Telebriefing Transcript
CDC Announces New Strategies to Promote
Continued Influenza Vaccination
January 27, 2005
DR. GERBERDING: Thank you for taking part in today's telebriefing. What
we're going to do today is update you on the current influenza season and
then describe some additional strategies that CDC is taking to help
clinicians to continue to vaccinate people against influenza.
I'm joined here today by Dr. Jeanne Santoli, from our National
Immunization Program, who has really been working nonstop throughout the flu
season with our partners across the public health system and the
manufacturing arms of the nation to really do everything possible to make the
best use of the limited supply of vaccine we've had this year.
The big perspective here is that the flu season is not over. It may not
even have peaked. We know that February is the most common peak season, but
we often see through well into March. So we are concerned that we still have
a large number of unvaccinated people who are at high risk for flu
complications. What we're really dealing with is a national shortage of
vaccine, a supply and demand mismatch at the local level.
We know flu is unpredictable. We've learned that flu vaccine supply is
unpredictable, and what we're discovering now, of course, is that the demand
for a flu vaccine is also very unpredictable, and it's varying from group to
group and area of the country to area of the country.
So CDC's broad goal in all of this is to try to make the best use of the
vaccine doses that we have, and that means encouraging immunization of people
who need it, and it also means using some common sense and not letting
vaccine go to waste in areas where the supply is ample or even in excess.
The new steps that we're taking today include measures to help make good
use of the supply, as well as measures to encourage immunization of those who
need or want to be vaccinated.
The first thing we're doing is, of course, emphasizing our support for
local and state jurisdictions who are broadening the availability of flu
vaccine to people who are not in the previously recognized priority groups.
So, if a local area has vaccine and can't redistribute it, it certainly makes
sense that they open up the vaccination to anyone in that jurisdiction who
would like to be vaccinated.
The second major change that we're making today is to take advantage of
the CDC vaccine stockpile. What we're doing with our stockpile is that we're
loaning it to the manufacturer, formerly known as Aventis Pasteur, who is now
known as Sanofi-Pasteur, and allowing the manufacturer to market that vaccine
to providers. And the wonderful advantage to the providers of this approach
is that the manufacturer will provide a return on any vaccine that's not
used. So, in other words, if a clinician orders some vaccine and doesn't use
it, they can return it to the manufacturer, and they will get a refund of
their investment. So this really eliminates any risk to providers who are
reaching out to get doses of vaccine for local use, and we have about 3.1
million doses of vaccine that are available through this new program.
The third step that we're taking today is to allow the vaccine that
governmental agencies currently have under the Vaccines for Children program
to expand the use of that vaccine to anyone who needs to be vaccinated in
their jurisdiction. Most jurisdictions have actually met the demand for
vaccination of children, but we wanted them to be able to use this vaccine
supply for broader populations if that would be helpful to improving the
overall coverage in their community.
So these steps are designed to help us make the very best use of the
vaccine supply we have. We're still encouraging people, especially those in
priority groups, not to give up, to contact local health officials or their
provider, and we're also working with professional organizations to encourage
providers who have patients with unmet needs to have those providers contact
the manufacturer and request doses of vaccine, especially since now there's
no financial risk to them.
I think it's also important to emphasize that these are extraordinary
measures that are being taken during the year of unprecedented supply-demand
mismatches, and we are very grateful to the people who stepped aside and
allowed us to concentrate on high-priority people early in the season. We're
also extremely grateful to the public health officials at all levels in this
government who have really done everything they can to make our vaccine
supply go as far as possible.
And, of course, we're very grateful to the manufacturers who have
cooperated in unprecedented ways--the private sector, public sector
enterprise here has been fantastic--and also to all of the providers who have
been worried about their patients and have really tried, to the extent
possible, to cooperate with the program and get people vaccinated.
These measures that we're taking this year are really one-time measures.
We are certainly not setting a precedent here, but we think this is a
strategy that will allow us to continue to vaccinate people and not let our
precious vaccine supply go to waste.
So let me take some questions.
OPERATOR: Thank you. Our first question is coming from Charles Seabrook of
the Atlanta Journal- Constitution. Your line is open, sir.
QUESTIONER: Thank you.
Dr. Gerberding, I know, of course, you're still trying to get through this
flu season, but anything from this that tells you about looking ahead to next
year?
DR. GERBERDING: Well, we know that the flu vaccine supply is
unpredictable, and we are still uncertain about the status of Chiron's
production capabilities. So we are engaged right now in some contingency
planning.
The Advisory Committee on Immunization Practices is meeting as we speak to
consider prioritization and subprioritization schemes if we have an unusual
shortage next year. But in addition, the Department of Health and Human
Services, the CDC, the NIH, the FDA, we're all working collaboratively to try
to maximize the available vaccine supply, and we're doing that by working
with Sanofi-Pasteur to encourage the safest and largest production capability
there, but also with international sources of vaccine.
I should also say that governments are working very hard with Chiron. The
regulators are working to do everything possible to bring their capability on
board, but we have to be prepared for a supply that does not meet our need
for optimal immunization coverage. And, again, we'll be in a situation where
we would be making the best use of the vaccine that we have available.
OPERATOR: Thank you. And our next question is coming from Miriam Falco
with CNN.
QUESTIONER: Hi, Dr. Gerberding. Do we know how many vaccine doses are
still unused? And why not, you emphasized that certain local jurisdictions
can open up the vaccine program to anyone. Why not make that nationwide the
call if the folks aren't going to get the vaccine? And, finally, how long
will you continue to run the Thank You PSAs encouraging people to wait?
DR. GERBERDING: Let me try to get to each of your questions, and thank
you.
The reason why we are not just opening this up nationally is because the
mismatch between supply and demand is very much a local issue. We have local
jurisdictions and even local practices who have more vaccine than they can
use, and then they have areas where they are still looking for vaccine. So we
have to try to accommodate, to the best extent possible, both of these
circumstances. And the people who really know best how to manage their local
situation is the local health agency.
The total number of doses that are in the hands of clinics and providers
right now is relatively small. In the CDC stockpile, we have 3.1 million
doses available, and we think there are approximately 1.3 million doses of
the Vaccines for Children, a vaccine that is out in the state and local
health departments, and that is the vaccine that we will be freeing up for
broader use.
So the short answer is somewhere around 4.4 million doses of vaccine that
we're making available today through these expansions in our program.
In terms of the PSAs, they will be coming off-line.
OPERATOR: Thank you. And our next question is coming from John Lauerman of
Bloomberg News. Your line is open, sir.
QUESTIONER: Hi. Thanks for taking my question.
I was wondering if you could just be very specific about what this
situation is in terms of loaning the vaccine to Sanofi. Does that mean that
they can sell the shots? Presumably, these are shots that they already sold
to you. Will they be able to sell them? At what price will they be selling
them? If you could just clarify that a little bit.
DR. GERBERDING: Sure. And I'm going to maybe ask Dr.Santoli to provide
some of the specific details, but our authorization and our funding allows us
to utilize our stockpile contract so that the manufacturer can distribute
vaccine and pay us for what they use. So this is something that is part of
the authorization that CDC received when it developed the stockpile. We want,
of course, this year to not have that stockpile go unused.
And this is a way that allows us to effectively take advantage of the
manufacturers capabilities of distributing vaccine and an ordering system
that already exists for providers and a lot of the infrastructure necessary
to move vaccine out to providers is not something that CDC has, but it is
certainly something that the manufacturer can provide. So it's a permissible
legal mechanism to allow the manufacturer to basically distribute our vaccine
for us.
OPERATOR: Thank you. Our next one is coming from Mary Carey of the
Congressional Quarterly. Your line is open, ma'am.
QUESTIONER: Thank you. I just want to make sure I understand. So are you
saying, basically, anyone who wants a flu shot now can go get one?
DR. GERBERDING: We're not saying that because keep in mind there are two
situations here. One is overall a national shortage of flu vaccine, but at
the same time, in local jurisdictions, some have more than they need and some
don't have enough. And so we are not encouraging everyone who wants a flu
shot to go out and get it. We're encouraging people, particularly those in
the priority groups, to continue to check with their provider and their local
health official to determine where they may be able to get vaccine in their
community. But, really, if the local health officials feel that they have
enough vaccine to open it up to the public in that jurisdiction, they'll do
so. The demand for vaccine right now is very low, and so we're concerned, of
course, first and foremost, that the people who are at risk for serious flu
complications still try to get vaccinated and that their providers encourage
vaccination. That's why this provider program through Sanofi-Pasteur is such
a valuable additional tool to help us.
Next question, please.
OPERATOR: Thank you. Our next one is coming from Anne Wlazelek from the
Morning Call.
QUESTIONER: Hi, Dr. Gerberding. Thank you so much. I'm wondering if you
have any handle on what percentage of the population at risk who is
recommended to get this shot has been vaccinated or has not been vaccinated.
DR. GERBERDING: We've been making some assessments of vaccine coverage in
various groups as we've gone through the flu season this year. And we can
refer you to estimates from last month that were published in our MMWR, and
we will be updating those estimates next week. But, basically, the bottom
line is that our high-priority groups are undervaccinated compared to what we
achieved the same time last year.
OPERATOR: Thank you. Our next one is coming from Maggie Fox of Reuters.
One moment. Your line is open, ma'am.
QUESTIONER: Hi, Dr. Gerberding. Thanks.
I wanted to ask you about what kind of good are you doing for yourself for
next year if you get vaccinated this year? I know the formula changes every
year, but you can take a gamble that it's not going to change, as it did last
year, more than one strain.
If people go ahead and get vaccinated even late in the season, are they
giving themselves a little bit of extra protection for next year?
DR. GERBERDING: It's really hard to answer the question because flu is so
unpredictable and we just simply don't know what strains are going to be the
important strains or whether there would be any cross-protection from this
year's vaccine. So I would hesitate to speculate from a forward-looking
perspective, but immunity through the vaccine also doesn't remain high for
long periods of time. There is some waning of immunity fairly quickly, so the
best time to get vaccinated for flu is right before the flu season starts.
Next question, please.
OPERATOR: Thank you. Our next one is coming from Judith Rusk from
Infectious Disease in Children.
QUESTIONER: Hi. Thank you, Dr. Gerberding and Dr. Santoli. I was just
wondering--I had a couple questions. First of all, is this a judgment call
for local physicians in their offices, or are there guidelines to help them
decide if they can open this up to more of their patients? Second, could you
give us an update on the current situation? And third, the GSK vaccine that
was brought in I think under an IND earlier in the season, could that
possibly be approved in time for next season?
DR. GERBERDING: The person who has the authority to make decisions about
policy for immunization is really the state or the local health official,
depending on the state jurisdictional arrangement. So we're recommending that
providers really get the advice of the local health agency to really
determine what is the best policy for their jurisdiction.
I also think that physicians are the ones who know their patients the
best, and we really always want to defer to physician judgment in making
decisions. I'm a doctor, and I feel very strongly that when it's my patient
I'm probably the person who has the best ability to determine whether the
patient can benefit from the vaccine. So that's certainly a matter between
physicians and their patients.
Your question about Chiron, I think I've said everything I can really say
about what is known of the situation right now. All of the involved parties
are working aggressively to support Chiron's ability to bring its vaccine
production back on-line. The company has acknowledged some uncertainty in
their ability to do that, although they're certainly aiming in that
direction, and we are cautiously hopeful that they'll be able to be
successful, but we can't count on it, and we need to be prepared for the
possibility that they may not be able to come back on-line, and if they don't
come--if they do come back on-line, I believe the current projections are
that they would not have the production capability that they were expected to
have this year. So in either case we will have to make some adjustments in
our assessment of what Chiron will be able to produce.
Your third point about the IND vaccine, we have already purchased as a
backup, in case the flu (activity) got much worse or evolved more quickly
this year, the IND vaccine from GlaxoSmithKline. About 1.24 million doses of
that have already been purchased, and we are certainly talking to other
manufacturers. We look upon this IND vaccine as an insurance policy for us.
If we got into trouble we would have it available, but also it's helping us
interact with some of the international vaccine producers in constructive
ways that might allow us to more easily access vaccine from these resources
in the future, and I think that's very, very important.
Everyone agrees that we need a broader market for flu vaccine, and by
engaging now, we're setting the stage for being able to scale up or speed up
our ability to make bona fide purchases and get the vaccine license.
Next question, please.
OPERATOR: It is from Betsy McKay, Wall Street Journal. Your line is open.
QUESTIONER: Hi. Thank you, Dr. Gerberding. You may have answered this
already, but can you tell us how many vaccine doses have been administered so
far this year? And secondly, just following up on what you just said, what
you were just talking about, if Chiron is not able to produce at all or only
part of a supply for next year, will you be able to buy doses from other
manufacturers who are not currently licensed in the U.S. market?
DR. GERBERDING: We don't have exact information about doses of vaccine
that are actually administered. We have reliable information about vaccine
sales. So we are estimating, based on sales from formerly Aventis Pasteur,
now Sanofi Pasteur and MedImmune, who is the manufacturer of FluMist, who by
the way, is also anticipating increasing their capability next year.
We are estimating somewhere around 57 or 58 million doses of vaccine have
been purchased, and hopefully the majority of that has been used this year.
But we won't really know the answer about vaccine coverage until we have a
chance to do the kind of retrospective assessment long after this year's
season has passed.
The international issue about being able to get licensed vaccine
internationally is one that obviously is a high priority. I'm not going to
speculate about the timing of the licensure in the United States because I
think the FDA is working on this with GlaxoSmithKline and perhaps other
manufacturers, but we are unable to say whether or not the product can be
licensed in time for next year's flu season at this point.
OPERATOR: Our next question is coming from Anita Manning, USA Today.
QUESTIONER: Thank you very much, Dr. Gerberding. Can you tell us when
doctors or hospitals are likely to start to place orders for next flu season,
or when they normally would? And what does the CDC advise in this
uncertainty? And then the second part of that question is, do you think that
this experience has changed forever the way flu vaccine will be distributed?
I'm just wondering if doctors are going to start to say, "I'm going to let
the Wal-Marts and the public health department deal with it rather than the
providers themselves." Thank you.
DR. GERBERDING: These are big strategic questions that the Department of
Health and Human Services is engaging in right now, and also working with
Congress and working with the administration to really try to establish a
more effective long-term solution to the problem, as well as the
flexibilities that we may need to provide the mid-term and near-term
protection that people really need.
Ordering for next year's vaccine, as I understand it, has been temporarily
delayed because of the planning for how to start the season and what the
other vaccine company will be able to provide. It's just still uncertain. So
right now orders for next year to Sanofi Pasteur are not yet being processed.
And I think what we really need to be prepared for is that as we learn
more about the benefits of flu vaccine, we are likely to expand the
indications for using the vaccine, and we simply have to come up with some
more robust manufacturing process. We need a supply that is reliable. And we
need to stabilize the demand for vaccine by creating new mechanisms and new
programs to administer vaccine to adults.
I think most of the folks on the phone recognize that we have a very
robust immunization program for children in this country, but we don't have a
bona fide comprehensive adult immunization program, and that's one of the
questions on the table by CDC and by other experts, is what really would be
the best way to optimize delivery of flu vaccine every year so that we
stabilize demand and got the kinds of coverage levels that we are really
hoping to achieve.
Having said that, it's been wonderful this year the kind of cooperation
we've had from CMS and from other sister agencies in the Department,
certainly the private sector, the trade associations, supporting nursing
homes, the Visiting Nurses Association, and so forth. These agencies really
have done an excellent job of accelerating access to vaccine among millions
of seniors, and that has been something that I think we've learned from. We
would like to be able to implement that kind of program every year.
OPERATOR: Thank you. Our next one is coming from Richard Knox, the
National Public Radio.
QUESTIONER: Yes, thank you very much. I may have missed something, but
just to be clear, the vaccine loan program by which the manufacturer takes on
responsibility for distribution, who has financial risk for unused vaccine?
Would that be the government rather than the manufacturer?
And secondly, is there a date by which Chiron needs to say we can do it or
we can't do it, or we can do so much of it? You know, is there some sort of a
deadline that needs to be met?
DR. GERBERDING: The vaccine that is being loaned to the manufacturer is
CDC's vaccine. We have already paid for it. So what we are doing is allowing
it to be distributed through the manufacturer by loaning it to them, just as
people would do if they were purchasing vaccine in the first place from the
manufacturer. They will pay for it, but if they don't use it, they get their
money back.
With respect to Chiron, we really can't predict at what point Chiron will
or will not know its production capability. That's really something that's
best addressed to Chiron.
I just can take one more question, please.
OPERATOR: Then our last question is coming from John Lauerman from
Bloomberg News.
QUESTIONER: Yes. I was trying to just clear up, if you could--so Sanofi
will be selling the shots, and if they sell a shot, they pay you; is that
right? And if they--anything that they don't sell, they don't have to pay for
it? Is that what the situation is?
DR. GERBERDING: Basically what will happen is that what is sold and used
will be credited to the stockpile for next year. So we are sort of revolving
this in a way that makes sense from the taxpayer dollars perspective, but
still allows us the flexibility to get this vaccine out the door to people
who need it this year. This is really a good business strategy to not let
vaccine go to waste, but also to protect the stockpile and CDC's, the
government's investment in the stockpile. So it's a win-win situation.
Thank you very much for your interest and for taking time to follow up on
this important health issue.
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