EIIP Virtual Forum Presentation – December 18, 2002

Planning for Smallpox
What Emergency Managers Need to Know

Karen M. Becker, DVM, MPH
Senior Health Adviser
Office of Public Health Preparedness
U.S. Department of Health and Human Services

Avagene Moore, CEM
Moderator, EIIP Coordinator

The following version of the transcript has been edited for easier reading and comprehension. A raw, unedited transcript is available upon request to [email protected]

[Welcome / Introductions]

Avagene Moore: Welcome to the EIIP Virtual Forum! On behalf of my partner/associate, Amy Sebring and myself, we are pleased to see many familiar names with us today - it is also nice to see so many new "faces" present.

If you have not reviewed today's background page, please take a few minutes later today and do so. There are some very valuable links included that will further add to your knowledge of today's topic. Because of the events of the past week, a lot of additional content is now available on these sites for the benefit of all US citizens.

Please note that we are discussing planning for smallpox vaccination in terms of "pre-event" (before an outbreak of smallpox) and "post-event" (after an outbreak of smallpox.)

And now it is my pleasure to introduce our speaker.

After the attacks of September 11, 2001, Karen M. Becker, DVM, MPH, was called from her position at the U. S. Department of Human and Health Services' Office of International and Refugee Health to work in Secretary Tommy Thompson's Emergency Command Center.

When the Office of Public Health Preparedness was created in October 2001, Dr. Becker came on board as a Senior Health Advisor to the Director, to develop programs that will strengthen state and local public health emergency preparedness.

We are delighted to have you with us today, Dr. Becker. I am sure the members of our audience will have a number of good questions for you after the interview portion of our program.

Dr. Karen Becker: Hello to all of my colleagues out in the field. I hope to sometime have the chance to meet you all in person.

[ Presentation ]


Avagene Moore: And now, for our first question: What guidance has been given to the States for their pre-event vaccination planning?

Dr. Karen Becker: The CDC Draft Smallpox plan was developed and released to the states to assist them with their smallpox response plans. This plan identifies the public health and medical activities that must be undertaken to control an outbreak of smallpox and assists state planners with suggestions on how to accomplish these activities. In addition, guidance for developing a large-scale vaccination clinic plan has been released to state public health officials and emergency planners.

Both of these plans as well as a template for hospital preparedness are accessible on the CDC Web site along with many educational and training resources. Please also note that a number of new planning resources have also recently been posted to the CDC smallpox Web site at http://www.bt.cdc.gov/agent/smallpox/ including the guidance to the states.

Specifically for pre-event vaccination, the goals of the National Smallpox Vaccination Program (NSVP) are to increase the nation's smallpox preparedness capacity by:

1) Offering vaccination safely to volunteer public health teams (smallpox response teams) and

2) Offering vaccinations safely to key volunteer healthcare workers, (such as hospital staff) who would treat and manage any initial smallpox cases and suspect cases.

Some of the highlights of the guidance to the states for pre-event vaccination are:

* appointment of a state coordinator for the smallpox immunization program, description of the program operation and management and timeline for program implementation;

* identification of at least one public health smallpox response team, number of teams needed and their proposed composition, and timeline for their selection and vaccination;

* criteria for hospitals and healthcare workers expected to participate, estimated number of participants, and timeline for selection and vaccination; and

* other guidance pertaining to selection of clinic sites and vaccination teams, as well as other planning aspects for implementation.


Avagene Moore: What is the review process for State plans for pre-event vaccination planning?

Dr. Karen Becker: States are just now turning in their response and large-scale clinic plans to CDC for review. Guidance for preparedness measures will be utilized for staff to review plans and help states identify areas where further planning may be needed.

With respect to the pre-event vaccination plans, a system is in place to review the plans within 48 hours of their arrival by primary reviewers at the National Immunization Program and then to subject matter experts in various centers for review of the more technical sections. The primary reviewers will make recommendations for overall approval/disapproval, based on the minimum requirements set forth in the guidance.

CDC project officers will coordinate conference calls with the state program officials, primary reviewers and the subject matter experts to address any identified deficiencies in the most expeditious manner possible.


Avagene Moore: Emergency Managers work closely with elected officials and first responders. What are the pre-event vaccination recommendations with respect to continuity of government functions?

Dr. Karen Becker: Public health planners and other community response planners and emergency managers are encouraged to work together to develop comprehensive and coordinated plans that integrate all necessary emergency response functions, including continuity of essential government functions. Vaccinations can and will be scheduled to prevent or minimize affect on essential government functions


Avagene Moore: Assuming smallpox vaccinations will be voluntary, what information will be shared upon which individuals will base their decision and how will they get it?

Dr. Karen Becker: Yes, all vaccinations of smallpox response teams and healthcare workers will be strictly voluntary. Individuals will be provided with:

* information about the vaccine,

* who should and shouldn't get the vaccine based on certain medical conditions,

* what the expected normal reaction to vaccination would be, and

* what some of the more serious reactions are to the vaccine so that they can make up their own mind regarding the risks and benefits of smallpox vaccination.

Vaccination will be provided in state based immunization programs that are currently being established by state public health officials.


Avagene Moore: When it comes to post-event vaccination planning, that is an immunization program after an outbreak of smallpox has occurred, what resources are State and Local governments expected to provide?

Dr. Karen Becker: They are expected to provide the majority of the vaccination clinic manpower, including security, vaccination personnel, transportation modes, vaccine distribution, etc. In addition, pre-selection of clinic sites and setup protocols should be done as a part of state and local planning.

Post-event vaccination activities include 2 areas:

1) Preparedness - Development of plans and pre-event vaccinations as we have just been discussing. In most cases, planning is being done by existing public health personnel, and;

2) Response - Implementing smallpox control activities (case investigation and monitoring, disease surveillance, and vaccination programs).

The occurrence of a smallpox outbreak would be considered a national emergency that would require diversion of all available state/local resources.


Avagene Moore: What resources will the federal government provide?

Dr. Karen Becker: The federal government will provide vaccine through the national pharmaceutical stockpile in a smallpox outbreak. In addition, the government will provide manpower assistance to the extent that it can but in a nationwide response, state and local governments will most likely have to rely on local manpower resources to carry out the bulk of the vaccination activities.

The Federal government has recently provided over $1 billion to assist state public health planners to enhance overall preparedness for bio terrorism. However these funds will not be available or sufficient to cover smallpox response activities.

CDC is currently working to estimate the cost of conducting mass smallpox vaccinations.


Avagene Moore: What is the current policy/strategy with respect to post-event smallpox (e.g., "ring" vs. mass immunization) and what are the priorities?

Dr. Karen Becker: The priority for vaccination in a smallpox outbreak is first identifying and vaccinating those that were exposed and their close contacts. Second, vaccinating those that have a high risk of exposure (responders that will be evaluating or caring for smallpox patients), and then other responders that have a lower risk of contacting smallpox patients. In addition, local, state, and Federal planners are developing plans to expand to large-scale voluntary vaccination also if needed in a smallpox emergency.

Ring vaccination (identifying, vaccinating and monitoring contacts to smallpox cases) is critical and will occur regardless of the extent to which broader population-based vaccinations occur.


Avagene Moore: What is the status with respect to post-event vaccination planning by the States?

Dr. Karen Becker: States are in the process of finalizing their post-event plans and submitting them to CDC for review and comment. Pre-event plans are currently being reviewed by the CDC. CDC is working with states to ensure that critical elements are being covered in the plans and will provide on-site assistance, if necessary, although, so far no states have requested this. We expect that actual vaccinations of hospital and public health response teams will begin in late January.


Avagene Moore: What local planning remains to be done?

Dr. Karen Becker: As local plans are completed, practicing and evaluating these plans is the most important next step. This will help familiarize responders and systems to their roles, identify gaps and weaknesses, and solidify coordination.

In some cases, identification of specific clinic sites, and individual job assignments still need to be done. In most cases, state and local public health agencies are still working with individual hospitals to identify the individual volunteers who will comprise the response teams.


Avagene Moore: How will State and Local emergency managers provide input into these and future recommendations, plans, and policies?

Dr. Karen Becker: State and local emergency managers should work directly with public health, medical, and other response planners in their community in the refinement of these plans as they are being developed. Their input is important from the very beginning to assure comprehensive and coordinated plans.

Avagene Moore: Thank you, Karen. We will now open up the session for Q&A.

[ Audience Questions & Answers ]


Rick Tobin: I sat through the CDC class two weeks ago. Why isn't gamma globulin being included in the National Pharmaceutical push packages?

Dr. Karen Becker: VIG is going to be kept in strategic sites within the stockpile, but at present there are limited supplies because we cannot afford to waste any, there will need to be a thoughtful process of making sure that VIG is indeed indicated. By September, we should have enough VIG from collecting plasma from vaccinees and harvesting antibodies to vaccinate the entire US population.


Rae Varian: A smallpox outbreak will immediately result in a nationally declared disaster?

Dr. Karen Becker: No, Rae. The response to a smallpox outbreak will depend on the extent of the outbreak and its geographical distribution. The primary strategy is to vaccinate those contacts of cases, suspected contacts, and contacts of contacts, and of course make sure those investigating the outbreak and vaccinating, etc., are protected.

The plan is not to panic and expand into a mass vaccination unless it is indicated. A slow expansion of the ring dictated by the epidemiological evidence is what we plan to do but of course there will also be the political pressures that we need to deal with as well and what the public is demanding.


Sunnie Baldwin: Will non-governmental organizations (NGOs) be participating? If so, do we plan with our local emergency managers or will all direction be via National Directives from the respective NGOs? We are currently participating at the advisory level in our area of Texas. We are networking through our Regional Planning Commissions and LEPCs. Is this the correct way?

Dr. Karen Becker: All public health emergencies are local, and local participation is essential to a successful response. However, so that preparedness and response efforts are coordinated, the State or Municipal Health Departments who are grantees of the BT funding, should be who emergency managers and other responders should be working with. Much of the smallpox planning and response efforts are linked to the critical capacities that have been included in the general state and municipal workplans that have all been approved.

In the guidance, we require that local involvement be demonstrated and we encourage emergency responders to work closely with the state health departments and cities who are grantees.

Yes, I think you are doing this correctly but most importantly are you satisfied with the process so far?


Santosh Kumar: Is there criteria or an indicator or any guidelines when we may have to switch from ring vaccination to mass vaccination? I heard the mass vaccination is completely ruled out and ring vaccination will enhance to mass vaccination.

Dr. Karen Becker: Tricky question and one that is often thought through when we practice scenarios. The knee jerk reaction will be to bow to political pressures from those who do not understand that smallpox does not spread like wildfire. This disease is less contagious than others, such as influenza and measles.

Public health experts believe strongly based on experience that we can control outbreaks with expanded and intensified surveillance, rigorous contact tracing, and a good vaccination strategy that reaches those who are vaccinating as well, including first responders who are responding to community needs.

However, if smallpox begins to pop up in different places and public panic because of the unpredictability occurs the President might be advised to begin mass vaccination. However, this is not a black and white issue - we might expand the ring strategy in some regions without having to jump into a National mass vaccination program. We can always expand the program but once we decide to mass vaccinate we cannot reverse this decision so we need to be very careful when making these decisions.


Milford NH: Is there a quarantine period for vaccinated individuals?

Dr. Karen Becker: On quarantine, I cannot recall from my history books or during my experience that quarantine has ever resulted in helping control an infectious disease outbreak. The economic, ethical, and social implications are enormous both for the US and other countries.

While isolation of confirmed or suspected cases is important to disease control, quarantine often results in enormous economic losses, people rebelling, and enormous other problems because we are obligated to make sure the quarantined people are taken care of.

Instead, a strong communication strategy to the public is essential and we should be telling people to stay in their homes and not go out if at all possible. Sometimes when there is a quarantine one cannot even be sure if uninfected people are being kept confined with infected individuals.


Chris Waters: Since many first responders will be police officers who have the least knowledge of the outward signs of smallpox, why aren't these first responders vaccinated at the same time as health workers, considering this also takes in large numbers of volunteer responders? Also has the question on product liability been addressed?

Dr. Karen Becker: Police officers are not as likely to have direct and prolonged contact with people showing symptoms, i.e., rash and fever; however, they will be part of the next phase of vaccinees. We need to approach this carefully and slowly to justify the serious side effects of this vaccine.

On liability, this is being sorted and is a very difficult issue. Currently all vaccinators will be Federalized and the facilities will also be protected by the Federal Government. However, what is a more difficult issue and is not yet resolved is how to compensate those with adverse reactions that require medical attention. Lawyers at HHS are working closely with us to try to figure out how to best deal with this complex issue.


K. Clark: Are you saying all vaccination sites will be protected by federal agents?

Dr. Karen Becker: No, I am sorry, what I meant to say was the places where vaccinations will be held will be government sites and will be protected under Federal Government liability regulations. Private doctors will not be vaccinating in their offices.


Isabel McCurdy: As a Canadian, are these vaccinations mandatory for American first responders?

Dr. Karen Becker: No, this will be a voluntary vaccination program while the military vaccinations are mandatory.


Valerie Quigley: What is the latest consensus on those of us who were vaccinated when we were kids? Are we still protected? I was told that those who were previously vaccinated had few side effects with the second vaccination. True?

Dr. Karen Becker: Unfortunately immunity only lasts about 10 years. However, there is reason to assume that those who were vaccinated twice have higher levels of immunity than those vaccinated once. It is thought that those who have been vaccinated, while not completely immune against smallpox anymore would be much less likely to suffer from an adverse vaccine reaction than someone who has never been vaccinated.


Rick Tobin: We need to consider the impact of inoculating a complete community's healthcare workers at once. Many hold down jobs in two or more healthcare facilities.

Dr. Karen Becker: The States have been asked to include in their plans the logistical issues of exactly how many people will be needed and how this can be done without devastating the continuity of operations for other health care needs. I would encourage you to look at your State's plan to see how this is being considered and dealt with.


Bill Shoaf: At one point in time, smallpox vaccinations were given to the public at large with the intent of eradicating the disease. The vaccinations were stopped when we believed we had obtained our goal. Now that we know this isn't the case, are there plans to eventually return to nation-wide vaccinations further down the road - when time and resources allow?

Dr. Karen Becker: Bill, this is a thought provoking question. If we have eradicated smallpox, and now we are thinking about vaccinating against this again - what does this mean for polio and other diseases that we want to get rid of for good? The President announced last week that smallpox vaccine will be offered on a voluntary basis to Americans who want it but without any disease I am not sure we can justify making it part of the National Immunization Program. But if we develop a safer vaccine this might become an option.


Rae Varian: What would be a likely scenario for a smallpox outbreak? I'm developing an exercise and want to set the stage realistically.

Karen Becker: I would be happy to share with you some of the smallpox scenarios we have worked with. The most important thing to keep in mind is to keep it simple and not create an out-of -this world scenario that we cannot even begin to know where to begin to deal with it. Begin by practicing the basic infrastructure needs, such as how our communication systems work.


James Flach: What plans are in effect to educate the general public now to avert panic in the event of a ring? I worry about the unknowing public making ring containment impossible.

Dr. Karen Becker: James, detailed information will be needed on an ongoing, real-time basis to inform policy makers, health officials, clinic managers, and the public about the status of smallpox response activities. Data must be analyzed and shared continuously to enable managers at all levels to identify and resolve problems, evaluate progress toward program objectives and redirect the activities, as necessary.

There are existing CDC materials on hand but state and local planners are also being asked to develop specific communication plans so that public panic is averted and we are speaking with a credible and consistent voice.


Don Hartley: An issue that concerns me is once an outbreak occurs, no matter how contained or small, there will be a media feeding frenzy that will serve to create a more panicky public and increase political pressure for mass vaccinations. Media competition and the show business aspect of today's journalism will only serve to exacerbate the problem.

Dr. Karen Becker: Our public affairs people are currently working on strategies to help minimize the damage done by some media mongers. There are good journalists who print accurate and useful information and we are working to strengthen relationships with them and include them in our communication plans at Federal and State levels. These partnerships need to be developed and strengthened now, not during the crisis and we need to come out frequently with public messages on the status of the situation to reassure the public we are keeping them involved and updated on the status of the outbreak.


Marla Hoyos: How long should a healthcare worker be out of work after receiving the prophylactic vaccine? It would be the third time vaccination for me, and it wasn't fun the second time around.

Dr. Karen Becker: We estimate that about 30% of vaccinees will take a day or two off of work, however, we are not recommending that people stop working unless they feel the need to do so.


Theresa Wigley: Because of the extreme cost of the vaccination program, will any financial assistance be available for rural areas with one person in the health dept?

Dr. Karen Becker: Last February the States received over 1 billion dollars to strengthen their ability to plan for and respond to public health emergencies. Additional funds (about the same amount) will be made available for 2003. Additionally, there will be Federal assistance (vaccines from the stockpile, VIG if needed). The CDC is also currently working to estimate the true cost of conducting more extensive vaccination programs if necessary to make sure that your needs are met.


Johannes van Dam: Do you have additional comments about the duration of protection from vaccination? You mentioned a consensus on duration of protection of 10 years after previous immunization.

Dr. Karen Becker: Yes, we are learning from the vaccine program which is going on in Israel at present and past studies there is waning immunity over time but no one who was vaccinated with the old program can be considered protected from smallpox. We will certainly learn more as we begin to vaccinate so that we do not have to rely so heavily on experiences over 30 years ago!

Yes, 10 years - about that plus or minus a few years on either side


Peggy Peirson: I was told that someone who had minimal scarring from an earlier vaccination could be concluded to have had a lesser immune response, and would therefore be less "immune" from the first inoculation. If you can't find your scar or it's very faint, you never got much benefit from the vaccination, and would be higher risk to receive it now again. (This from a physician.) Any truth to that?

Dr. Karen Becker: Studies have shown that it is difficult to draw a correlation between the visible scarring and the actual immune response elicited. What really matters is the actual "vaccine take" during the first week or so. The best way to predict reactions is to review the contraindications for vaccination (immune suppressed, pregnant, eczema, etc) and make sure you do not fall into the high risk category for adverse vaccine reactions.


Steve Davis: Is each state developing their own Concept of Operations (CONOPS) for this or is there a standard approach being recommended/required (like the Federal Response Plan, Incident Command System [ICS], etc.) so that the state-national interface works smoothly? I am hearing differing information on the use of ICS for managing an outbreak.

Dr. Karen Becker: The CDC has guidance that should serve and has served as a template for the States so that there is some level of standardization to this process while also allowing flexibility. You can find these on the CDC Web site provided earlier.


Sheena Vivian: From the Canadian side: given that our countries have a tremendous amount of reciprocal travel, are smallpox vaccination plans being coordinated with Health Canada?

Dr. Karen Becker: Yes, we are working closely with Canada on coordination of plans and, in fact, I am working closely with Canadian colleagues at Health Canada in the planning for a smallpox Command Post Exercise. We are also working closely with countries within a group called the Global Health Security Action Group. Just returned form a meeting in Mexico where our Health Ministers agreed that we should work together to share and coordinate plans.


K. Clark: Is INS making any provisions not to penalize the undocumented population in light of the vaccination registration requirements?

Dr. Karen Becker: Yes, if there is a smallpox outbreak it is sound public health practice to follow the strategy of vaccinating those exposed, contacts, and contacts of contacts regardless of citizen status.

[ Closing ]

Avagene Moore: We are out of time for this Virtual Forum. Karen, we are most appreciative of your time with us and for helping us better understand the smallpox vaccination program.

Audience, you were great too. And we mustn't forget Amy who always does a great job. Thanks, Amy! Thank you all!

Dr. Karen Becker: I really enjoyed this forum and hope you all have a wonderful holiday and look forward to working with you in 2003!

Avagene Moore: Happy Holidays to all!!