July 29, 2009
NOTE: This is a rough, unedited transcript and transcription errors may appear
Dave Daigle: Today, we have Dr. Anne Schuchat who will update us. She is our director for the National Center for Immunization and Respiratory Diseases.
Anne Schuchat: Today, we convened in an urgent meeting scheduled outside of our usual three times a year meeting schedule. The committee was asked to deliberate about the H1N1 vaccine and they were asked to look at two particular questions. Targets populations that ought to be the focus of immunization activities and the second question about prioritization and who ought to get vaccines first in the circumstances were there may not be enough. The ACIP is a committee that includes 15 members. They are doctors and scientists, vaccine experts, those with expert in public health or clinical care and there's a public representative as well. This is one important step in a longer term process to plan for prevention and preparedness around the 2009 H1N1 influenza challenge so this is one part of a broader vaccine development production and planning effort.
The committee took -- healthy discussion, reviewed the epidemiology and the science and really made two critical recommendations that CDC will take under advisement. They recommended five target groups for the initial focus for immunization. These are groups that had higher risk of disease or who had greater burden of complications there are five groups that we will be very helpful for our planning purposes going forward. They include pregnant women, household contacts of children who are under six months of age, health care workers and emergency medical services personnel, children and young people between the ages of six months through 24 years of age, and nonelderly adults with underlying risk conditions or medical conditions that increase their risk of complications from influenza. These are generally populations that were defined by the epidemiology of this 2009 H1N1 virus outbreak and these are the recommendations that will really help our state and local authority goes forward with their planning efforts.
Second key question they were asked to deliberate about was prioritization. If the populations for whom vaccines are recommended are larger than the am of vaccine that we will have, are we to prioritize or not? And they really discussed this in two ways. First, they said that, in general, under most circumstances, we really ought to promote vaccine in all of these five focus groups and that picking them or prioritizing some before others would not benefit the public. We have learned from shortage situations in the past that when we really focus intensively on prioritization, sometimes we have vaccine left at the end of the season. So their default that was prioritization probably doesn't make sense in this circumstance, we should really go out full force to identify opportunities to vaccinate these five target groups. But they also did consider a just in case scenario, a prioritization scenario that might be necessary if the initial supplies very limited or if in local communities there is just not quite enough, their demand and supply aren't matching. So, they did come up with a prioritization or a who's first in line kind of scheme. Again there were five groups in that prioritization but it is a much smaller total population. That prioritized small group which really won't be used under most circumstances but have in our pocket in case we need it includes, again, pregnant women, household contacts of children under six months, a subset of the health care workers and emergency services personnel who have that direct patient contact or direct contact with infectious substances, children between the ages of six months and -- through 4 years of age, and children 5 to -- through 18 years of age who have underlying risk factors that put them at greater risk of complications of flu. So, that's much smaller subset than the first one but our real operating assumption is that they will go forward with the broader group.
As I mentioned this is just one part of a broader plan around vaccination planning and really around preparing for the H1N1 virus and other influenza viruses that will be coming soon to a place near you. It is very important that we remember seasonal influenza vaccine is recommended for a lot of people and emphasize how important seasonal influenza vaccine is and recommendations for that vaccine really need to go forward and we should be offering vaccine as soon as it is available. There are other steps involved with the vaccine decision making. There are other advisory committees, a public engagement effort over the next month which is going to seek some public input into this vaccination effort and understand [inaudible] communities around the country about this and there will be clinical trials that will be launched very soon here in the U.S., some that have started in other parts of the world that will help us understand more about the H1N1 vaccines that are being developed. I know everyone wants to know when will we have vaccine and how much will we have and as I've been telling you, influenza vaccines, seasonal or new H1N1 vaccines, production could be unpredictable. Right now, we are to on track, expecting vaccine doses in the fall. Exactly how many, exactly when will be tough to pinpoint but we have a lot of planning assumptions that we are working around and those are part of the broader story.
So, I think the key message today is that a very important step occurred in our planning for vaccination for the fall, that an evidence-based process led to recommendations for people who are at higher risk of disease or complications to be a focus of their immunization efforts and the public health community, a medical community and a public sector, we really want to work together going forward to protect ourselves and our communities from this new influenza. I think right now we should move to questions. I apologize again for keeping you here late today.
Dave Daigle: Do we have a question in the room? Betsy?
Betsy McKay: Thanks, Dr. Schuchat. Betsy McKay from the "Wall Street Journal." I wanted to ask right off the bat about prioritization because this broader group includes roughly 160 million people, maybe smaller, and we also learned today that the number of doses expected to be available in October is probably between 120 million and 160 million. So, assuming that you need two doses, that is not going to be enough to cover that group. So, how do you see this playing out right off the bat?
Anne Schuchat: Right. That's a great question. We think it's really important to differentiate the size of the target population from the number of doses that we have and the number of doses that we need. We know that with seasonal influenza, we actually recommend the seasonal influenza vaccine for 83 percent of the country, a huge number of people. But we actually only reach less than 40 percent of the people, so that we know that we have 120 million doses the past couple of years. And really, there is, I think, about 280 million people that are recommended to receive the vaccine. A pretty -- pretty clearly, if we use seasonal influenza demand and uptake as our sort of expectation, we may have plenty of vaccine right away. On the other hand, there's a lot of uncertainties. With this particular virus, we don't know exactly what supply or demand will be at any one time in any one community. So the committee took that under advisement and came up with scenarios to plan for. That is why they do come one that just in case prioritization group, which is actually only about 41 million people. As you mentioned, the two-dose idea, we do think it is likely most people will need two doses of this vaccine and that is the way we are planning, as we learn more, we will share whether that turns out to be the case.
Dave Daigle: Thank you, Betsy. Can we take one from the lines, operator?
Operator: If you do have a question, please press star 1. Our first question comes from David Brown from the "Washington Post." Your line is open.
David Brown: Yes, thank you very much. Dr. Schuchat, can you talk a little bit about the over 25 -- you know, the 25 to 64 and 65 and over? It got a little complicated toward the end to of the meeting? And also, an unrelated question, since Thimerosal is the issue that never goes away is there going to be enough Thimerosal-free vaccine available for every -- everyone under, let's say age 5 who wants the vaccine?
Anne Schuchat: Thanks for those questions. The 25 to 64-year-old population, people who have underlying risk factors that put them at greater risk for complications of influenza and that group is one of the target populations that we really hope will be the focus of immunization efforts initially. The committee also deliberated about others in the 25 to 64-year-old group who are healthy without those underlying conditions and presumably who didn't already have another condition like being a health care worker to or being pregnant or being a healthful contact of a person under six months. And for that healthy really unaffected 25 to 64-year-old group, the committee recommended that after the initial focus, that that group ought to be offered vaccines, that it was important to address demand in the first five target groups initially and make sure we really reached them, but that healthy adults would also be offered the vaccine. They next deliberated about people 65 and over and that is important to discuss. People 65 and over are at high risk for influenza complications from seasonal influenza and very important that people in that age group get their seasonal flu shot and they are very good at get seasonal flu shots and we really want to encourage them to do so. The H1N1 outbreak so far has to a large extent, spared that population and so that group was voted on last and really, the idea was after these other younger age groups have been addressed, if supply is adequate, if global circumstances and the epidemiological data permit, vaccine could be offered at that time but it was really a sequential group. The five target groups first, healthy adult group next and the 65 and over later. And I think we really want people 65 and older to know how important this influenza vaccine is and as soon as it is available it is a good thing to get. So far, the H1N1 virus has been sparing those people to a great extent.
The second question was about Thimerosal free. The government has procured doses of Thimerosal free vaccine, two forms there's needles and syringes being prepared Thimerosal free and there is nasal spray which does not have Thimerosal in it. That is licensed for children 2 years and above all wait for adults up through age 49. So we do think that there will be Thimerosal-free formulations available for those people who are interested in that sort of preparation. In general, the ACIP and CDC does not express a preference for Thimerosal-free based on that component. Another question from the room?
Dave Daigle: Sure. Thanks. Mike?
Mike Stobbe: Mike Stobbe from the AP. One question to clarify, when we talk about how many doses will be available this fall, a discussion of how many micrograms of antigen will be available in each one. How many micrograms are we talking about when we talk about the number of dose and could that change depending on additional information that comes in?
Anne Schuchat: The planning assumption for discussion today were the vaccine would contain 15 micrograms of antigen for the inactivated form and essentially that we would use the amount of antigen that the seasonal flu virus vaccines contained for this H1N1. So it is 15 micrograms and equivalent for [inaudible]. The planning assumptions are reasonable. The FDA is considering this right now, deliberating but likely -- [ inaudible ] strain in terms of formulations and so that's where the 15 micrograms comes from there will be trials that will look at dosing, look at a lower dose and a higher dose and trials that will also look at the 15 micrograms with adjuvant to see whether we get a whole lot more bang for the buck, but I think most of the experts right now think that the 15 micrograms doses is very likely the right one. Okay, phone next?
Operator: Our next question comes from Emma Hitt with Medscape. Your line is open
Emma Hitt: Yes, thanks for taking my question. How do you expect the H1N1 vaccine to be delivered alongside the seasonal influenza vaccine. Can they both be received at the same time or delivered simultaneously?
Anne Schuchat: Thank you. The -- some of the studies that are being carried out will look at simultaneous administration versus sequential administration of the seasonal vaccine and the H1N1 vaccine. For planning purposes, assuming the seasonal vaccine is going to be available first and want to encourage people to offere if they are a provider or a program, and receive it if you are one of the people recommended to get it, but there's likely to be overlap this season between seasonal flu vaccines being offered and the H1N1 vaccine being offered. Our assumption is that it is very likely they can be given together there will be more data coming out about that but for the time being, we are expecting it is likely they can be given at the same visit there will be more information about that it was very clear from the committee's recommendations today how important they view the seasonal influenza vaccine and that that is really the base from which we expand in terms of thinking about this H1N1 vaccination effort. Thank you. I'm sorry -- Okay.
Dave Daigle: In the room?
Reporter: Thank you. Dr. Schuchat, the committee took adjuvented vaccine off the table today and so all their recommendations apply only to the licensed formulation. What would -- can you explain the scenario going forward how we might consider adjuvant and how the committee's decision might affect the use of adjuvant should we decide that we need to do that?
Anne Schuchat: Adjuvants are components of vaccines that are often included to increase the immune response to the vaccine and there have been discussions that sometimes adjuvants could be dose-sparing and sometimes they might broaden the immune response and perhaps be helpful in expanding the immune response if there's a strain -- if the strain changes a bit. So the way that we are thinking right now is that our base case is unadjuvanted vaccine, which we believe could be used as a licensed product and available probably a little bit quicker than the adjuvanted form could be. With adjuvanted vaccines, you have tradeoffs of how much benefit would you get in terms of a better or different immune response and there will be dose-sparing but also what are the safety constraints? Here in the U.S., none of adjuvants s that are being considered are licensed right now, so if we went for adjuvanted vaccine it would be used under what we call an emergency use authorization, really special circumstances. And so, we are evaluating you the need forage vent but our working plans right now are that we are expecting not to need them. This is something that the inputs would be the changes in the virus, major antigenic changes in the virus that make the immune response with a nonadjuvanted vaccine unacceptable and a challenge with the dose, really not having an immune response from this particular one where we really, you know, need such a large amount of antigens that adjuvants are needed. Neither of these two circumstances are considered by the experts very likely but we are going through the steps to make sure we have adjuvant available and to study it because it is very possible we would need it.
Dave Daigle: Another one from the phone please, operator.
Anne Schuchat: Yeah, from the phone? Oh, to okay. Next question?
Operator: Our next question comes from John Cohen.
Operator: Science Magazine. Your line is open.
Caller: Thanks for taking my call. Just a point of clarification, I don't believe FDA does adjuvants they license products but I could be wrong but I'm fairly certain that is accurate. I had two quick questions, one is about the process of recommendation, what's the CDC do at this point and what's the time line for adopting the recommendations or rejecting them? And what's the timing of clinical trial data and availability of product in making the decision to use that product? I mean it seems possible to me you could have product ready and a lack of clinical trial data to know how much -- how many micrograms to use and whether it needs to be adjuvanted or not.
Anne Schuchat: Thank you. I appreciate the correction about FDA. What I'd like to clarify is that in the U.S., the influenza vaccines that we had licensed for use do not included adjuvants. In Europe there are licensed adjuvanted vaccines primarily for the elderly. Our licensure hasn't yet included any vaccines with adjuvants and haven't seen an enormous safety data business on those. The process here is these recommendations will be reviewed quickly by CDC and expecting them to rapidly be disseminated to the state and local health departments that are actively planning for vaccination efforts, so we think these recommendations will immediately be helpful to planners to start to reach out to the private providers and the present and public sector as well as to communities. We also expect to be starting to get the word out to people about are you in a group that ought to be thinking about the H1N1 vaccine when it becomes available, assuming we move forward with the large program? So we don't expect a delay of any major amount. Now there are other steps, as you mentioned, in terms of other processes going forward. There are clinical trials going on and there are a number of considerations. The FDA may license this H1N1 vaccine based on the applications from the companies without wait fogger any clinical trial data, just based on the way they license seasonal flu vaccine each year. The clinical trials will give us information that is helpful but there are other decisions to be made going forward, literally take nothing account the circumstances. Is it more important to move forward before we have all the clinical information to really make sure we can take advantage of protection and based on the safety and immune response record of the seasonal flu vaccines or is it more important to go a little bit slower and wait for the results of these trials? This is something that the health and human services agencies are looking into and some of the advisory committees are also looking into that. The national biodefense and science -- the national biodefense sciences board, which advises HHS's preparedness group, has actually recommended, you know, going forward without waiting for those clinical trials, at least in some amounts of vaccine, just a serious question that we are deliberating on right now. I also want to mention that we are doing a public engagement exercise to really understand values of the public in terms of how intense our vaccination efforts really ought to be. There is always this balance between prevention and information, safety is a concern for people. You know, really what -- we want to understand with where the public is on this matter because it is a pretty big matter for consideration. Question in the room? Yeah that would be.
Reporter: On the public message, is it dangerous, this counter vaccination method, that you heard in there today that there is still people out there who believe that there's some risk involved in these vaccines? We interviewed someone today who told us that they thought it was not clear the benefits from these vaccines is actually greater than the risks? Could you talk to that and do you really need to be a little bit more forceful on, you know, your thoughts on that message? Vaccine safety is extremely important. And at CDC, we value this highly. We really want to make sure that the interventions we recommend and promote are beneficial and that people have good information. It's critical to me that science is translated into accessible information and that the public, particularly parents, can make good decisions for their children or their family's health. So we know that there are some people who are reluctant to vaccinate and they have heard information that concerns them. I want to make sure they have good information to address those concerns so that they can make good choices. I think that's really critical. And going forward with an H1N1 vaccination program, very similar to our other vaccination efforts, safety information is important to people and we need to share what we know when we know it, even if it's bad news going down the line. So, I think we want to make that commitment to people. Oh, to the phone lines?
Operator: Our next question comes from Stephen Smith with the Boston Globe, your line is open.
Stephen Smith: Good afternoon. I was hoping, first of all, to confirm that your -- that target group recommendations would cover 160 million people. And then secondly, I'm wondering what has been decided in terms of the dissemination of an H1N1 vaccine. In other words, will it piggy back on the existing system in place for seasonal flu vaccine or given that there is likely to be a truncated time line, is there going to be some system where it might be distributed through the strategic national stockpile network? And also in terms of payment, is it anticipated that there will be a mix similar to the seasonal vaccine that some of it will be covered by life insurance, some of it will be covered by governmental agencies, both state and federal, where is the thinking on those issues?
Anne Schuchat: Thank you. The five target groups, the estimate is not clean. The estimate is 159 million, but there's a lot of overlap in some of the groups but it there is probably a lower number than that. What we try to stress we are not expecting -- first of all, there is overlap and secondly, with coverage expected to be 20 to 50% for seasonal flu, the size of that population may not be so relevant in terms of what the actual demand would be. You asked about the distribution and use of the vaccine. We are not expecting that this will work exactly the way the seasonal flu vaccine works. The federal government has procured the vaccine and we are expecting the cost of the vaccine to be borne by the federal government. The administration for vaccination -- for vaccine that we think would be more of a mix, when vaccine is in public settings, school clinics, immunization efforts or community center that is vaccine administration costs would be -- would come out of the public resources that the health departments are receiving but that when it is given in the private settings in doctor's offices or retail settings, for instance that insurance would be billed for that whether it is public insurance like Medicaid or private insurance. And there is a set of activities going forward to make sure we can make this smooth. As you say this is different from seasonal influenza because we may be trying to vaccinate a lot of people relatively quickly, particularly if the disease increases earlier this year, kid goes back to school and so forth. So, we want to remove the barriers we don't want people not to be able to access vaccine because they are not insured and we don't want community clinics or school clinics to go very slowly or inefficiently for needing to screen for insurance, for instance. So there is a lot of planning right now. So it is intended that formula or prorata distribution of vaccines for the state and local program areas will go forward and that they will be directing vaccines to public and private settings. We want the public private sector to help with this and we know that won't be enough and need the public sector quickly Any other questions from the room? Another from the line, operator.
Operator: Our next question from Deborah Cox from U.S. News & World Report. Your line is open.
Deborah Cox: Thanks for taking my question. I would lick to get back a little bit to the public education efforts. I wanted to ask, first of all, how the CDC plans to reassure the public who may be concerned because they read reports about the last time the flu vaccine was given and the association with GBS and also wanted to ask if you are testing the vaccine in pregnant women, if they are part of the clinical trials?
Anne Schuchat: Thanks. I will do the questions in reverse. On the -- there are plans for testing of the vaccine if pregnancy and NIH is overseeing that effort. The information and communication is vital for any vaccination program and particularly for something like this when we have a new H1N1 strain, a lot of concern in the spring, disease in children, really, really charged issues. You know, youth deaths in pregnant women and tragic events that concern all of us and also a population that has questions about vaccines, so we are with intense civil planning a communication and education program and we are also intense civil planning a safety monitoring program. There's only so much information we can learn about safety before vaccines go into people because they are not tested in millions of people, even if the test goes all the way until the conclusion it would be hundreds of thousands, not really hundreds of thousands but millions of people. And to find those rare severe events like a Guillain-Barre syndrome scenario that happened in 1976 it is really only when vac seep goes out in large numbers that becomes evidence. So it is vital to us to have a good monitoring syndrome that if there are problems, we want to be able to interpret them quickly, figure out whether they are coincidences or are real and really take action. So I this think that it's very important for people to have good information about what's the disease likely to be what do we know about the vaccines and to make good choices but we are planning both an education information program and also a safety monitoring program. Another question from the -- sorry from the phone next?
Operator: Our next question is from Shelley Adler with the Associated Press.
Shelly Adler: Hi, thanks for taking my question. I'd like to know how dangerous the H1N1 virus is for pregnant women and why.
Anne Schuchat: Thank you. Um, we have seen pregnant women disproportionately affected by this virus. They have apparently a four-fold increase of being hospitalized here to the general population that gets this virus so we do think that when influenza, including this H1N1 virus strikespregnant women, worse things happen. We have a number of deaths among pregnant women and it really sands us to know about those. It's vital for pregnant women who have respiratory illness and fever to get early treatment and we think anti-viraled me SFOIRNS them can be like savings and that is a very important message. We also think it is important for them to get seasonal influenza vaccine and today the committee recommended that when the vaccine is available and a decision to go forward, that pregnant women really ought to consider getting the H1N1 vaccine so they are at higher risks of bad complications from influenza. We should go in the room here.
Reporter: Denise Grady from the New York Times. I just wonder if you could clarify something that Dr. Fiore said during his briefing and that was is obesity all by itself a risk factor or was it not? I'm sorry, I missed what he said.
Anne Schuchat: The information is incomplete right now. To the best of our basically, as we look at patterns of disease among people who are obese and people who aren't obese, we don't see as big a difference as you might expect. When we look at people morbidly obese, extremely obese, BMIs over 40 they apparently did appear to have more complications from the H1N1 virus than others it is important to say that a majority of people who were either obese or morbidly obese had other medical risk factors for inflew when ZWLA and its complications so they were often likely to have diabetes or chronic diseases of other types that put them at risk for higher complications. Look at a group that only had morbid obesity or only obesity it is not clear.
Denise Grady: [ Inaudible ].
Anne Schuchat: Let me clarify it.
Denise Grady: What I was trying to say --
Anne Schuchat: They would not be a targeted group.
Denise Grady: Right.
Anne Schuchat: Right. I think what is important to say is that most people -- we -- the committee reviewed the data on the underlying risk factors that were occur in people with this H1N1 virus and really found similar patterns to the seasonal influenza risk factors. And most of the people that are getting these hospitalizations or deaths do have an existing ACIP indication. A lot of those who were showing up as the people with morbid obesity have chronic respiratory disease and have other chronic conditions, diabetes and so forth that put them on the list some, we don't think we are missing a lot of people.
Dave Daigle: Do we have anymore from the room let's go to the line, operator.
Operator: Our next question comes from Molly McCray with KPIX-TV, your line is open.
Molly McCrea: Yes, hi. I didn't hear the information that I guess Denise Grady was referring to with -- the present topic regarding obesity So, an underlying medical condition does not include obesity in and of itself? So otherwise healthy obese patients would not be a target population even though some that case study done by the CDC seemed to indicate some of the morbidly obese had no underlying -- no diagnosed underlying conditions.
Anne Schuchat: The recommendations of the committee today stressed to use the available list of respecters that ACIP has traditionally used for seasonal influenza. I think issues like obesity remain under discussion and mo new information may be forth coming that may amend it I think it is reasonable for people to have an open mind about that. At this point, we think that most people who are at high risk would be covered with the indications that are already listed but I would say the book's not closed to on that one with.
Molly McCrea: And those -- those indications would be on the ACIP website?
Anne Schuchat: Oh what are they? The indications for seasonal influenza are first I'm going to say they are on our website because I might miss a couple, but they include chronic respiratory disease, chronic heart disease, chronic lung -- sorry, chronic lung disease is already included, chronic liver disease and chronic kidney disease, diabetes, immunosuppressive conditions or immunosuppressive medicines, pregnancy, these arethe underlying conditions. There are of course, another set of conditions that are age-related or household contact related. Those are the majority, I believe that I have just listed. Okay, so I think we have a question in the room.
Mike Stobbe: Thanks. Mike from the AP again. I just -- the potential for confusion is through the roof. And you are a clinician. I was wondering, as elderly people come in, what do doctors tell them? They are coming if seasonal flu not supposed to get. This and pregnant women has been a challenge, only 15% immunized and heard somebody from NIH say the evidence is scanty, I think is that the word he used in terms of safety data on that as a clinician, how are you going to talk to patient or what do you advise other doctors to say to keep all this straight and get the right people in?
Anne Schuchat: You know, I think that's great question. As a clin and as a public health expert, I talk to people about vaccines all the time and one of the tragedies is most people who have one of these risk factors don't even recognize that they are at risk, so it is really important that health care workers have a heightened awareness about this issue and the first thing that's important, that they get vaccinated, both with season aal flu vaccine and with the H1N1 vaccine when it becomes available, front line, what they do influences their patients. As a provide we are a person -- an elderly person coming in to see me, I would strongly recommend the seasonal influenza vaccine right now and tell them, you know, from most of what we have seen so far, it looks like you are probably going to be spared, you are probably at very low risk for this new virus compared to young people that is the best data that we have today. I do think it is important for us to be offering the seasonal flu vaccine as soon as it is available and of course, as information changes, we will be addressing -- we will, you know, we will be adjusting our advice.
Dave Daigle: Operator, we can take one more question from the phone.
Operator: Our next question comes from Stacey Singer with the Palm Beach Post. Your line is open.
Stacey Singer: Hi. Could you please explain why -- what the six months -- why -- what is it about six months that makes a household contact?
Anne Schuchat: Sure, yes. Thank you. Children under six months are not able to be vaccinated directly. Yet, they have a high risk of hospitalization but for seasonal influenza and we fear for this new virus. And because they can't be directly protected, the public health strategy is to protect those around them to keep from spreading the virus to them. So for our seasonal influenza recommendations and for other vaccines such as the teat tow vaccine, whooping cough vaccine for adults we really want people around young children, young babies to be protected, the babies under 6-month-old can be protected. So the recommendation for the H1N1 vaccine like the seasonal vaccine for household contacts, those under six months, is in order to protect that baby who can't be vaccinated but who is at risk for hospitalization.
Dave Daigle: So, thanks very much. This concludes our briefing, thanks for joining us on on the line and for those of you who came in.