DISCUSSION: What will make the Prioritization Guidance Acceptable?

COMMENT THREAD

• Honesty
  

  Submitted by Catherine Jackie Mitchell on 12/6/07 07:28 AM

  "Honesty is the first chapter of the book of wisdom."
  Thomas Jefferson
  

• Surge capacity manufacturing
  

  Submitted by Marianne Yourdon on 12/6/07 08:08 AM

  I copied statement below from the Department of Health and Human Services Website.
  
  http://www.hhs.gov/news/press/20...
  
  "The HHS Pandemic Preparedness Plan, issued in November 2005, outlines public health preparedness and response activities for an influenza pandemic. Major vaccine goals include the establishment of pre-pandemic influenza vaccine stockpiles for 20 million persons in the critical workforce and the expansion of domestic pandemic vaccine manufacturing surge capacity for 300 million persons within six months of the onset of an influenza pandemic."
  
  Maybe we are not there yet, but we are working in the direction of having enough by 6 months after the pandemic.
  

  • Goal --- Not Even Close Yet
    

    Submitted by Deborah Robinson on 12/6/07 09:08 AM

    Thank you for the link, Marianne. Yes I have seen that. But the 20 million pre-pandemic stockpile and creating the surge capacity for 300 million vaccines in 6 months is, as stated, a GOAL.
    
    My concern is that we are so far from that goal, so very far, that the government must already have a prioritization scheme WITHIN tier one that we don't know about. They would have to because we will not have the 23 million vaxs for the people in tier one immediately after the development of the pandemic vax. In fact, it may be 5 months after they develop the vax. That is my concern.

    • Limitations
      

      Submitted by Jay Schmid on 12/6/07 09:18 AM

      I agree that the limited availability and delay in getting a vaccine to everyone let alone Level A recipients is needed to know to accept the guidelines for their value as a directive. But I also feel the public needs to that the vaccine is no guarantee that is will be 100% effective *or* free of side effects. The vaccine needs to be viewed as a critical tool for *survival* of the most important elements of a functioning society and government and not merely as a life jacket.

  • change the policy when production capability has changed
    

    Submitted by larry wright on 12/6/07 10:37 AM

    Policy should be set based on existing conditions TODAY.
    
    We may very well be facing a pandemic within the next few days, weeks or months. I doubt it will be years. Present policy needs to reflect present reality. If the reality of vaccine or anti-viral drug availability changes, change the policy and change the expectation.
    
    I can tell you all right now that there is a significant expectation on the part of the general public that vaccines will be available within DAYS of the start of a pandemic, and that is simply not going to happen. There is also an expectation that there are enough antiviral drugs in the national stockpile to treat everyone, and THAT is not going to happend either.
    
    The pandemic will have gone through at least 2 waves before the general public ever sees a vaccine, and they are going to be ENRAGED if their expectation is not adjusted before a pandemic starts. I leave it to you all to imagine what a soon to be bereaved parent is going to be thinking (or doing) when they are told that their sick child is not going to get any vaccine.
    
    Set the policy for the current reality, and be upfront about the implications. That reaction will engender positive change, I have no doubt.
    

    • One thought
      

      Submitted by Joel Palmer on 12/6/07 11:39 AM

      Not to take anything away from the main point - that the truth needs to be made more clear - there was one statement I wanted to comment on. The possible behavior of a parent with a sick child being told they won't be vaccinated. A sick individual wouldn't be vaccinated in any event, the issue here would be with antivirals. Another aspect of the situation that we (public health and pandemic professionals) must do a much better job of educating the public about so that people have a reasonable understanding of what is realistic.

    • Use Tax forms
      

      Submitted by Ellen Rice on 12/6/07 12:19 PM

      We have tax season coming shortly. There ought to be a box that has a line for a required signature that says" Read and sign this box to receive your refund. You need to be prepared to take care of yourself during an outbreak of pandemic influenza. You need to prepare to be self sufficient, possibly for weeks, as illness breaks out. There is NOT a vaccine currently available for pandemic influenza and it may be a year or more after an outbreak before the proper vaccine can be produced for you."
      
      Sign here.
      

      • education
        

        Submitted by Catherine Jackie Mitchell on 12/6/07 12:21 PM

        Can't compel something to sign something they don't understand.

        • sorry
          

          Submitted by Catherine Jackie Mitchell on 12/6/07 12:22 PM

          That should have read someone not something

      • Information, yes; panic no
        

        Submitted by Donavan Merck on 12/6/07 02:07 PM

        It's time to get the information out, but to put something like this on a tax form goes overboard. People are panicked about so many things already. Why add more to their stress? Education, yes, over-the-top warnings, no. We have many better ways of getting information to our citizens.

        • Death and taxes
          

          Submitted by Katharine Fisher on 12/6/07 02:17 PM

          That's what they are lif's only certain things.
          
          Why not alert people to the threat to their very lives as they do their taxes? (They're in a bad mood anyway then!).
          
          But seriously, would you rather someone manage your stress or make sure that you are made aware of a threat to your life?
          

          • That should read
            

            Submitted by Katharine Fisher on 12/6/07 02:17 PM

            That's what they say are life's only certain things!
            

      • Tax form statement
        

        Submitted by Sharon Hutchins on 12/6/07 05:02 PM

        Ellen, what a creative idea! I fear all those forms are already printed up already for this year, however. But I wish we could do it!

  • There is confusion
    

    Submitted by Ellen Rice on 12/6/07 12:14 PM

    There is already some work done for an H5N1 vaccine. It may be that there will be doses on hand that are better than nothing but not quite as good as one would want. That also adds to the confusion. Does the electric lineman get the "kinda" good first shot or the "real" good shot in six months?

• Marianne is correct
  

  Submitted by Terry Adirim   on 12/6/07 09:02 AM

  Deborah,
  I don't believe your calculations are correct. You are right that it would not be probable that we could vaccinate 23 million people in one day. More to do with logistics than anything else. The vaccine prioritization process has been a very open and public process from the start. So far 14 billion dollars has been spent on pandemic planning and on improving technology and capacity for manufacture of vaccine. The committee that drafted the guidance (with input from scientists, ethicists, public health leaders in other countries, our own state and local public health people, and the public) is mindful of the capacity to make vaccine and that is why the top tier was limited to the 20-23 million that is there. The goal of the vaccine program is to immunize ALL Americans eventually and hopefully at some point in the future, we won't need the prioritization scheme.
  
  But your point about educating the public is well taken and it is something that we need to work on and apparently do a better job. Thanks.

  • Sub-Prioritization of Vaccination Among Tier One
    

    Submitted by Deborah Robinson on 12/6/07 09:25 AM

    With all due respect, Terry, there is a difference between CURRENT vaccine production capacity, vaccine production capacity 2 years from now, and US vaccine production capacity in 10 years. I am well aware of how much the US government has spent domestically and internationally on pandemic preparedness and planning. I am glad we are making these investments now so that in the future we will be much more prepared. But I am talking about CURRENT and near term capacity, not the government GOAL to immunize ALL.
    
    Terry, you have not given us the current domestic capacity of vaccine production and showed how long it will take to vaccinate the people in tier one. I wish you or someone else would do that if my numbers are so inaccurate.
    
    Bryant, THANK YOU very much for drawing my attention to the proposed sub-prioritization of vaccination among Tier One that is already in the Guidance. In my humble opinion, I think this web dialogue should have had a focus on this important issue. During the second and possibly third wave of a pandemic, it will probably only be the tier one people who will get vaccinated. That is based on the numbers Dr. Gellin has given previously - not the goal.
    

  • 14 billion $$??? I thought it was more like 7.5
    

    Submitted by Roy Kamen on 12/6/07 09:59 AM

    Terry - where are you getting the 14 Billion dollars from?
    I know Pres. Bush requested 11 billion and was given 7.5 I believe.
    
    are you counting private $$$ - could you identify the source of this info?

    • It might be 13 billion...
      

      Submitted by Terry Adirim   on 12/6/07 10:25 AM

      And it was not in one year and it may be for other emergency preparedness activities as well. This is the figure that is often cited It is not only for planning but also for research and development. I know that one program at HHS---Project Bioshield through which vaccine development is contracted is a billion dollar enterprise.

      • Terry - can you comment on this?
        

        Submitted by Roy Kamen on 12/6/07 10:31 AM

        I read that congress was looking into the HHS for not spending its budget on anti virals promised to the states.
        
        I know my town didnt participate in the program allowing towns to buy courses of Tamiflu for only $12 per.
        
        Do you know anything about that?

        • States paying for anti-virals
          

          Submitted by Terry Adirim   on 12/6/07 10:48 AM

          Congress looks into a lot of things real and imagined.
          
          I am not from HHS but have been working on PI issues for a while. I am not aware that HHS is withholding funds from the states. I believe that there are requirements for states to purchase a certain amount and the Federal govenment will provide a certain amount (through the Strategic National Stockpile). This is for the general population. I believe that the private sector is being encouraged to prepare and companies are paying for antivirals on their own for their workers (there are a number of companies/industries doing this).
          
          And I don't know why your town did not participate in whatever program was available to them.
          

          • Other issues in this
            

            Submitted by Joel Palmer on 12/6/07 11:43 AM

            Another thing to keep in mind is the problems that arise with this sort of funding. Feds (HHS) send money to the states. In some states the state public health agency makes the purchase, in some it's the locals. Some states don't even have local health agencies, and instead have state agencies with regions and districts. All of which makes it likely that funds shrink by the time they get to the local purchasing level.
            
            Finally, there are the general problems that infest government purchasing. We are waiting for funding from the 2006-2007 FY budget to be approved, even though we have technically passed the time for those funds to be distributed, because of complications within the state process.

          • States were given option to purchase antivirals
            

            Submitted by Cindy Deutsch on 12/6/07 12:35 PM

            States have not been required to purchase antivirals. They were offered the opportunity to purchase them at the same discount that the federal government received when they made their purchase.
            
            Unfortunately most states did not take advantage of the opportunity.
            
            The feds were supposed to purchase enough to cover 15% of our population. The states were each able to purchase enough to cover another 10% of their population.
            
            At the time these decisions were made, patients were given 2 pills a day for 5 days to treat flu. However we are often seeing doctors using double the dose for double the duration, and that it more successful is treating H5N1.
            
            So what was to cover 25% of our population may really only cover 6.25%.
            

          • And I don't know why your town did not participate in whatever program was available to them.
            

            Submitted by Roy Kamen on 12/6/07 12:40 PM

            Maybe cause nobody told them?
            
            Our PH guy was next to clueless until I met with them and hounded them.
            
            Isn't the Administration supposed to do that? We need some help here.

            • CT towns have not been allowed to participate in antiviral purchases
              

              Submitted by Katharine Fisher on 12/6/07 02:27 PM

              Here in CT, several towns have asked the State of CT if they might ride on that federal contract where the price of an antiviral course was initially $12, rising to $17 last November and purchase antivirals with town funds.
              
              The State of CT has forbidden them to do so.
              
              Other states have extended the ability to ride on that federal contract to their county and municipal entities. Not so here.
              
              Why? Officials in the State of CT have explained that they don't want the rich towns purchasing antivirals, if the poorer towns cannot (or do not have the interest).
              
              You are welcome to come here, and try working with these people.
              

              • This must be fixed
                

                Submitted by Roy Kamen on 12/6/07 06:26 PM

                All towns should have access to anti-virals. This is insane.

• vaccine production capacity vs demand
  

  Submitted by Brant Goode   on 12/6/07 09:06 AM

  Hi Deborah,
  You rightly note the concern about capacity to make sufficient vaccine in time to provide protection. In the best case we would have an excellent pre-pandemic vaccine that could be adminstered widely prior to a crisis event. In a good but perhaps less than best case we plan to ramp up capacity once a pandemic strain is identified, use state of the art production methods (still in development today) and produce sufficient quantities and provide to the population as fast as we could. Needless to say we are not yet 'there' but multiple efforts are in play that were not even just a few years ago.
  
  Regarding prioritization within Tier 1: The draft guidance does address this important point--see pp11-12.
  
  Brant

  • Britain may pre-pandemic vax everyone
    

    Submitted by Katharine Fisher on 12/6/07 02:31 PM

    Brant, Britain came out last week with the idea that they may vaccinate everyone in their country with a pre-pandemic vax.
    
    Is that kind of program being contemplated here?
    
    The very fact that the Brits are considering such a program bespeaks a kind of quiet desperation.
    
    Could we even feasibly do such a thing as pre-pandemic vax the entire population here in America?
    

• trial vaccines required large doseage
  

  Submitted by Cindy Deutsch on 12/6/07 01:39 PM

  The trial H5N1 vaccines also required a much larger dose of vax to produce an antibody response - twelve times higher than seasonal flu vax. That may reduce the number of doses produced unless they can come up with an adjunctive to stretch the vaccine.