Status report at DailyKos

The execution of the plan is being bungled. There was a great plan for what to do in the case of "Limited Vaccine Availability" - who to prioritize. That came to 49 million people many of who would need two dose. We do not now and will not for, best case, several weeks, have enough to get a first dose in each of those people even if we only used it on them. But what is happening? States are getting the vaccine and distributing it in no apparent logical way, to local boards of health who are often offering it to all comers, or if they are "good" to the original "Initial Target Group" only - which was the plan for at least 40 million dose beginning of October and 20 million a week after that.

There has been no loud and clear guidance from the Fed level that states and Boards of Health must distribute in a manner that allows those in the "Limited Vaccine Availability" group to ge to the head of the line. So healthy 23 year olds are getting the vaccine and 18 month old former premies with moderate neurodevelopmental issues and chronic lung problems are out of luck - no more to be had or your scheduled time is in 3 weeks.

Heck at this week's press conference there was exclusively a reminder about the "Initial Availability" grouping. The politicians are so worried about spinning that there will be enough that they are afraid to discuss and implement how to handle the current reality that for right now there is not enough and that some people need it more than others.

Kids will needlessly die because of that ineptitude.

Yeah, disappointing. That Bush's people were this bad didn't surprise. That Obama's crew is so idiotic does.

Meanwhile our medical group is trying to figure out who among our high risk pool needs it the most... that "Limited Avaialability" guideline doesn't prioritize enough, given how limited the availability really is. We really want to get the most bang for each vaccine we give out. We got some nasal - okay over 2 and healthy .... under 5's are priority ... still more people than doses that we got ... okay give it tot he 2-5s who also have a sib under 6 months, a twofer. And so on.

And meanwhile the Board of Health is giving it to a healtjhy 43 year old!!!

Don: At some point we'll find out what went wrong (although it hasn't gone horribly wrong but wrong enough), but I am not so willing to blame this on ineptitude. When you consider the nature and size of the task, the weakened and understaffed state health departments (the result of tax cutting) and the fact that the vaccine companies consistently gave CDC overly optimistic information, the fact we are still seeing a vaccine roll-out in the predicted 6 month window could be considered remarkable. No other country is ahead of the US as far as I know. If your state health department is screwing it up, then work hard to make sure they have adequate resources. We've tied their hands behind them and then blame them for not getting the job done. I don't see the private sector helping much here (remember the vaccine companies are the lead in the private sector). And as Frieden said (not very adroitly), you can't make a virus grow by yelling at it. So exactly what is it that should have been done differently? The people I know who are working on this are doing it night and day. Some hardly get to see their families. I'm not willing to blame either administration for this.

I must be somewhat inarticulate - no I am not upset that the virus grew slowly. It was always a race and there was always a real possibility, perhaps even probability, that the virus would win the race. No, that part of it is in the category of "natural disaster", in that it is out of peoples' hands.

But knowing to announce LOUDLY at high levels that"Limited Vaccine Availability" guidelines must currently apply is not out of people's hands. Having read the guidelines that are there, on the CDC's site, and knowing that when we have only 12 million doses, or even 30 million doses, that we must use those doses wisely and effectively, not on those at lower risk of death, or ICU admission, or even hospitalization, that is not an issue solved with more money or staff (as underfunded and understaffed as they may be). That's basic commonsense and leadership, both of which have been absent from our public health sector in this distribution phase at least.

I am private sector. And I have kids in my practice with both Down syndrome and asthma, with both diabetes and seizures, with both a renal transplant and seizures, under 2 with BPD and developmental delay, with muscular dystrophy, and with MS. Oh and more. The public sector doesn't have it for them for weeks because they've given out the appointments to healthy adults. And we haven't been given even enough to provide for our larger group's pregnant women yet. We of the private sector are not helping because the public sector is screwing it up and not letting us help.

Guess what? We pediatricians in private practice know how to deliver vaccines, we know who our patients are with significant risk factors and with comorbidities and we know how to reach them. Give it to us with a clear rank order priority guideline and we'd get the job done. But instead the public sector is hogging the vaccine for themselves and screwing the job up horribly, handing it out to healthy adults who need it less.

Avoidable pediatric deaths will occur because of this poor execution and I expected better this shift.

Yeah, I'm angry.

Don: As I understand it, CDC is sending vaccine directly to providers who use as they see fit. It is out of CDC's hands. Their recommended priorities (pregnant women, high risk kids, HCWs, etc.) seem reasonable but the state has discretion to change the way they are doing it. So I'm not sure who the "they" is that you are angry about. If you've got a lousy health dept. then maybe you should fund it better. CDC was blindsided by the shortfall because the vaccine companies told them it was going fine and at the last minute said, "oops. never mind." The "public sector" is not one thing, any more than the private sector is. But on balance, things are getting done.

I'm keenly aware of the problem. My grandson has asthma, he's 5 years old, and was scheduled to get the vaccine soon. Instead the virus got him first and he's now got 103 temp and is vomiting up his Tamiflu. But as far as I can see, it's nobody's fault. It was always a race and the virus won in his case. Now I'm just keeping my fingers crossed. That's all I can do.

I have heard critiques of sending all or most vaccine to private providers on the grounds that this de facto withholds it from eligible, but uninsured, high-risk persons. On a more positive note, my physician's office in this small Oregon community directed (nearly?) all of the 20 doses received to the local clinic treating pregnant women, and two of the (so far extremely few) public vaccine clinics held in Portland particularly targeted the city's underserved minority and refugee communities. Revere, you are looking into Perimivir, one presumes?

*the vaccine companies told them it was going fine and at the last minute said, "oops. never mind."*

That's a pretty strong claim. Do have any evidence to back that up, that the vaccine manufacturers were giving false information about how their production was going? Or are you making it up?

The "they" is Sebelius and various official organs who should have been, from the beginning of October on, highlighting this
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm

"Subset of Target Groups During Limited Vaccine Availability

... If the supply of the vaccine initially available is not adequate to meet demand for vaccination among the five target groups listed above, ACIP recommends that the following subset of the initial target groups receive priority for vaccination until vaccine availability increases (order of target groups does not indicate priority):

* pregnant women,
* persons who live with or provide care for infants aged <6 months (e.g., parents, siblings, and daycare providers),
* health-care and emergency medical services personnel who have direct contact with patients or infectious material,
* children aged 6 months--4 years, and
* children and adolescents aged 5--18 years who have medical conditions that put them at higher risk for influenza-related complications.

This subset of the five target groups comprises approximately 42 million persons in the United States. Vaccination programs and providers should give priority to this subset of the five target groups only if vaccine availability is too limited to initiate vaccination for all persons in the five initial target groups."

Notice that this is not the list that is being discussed even now in press conferences. When you have 12 million doses to cover 42 million individuals many of who need two doses in the highest need subset and the race to get protection is on, then that guideline applies, and HHS and the CDC should be strongly reminding the states that such is the case. They have failed to do so.

At state levels the communication should be clear who is going to get what. If we in practice are not going to get any then TELL US THAT. Announce the plan. Have a transparent process that has a clear goal in place. Not a haphazard system that looks like who gets it is who has the connection to get it. Having a means to get those who need it most to the front of the line is not an issue of more money; it is an issue of less stupidity.

In fact, even in July http://www.aafp.org/online/en/home/publications/news/news-now/clinical-…
the manufacturers were publicly stating that they would not be delivering "anything even remotely close" to the expected numbers by the fall, and government officials were responding that they were not concerned and they were taking yield problems into planning considerations. (And that we VFC participating providers would be the backbone of the distribution system, so be ready.) Vaccine makers for their part state http://www.washingtonpost.com/wp-dyn/content/article/2009/10/26/AR20091…
"Representatives of the companies said they kept the government informed along the way about challenges, including a slower-than-expected growth of the vaccine inside chicken eggs.

"We have a formal call with them once a week and are in touch with them probably on a daily basis," said Donna Cary, the top spokesperson for Sanofi Pasteur of Lyon, France."

So Sebelius blaming the big bad companies for misleading them seems like a bit of political misdirection. And isn't my point any way. I'm talking about leadership given the circumstance of an extreme shortage, and the lack thereof.

Don: No, I try not to just make things up. The similar situation in Canada was reported by Helen Branswell (I think that's who it was; I'm traveling and don't have access), and the explanation as given by CDC is this. The reagents used to determine the viral titer weren't available until late in the process and it was then that (some of) the companies discovered there was less antigen than they thought. This may look like ineptitude but what we are seeing, in my view, is the inevitable ups and downs as a very, very complicated problem is taken on in real time. We are looking at this day to day, when it's something that should be looked at on the scale of weeks, at least. The vaccine companies were asked to simultaneously make and keep producing seasonal trivalent vaccine and swine flu vaccine, finish them in several different kinds of formulations (with and without thimerosol, LAIV and injectable, seasonal and swine flu) and then get it distributed to different groups (pregnant women who need thimerosol-free and not LAIV, kids who can take either but thimerosol-free injectable), etc., etc.) with uncertain demand through health departments that are seriously understaffed and under resourced and a myriad of providers. The vaccine is going directly to providers, not through health depts. Public clinics are one of many providers. If the providers in your state (public and private) are doing a worse job than elsewhere, then there's work to do in your state.

This whole set-up is going on while CDC and health depts. are also trying to manage the zillion other things that go with a pandemic, including anticipating surge (where the private sector has completely fallen down on the job), school closing, public information, etc., etc. This isn't a partisan issue. Health depts. in Republican and Democratic states are struggling under the weight of this (and remember they have regular business to conduct, not just swine flu, and they were already struggling just to do routine public health), CDC is not a regulatory agency and has little or no control over the states and is itself understaffed. I know of at least one health dept. high level employee who quit because he couldn't see his family any more and was working harder than he was physically able. All this is happening with the media and politicians yelling at them.

When the dust has settled we may find there was serious malfeasance, but i'm not willing to say that from anything I've seen so far. I'm amazed they have been able to get as much vaccine out the door as they have. The virus is winning, as I have personal reason to know, but we're still in the fight as a society.

http://www.phac-aspc.gc.ca/fluwatch/09-10/w42_09/index-eng.php

This is Canada's Fluwatch site- and I am looking at the inf for the week of October 18-24.

Here is the thing- I want to know HOW a virus is subtyped, and why. And why some areas, namely Alberta and Ontario do not seem to be subtyping at the same rate as other provinces. This is why I think I am hearing ridiculous statements like there are other flus circulating in the area, and do I not know that? In snotty voices, while I am talking to people about taking the opportunity to be vaccinated. I live in one of those provinces, and I think I am being messed around with by my government and its media lackeys, who can point to these numbers and say that over half of the cases in our province are not necessarily due to H1N1. And people believe them.

I am so mad that public health can be manipulated in this manner. I am so mad that when I say that H1N1 has effectively crowded out the other flus, just like C Diff can do to stomach/colon flora, I am met with the "fearmonger" label. I had to look this stuff up and read it out loud to someone in my family that had been misinformed by the local media.

So- Revere, can you point me to soemthing that will explain the hows of subtyping, as well as tell me if there is a large extra cost to doing so.

Breathing now....

Obviously

Revere (or revere, or whichever of you is answering :)),

I appreciate that you are responding and that you feel for the over-worked under-funded public health worker, but your response doesn't really address my posts.

I have documented to you that the manufacturers were, as early as July, telling the public that they would not have enough, not anywhere near enough, and that the Feds' response was, essentially, "don't worry; be happy".

But more to the point, you seem to say that it is not the CDC's nor HHS's job to communicate loudly who should be prioritized and that there is a "Limited Vaccine Availability" Guideline that should be followed rather than giving it out in less effective manners. Their job instead is, apparently, to just throw it at the states and let them do with it what they will.

It seems to me that that is actually exactly what we expect from the Fed level once they've taken on the job of buying up and giving out the vaccine, even if they delegate the task of sub-distribution to the states. Guidance over how the job should be done. Your grandchild should have been able to get a dose in before a healthy 30 yo did. It seems like your grandchild was not one of the asthmatic children who ended up in the hospital or worse and I am happy for you and your family that such was the case. I hope that such ends up being the case for all of my high risk patients who cannot find a dose while I have none to give them and lower risk individuals are getting theirs ahead of them.

Don: I guess I didn't answer your question because I didn't understand it. I'm confused about what you are saying. CDC has issued numerous notices of the initial target groups (starting with pregnant women, etc.) For example, here:

http://www.cdc.gov/mmwr/PDF/rr/rr5810.pdf

This is the prioritization that has been in effect for quite a while. Are you asking for something different?

I am asking that they mention that those guidelines exist and should be being followed at the weekly press conference instead of continuing to only state the "Initial Target Group" guideline when they mention anything at all other than that there will be plenty ... soon .... and that isn't their fault.

Don: I listen to the pressers every week and they have mentioned them most (possibly every) week I've listened (I didn't do a count because I didn't want to listen again, but the transcripts are there). You can see for yourself at CDC.gov/media, click the transcripts link in the first para.

You may want to check those transcripts yourself. You seem to have heard that which was not said.

Today? "Different states are taking different approaches to vaccinating people. Some states are sub prioritizing." Not exactly the leadership as to how it should be done.

Oct 30th? "H1N1 vaccine supply is increasing steadily. Thereâs not enough for all providers or people who would want it. And this understands to be frustrating. But the gap between supply and demand is closing. ... But we continue to hear that there's confusion about who should get vaccine and when. We have left for each state, jurisdiction, to have some flexibility within the priority groups, if they want to subprioritize. But the overall priority groups remain as shown on this slide. Five priority groups -- and the slide outlines which of them -- there we go, which of them can be used for, can receive which types of vaccines. pregnant women, at this point are only recommended to receive the injectable vaccine. Care-givers of infants under the age of six months can receive either the intranasal spray or the injection. Unless of course, they have an underlying condition or are pregnant. Children and young adults age six months to 24 years of age can receive either the intranasal spray or the injection. Unless of course, they have an underlying condition or are pregnant. People aged 25 to 64 with an underlying medical condition, should receive the injection. And health care or emergency medical service workers can receive either the spray or the injection. Of course, again spray only if they don't have an underlying condition and are not pregnant. These are the five priority groups. There are some places that have subprioritized within that. And that's up to jurisdictions, that may depend on local supply and availability."

Is that the "Limited Vaccine Availability" Guideline? No. That's the "Initial Target Group" Guideline. At a point where there was a total of 26.6 million doses available for shipment, most of it not yet distributed, and 42 million individuals (many of who need two doses) in the higher risk "Limited Vaccine Availability" subset, is that the best guidance to offer? WE DON"T HAVE ENOUGH to target that initial target group right now and are unlikely to in any near term. We don't have enough to cover the higher risk subset even. What fantasy world are they living in?!? Prioritize the healthy 23 year old? The 61 year old with diabetes? And thereby unavoidably leave some 18 month old with BPD ... and your asthmatic grandchild ... without as a result. Wrong. Just wrong. Inexcusably wrong.

And before that? I can find no mention in those press conferences of how providers should prioritize, only understanding that it must be frustrating but don't worry, more will be coming soon. If you can find a SINGLE time they mentioned the "Limited Vaccine Availability" Guideline I'd be much obliged. I can't find it.

This is no time for partisan apologia. When its done wrong it is done wrong.

Don: All I am reading from you is anger. The initial target groups have been stated explicitly, even in your excerpts. As the vaccine becomes available it is supposed to be given first to those groups. When the first group demand is met by a provider he/she/it is supposed to move to the second group. The fact that at some points there isn't enough is a separate question from whether there are priorities, which is the first question you raised. When I answered that, you moved to the supply issue, which I had earlier discussed. So you are angry and frustrated. You apparently live in some state where things aren't going well. Help to fix it.

Yes, I am angry but if that is all you are reading then you are mistaken.

The issue of supply is one you brought up and I merely answered. I do not like the misdirection about who knew what when but that's just politics as usual.

My issue the fact that even now the guideline for prioritization being advertised by the CDC, when they mention any guideline at all, is the "Initial Target Group" guideline, which was created for a situation in which we had 140 million initial doses expected. At a point that we had extant H1N1 (or swine as you prefer) circulating and, initially less than 14 million doses delivered, the "Limited Vaccine Availability" (formulated to cover 42 million higher risk individuals in that subset) should have been LOUDLY promoted by the relevant national coordinating bodies. And perhaps help in how to subprioritize within that group. It has not been done.

Do you believe that the CDC and HHS should, at a point in which there is not enough vaccine to cover even half the highest risk individuals with a single of often two advised doses, be promoting the guideline that was designed to cover many more, less high risk individuals?

Or merely dodge and say that it is the states job to distribute as they see fit with no additional guidance from them?

OR should they be doing what they can to advise states and those who the states choose to distribute to that at least the "Limited Vaccine Availability" guideline should be followed to the best of their availability until supply opens up (which they believe will be soon) and that they would advise certain groups be of higher priority within that even that subset?

If you believe that all I am doing is venting and not trying to fix it then you are mistaken. Taking this to public forums (that apparently those connected to the decision makers read) is my best means of influencing decisions made at that level. At my local level all I can do is to make sure that our 300 plus medical group is ready to distribute what we get as rationally and efficiently when we do get it. So far we have not gotten enough injectable to cover our pregnant women and staff that cannot do nasal but we have been sure that no one in a lower risk group is getting what would do more good there. Next we have identified children with multiple co-morbidities or more severe disease... and so on. We have a system in place to contact them and get them vaccinated as soon as we have supply. Including our All-Kids and VFC patients (for those worried that we in private practice cannot get to those without private insurance) We are ready to make sure that those of our patients who need it most get it first. What more can I do? What do you suggest?

Don S., just want to say I understand what you are saying and how hard it is to struggle on the front lines, especially for these kids/patients. Revere, I would agree the basic though not only issue is the slow growth of the vaccine material using current methods. One would imagine, too, that having a new directorate in HHS would still be causing the usual disruptions that occur with changes in administrations. --Another thought, too "light reading" perhaps at a time of urgency, yet for what it says accurate, is in Barbara Ehrenreich's article on CBS last night, http://www.cbsnews.com/stories/2009/11/04/opinion/main5522177.shtml, pointing up the role of dependency on private industry in the slow delivery. Meanwhile, I hope, Revere, that your grandson is feeling better.

Paula,

Thank you.

And I also hope that revere's grandson, and all my higher risk patients who are unable to get vaccine because of the bungling committed at many levels that made a bad situation worse, do well.

revere,

Sorry to be cluttering up your site but I do have to ask one more question. You wrote that I "apparently live in some state where things aren't going well" ... can tell me which states HAVE had things going well?

Don: I can't speak with solid evidence, but anecdotally (based on lack of complaints) I would say New Hampshire and Oregon. But I've not done a complete census, obviously. It is based on reports from people in each place who told me that where they were there wasn't a problem.

Revere, um, I don't know where in Oregon you were in contact with, but in my county last week the sole 20 doses of vaccine to reach the biggest local provider went (correctly) immediately to one of two women's clinics, to reach pregnant women. More vaccine was expected through public health this week, but to my knowledge has not happened (yet?). A glance through nearly every county's site (through flu.oregon.gov) gets "Due to insufficient supplies, no [vaccine clinics for highrisk persons] are currently scheduled" and suggestion to contact one's provider. This seems as if there's at least some problem.

Paula: If I read what you say correctly, as far as you can see, any problems in Oregon are related to supply, not to misallocation, is that right?

Yes, right, Revere. Guess I misunderstood you. And Multnomah County (Portland), in particular, was going out of its way, re the public clinics that it had to cancel, to reach underserved minorities.

It does indeed seem like things are going well in New Hampshire. Let's look there as a model and figure out why and how to export what they are doing right. http://www.fosters.com/apps/pbcs.dll/article?AID=/20091105/GJNEWS_01/71…

Well first off is something that helps - "New Hampshire is not seeing the surges of patients requiring hospitalization that other states have in the Midwest, Southeast and Southwest" Yes a bit less panic of the populus helps. But they still deserve much credit:

"... more than 425 registered health care providers are already administering H1N1 vaccine to pregnant women and children ages six months to five years old in New Hampshire. ... they will start administering H1N1 vaccines to pregnant women, children ages 6 months to 18 years who have medical conditions, such as asthma, and their siblings; and health care and emergency service workers who have direct contact with patients ... "

They are using office based providers and limiting according to the "Limited Vaccine Availability" Guideline. And it is working out moderately well. Well done New Hampshire.

Most states are not doing that. Even Oregon http://www.currycountyreporter.com/news/story.cfm?story_no=5318
"... The H1N1 influenza vaccine continues to arrive in Oregon with the U.S. Centers for Disease Control (CDC) predicting an estimated cumulative total of about 327,700 doses by November 6, enough to vaccinate 16.7 percent of the priority groups. ... Priority groups include pregnant women; children and young people aged 6 months to 24 years; people aged 24-65 with underlying health conditions; people caring for infants 6 months and younger; and health care, emergency, and frontline law enforcement workers. In Oregon, priority groups account for about half the state's population." Yup, if you use the "Initial Target Group" guideline then half the population is "high risk" and you have only enough for 16.7% of them. If you follow New Hampshire's example, and use the "Limited Vaccine Availability" guideline you do more good with what you got.

My point remains - New Hampshire is the notable exception that proofs the rule. Few places know how to do it right but when it is done right it works. With proper leadership it could be being done right in more places than just New Hampshire.

Now you have suggested that I work to change it in my state. Please advise me. How do I get my state (Illinois) to follow New Hampshire's laudatory example? (Work through private providers and with highly prioritized guidelines that are consistent with the actual available supply, getting those who need it most to the front of the line.) And please do not tell me that the answer is to throw more money at my Board of Health.