IOM Ebola Workshop Videos

Credit IOM

 

# 9288

 

 

On Monday, the IOM (Institute of Medicine) sponsored a workshop in Washington D.C. on Ebola research priorities, and about four hours of video from this conference has now been uploaded to the IOM’s Youtube Account in their 11/4/2014 - Open Session play list.

 

While I’ve not had time to watch all of the videos, I’m aware that the media has picked up on some of the uncertainties expressed by presenters (see Reuters’s U.S. scientists say uncertainties loom about Ebola's transmission, other key facts) regarding the virus.

In the biological sciences, absolutes are hard to come by.  There are always outliers, unusual or paradoxical responses, and exceptions to the rules.  Which is why it is import to discuss research priorities, to better sort these things out.

 

First a brief description of the workshop from the IOM edu website, followed by links to the individual videos.

 

Research Priorities to Inform Public Health and Medical Practice for Domestic Ebola Virus Disease (EVD): A Workshop

---

When:
November 3, 2014 (8:30 AM Eastern)

Where:
National Academy of Sciences Building (Auditorium) • 2101 Constitution Avenue, NW, Washington, DC 20418

---

An ad hoc committee, under the auspices of the Institute of Medicine in collaboration with the National Research Council will organize a one-day workshop that will explore potential research priorities arising as a result of the emergence of Ebola Virus Disease (EVD), a hemorrhagic disease caused by a filovirus, in the United States. The workshop will focus primarily on basic science and environmental health research issues of specific concern to affected and potentially affected U.S. communities. The workshop will help inform future research that could be conducted under real-world conditions (i.e., during an event) that would provide public health officials and the general public with additional accurate information about virus transmission, mitigation of health risks, and appropriate measures to prevent the spread of disease. Specific topics that may be discussed include:

• Routes of transmission and persistence of the virus to inform public health practice.
  • Examine characteristics and properties of the virus that influence the stability and viability of EVD in order to continue to inform public health efforts, handling of potentially infectious materials, and protection of at-risk responders.
  • Assess methods of viral inactivation and alternative solutions for effective disinfection of contaminated surfaces.
  • Explore considerations regarding the real-world use of personal protective equipment (PPE) among non-traditional workers or others that may be exposed to infected individuals or contaminated materials, including real-time training and education.
• Strategies to address issues of concern to healthcare workers and the general public, including the use of PPE and personal protective behaviors to prevent spread and reduce exposure.

The committee will develop the agenda for the workshop session, select and invite speakers and discussants, and moderate the discussions. An individually authored brief workshop summary based on the presentations and discussions held during the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

 11/4/2014 - Welcoming Remarks   7:50

 11/4/2014 - Workshop Objectives and Introductions  10:19

 11/4/2014 - Charge to Participants  7:53

 11/4/2014 - Characteristics of the Ebola Virus in the U.S. Environment: What do we know? 17:44

 11/4/2014 - Panel - Peters  18:01

 11/4/2014 - Panel - Howard 7:53

 11/4/2014 - Panel – Hodgson 8:31

 11/4/2014 - Panel – Lemieux  18:05

 11/4/2014 - Panel - Observations from Africa to Inform a Research Agenda 14:21

 11/4/2014 - Panel - Discussion with Attendees   49:24

 11/4/2014 - Open Session  37:45

 11/4/2014 - Report back by breakout facilitators and rapporteurs  38:17

 11/4/2014 - Discussion with attendees  20:12

 11/4/2014 - Wrap up and Adjourn  6:31

NEJM: Lessons Learned From The 2009 Pandemic

Credit NEJM

 

# 8435

 

 

Although it seems like just yesterday, it’s been nearly five years since we first received word that a new swine-origin H1N1 virus had been identified in both San Diego and Imperial County, California and in San Antonio, Texas (see CDC Issues Outbreak Notice On Swine Flu).  Soon it became apparent that an outbreak had been ongoing for several weeks in Mexico, and early reports suggested a worrisome morbidity and mortality rate.

 

While it would take another six weeks - as the World Health Organization waited to see if the virus would continue to spread - on June 11th, 2009 the `swine’ H1N1 outbreak was declared a pandemic (see Chan Declares Level 6, Calls Pandemic `Moderate’ Severity).

 

This week Harvey V. Fineberg, M.D., Ph.D. - President of the Institute of Medicine (IOM) – has penned a review for the NEJM on what went right, and what went wrong, during the first pandemic response of the 21st century.  After a frank recounting of the public health challenges (both met and unmet) during the pandemic,  Dr. Fineberg notes:

 

In light of these structural impediments and operational deficiencies, the world was very fortunate that the 2009 H1N1 influenza pandemic was not more severe.

In 2011, an expert panel - chaired by Dr. Fineberg - produced  a 180-page assessment of the International pandemic response (see WHO Panel: World Ill-Prepared To Deal With A Pandemic), which concluded:

“The world is ill prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public-health emergency.” 

 

In this latest review, Dr. Fineberg finds that – despite progress made over the past three years -  that this original assessment remains basically unchanged. 

 

The full article is available on the site, which I’m certain you’ll want to read in its entirety. 

 

Pandemic Preparedness and Response — Lessons from the H1N1 Influenza of 2009

Harvey V. Fineberg, M.D., Ph.D.

N Engl J Med 2014; 370:1335-1342April 3, 2014DOI: 10.1056/NEJMra1208802

Lessons from the 2009 H1N1 Influenza Pandemic.

A number of viruses have pandemic potential. For example, the coronavirus responsible for the severe acute respiratory syndrome (SARS), which first appeared in southern China in November 2002, caused 8096 cases and 774 deaths in 26 countries before coming to a halt by July 2003 mainly owing to isolation and quarantine.1 In terms of persistence, versatility, potential severity, and speed of spread, however, few viruses rival influenza virus. Endemic in a number of species, including humans, birds, and pigs, influenza virus causes annual outbreaks punctuated by occasional worldwide pandemics, which are characterized by sustained community spread in multiple regions of the world.

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National Academies Webcast On H5N1 Research: May 1st

 

 

# 6304

 

On Tuesday, May 1st, the National Academies will host a day long workshop on the far reaching implications of life sciences research and associated technologies. These issues have recently come to the forefront during the public debate over H5N1 research.

 

The workshop, put together by the National Research Council and the Institute of Medicine, will be webcast starting at 8:30 a.m.  EDT and running to 5:15 p.m. EDT on May 1st, and may be accessed from the National Academies' homepage (www.nationalacademies.org).

 

 

Below you’ll find the press release, and a link to further details on the National Academies webpage.

 

National Academy of Sciences

Lessons learned from the H5N1 research controversy -- May 1 workshop

Recent debate about whether to publish research findings on more easily transmitted strains of the H5N1 avian influenza virus has sparked an international discussion about the appropriateness of this type of research and the ways that research risks are assessed. At this National Research Council-Institute of Medicine workshop, scientists, policymakers, and the public will examine the implications of advances in the life sciences and associated technologies on assessments of risk and benefits; research-related decisions and social responsibility; current measures for minimizing research risks to individuals and the larger public; and whether additional measures may be necessary to deal with new risks raised by new scientific capabilities.

 

The workshop will take place from 8:30 a.m. to 5:15 p.m. EDT at the 20 F Conference Center, 20 F St., N.W., Washington D.C. Seating is limited; reporters who wish to attend should contact the Office of News and Public Information; 202-334-2138 or e-mail news@nas.edu. Registration for the meeting and an agenda are available at http://www.nationalacademies.org/stl. Those who cannot attend may watch a live video webcast at http://www.nationalacademies.org.

 

For more information, or to register to attend in person, visit:

 

Issues Raised, Lessons Learned, and Paths Forward for Dual-Use Research in the Life Sciences: The H5N1 Research Controversy - A Workshop

IOM Report On Vaccine Safety Concerns

 

 

# 5884

 

It is no secret that vaccines, like all drugs and medications, can cause adverse effects in some subset of their recipients. In very rare instances, those side effects can be serious, although most of the time they are minor and transient.

 

Today, the IOM (Institute of Medicine) released a massive (660+ page) analysis and review of more than 1,000 previous studies that looked at suspected health effects related to eight types of vaccination.

 

• chickenpox
• influenza
• hepatitis B
• human papillomavirus
• diphtheria, tetanus and pertussis (DTaP)
• measles, mumps and rubella (MMR)
• hepatitis A
• meningococcal disease

 

While a small number of rare adverse effects were causally linked some to specific vaccines – particularly among immunocompromised recipients of live-virus vaccines – the news is overwhelmingly positive.

 

First some excerpts (slighted reformatted for readability) from the press release by the National Academy of Sciences, then the link where you can download a prepublication PDF version for free.

 

National Academy of Sciences

Public release date: 25-Aug-2011

Few health problems are caused by vaccines, IOM report finds

WASHINGTON — An analysis of more than 1,000 research articles concluded that few health problems are caused by or clearly associated with vaccines. A committee of experts convened by the Institute of Medicine to review the scientific literature on possible adverse effects of vaccines found convincing evidence of 14 health outcomes -- including seizures, inflammation of the brain, and fainting -- that can be caused by certain vaccines, although these outcomes occur rarely. It also found indicative though less clear data on associations between specific vaccines and four other effects, such as allergic reactions and temporary joint pain. In addition, the evidence shows there are no links between immunization and some serious conditions that have raised concerns, including Type 1 diabetes and autism. The data were inadequate to reach conclusions about other suggested adverse effects.

 

<SNIP>

 

Convincing evidence shows that the measles-mumps-rubella (MMR) vaccine can lead to fever-triggered seizures in some individuals, although these effects are almost always without long-term consequences, the report says. The MMR vaccine also can produce a rare form of brain inflammation in some people with severe immune system deficiencies.

 

In a minority of patients, the varicella vaccine against chickenpox can induce brain swelling, pneumonia, hepatitis, meningitis, shingles, and chickenpox in immunocompromised patients as well as some who apparently have competent immune function, the committee found.

 

The majority of these problems have occurred in individuals with immunodeficiencies, which increase individuals' susceptibility to the live viruses used in MMR and varicella.

 

Six vaccines -- MMR, varicella, influenza, hepatitis B, meningococcal, and the tetanus-containing vaccines -- can trigger anaphylaxis, an allergic reaction that appears shortly after injection. And, in general, the injection of vaccines can trigger fainting and inflammation of the shoulder, the committee noted.

 

The evidence suggests that certain vaccines can lead to four other adverse effects, although the data on these links are not as convincing, the report says. The MMR vaccine appears to trigger short-term joint pain in some women and children. Some people can experience anaphylaxis after receiving the HPV vaccine. And certain influenza vaccines used abroad have resulted in a mild, temporary oculo-respiratory syndrome characterized by conjunctivitis, facial swelling, and mild respiratory symptoms.

 

The committee's review also concluded that certain vaccines are not linked to four specific conditions. The MMR vaccine and diphtheria-tetanus-acellular pertussis (DTaP) do not cause Type 1 diabetes, and the MMR vaccine does not cause autism, according to the results of several studies. The evidence shows that the flu shot does not cause Bell's palsy or exacerbate asthma. Suggestions that vaccines can lead to these serious health problems have contributed to parental concerns about immunization for their children.

(Continue . . . )

 

 

There are, of course, many instances where there is simply insufficient evidence to decide – one way or the other – whether a vaccine might have contributed to some rarely reported side effect.

 

All drugs can have side effects. 

 

And there is always a risk-reward calculation that we must all make when deciding to take medications, whether it be a vaccine, an antibiotic, or an over-the-counter headache remedy.

 

The evidence of the rewards that vaccines provide can be easily seen by the dramatic drop in vaccine-preventable illnesses in countries where they are widely used.

 

The chart below (source: CDC) shows the remarkable effectiveness of the measles vaccine campaign.

 

 

Vaccine critics are unlikely to be assuaged by today’s IOM report, but for those willing to look at the available evidence, this report should be reassuring.

 

You can access this report online, or download it as an 18MB PDF file from the The National Academies Press.

 

Adverse Effects of Vaccines:

Evidence and Causality

  Status: Prepublication Available

  Size: 800 pages, 6 x 9

  Publication Year:2011

Description

Immunizations are a cornerstone of the nation's efforts to protect people from a host of infectious diseases. Though generally very rare or very minor, there are side effects, or "adverse effects," associated with some vaccines. The IOM reviewed a list of adverse events associated with eight vaccines to evaluate the scientific evidence about the event-vaccine relationship. Using epidemiologic and mechanistic evidence, the committee developed 158 causality conclusions, assigning each relationship between a vaccine and an adverse health problem to one of four causation categories. Overall, the IOM committee concludes that few health problems are caused by or clearly associated with vaccines.

 

 

For more coverage on today’s IOM report, you may wish to check out the following media stories.

 

Vaccines given a clean bill of health - Nature.com

Report Finds Few Health Problems Tied to Vaccines - Wall Street Journal (blog

U.S.mandated report finds vaccines safe for kids -USA Today

IOM: PPEs For HCWs 2010 Update

 

 

 

# 5265

 

 

Regular readers will no doubt recall the controversy that surrounded the substitution of surgical masks for N95 respirators for some HCWs dealing with the 2009 H1N1 pandemic.

 

Nurses Protest Lack Of PPE’s

Report: Nurses File Complaint Over Lack Of PPE

California Nurses Association Statement On Lack Of PPE

 

For decades, the assumption was that only properly fitted N95 masks protected the wearer, and that surgical masks were only worn by HCWs to protect the patient during invasive procedures.

 

N-95 Respirator         Surgical Facemask

 

But over the past two years we’ve seen dueling studies that alternately show surgical masks to be an effective barrier against respiratory viruses  . . . or pretty much useless.

 

Take your pick.

 

In October of 2009 the NEJM published a perspective article (see NEJM Perspective: Respiratory Protection For HCWs) based on a 2009 IOM evaluation of surgical masks vs. respirators, and came out in favor of the N95.

 

A few days later JAMA (Journal of the American Medical Association) published a study which reported that HCWs using surgical masks experienced `noninferior rates of laboratory-confirmed influenza’.

 

In March of 2010, we saw the following study (see Study: Efficacy of Facemasks Vs. Respirators) in Clinical Infectious Diseases, that suggested that surgical masks are just as effective as respirators in protecting HCWs.

 

In guidance, updated as late as March of 2010, the CDC continued to recommend N95 respirators for HCWs who came in close contact with suspected or confirmed influenza patients.

 

But in June of last year, the CDC proposed new guidance that relaxed those recommendations to using surgical masks for routine care, and reserving N95 masks for aerosol producing procedures (intubation, suctioning, etc).

 

Still, the controversy remains. 

 

Adding to the confusion, we’ve seen recent studies that give more credence to the notion that influenza may be spread in aerosolized form (see Study: Aerosolized Transmission Of Influenza), as opposed to primarily by large droplets. 

 

But the truth is, our knowledge of how influenza spreads, and what barriers work to protect HCWs, is severely limited. 
 

 

I’ve mentioned the National Academies Press a number of times before as a terrific source  for scientific reports, and books that may be purchased, viewed online - or in many cases - downloaded for free.

 

If you have a scientific bent at all, you owe it to yourself to visit http://www.nap.edu/ to peruse the more than 3,000 titles available.

 

The IOM (Institute of Medicine) has just released, through the National Academies Press,  an extensive, 200+ page update on the use of PPEs (personal protective equipment) for healthcare workers when facing pandemic influenza and other viral respiratory illnesses.

 

The short version is, we need better science upon which to make decisions regarding the right kind of protection for HCWs. 

 

While the entire 200 page pre-publication pdf can be downloaded for free, you can also view an executive summary and an abbreviated list of recommendations.

 

Preventing Transmission of Pandemic Influenza and Other Viral Respiratory Diseases: Personal Protective Equipment for Healthcare Personnel Update 2010

Released: January 27, 2011

Type: Consensus Report

In 2009, the H1N1 influenza pandemic brought to the forefront the many unknowns about the virulence, spread, and nature of the virus, as well as questions regarding personal protective equipment (PPE) for healthcare personnel. Researchers still have much to learn about how influenza is transmitted from person to person, and one major question that arose during the H1N1 influenza pandemic was determining what types of PPE—particularly face masks or respirators—are needed to protect healthcare personnel from disease transmission. Because the focus of research efforts often shifts to other health concerns between pandemics, continuing the research momentum is critical to ensure that the nation is prepared for the next influenza pandemic.

 

In light of the unanswered research questions following the 2009 H1N1 influenza pandemic, the National Personal Protective Technology Laboratory at the National Institute for Occupational Safety and Health (NIOSH) asked the IOM to assess the progress of PPE research and to identify future directions for PPE for healthcare personnel. While the IOM finds that there are gaps and deficiencies in the research about PPE use in health care, there is sufficient knowledge to recommend a four-pronged strategy for effective PPE use:

1. Deliberate planning and preparation at the leadership and organizational levels
2. Comprehensive training for all personnel, including supervisors and managers
3. Widespread and convenient availability of appropriate PPE devices
4. Accountability at all levels of the organization

The IOM also offers several recommendations for continuing the momentum of PPE research that are detailed in the report and the report brief. The more scientists and researchers know about how to maximize the effectiveness of PPE and its use, the more prepared we will be for the next influenza pandemic.

Report at a Glance

Recommendations (HTML)

Report Brief (PDF, HTML)

IOM Book On Infectious Disease

 

 

 

# 5248

 

 

I’ve mentioned the IOM (Institute of Medicine) a number of times in the past, and have directed my readers to the National Academies Press for scientific reports, and books that may be purchased, viewed online - or in many cases - downloaded for free.

 

If you have a scientific bent at all, you owe it to yourself to visit http://www.nap.edu/ to peruse the more than 3,000 titles available.

 

Today I’d like to call your attention to a recently published (2010) 44-page booklet, authored by the Institute of Medicine and geared for general audiences, on infectious diseases.

 

 

The National Academies Press describes it this way:

 

About a quarter of deaths worldwide--many of them children--are caused by infectious organisms. The World Health Organization reports that new infectious diseases are continuing to emerge and familiar ones are appearing in new locations around the globe. What's behind this trend? How can invisible organisms cause such harm? And to what extent has human behavior amplified the problem?

What You Need to Know About Infectious Disease provides an overview of infectious disease, drawing on reports of the Institute of Medicine. Written for a general audience, it describes the biology, history, and future trends of some of the world's most widespread and harmful infections and explains what we need to do--as individuals and as a society--to address this global challenge.

 

 

In order to download this book, you’ll have to provide your name and a valid email address, but it is otherwise free.

 

This book provides a relatively painless introduction to the world of emerging infectious diseases - particularly for students and the lay public - as it never burdens the reader with too much scientific detail. 

 

It does, however, cover most of the major bases (how diseases work, major disease threats, global challenges, prevention & treatment), and is nicely complemented by a variety of graphics and pictures.

 

My thanks to Laidback Al on FluTrackers for posting this link.

IOM Report On Vitamin D

 

 

# 5100

 

 

The IOM (Institute of Medicine) released a lengthy report today giving their recommendations regarding the Dietary Reference Intakes (DRI) of what a lot of doctors have touted as practically a miracle supplement;  Vitamin D.

 

The IOM’s Food and Nutrition Board substantially increased their daily recommendations for Vitamin D, but they fell well short of endorsing the high daily doses that have become in vogue over the past decade.

 

Given the popularity of this supplement, particularly  among alternative and complementary medicine practitioners, I expect we’ll see a fair amount of controversy and discourse over these findings.

 

The entire 999 page report is available online for free, or may be ordered as PDF files, or as a hardback from the National Academies Press.

 

Luckily, for those of us with time only to deal with the condensed version, we have some alternatives.

 

First Dick Knox of NPR, has a story called:

 

Medical Panel: Don't Go Overboard On Vitamin D

by Richard Knox

 

 

We’ve also a press release from the IOM.

 

Nov. 30, 2010

FOR IMMEDIATE RELEASE

IOM Report Sets New Dietary Intake Levels for Calcium and Vitamin D To Maintain Health and Avoid Risks Associated With Excess

WASHINGTON — Most Americans and Canadians up to age 70 need no more than 600 international units (IUs) of vitamin D per day to maintain health, and those 71 and older may need as much as 800 IUs, says a new report from the Institute of Medicine. The amount of calcium needed ranges, based on age, from 700 to 1,300 milligrams per day, according to the report, which updates the nutritional reference values known as Dietary Reference Intakes (DRIs) for these interrelated nutrients.

 

The report's recommendations take into account nearly 1,000 published studies as well as testimony from scientists and stakeholders. A large amount of evidence, which formed the basis of the new intake values, confirms the roles of calcium and vitamin D in promoting skeletal growth and maintenance and the amounts needed to avoid poor bone health. The committee that wrote the report also reviewed hundreds of studies and reports on other possible health effects of vitamin D, such as protection against cancer, heart disease, autoimmune diseases, and diabetes. While these studies point to possibilities that warrant further investigation, they have yielded conflicting and mixed results and do not offer the evidence needed to confirm that vitamin D has these effects. Rigorous trials that yield consistent results are vital for reaching conclusions, as past experiences have shown. Vitamin E, for example, was believed to protect against heart disease before further studies disproved it.

 

"There is abundant science to confidently state how much vitamin D and calcium people need," said committee chair Catharine Ross, professor and Dorothy Foehr Huck Chair, department of nutritional sciences, Pennsylvania State University, University Park. "We scrutinized the evidence, looking for indications of beneficial effects at all levels of intake. Amounts higher than those specified in this report are not necessary to maintain bone health."

(Continue . . .)

 

 

The IOM has also released a relatively short Report Brief, which may be accessed at the following link.

Report Brief

Released: 11/30/2010

Download: PDF

Dietary Reference Intakes for Calcium and Vitamin D

Calcium and vitamin D are two essential nutrients long known for their role in bone health. Over the last ten years, the public has heard conflicting messages about other benefits of these nutrients—especially vitamin D—and also about how much calcium and vitamin D they need to be healthy.

 

To help clarify this issue, the U. S. and Canadian governments asked the Institute of Medicine (IOM) to assess the current data on health outcomes associated with calcium and vitamin D. The IOM tasked a committee of experts with reviewing the evidence, as well as updating the nutrient reference values, known as Dietary Reference Intakes (DRIs). These values are used widely by government agencies, for example, in setting standards for school meals or specifying the nutrition label on foods. Over time, they have come to be used by health professionals to counsel individuals about dietary intake.

(Continue . . . )

 

And finally, we’ve this handy chart summarizing the new DRI recommendations for both Vitamin D & Calcium.

 

 

 

While this report will undoubtedly upset a lot of people who have embraced high dose Vitamin D as beneficial, it is important to remember that this isn’t necessarily the final word on the subject.

 

This simply represents the IOM’s best judgment based on the evidence available to date.

 

There are studies underway that could conceivably alter these recommendations sometime in the future.

 

Good science takes time, and is constantly evolving.

 

Until then, however, the IOM finds that the existing evidence of health benefits from high daily doses of Vitamin D remains inconsistent and inconclusive.

 

 

 

Full Disclosure:  While I don’t promote Vitamin D in this column, I have blogged on several flu-related Vitamin D studies over the years, Including:

Study: Vitamin D And Flu-Like Illnesses

Scientists To Study Vitamin D And The Flu

Vitamin D To Ward Off Flu?

 

And . . .  on the advice of my doctor I’ve been taking 2000-3000 IU/Day of Vitamin D for a couple of years now.  I am pleased to find that this falls short of the IOM’s Maximum daily intake.

 

Admittedly, I have no direct evidence of benefit, but for the time being (and since I have at least a year’s supply in the cupboard) I have no plans of changing this regimen.

 

Not a recommendation or an endorsement.  Just what I plan to do.

IOM: Priorities For The National Vaccine Plan

 

 

# 4154

 

 

 

Given our reliance on 50 year old vaccine production technology and its inherent delays and supply problems, along with public misinformation and high levels of distrust of vaccines in this country, it is fair to say we’ve been very lucky that the H1N1 pandemic of 2009 was no worse than it has been to date.

 

Had this been the highly virulent H5N1 virus, or a 1918-style influenza  we’d be looking at a bigger crisis, and there would be little public patience for vaccine delays or excuses. 

 

The IOM (Institute of Medicine) has just released a 300 page report entitled  Priorities For The National Vaccine Plan  which attempts to identify portions of our National Vaccine Plan that need improvement.  

 

Areas where improvements are recommended include:

 

VACCINE DEVELOPMENT

VACCINE SAFETY

COMMUNICATION

VACCINE USE AND SUPPLY

GLOBAL VACCINE ISSUES

 

Ultimately it will be up to the HHS and the National Vaccine Program Office (NVPO) to take these recommendations and turn them into action. 

 

In a statement on the release of this report,  Director of the NVPO, Dr. Bruce Gellin said:

 

'I commend the Institute of Medicine for their insightful recommendations on the National Vaccine Plan released today. The expert panel assembled by the IOM spent nearly two years engaging a broad range of stakeholders to gain insight on priorities for the nation’s vaccine strategy for the next decade, and the National Vaccine Program Office and the Department of Health and Human Services extend their appreciation and gratitude.

 

This report represents an important midcourse review for the plan, and the Department will thoughtfully consider the report’s recommendations during the next phase of development. As the Plan moves toward finalization in summer 2010, the IOM’s priorities will join the input of many stakeholders as we continue to chart the future of the Nation’s vaccine and immunization enterprise. The Plan and its priorities aim to be national, not just federal, in scope and will set forth a vision for the next decade. We thank the IOM and the expert committee for their efforts to reflect a broad, national perspective in these recommendations.'

 

The draft version can be read online, or a pre-publication PDF or hard copy can be ordered through the National Academies Press. For those disinclined to purchase or read (online) the entire report, there are summaries available.  

 

 

Report Brief

Released: 12/11/2009

Download: PDF

As a fundamental component of medical care and of public health, vaccinations prevent the spread of infectious and potentially deadly diseases. However, there are many complexities involved in the process of making and providing vaccines, from research and development of new vaccines to the financing of immunization services. The National Vaccine Plan was required by the 1986 National Childhood Vaccine Injury Act to facilitate coordination of the vaccine enterprise across the United States. The National Vaccine Plan is centered on five goals:

• Goal 1: Develop new and improved vaccines
• Goal 2: Enhance the safety of vaccines and vaccination practices
• Goal 3: Support informed vaccine decision-making by the public, providers, and policy makers
• Goal 4: Ensure a stable supply of recommended vaccines, and achieve better use of existing vaccines to prevent disease, disability, and death in the United States
• Goal 5: Increase global prevention of death and disease through safe and  effective vaccination.

In 2008, the National Vaccine Program Office (NVPO),which is located in the Office of the Assistant Secretary for Health in the Department of Health and Human Services (HHS), asked the Institute of Medicine (IOM) to convene a committee to hold workshops with national expert stakeholders in medicine, public health, and vaccinology.

 

The committee was charged with reviewing a draft update of the National Vaccine Plan and identifying priority actions under each of the five goals that NVPO and its partners can take when finalizing and implementing the Plan. The committee found that although the National Vaccine Program has had some great successes and can provide examples of excellent coordination, neither the NVPO nor the Plan have functioned as intended in the 1986 legislation.

 

Overall, the committee concludes that because vaccines are considered a major public health intervention that involves multiple government agencies and stakeholders (including health care providers, patients, researchers, health departments, and vaccine manufacturers), an effective coordinating entity is required. Therefore, the committee recommends the Secretary of HHS demonstrate support for the National Vaccine Plan by declaring its primacy as the strategic planning tool applicable to all relevant federal agencies and by allocating the resources necessary to assure robust planning and implementation.

 

(Continue . . . )

 

 

Read Full Report
Date:  Dec. 11, 2009

Contacts:  Christine Stencel, Senior Media Relations Officer

Alison Burnette, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail news@nas.edu

FOR IMMEDIATE RELEASE

National Vaccine Plan Should Prioritize Efforts to Tackle Unmet Health Needs,  More Resources for Safety Research and Communication

 

WASHINGTON -- While vaccines help prevent many diseases in the United States, we lack immunization protection against several serious illnesses, says a new report from the Institute of Medicine that identifies priority areas for updating the National Vaccine Plan.  The revised plan should include a strategy to accelerate development of high-priority vaccines, said the committee that wrote the report.  In addition, it should emphasize the importance of expanding funding for safety research and monitoring, and include the development of a national communications strategy to clarify the importance of vaccines and bolster public confidence in the immunization system.

 

The National Vaccine Plan aims to provide centralized coordination of the various components involved in protecting Americans from vaccine-preventable illnesses and vaccine-related adverse reactions.  The immunization system engages many partners -- including multiple government agencies and departments, vaccine researchers, manufacturers, public health officials, health care providers, and the public -- in identifying vaccine needs, researching and developing new products, assessing safety, and getting people immunized.  The U.S. Department of Health and Human Services (HHS) released a draft update to the plan in 2008 and requested that IOM conduct an independent assessment of issues that merit priority attention.

 

The updated plan should call for a greater proportion of vaccine research and development to be directed at specific goals, such as producing vaccines against diseases for which there are none or developing a single vaccine that would work against all influenza viruses, the committee said.  The majority of vaccine research and development stems from the focus and interests of individual researchers rather than a set of priority targets identified through a centralized planning process. 

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NEJM Perspective: Respiratory Protection For HCWs

 

 

# 3788

 

While the debate over what constitutes suitable protection for HCWs (Health Care Workers) when dealing with influenza patients continues, the IOM recently came out with their analysis and they came down decidedly on the side of N95 respirators instead of surgical masks.

 

The complete 68 page IOM report can be downloaded by clicking the graphic below.  It is free, although you’ll be asked for your email address.

 

 

The CDC’s current recommendations are also for N95 respirators, although they are `reviewing the data’.  Many hospitals continue to use surgical masks instead of N95s, despite the CDC’s recommendation.  

 

Critics of N95s point out that they can be uncomfortable to wear for extended periods of time, and that they are in short supply.   Many HCWs, however, question whether the reluctance of some facilities to embrace N95s for influenza infection protection has had more to do with their cost than with their availability or comfort.

 

Today the NEJM has a Perspective article which reviews the IOM report data, and comes down in favor of N95’s.   I’ve provided some of the more pertinent passages below, but follow the link to read it in its entirety.

Published at www.nejm.org September 30, 2009 (10.1056/NEJMp0908437)
Novel H1N1 Influenza and Respiratory Protection for Health Care Workers

Kenneth I. Shine, M.D., Bonnie Rogers, Dr.P.H., R.N., and Lewis R. Goldfrank, M.D.

(EXCERPTS)

Health care workers have long relied heavily on surgical masks to provide protection against influenza and other infections. Yet there are no convincing scientific data that support the effectiveness of masks for respiratory protection.

 

The masks we use were not designed for such purposes, and when tested, they have proved to vary widely in filtration capability, allowing penetration of aerosol particles ranging from 4 to 90%.

 

These masks — which are open on the sides, top, and bottom — may be useful in source control when worn by a patient, but even then, there is evidence that material escapes around the mask's margins after a sneeze or forcible cough.

 

By contrast, respirators cover the nose and mouth (at a minimum) and are designed to purify the air that the wearer breathes in, either by filtering it or by providing an independent air supply.

 

It has been demonstrated that N95 respirators filter out 95 to 99% of relevant aerosol particles. Although these respirators function best when they are individually fitted, unfitted respirators do have efficacy. The available evidence indicates that the tight fit and enhanced filtration capacity of these devices offer better protection against aerosol particles than do surgical masks.

 

Until more data are available, the committee recommends that clinicians reach for the N95 respirator when confronting patients with influenza-like illnesses, particularly in enclosed spaces.

 

 

Authorities have been warning that a pandemic was likely since 2005, and  nearly 18 months ago OSHA  published a recommended stockpiling guideline for Health Care facilities, where they estimated that every nurse with direct patient contact would need roughly 480 - N95 respirators for a 12 week pandemic wave.

 

 

Despite this guidance, many facilities failed to purchase the OSHA recommended stockpile of PPEs (Personal Protective Equipment), and so N95s are reportedly in short supply at many hospitals.  

 

This shortage is being used as a justification by some hospitals that are issuing surgical masks to HCWs caring for flu patients, instead of N95 respirators.

 

And in the absence of N95s, admittedly that may be the only viable option.

 

We are indeed fortunate that we are dealing with a milder swine flu virus, and not the much deadlier bird flu virus. But that was a matter of luck, nothing more. 

 

And we are not out of the woods yet, as a more virulent virus could still emerge down the road.

 

The failure of many institutions to prepare for an event that public health officials have been warning about for nearly 4 years is hard to fathom.  

 

No doubt they had reasons that sounded reasonable to them at the time.

 

Whether those reasons will sound as reasonable to their employees – some of whom may be asked to work around flu patients this winter without the protection of N95 respirators - remains to be seen.

IOM Recommends N95s For HCWs

 

# 3696

 

 

N-95 Respirator               Surgical Facemask

 

 

Over the past 60 days the debate has raged over whether to sanction surgical facemasks as `good enough’ protection for healthcare workers caring for patients with the H1N1 virus.   Currently, the CDC recommendation is for those in close contact with novel flu patients to wear the more protective N95 respirator.

 

The problem is, we have a very limited supply of these more-expensive N95 respirators, and could use up our stockpile in a matter of weeks should we see a severe pandemic.   

 

Still, the science that suggests that surgical masks are protective is scant, at best.  And so the IOM (Institute of Medicine) has just released their recommendation to retain the current CDC guidelines for HCWs (Health Care Workers).

 

 

 

Health workers urged to use special masks for flu

By LAURAN NEERGAARD (AP) – 

WASHINGTON — Health workers caring for patients who have or may have swine flu should wear a special type of mask called an N95 respirator, not looser-fitting surgical masks, the Institute of Medicine advised Thursday.

 

Health authorities have stressed that the general public doesn't need to wander around wearing masks against flu, which doesn't spread only through the air. But doctors, nurses and other health workers will come into close, possibly prolonged, contact with the very sick. That puts them at higher risk of catching swine flu than, say, an office worker or restaurant waiter.

 

Still, "it would be a mistake for anyone to rely on respirators alone as some sort of magic shield," said Kenneth Shine of the University of Texas Health System, Austin, who chaired the Institute of Medicine committee.

(Continue . . .)

 

The complete 68 page IOM report can be downloaded by clicking the graphic below.  It is free, although you’ll be asked for your email address.