital in Sydney, Australia.

Main outcome measures Primary outcome was laboratory evidence of influenza. Secondary outcome was baseline self-reported acute respiratory tract infection.

Results Of 559 participants, 34/275 (12.4%) cases and 19/284 (6.7%) controls had influenza (OR 1.97, 95% CI 1.09 to 3.54); half were vaccinated. None were recognised as having influenza during their clinical encounter. After adjustment, influenza infection was no longer a significant predictor of recent AMI. However, influenza vaccination was significantly protective (OR 0.55, 95% CI 0.35 to 0.85), with a vaccine effectiveness of 45% (95% CI 15% to 65%).

Conclusions Recent influenza infection was an unrecognised comorbidity in almost 10% of hospital patients. Influenza did not predict AMI, but vaccination was significantly protective but underused. The potential population health impact of influenza vaccination, particularly in the age group 50–64 years, who are at risk for AMI but not targeted for vaccination, should be further explored. Our data should inform vaccination policy and cardiologists should be aware of missed opportunities to vaccinate individuals with ischaemic heart disease against influenza.

 

 

While these researchers found receiving the flu vaccine to provide statistically significant protection against a heart attack, a bit counter-intuitively, they were unable to directly link influenza to an increased risk of AMI.

 

They write:

 

While we showed a protective effect of influenza vaccination against AMI, we were unable to demonstrate a direct effect of influenza infection on AMI. This could reflect low statistical power, with laboratory-confirmed influenza being a much rarer event than vaccination, which showed significant association. Furthermore, the high vaccination rate in our participants likely reduced the risk of influenza and our ability to detect a difference between groups.

 

 

Teasing out the details of this study we have a report today in the Australian Academic & research news publication The Conversation, that includes the following reaction from other researchers.

 

2 August 2013, 9.04am AEST

Flu jab may halve heart attack risk: study

(EXCERPT)

Minimising risk

Julie Redfern, Senior Research Fellow, Cardiovascular Division at George Institute for Global Health welcomed the finding.

 

“Prevention of heart attacks and cardiovascular disease is a national health priority. Improving risk factors and implementing other simple measures aimed at preventing heart attacks and reducing the burden of disease are of great importance,” said Dr Redfern, who was not involved in the study.

 

“The potential of this study, after further research, that found a benefit of the flu vaccination on heart disease risk is important and could be one strategy that help minimise future heart risk.”

 

Garry Jennings, Director and CEO, Cardiologist at Baker IDI Heart and Diabetes Institute said the researchers had made a very interesting finding.

 

“It is not possible to say whether the flu vaccination was protective or whether people who have flu injections have other characteristics that lower their risk of heart attack. There is some support for the latter in that flu itself did not seem to increase the risk but people who had flu vaccination had lower risk,” said Dr Jennings, who was also not involved in the study.

 

“As the authors point out, this is cause for further investigation, particularly as there are some theoretical links related to inflammation that might have a role in the timing of a heart attack.”

 

 

While this study delivers something less than 100% proof that flu vaccines provide some protection against heart attacks, it does add incrementally to previous studies which have found links between respiratory infections, heart attacks, and `excess winter mortality’.

 

And if this link is valid, it makes sense that if you reduce the incidence of influenza (vaccines are usually about 50% effective) among those with coronary artery disease, you ought to reduce their rate of heart attacks.

 

But whether it makes sense or not, more research will be needed to know for sure. For more on this story, you may want to read Jason Gale’s report in Bloomberg News.

 

Flu Vaccine May Lower Heart Attack Risk, Researchers Find

By Jason Gale - Aug 21, 2013 6:30 PM ET

CDC: Uptake Of Flu Vaccine By HCWs

Photo Credit – CDC PHIL

 

 

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Although the effectiveness of the seasonal flu shot can vary from one year to the next - and the protection it offers can differ between recipients depending upon their age, general health and individual immune response -  it remains the single best preventative we have against the influenza virus.

 

Recent studies (see A Comprehensive Flu Vaccine Effectiveness Meta-Analysis) have shown the flu shot to be moderately effective in preventing influenza – at least among healthy adults under the age of 65.

 

For the elderly and for those with immune problems the flu vaccine’s effectiveness is often lower (see Study: Flu Vaccines And The Elderly).

 

There is no doubt that we need better flu vaccines – particularly for those at greatest risk from influenza infection; the elderly and those with chronic illnesses (see CIDRAP: The Need For `Game Changing’ Flu Vaccines).

 

But until they can be developed, the vaccines we have can and do help reduce the spread of the virus. And in healthcare facilities, where patients often fall into the `elderly or chronically ill’ category, controlling the spread of influenza is a high priority.

 

Which is why there has been such a push to get HCWs (healthcare workers or HCPs Healthcare Personnel) to take the seasonal flu shot each year - not just to protect their health - but the health of their patients and their co-workers.

 

The strong recommendation from ACIP (see 2011 MMRW Immunization of Health-Care Personnel) is that all HCP receive an annual flu vaccination, but the CDC does not actually mandate the vaccine.

 

Yesterday the CDC updated their annual survey of vaccine uptake in the medical profession.  After several years of increases in flu vaccination among HCPs, last year saw little improvement over the previous year.

 

 

Health Care Personnel Flu Vaccination

Internet Panel Survey, United States, November 2012

On This Page

• Key Findings
• Who Was Vaccinated?
• What Can Be Done? (Recommendations)
• Data Source and Methods
• Limitations
• Related Links
• References/Resources

Updated on July 17, 2013 to reflect revised information.

• Available as PDF  [627 KB, 15 pages]

Footnotes | Data Source and Methods | Limitations

Influenza (the flu) can cause disease among health care personnel (HCP) and their patients.

• Flu vaccination has been shown to reduce the risk of flu and absenteeism in vaccinated adults and HCP vaccination in particular has been shown to reduce the risk of respiratory illness and deaths in nursing home residents (1-5).
  • The Advisory Committee on Immunization Practices (ACIP) recommends that all HCP receive an annual flu vaccination (6).
• Flu vaccination coverage among HCP has improved but remains below the national Healthy People 2020 target for flu vaccination among HCP is 90% (7).
  • In 2008, HCP vaccination coverage was 49% (8).
  • For the 2009-10 flu season, vaccination coverage increased to 58-63% (9).
  • Coverage remained higher for the 2010-11 (56-64%) and 2011-12 (62-67%) seasons (10-11).

CDC analyzed data from an internet panel survey conducted among HCP during November 2012 to provide a timely estimate of how many HCP were getting vaccinated. The results of this survey provide information for use by vaccination campaigns during National Influenza Vaccination Week (December 2-8, 2012). This report provides early flu season estimates (early November) of vaccination coverage by HCP so far this year. Final 2012-13 flu season HCP coverage estimates will be available after the end of the season.

Key Findings

• Early-season 2012-13 flu vaccination among HCP was the same as coverage by early-season 2011-12, 63.4%.
  • During the previous two seasons, flu vaccination coverage increased by 3-8% from midseason to end of the season.
    • If a similar proportion is vaccinated after November this year, overall coverage will be similar to the prior year.
• By occupation, flu vaccination was highest among pharmacists (88.7%), physicians (85.3%), nurse practitioners/physician assistants (85.0%), nurses (79.7%),  and other clinical professionals (75.5%).
  • Flu vaccination was lowest among assistants or aides (46.8%) and administrative/non-clinical support staff (54.3%).
• By work setting, flu vaccination coverage was highest among HCP working in hospitals (82.5%).
  • Flu vaccination was lowest among HCP working in long-term care facilities (47.9%).
• Among unvaccinated HCP who did not intend to get the flu vaccination, the most common main reason reported for not getting vaccinated was that they do not want vaccination. The second most common main reason was the belief that the vaccination was ineffective.
• Conclusion/recommendation:
  • Educating HCP, especially assistants or aides and non-clinical staff, and HCP working in long-term care facilities about the importance, effectiveness, and safety of annual flu vaccination may increase overall vaccination coverage.

(Continue . . . )

 

 

While the CDC only recommends the flu shot, many professional medical organizations have adopted policies calling for mandatory vaccination of health care workers (HCWs).

 

APIC Calls For Mandatory Flu Vaccination For HCWs

AAP: Recommends Mandatory Flu Vaccinations For HCWs

SHEA: Mandatory Vaccination Of Health Care Workers

IDSA Urges Mandatory Flu Vaccinations For Healthcare Workers

 

In recent years an increasing number of medical facilities have implemented mandatory flu vaccination as a condition of employment, including Seattle’s Virginia Mason Medical Center and BJC Heathcare of St. Louis, Missouri  (see here and here).

 

While many infection control experts see this as a long overdue step in patient and co-worker protection, this is a hugely divisive issue.

 

Many employees see this as an infringement of their rights to decide what will be injected into their bodies (see HCWs: Refusing To Bare Arms & HCWs: Developing a Different Kind Of Resistance).

 

 

Several states have recently passed laws requiring HCW immunization, including last October when Rhode Island Adopts New Flu Vaccination Requirements For HCPs, although there are court challenges ahead.   

 

Love the idea or hate it, the move towards making yearly flu vaccination a requirement for the healthcare industry does seem to be slowly gaining traction.

Lancet: `Small Increased Risk’ Of GBS From 2009 Pandemic Jab

Photo Credit PHIL

 

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Guillain-Barré Syndrome (GBS) is a rare, occasionally deadly, neurological disorder that gained notoriety in 1976 after it was linked to an emergency flu vaccine that was rolled out in anticipation of a `swine flu’ pandemic.

 

As it turned out, the feared pandemic never came.

 

But before the campaign was abandoned - among the 40 million people who were vaccinated - around 500 people developed GBS and 25 died.

 

While not all of those cases were likely caused by the vaccine, the incidence of Guillain-Barré Syndrome was  around 1 in every 100,000 vaccinations. Or five times the expected background rate of this disease.

 

I was a young paramedic at the time, and chronicled my small part in that bit of influenza history some time ago in Deja Flu, All Over Again.

 

In the United States, somewhere between 3,000 and 6,000 people develop the disorder each year. While most GBS victims fully recover, some people are left with permanent nerve damage.

 

This from the CDC Guillain-Barré page.

What causes GBS?

Many things can cause GBS; about two-thirds of people who develop GBS symptoms do so several days or weeks after they have been sick with diarrhea or a respiratory illness. Infection with the bacterium Campylobacter jejuni is one of the most common risk factors for GBS. People also can develop GBS after having the flu or other infections (such as cytomegalovirus and Epstein Barr virus). On very rare occasions, they may develop GBS in the days or weeks after getting a vaccination.

 

In 2010 studies showed you are many times more likely to develop GBS in the weeks following an influenza infection, than you are after getting the flu vaccine (see Lancet: The Influenza - Guillain Barré Syndrome Connection).

 

Still, some risk of developing GBS is assumed likely with flu vaccines, although most years it is too small to measure.  

 

Today, The Lancet has published a meta-analysis on the 2009 unadjuvanted monovalent pandemic flu vaccine and its association with GBS, finding a `small increase’ in risk.

 

 

Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis

Dr Daniel A Salmon PhD. Michael Proschan PhD , Richard Forshee PhD , Paul Gargiullo PhD , William Bleser MSPH , Dale R Burwen MD , Francesca Cunningham PharmD , Patrick Garman PhD , Sharon K Greene PhD , Grace M Lee MD , Claudia Vellozzi MD f, W Katherine Yih PhD , Bruce Gellin MD , Nicole Lurie MD , the H1N1 GBS Meta-Analysis Working Group†

Summary

Background

The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barré syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barré syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barré syndrome.

Methods

Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barré syndrome per million vaccinations. We used a self-controlled risk-interval design.

Findings

Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barré syndrome (incidence rate ratio 2·35, 95% CI 1·42—4·01, p=0·0003). This finding translated to about 1·6 excess cases of Guillain-Barré syndrome per million people vaccinated.

Interpretation

The modest risk of Guillain-Barré syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks.

Funding

US Federal Government.

 

Based on these numbers, the U.S. might have seen an additional 100-150 cases of GBS due to the rollout of the monovalent pandemic flu shot. Of those, 80% would be expected to recover completely.

 

There is no such thing as a 100% benign, completely safe drug.

 

Yesterday, in FDA: Drug Safety Communication On Azithromycin & Cardiac Risk, we looked at the small risk of adverse cardiac arrhythmias associated with a very popular – and lifesaving – antibiotic.

Every year, thousands of people die, or experience serious complications, as a result of taking over-the-counter (OTC) medications.

 

Prescription drugs, being generally stronger, are even more problematic. It is always a balancing act - a risk-reward calculation - when deciding to take any drug.

 

Regarding the risks of taking the 2009 H1N1 monovalent shot - balanced against a possible increase of 1.6 cases of GBS per million vaccine recipients - we must compare:

 

The CDC has estimated that the 2009 pandemic flu infected more than 60 million Americans. The virus hospitalized more than 200,000, and killed more than 12,000 (most under the age of 65).

 

Harder to measure, but Influenza infections have been linked to increases in Narcolepsy (cite Narcolepsy Onset is Seasonal and Increased Following the H1N1 Pandemic in China).

 

Influenza infections have also been linked to GBS and developing Parkinson’s Syndrome later in life (Revisiting The Influenza-Parkinson’s Link).

 

While there were other, mostly minor and temporary adverse effects linked to the flu shot - even if we assume a modest 50% effectiveness at preventing infection – when it comes to seeing a good outcome, the flu shot wins by a mile.

 

That is not to say that the flu shot is perfect. Most years it provides `moderate’ protection, and this year we are seeing particularly disappointing Vaccine Effectiveness (VE) numbers (see Helen Branswell CP article Flu shot gave minimal help to seniors).

 

As we’ve discussed often, there is a pressing need for better flu vaccines (see CIDRAP: The Need For `Game Changing’ Flu Vaccines).

 

But until they can be developed - the flu shots available now have an enviable safety record - and the CDC considers it to be the best single preventative action you can take against the flu.

NIVW 2012

 

Credit CDC

 

# 6759

 

Regular readers of this blog know by now that I get the flu vaccine every year, and that I encourage others to do the same. Not because the vaccine is perfect (it isn’t), but because it is the best preventive measure we have available to us at this time.

 

This week (Dec 2-8)  is National Influenza Vaccination Week (NIVW), the CDC’s annual attempt to reach flu vaccine holdouts before the heart of the flu season arrives.

 

So this week, you’ll be hearing a lot about the flu vaccine on the news and online.

 

The theme this year is It’s Not Too Late To Vaccinate.

 

The CDC will hold a Twitter chat on Wednesday, December 5th, from 1-2pm EST hosted by Dr. Mike Jung. You can participate or follow the conversation via the twitter hash tags @CDCFlu and #NIVW2012.

 

And you’ll find videos and promotional materials on the National Influenza Vaccination Week website, including:

• NIVW Matte Article: It’s not too late to vaccinate – Get your flu vaccine today!  [106 KB, 2 pages]
• 2012-2013 NIVW Update  [223 KB, 2 pages]
• 2012 NIVW Key Points  [308 KB, 3 pages]
• CDC Influenza Awareness Campaign: Media Toolkit  [521 KB, 22 pages]
• NIVW 2012 Flyer and Poster including customizable versions

 

 

I’d be remiss if I didn’t point out that In this year’s NIWV talking points, noticeably absent are any estimates of vaccine effectiveness.

 

Flu campaigns in the past have touted that for healthy adults under the age of 65, in years when the vaccine is a good match to circulating strains, effectiveness ranges from 70%-90%. This year, that message is replaced with a more generic:

The flu vaccine is the best way modern medicine currently has to protect against this potentially serious disease.

a.  While how well flu vaccines work can vary, the findings of many studies from multiple countries across age groups support the benefits of vaccination, especially during years when the vaccine is well-matched to circulating viruses.

The reason for this change is that studies in recent years have shown the effectiveness of the flu vaccine to vary considerably from year-to-year, and among different age cohorts.

 

A little over a year ago, CIDRAP’s  Comprehensive Flu Vaccine Effectiveness Meta-Analysis) found the trivalent inactivated vaccine (TIV) had a combined efficacy of 59% among healthy adults (aged 18–65 years).

 

Among children aged 2-7, the LAIV proved more protective, showing efficacy in 9 out of 12 flu seasons (75%) with a pooled efficacy of 83%.

 

Not awful, but not terrific either. This is a problem we’ve covered many times before, including:

 

CID Study: Effectiveness Of 2010-11 Flu Vaccine

Study: Flu Vaccines And The Elderly

Flu Shots For The Elderly May Have Limited Benefits

 

 

All of which makes issuing blanket statements about the vaccine’s effectiveness problematic. While I might prefer the CDC could find a way to be more precise, I have to admit are simply too many caveats and exceptions to fit into an easily deliverable press meme.

 

Despite their limitations, flu shots have an excellent safety profile (see Harvard Study Reaffirms Safety Of Flu Vaccine), and remain one of the most important steps we can take to avoid catching influenza each year.

 

Of course, flu shot or not, practicing good flu hygiene is important, too.  Washing your hands frequently, covering coughs & sneezes, and staying home when sick.

 

Flu shots are like seat belts in your automobile. They may not guarantee you’ll walk away from a collision unscathed, but they certainly improve your chances.  

 

Which is why I buckle up every time I get into a car, and why I get the flu shot every year. Not because I’m 100% certain of a good outcome, but because sometimes you’ve just got to play the odds.

Canada & Switzerland Clear Novartis Flu Vaccine For Use

 

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Last week (see Novartis Fluad And Agriflu Vaccines Suspended In Canada), Canada joined Italy, Switzerland, and France in temporarily suspending the use of two Flu vaccines produced by a Novartis plant in Italy pending a review after `protein clumping’ was observed in some vials.

 

Today  Reuters is reporting that Health Canada, and the Swiss government have lifted their suspensions, after being reassured of the vaccine’s safety.  

 

 

Italy, reportedly, is `cautiously positive’ that they will be able to lift their ban in the next few days as well.

 

As I mentioned on Saturday, the clumping of proteins is not uncommon in flu vaccines, and has never been associated with a health risk in the past.  But given ongoing fungal meningitis outbreak due to contaminated steroids in the United States, public health officials are understandably being cautious.

 

Here is the Health Canada announcement, released earlier today.

 

Voluntary Suspension of Flu Vaccines (Agriflu and Fluad) Lifted

Information Update
2012-164
October 31, 2012
For immediate release

OTTAWA - Health Canada has completed its review of safety information for Agriflu and Fluad and is releasing the two seasonal flu vaccines for immediate use. As a precautionary step, the products were temporarily pulled from distribution last week by the manufacturer and held from use in flu vaccination clinics at the request of Health Canada while it investigated any possible concerns.

 

Health Canada looked at the results of its own testing, conducted a health risk assessment, and reviewed information from its European partners and data submitted by Novartis in making its decision. None of the information reviewed indicated a safety issue.

 

The Public Health Agency of Canada is now advising health care professionals in possession of these vaccines that they can start using them once again. As such, those administering the vaccines are reminded to follow existing labelling directions as well as allowing the vaccine to come to room temperature before use. The products should also be shaken and checked for any white floating material before they are injected. Such material is not uncommon in vaccines and does not pose a risk to health.

 

The Public Health Agency of Canada closely monitors for vaccination-related adverse events to detect potential safety issues in a timely manner. To date it has received no reports of serious or unexpected adverse events related to these vaccines.

 

The Public Health Agency of Canada and Health Canada will continue to work with the company to monitor the safety and effectiveness of the vaccines used here in Canada. Should a safety concern be identified, immediate and appropriate action will be taken.

 

Agrippal is marketed in Canada as Agriflu and is authorized for use in people older than 6 months. Fluad is authorized for use in Canadians 65 years of age or older.

 

Flu season is upon us, and a seasonal influenza vaccine is a safe and effective way to protect children, families and communities from influenza viruses. Canadians can learn more about fighting flu by getting a copy of Fight Flu: Your Seasonal Flu Guide by contacting 1 800 O-Canada or visiting  Fight Flu.

 

CMAJ On Mandatory Flu Shot For HCWs

Photo Credit – CDC PHIL

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In an editorial today, the CMAJ (Canadian Medical Association Journal) endorsed requiring HCWs (Health Care Workers) to get a seasonal flu shot, thus joining a growing list of medical associations around the world calling for similar policies.

 

First, the press release followed by a link to the editorial, then I’ll return with more.

 

Canadian Medical Association Journal

Mandatory flu vaccine for health care workers to protect patients

All health care workers in health care institutions should be vaccinated with the annual influenza vaccine to protect patients, argues an editorial in CMAJ (Canadian Medical Association Journal).

 

Each season, 20% of health care workers get influenza, and 28% of young healthy adults who get it have asymptomatic or subclinical infections," writes Dr. Ken Flegel, Senior Associate Editor, CMAJ. "Some of them may shed virus up to a day before symptoms appear. It is time that all people who work in a health care institution be vaccinated."

 

In Canada, there are approximately 20 000 hospital admissions related to influenza and an estimated 4000 to 8000 deaths attributed to the illness. However, 55%% of physicians do not get vaccinated against the flu and are putting patients at risk of illness and death.

 

Dr. Flegel argues that flu vaccination for health workers must be compulsory, although there could be exemptions for medical or religious reasons. A vaccination rate above 90% is required to prevent outbreaks in hospitals. Mandatory programs for health care workers in many US institutions have resulted in participation rates of about 95%.

 

"Our schools have shown us the way. During measles outbreaks, access to schools has been successfully denied to nonvaccinated children and staff. The time has come for health care institutions to demand that all health care workers be vaccinated. Our patients' lives depend on this change," Dr. Flegel concludes.

 

You can read the entire editorial at this link:

 

EDITORIAL

Health care workers must protect patients from influenza by taking the annual vaccine

October 29, 2012

We know that health care workers import and transmit seasonal influenza to patients. We know that many patients get seriously ill from it and that some die. We know that the annual influenza vaccine can interrupt most of this imposed disease burden. It is time that we act on our knowledge and require all health care workers to be vaccinated. 

Full article

 

 

Despite vocal resistance from some HCWs and their unions, calls for mandatory flu vaccination for health care workers have been coming from many professional organizations for several years.

 

A few earlier blogs on these include:

 

APIC Calls For Mandatory Flu Vaccination For HCWs

AAP: Recommends Mandatory Flu Vaccinations For HCWs

SHEA: Mandatory Vaccination Of Health Care Workers

IDSA Urges Mandatory Flu Vaccinations For Healthcare Workers

 

In 2011, the following editorial opinion appeared in The Lancet.

 

The Lancet, Volume 378, Issue 9788, Pages 310 - 311, 23 July 2011

doi:10.1016/S0140-6736(11)61156-2

Time to mandate influenza vaccination in health-care workers

 

This perspective was penned by Arthur Caplan, Ph.D., who is director of the Center for Bioethics at the University of Pennsylvania, and addresses the ethics of mandating yearly influenza vaccination for Health Care Workers (HCWs).

 

Caplan argues that the evidence overwhelmingly shows that vaccinating HCWs helps to protect patients from infection (and possible death), and that the influenza vaccine is both safe and effective.

 

Citing language common to all oaths sworn by health care professionals (Doctors, Nurses, Techs, etc.), he points out the universal concept that the interests of the patient must come first, and that all HCWs must honor the core medical principal of, “First, do no harm.”

 

Both tenets, he argued, are violated when HCWs fail to accept a yearly flu vaccination.

 

While strongly advocating HCW influenza vaccination, the CDC has stopped short of mandating them. I blogged on this back on June 23rd, 2010  in  CDC: Proposed Influenza Infection Control Guidance.

 

And earlier this month we saw Rhode Island Adopts New Flu Vaccination Requirements For HCPs.

 

Although many infection control experts see this as a long overdue step in patient and employee protection, compulsory vaccination remains a hugely divisive issue, with many HCWs believing that it is an infringement of their rights to decide what will be injected into their bodies.

 

I’ve covered some of the HCW’s objections to forced flu shots in the past, including:

 

HCWs: Refusing To Bare Arms

HCWs: Developing a Different Kind Of Resistance

 

While their concerns over the vaccine’s safety may be overblown, one of their arguments that does carry some weight is the relative effectiveness of the flu vaccine.

 

It simply isn’t as good as with other vaccines.

 

Most years (see CIDRAP: The Need For `Game Changing’ Flu Vaccines), protection from the flu shot runs under 60% for healthy adults, and probably even less for those over 65 or with weakened immune systems.

 

Having a better flu vaccine would remove at least one of the objections that many HCWs have voiced.

 

Popular with HCWs or not, hospitals are increasingly looking at this as both a liability and an economic issue. Unless the courts intervene, the momentum increasingly appears to be moving towards mandating yearly flu shots for many Health Care Workers down the road.

Week 41 Flu Activity & Flu Shot Finder

 

 

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While the 2011-2012 flu season has yet to get rolling in North America and Europe, the experiences south of the equator over the last few months suggest we may see a fair amount of influenza activity later this year.

 

For now, the CDC’s weekly  KEY FLU INDICATORS report, aside from noting the single trH3N2 case in Maine, paints an  otherwise unremarkable picture of flu activity this fall. It should be noted, however, that many years influenza doesn’t make an impact until December or January.  

 

Influenza activity in the United States remains low according to the second FluView of the 2011-2012 season. Nationally, all key flu indicators were low. Below is a summary of the most recent key indicators:

• Visits to doctors for influenza-like illness (ILI) remained below the national baseline this week. All 10 U.S. regions reported ILI activity below region-specific baseline levels as well.
• No states reported widespread, regional or local influenza activity. Sporadic influenza activity was reported by 18 states (a decrease from 20 states last week) and the District of Columbia, Guam, Puerto Rico and the U.S. Virgin Islands. Thirty-two states (an increase from 29 states last week) reported no influenza activity.
• The proportion of deaths attributed to pneumonia and influenza (P&I) based on the 122 Cities Mortality Reporting System increased slightly from last week, but remained within the level expected for this time of year.
• No influenza-associated pediatric deaths were reported this week.
• Nationally, the percentage of specimens testing positive for influenza in the United States was 0.5%, a decrease from what was reported last week (1.2%).
• Though very few viruses have been submitted so far this season, these include 2009 H1N1 viruses, influenza A (H3N2) viruses and influenza B viruses. Overall, these viruses remain susceptible to the antiviral drugs oseltamivir and zanamivir.
• One report of human infection with swine origin influenza A (H3N2) is being reported this week.

 

 

The CDC recommends getting your flu shot now – to give your body enough time to develop antibodies before you are exposed to the virus. I got my shot the last week of September, but I know many people are still putting it off.

 

To make it easier for you to get the jab, Flu.gov has a handy, interactive web app that allows you to input your location, and get a list of pharmacies, clinics, and stores where you can get the flu vaccine near you.

 

 

 

By entering my zip code, I’m presented with a local map showing 26 places offering flu shots, along with their prices, phone numbers, and hours of operation.

 

 

I’ve  made my case for getting the seasonal flu shot every year many times, including in Flu Shot Ethics and NPM11: Giving Preparedness A Shot In The Arm, so I’ll not repeat them here.

 

While the vaccine doesn’t offer 100% protection, the CDC maintains it is the single best thing you can do to protect yourself – and others – from influenza. 

 

And this year, just about everyone over the age of 6 months is encouraged to get the shot (see MMWR: ACIP Updated Flu Vaccination Recommendations).

 

 

The CDC reminds you that:

 

The CDC’s Expert Flu Vaccine Commentary

 

 

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Since the recommendations for seasonal flu vaccines have changed in recent years, and there are some new options available as well, there’s some confusion out there as to what the CDC is currently recommending.

 

Many people mistakenly believe that since the vaccine formula is unchanged since last year, they don’t need a shot this year. Or that since they had `the flu’ last year, they are already immune.

 

But the flu shot’s immunity can wear off over time, and the `flu’ you had last year – assuming it was the flu – was only one strain.  The seasonal flu shot has antigens against three different strains (H1N1, H3N2, B).

 

So yes, if you want to be protected you still need a flu shot.

 

The general public can get a lot of their questions answered at FLU.GOV, but the CDC also provides information geared for doctors, nurses, and other health care providers.

 

Their Expert Commentary Series is a collaboration between CDC and Medscape and is `designed to deliver CDC's authoritative guidance directly to Medscape's physicians, nurses, pharmacists, and other healthcare professionals.’

(Note: Free registration required to access)

While aimed primarily at Health Care Professionals, these concise briefings can also prove valuable to those of us who follow public health issues.

 

Last Friday, the CDC released a 7 minute video expert briefing on this year’s flu vaccination recommendations, presented by Dr. Tim Uyeki, Deputy Chief for Science in the Epidemiology and Prevention Branch of the CDC’s Influenza Division.

 

You can view the video, and read the transcript at:

From CDC Expert Commentary

Influenza Vaccination 2011-2012: Recommendations

Tim Uyeki, MD, MPH, MPP

 

 

You can find additional information on this year’s flu vaccine at:

 

MMWR: ACIP Updated Flu Vaccination Recommendations

FDA Approves 2011-2012 Seasonal Influenza Vaccines

 

And in a personal note, yesterday I popped into my local CVS pharmacy and in less than 10 minutes, got my yearly flu shot.  

 

It was quick, easy, and relatively painless.

 

I know some people are still reluctant to get the shot every year, but you’ll find my reasoning on why I consider it worth getting in:

 

NPM11: Giving Preparedness A Shot In The Arm

Flu Shot Ethics

APIC Calls For Mandatory Flu Vaccination For HCWs

 

 

# 5282

 

 

APIC (the Association for Professionals in Infection Control and Epidemiology, Inc.) has joined the chorus of other professional infection control and medical organizations (including SHEA, IDSA, & AAP) who are calling for mandatory yearly flu vaccinations for healthcare workers (HCWs).

 

If this story sounds a bit like Deja Flu, you probably recall that in October of 2008 APIC released a similar statement (see APIC Seeking Mandatory Flu Shot For HCWs), but in that case provided for an informed `opt out clause’ if HCWs signed a declination form saying they understood the risks to patients.

 

The new statement eliminates that escape clause, recommending that that hospitals, nursing homes, and other facilities employing HCWs:

 

“require influenza immunization as a condition of employment unless there are compelling medical contraindications."

 

You can read the entire 4-page position paper, outlining their recommendations and rationale behind them, on the APIC home page.

 

APIC Position Paper:  Influenza Vaccination Should Be a Condition of Employment for Healthcare Personnel, Unless Medically Contraindicated

 

The paper also calls for those who are exempted for medical reasons to:

 

“. . .  be educated on the importance of careful adherence to all of the non-vaccine related HICPAC prevention strategies, including hand hygiene and cough etiquette.

Further, they may be  required to wear a surgical mask when contact with patients or susceptible employees is likely. “ 

 

Over the past year several other professional medical organizations have made similar calls for mandatory vaccinations.

 

AAP: Recommends Mandatory Flu Vaccinations For HCWs

SHEA: Mandatory Vaccination Of Health Care Workers

IDSA Urges Mandatory Flu Vaccinations For Healthcare Workers

 

While strongly advocating HCW influenza vaccination, the CDC has stopped short of mandating them. I blogged on this back on June 23rd, 2010  in  CDC: Proposed Influenza Infection Control Guidance.

 

Similarly, a UK Department of Health report issued in June 2010 called Learning The Lessons From the H1N1 Vaccination Campaign For Healthcare Workers  – while not mandating vaccination – stresses the `professional duty’ of all HCWs to get the vaccine.

 

New York State attempted to require vaccination as a requirement to work as a HCW in 2009, but legal challenges and vaccine shortages forced them to abandon – at least temporarily – that mandate  (see New York Rescinds Mandatory Flu Shots For HCWs).

 

While many infection control experts see this as a long overdue step in patient and co-worker protection, the obstacles that lay before these sorts of policies are substantial.

 

This is a hugely divisive issue, with many HCWs believing that it is an infringement of their rights to decide what will be injected into their bodies.

 

There will almost certainly be legal challenges, and possibly labor disputes as well. I’ve covered HCW’s objections to forced flu shots in the past, including:

 

HCWs: Refusing To Bare Arms

HCWs: Developing a Different Kind Of Resistance

 

 

Only a few large hospitals have thus far managed to implement mandatory flu vaccinations, including Seattle’s Virginia Mason Medical Center and BJC Heathcare of St. Louis, Missouri  which I blogged about here

.

Details on how Virginia Mason Medical Center implemented mandatory HCW vaccinations can be read in the following  PDF.

 

 

Over the past 5 years Virginia Mason MC has maintained a 98% vaccination rate, and has vigorously promoted the uptake of flu shots not only in the workplace, but the greater community as well.

 

An abstract from a study that appeared in the August 2010 Infection Control and Hospital Epidemiology journal concludes that a policy of mandatory HCW vaccination is feasible, sustainable, and effective.

 

DOI: 10.1086/656210

Mandatory Influenza Vaccination of Healthcare Workers: A 5‐Year Study

Robert M. Rakita, MD; Beverly A. Hagar, BSN, COHNS; Patricia Crome, MN; Joyce K. Lammert, MD, PhD

(EXCERPT)

Results.

In the first year of the program, there were a total of 4,703 HCWs, of whom 4,588 (97.6%) were vaccinated, and influenza vaccination rates of more than 98% were sustained over the subsequent 4 years of our study. Less than 0.7% of HCWs were granted an accommodation for medical or religious reasons and were required to wear a mask at work during influenza season, and less than 0.2% of HCWs refused vaccination and left Virginia Mason Medical Center.

 

Impressive results. 

 

And, when combined with increased calls from infection control organizations to adopt similar practices, likely to inspire other facilities to follow suit.