Transcript for CDC Telebriefing: Updates on Zika response efforts

OPERATOR: welcome.  Thank you for standing by.  At this time, all participants are in a listen-only mode until the question and answer portion of today’s conference.  During the question and answer session you may press start followed by “1” to ask a question. I would now like to turn it over to Mrs. Kathy Harben. Kathy, you may begin.

KATHY HARBEN: Thank you, operator.  Thank you all for joining today’s briefing on Zika virus outbreak in Puerto Rico with us today are the Director of CDC Dr. Tom Frieden and the Director of NIH’s National Institute of Allergy and Infectious Diseases Dr. Tony Fauci. Dr. Frieden just returned from Puerto Rico to see firsthand how the CDC is working with the Puerto Rican Department of Health to respond to the Zika Virus Outbreak and to determine what still needs to be done to protect people from Zika Virus infection. Particularly pregnant women. Dr. Fauci will provide the latest update on the NIH’s Zika research progress and the work and resources needed to develop a vaccine which is safe and tested. Both will have brief statements and then will answer questions.  Now I’d like to turn the call over to Dr. Frieden.

Dr. FRIEDEN Well, good morning, everyone, and thanks very much for joining us.  I’ve just gotten back from Puerto Rico where i was able to observe what the CDC team is doing there, what the Puerto Rican government is doing there, to meet with pregnant women who are very concerned about Zika and to see some of the activities that are intended to reduce the risk there, including work in WIC clinics and with the American college of obstetricians and gynecologists.  The bottom line here is that Puerto Rico is on the front line of the battle against Zika and it is an uphill battle.  We need urgent action to minimize the risk to pregnant women.  And everyone has a role to play.  Rainy season is around the corner and funding from Congress is urgently needed. I was both encouraged by the progress i saw and by the many actions that have been taken, but also aware of the enormous challenges that remain.

There is nothing about Zika control that is quick or easy.  In fact, the only thing quick about Zika is the mosquito bite that can give it to you and the only thing easy are wrong answers.  We are learning more about Zika every single day.  The link with microcephaly and other possibly serious birth defects is growing stronger every day. The link with Guillain-Barre syndrome is likely to be proven in the near future. The documentation that sexual transmission is possible is now proven.  Never before have we had a mosquito-borne infection that could cause serious birth defects on a large scale.  I’m very concerned that before the year is out there could be hundreds of thousands of Zika infections in Puerto Rico and thousands of infected pregnant women.

CDC and our partners are doing a lot.  We’re taking action to mitigate the impact to the greatest extent possible.  We currently have nearly 100 of our staff on the ground in Puerto Rico working on the response as part of more than 750 staff involved in the Zika response from CDC. We remain activated at level one of our emergency operations center.  That’s the highest level.  We’ve been able to scale up production of test materials and accelerate approval with wonderful participation and support from the food and drug administration such that both PCR and IGM testing are increasingly available.  We have in Puerto Rico and the other U.S. territories that are affected — specifically U.S. Virgin islands and American Samoa — begun the distribution of Zika prevention kits which contain both repellents as well as condoms as well as information for women on what they can do to reduce their risks.

We’re also working to rapidly define which insecticides are likely to be most effective in Puerto Rico.  We’re finding widespread resistance to some insecticides.  Testing for insecticides resistance is not easy.  You have to go out and collect the mosquito eggs. You then have to hatch the eggs in an insectary, allow the mosquitos to mature and then you can do tests for the resistance using the CDC bottle method of resistance.  And i was able to observe that.  It’s very impressive when you see 20 mosquitos all flying around happily in a bottle that’s been coated with an insecticide that is being widely used and next to it another bottle where all 20 mosquitos have been rapidly knocked down and most of them killed.  We’re also looking at the possibilities for environmental mitigation and different ways of addressing the risk of mosquito-borne disease.  I met with pregnant women there and saw how high the level of awareness and concern are about Zika.  We’re looking at things like installation of screens and mitigation of risk factors.

We’re also looking at a core way of thinking about the three key priorities for Puerto Rico.  The first is to protect pregnant women.  And that means with repellent, that means condoms during sex for men who have sex with women who are pregnant.  That means screens.  That means mitigation with air conditioning and screens and places like WIC clinics and obstetricians’ offices where pregnant women may be present.  Second is mosquito control.  This is something where i was encouraged by the open mind that Puerto Rican communities and leaders have about trying new methods of mosquito control, many of which have been used elsewhere in the United States or around the world.

There is no silver bullet to control the Aedes Egyptii mosquito or reduce the risk of Zika infection on a population-wide basis but there are some things that we may be able to do if we have the resources that would significantly reduce risk.  And I think the bottom line is it’s worth trying whatever might work to protect women.  We know we won’t be able to protect 100% of women but for every single case of Zika infection in pregnancy we prevent, we are potentially preventing an individual, personal and family tragedy.  So our goal is to protect as many pregnant women as possible and that’s going to take a multilevel assault.  I think of it as a four-corner approach of attacking mosquitos inside of the home, outside of the home, at the larval stage and at the adult mosquito stage.  Pregnant women can use Deet, long sleeves and pants, screens and air conditioning.  Men can use condoms when they have sexual relations with women who are pregnant.  Women who don’t live in an area of Zika transmission should consider postponing travel to where Zika is spreading and for women who don’t want to get pregnant it’s quite important that there’s access to voluntary contraception.  Most of the pregnancies in Puerto Rico are unplanned, unintended and there is an unmet need for contraception. And we met with the providers and are working to address that need, emphasizing that whether or not to become pregnant is a decision for the woman to make in consultation with her partner, her family, and her provider but for those women who choose contraception it should be readily available.

I would also like that say that Puerto Rico remains a great place to visit as long as you’re not pregnant.  The response needs to be adaptive as we learn more and figure out what will be likely most effective to minimize the risk.  One of the critical approaches is to keep the risk of infection low for as long as possible hoping that we will have a vaccine within the next several years.  And i know dr. Fauci will speak about that.  but that is crucially important, because a vaccine, as dr. Fauci will outline, we think is plausibly going to be effective and available if not now it won’t be for some time but it is a great opportunity… (Inaudible)  The pregnant women who are at risk are members of families, they’re members of communities.  They’re in Puerto Rico in a community that’s experiencing really enormous challenges economically and otherwise now, and we know the cost of caring for one infant with a birth defect can be up to $10 million or more.  Funding is crucially important and urgently needed.  The rains are coming and with the rains will come mosquito season and with mosquito season will be the risk of explosive spread of Zika as well as dengue and other Chikungunya.

So we can’t let down our guard.  We continue to see threats to health, including the health of Americans around the world, including in Africa.  For example, we’re now seeing Lassa fever in several countries in Africa where we are needing to respond urgently and aggressively.  And I’ll before turning it over to Dr. Fauci with just one conversation i had in a focus group with pregnant women.  There had been the misperceptions on the part of many people that the people of Puerto Rico were not concerned about Zika because they had seen dengue and Chikungunya and figured this was just one more infection.  i can tell you firsthand that is not the case.  That every pregnant woman we met with had a high degree of awareness and concern and when i asked a group, a woman in the group plainly dressed from a poorer family there said very clearly “of course we’re worried.  If i have a child who can’t talk or can’t take care of themselves, that’s going to impact the rest of my life and the rest of my child’s life and in fact, I’ll be worried for my whole life even after i die who is going to take care of them.”  So it’s crucial that we continue as we’re doing to find what works, communicate openly what we find out,  and we hope Congress will provide resources needed for a robust response.  Thank you.

OPERATOR thank you, Dr. Frieden.  We’ll now hear from Dr. Fauci.

TONY FAUCI: thank you very much and thank you, Tom.  I’m going to talk a bit about the research agenda that would hopefully get us to some of the interventions that will ultimately be needed for the intermediate and long-term problems that we certainly will face and are facing but before i get into that, i just want to take a moment to underscore how important what Tom has told you what he and his team in collaboration with the people in Puerto Rico are doing.

They are truly the immediate front line response troops that absolutely need to be supported and that’s the reason why i want to emphasize to everyone and without a doubt how important it is for us to get the resource support in the form of the supplement that the president has asked for with regard to what we need for Zika.  Because we cannot do in a sustained way what tom is talking about and what i will be talking about in just a moment without those resources and i feel very strongly that we need to support what the CDC is doing and make sure that they can do the job they do so well.

Now, having said that, there are other aspects to the response and that is the research area.  And there are multiple aspects.  We think of the research as just being getting, for example, a vaccine, which I’ll get to in just a moment.  But it’s very important that there are unanswered questions. one of the things that i think we’ve all experienced, those of us in the public health and scientific community as well as the press that as the weeks and months go by we learn more and more and realize how much we don’t know.  and unfortunately the more we learn, the worse things seem to get in the sense of what tom outlined for you with the progression of things that we are now learning about Zika and he outlined them very well from the microcephaly to the other neurologic abnormalities, sexual transmission, et cetera, et cetera.  So we need to stay ahead of this in our knowledge.  and one of the ways we do that by the kinds of natural history studies to ask and answer the important questions about the differences between symptomatic and asymptomatic infection and its effect on the pregnant woman and the fetus.  How long the virus remains in the semen of an individual after they’ve been infected.  The cohort studies that we just heard the first of what will be a number of cohort and case-controlled studies.  I want to point out to the group that are listening that the “New England journal of medicine” paper that appeared last Friday is really quite disturbing.  As you well know, that was a study that showed in Zika-infected women, 29 percent had fetal abnormalities that were detected by Doppler ultra-sonography.

Now something that you can determine by an ultrasound, which means that there very well may be many, many more that you don’t realize until after the birth of the baby.  The other issue is the alarming finding that there was negative impact on the fetus even if the mother was — was infected a little bit later on in the pregnancy.  Obviously with all of these things, first trimester is the most vulnerable.  But we saw from that paper that, in fact, there were still effects if you get infected later on in pregnancy.  So we need to know about that.  With regard to the virus itself, we have studied in great detail other viruses, the most recent of which was Ebola.  We’ve done that with HIV/AIDS and others.  We need to know more about the molecular virology.  We need to know the differences in various clones of this virus, what impact it has on pathogenesis, we need to understand the nature of the immune response, both the innate and adaptive response and, importantly, we need to establish animal models.  the CDC is taking the lead on the diagnostics with their diagnostic and reference laboratory and virus diseases branch that they have there but there’s a lot of fundamental basic research on trying to get the very best highly specific and sensitive anti-body test.  We all know that a PCR can easily identify people that are infected but with this disease that’s generally a fleeting period of time measured in several days to a week or so.  We need to be able to do diagnostics about whether a person was or was not infected.

With regard to vaccines, i just want to clarify, and I’m sure we can do more of that in the question period.  But you’re going to be reading about various projections of when you’re going to have a vaccine.  And i think that’s because people inadvertently and innocently conflate getting a vaccine into humans in an early trial versus the classic all the Is are dotted and Ts are crossed with an FDA-approved vaccine which, under the best of circumstances, definitely takes years to get there.  But let me tell you where we are right now.  We have a number of candidates that are essentially lined up with some, a few weeks to months or what have you ahead of the others. Take one as an example which was a DNA vaccine that we were able to successfully use in west Nile.

Vaccines are always challenging, but what we have to our advantage is that we’ve been able to make — we, the scientific community and the public health community — successful vaccines against other viruses such as yellow fever, such as dengue, such as west Nile, so we believe we can get a vaccine.  I feel cautiously optimistic that we will get one, unlike a situation where we’ve never made a vaccine against this particular type of virus.  We are now producing the DNA Zika version of that and we’re going to do pre-clinical tox over the next couple of months, we’re working closely with our colleagues at the FDA.  we’re getting a number of inquiries from pharmaceutical companies who want to partner on any of the number of the candidates and i hope — and i think it will happen — that barring any of the vicissitudes that you have to be prepared for, that we’ll be able to start a phase one trial for safety and immunogenicity by the end of the summer early fall of 2016.  that usually takes several months, three or four months to get the answer so if by early 2017 we have a candidate or candidates that are safe and can induce an immune response.  i think the confusion there is from that point how long is it going to take to know if it’s effective and whether you can try and see if you can get an accelerated approval.  That will depend entirely on two things — one, how effective it is and, two, how many infections there are in the community.  because if early 2017 comes and we still have a massive outbreak in the region down there and the vaccine is effective, we may be able to know that it’s effective and safe in a matter of ten months or by the end of 2017.  At that point then you consider what the regulatory options are.  So it’s impossible to predict.  what i can tell you is that we’ll be testing a vaccine in phase one by this year, sometime in 2016 likely in the early fall and then finally obviously there are therapies and we’re screening a whole bunch of compounds that have not only activity hopefully against Zika virus but against other flaviviruses.  But right now the therapeutic part, though ultimately important, is not the top-tier type of approach.  The thing we really need is to protect women of child bearing age, is going to be to get an effective vaccine that we can implement the way we do a rubella vaccine, where you vaccinate people before they become pregnant so you protect them during their pregnancy.  So let me stop right there and tom and i would be happy to answer any questions.

KATHY HARBEN Thank you, Dr. Fauci.  Julie, we’re ready for questions.

OPERATOR thank you.  If you would like to ask a question, please press “star 1” and you will be prompted to record your first and last name.  Please unmute your phone when recording your name and to withdraw your question press “star 2.”  One moment, please.  Our first question comes from Mike Stobbe from the Associated Press.  Your line is open.

MIKE STOBBE: thank you, thank you for taking my call.  Two questions.  Dr. Frieden, could you update us on cases both in Puerto Rico and in the 50 states and could you include in that update how many reports are being investigated of sexual transmission.  Could you include how many pregnant women have been infected and what the outcomes of those are?  Have that changed?  And the second question about the insecticides that you’re finding are not working in Puerto Rico. Is pyrethrum one of them?  If it is, does that mean CDC will change its advice to travelers regarding pro meth written?

TOM FRIEDEN In terms of the first question we will be releasing numbers today.  If i can do that later on the call, i will.  In terms of the second question.  Pyrethroids are a broad class of insecticide that includes pyrethroids specifically.  We are concerned about the degree of pyrethrin resistance we’re seeing in Puerto Rico and that does have implications for things like treatment of clothing but the studies will take a week or two to complete.  There is a fair amount of variability of resistance geographically.  so there are some places that may have more resistance, some places less even within relatively small areas so we’re sampling 19 different areas within Puerto Rico and testing nine different pyrethroid compounds.  So far we have seen one that looks promising but we’ve only tested four areas so far, so 15 more areas have to be tested and, again we’ll know that within the next week or two.  It’s a question of waiting for the mosquitos to mature and doing the testing batch by batch to see what the resistance level is.  In terms of cases, we have seen — we have no information to update from the report of six probable or definite cases in pregnant women, 193 travel associated cases.  The data from Puerto Rico, they will release on Friday their data, the data coming to Arbonet is about 160 cases in Puerto Rico.  But we do anticipate the number of travelers continuing to increase steadily and the number of cases in Puerto Rico at some point beginning to increase not steadily but dramatically.

OPERATOR: Our next question comes from Helen Branswell with STAT News. Your line is open.

HELEN BRANSWELL Thanks very much for taking my question.  I have a couple if i could, please.  Dr. Frieden, you talked about the possibility of installing screens in the homes of women who are pregnant.  i was in Puerto Rico a couple of weeks ago.  You don’t see that many homes with screens and I’m wondering when will this decision be made because the rainy season, as you point out, is coming very soon.  If you’re going to do that work it really needs to be done very quickly and what is halting people from making a decision to proceed with that?  And my second question would be to Dr. Fauci.  The WHO had a research — a Zika research priorities meeting this week and one of the things that came out of it was the suggestion that any vaccine that’s developed in the short term ought to be an inactivated vaccine because the target audience will be pregnant women.  Are the NIAID experimental vaccines that are being proceeded with, are they all inactivated vaccines?  Thanks very much.

TOM FRIEDEN: in terms of screens, what we’re finding in Puerto Rico is that it’s crucially important to pilot test everything we try to do on a large-scale basis.  It’s clear that installing screens is not necessarily quick and simple.  For example, we did a pilot of this last weekend, there were issues of tenants and landlords, of houses that had open eaves in which case screens would have little or no impact.  There’s also acceptability issues because it may at least be perceived to cut down on the level of breeze and increase in temperature in a house.  There are some simple kind of roll-on screens that could perhaps be done in a makeshift or quick fashion.  We’re looking at issues of installation versus vouchers so i think we recognize that there is no single mosquito-control method that is foolproof, but combining a series of methods that have some efficacy is our best bet to reduce the risk to pregnant women and screens are one part of that.

TONY FAUCI so let me answer the second question, Helen.  The array of vaccines that we have in the queue that are coming up involve both inactivated or inert non-live attenuated as well as a variety of live attenuated.  Whenever you’re doing a vaccine trial in a pregnant woman, women who are already pregnant, that always becomes a little bit problematic, particularly if one of the potential adverse events is on pregnancy.  so we certainly agree that when you’re talking about a vaccine that’s targeted for a pregnant woman, for example, the DNA vaccine that i mentioned as my prototypic example of what we do and would fall into the category of a non-live attenuated but actually inert vaccine in the sense of it doesn’t replicate.  We also have a number of other candidates such as whole particle inactivated vaccine.  But we are pursuing live attenuated vaccines in the long run because although you would not want to be giving that to a pregnant woman unless you really, really were very careful and had good safety studies, but i don’t think that’s the issue right now.  You would want something like that early on to get women before they become of child bearing age.  The ultimate goal would be we would have a vaccine for Zika in the live attenuated category that’s very similar to what we have for rubella, in which even though we vaccinate everyone, all the children as they go into school, the real target of rubella is girls, young women, who ultimately will be of child bearing age and deliver.  So it’s a two-pronged approach.  It’s an approach that would be quite safe, we hope, for pregnant women, namely non-live vaccines as well as live vaccines which are generally quite effective historically and have that for women before they become pregnant.  That’s our plan.

HELEN BRANSWELL: Thank you.

OPERATOR our next question is from Betsy McKay from “wall street journal.”  Your line is open.

BETSY MCKAY: Hi, thanks very much.  Dr. Frieden, just one question.  Are you encountering any shortages of supplies or any supply issues with mosquito repellents containing Deet or insecticides that you think do work?  You know, when putting together these prevention methods in Puerto Rico.

TOM FRIEDEN: we haven’t yet seen any shortages of insecticides but as we define which are the ones that still work there are, we’ll have to look at what the market is for those.  We also are looking at all three classes of insecticides, not just the pyrethroids but also organophosphates and the carbamates.  The latter two classes have not been used in Puerto Rico and so are likely to be relatively more effective for control measures.  I think partly it’s a matter of going one step at a time but as quickly as possible.

BETSY MCKAY: and what about mosquito repellents containing Deet?  Any issues there?  The ones that go into your prevention kits?

TOM FRIEDEN:  no, we haven’t had any problem with effectiveness or supply.

BETSY MCKAY Okay, great.  Thanks.

TOM FRIEDEN:  And i believe that the government of Puerto Rico has issued a price control order, i was told, for that so that they would avoid price gouging for them.

BETSY MCKAY okay.  Thank you.

OPERATOR: our next question comes from Dan Childs with ABC news.  Your line is open.

DAN CHILDS thank you so much for holding this.  I actually have one question and one follow-up.  The first one is what will be able to be done without the funds requested from congress?  I know this is an issue that’s come up before because we’re still waiting for these monies.  So how might the absence of those funds affect the timetable that dr. Fauci has proposed for a vaccine?

TONY FAUCI Well, I’ll take the vaccine first.  It will not only hold up what I’m going to be doing, it certainly would hold up what tom and the CDC will do but I’ll leave that for him to comment on.  For myself, we’ve already started down the road of the making the product for the first vaccine candidate by moving money out of other important areas into this area.  You can’t do that for a very long period of time so when you’re starting to think in terms of ultimately doing a larger phase two trial, you have to start preparing for it right now.  so what this might mean if we don’t get that money we may find ourselves, you know, halfway through a phase one trial and not being able to finish and be able to take that next immediate step into the larger trial because you don’t just invent the phase two trial after you finish the phase one, you have to start preparing for it long in advance.  That’s the thing that I’m concerned about that if we don’t get the money that the president asked for it’s going to slow down a number of things, not just vaccine, but vaccine is the most concrete one that will be slowed down.

TOM FRIEDEN: and from the CDC standpoint we are scraping together every dime we can to respond to this.  It’s not easy to do that and it makes the response much more complex and much less smooth because there are different administrative challenges using different sources of funding.  So we’re trying as hard as we can to respond as effectively as possible.  But it makes it very difficult to do things like plan for large-scale mosquito-control activities in Puerto Rico, plan for large-scale house-to-house mosquito abatement activities in Puerto Rico.  Establish and support rapid response teams to respond to clusters in the United States.  Improve mosquito surveillance and control.  We don’t really know where these mosquitos are in the U.S. The maps that are on our web site are very clearly tagged with the comment that they are both incomplete and out of date.  They depend to a great degree on local mosquito-control activities which vary enormously in their level of resources and the intensity with which they do surveillance.  It also limits our ability to set up long-term studies to understand what happens to women who become infected with Zika while pregnant.  I reviewed those studies in Puerto Rico now they are very labor intensive.  you’re talking about the possibility of thousands of women whose pregnancies and infants need to be followed for several years ideally at least so we can learn more about how to reduce the risk to others, as well as to partner robustly with countries around the hemisphere and in the Caribbean so that we can both learn more and support them more in their efforts.

DAN CHILDS: And just a follow-up.  You mentioned the concern of clusters in the continental U.S. Given that you mentioned that the rainy season is approaching in Puerto Rico, what might be the window of increased risk for clusters of infection in states where we already know these mosquitos exist like Texas and Florida?  Is this something that health officials are already sort of plotting out and planning for?

TOM FRIEDEN Well, June and July is usually the start of mosquito season.  It can start earlier than that or after that and different in different places.  That’s why in conjunction with the White House we’re organizing at the CDC campus a Zika Action Summit that will be on April 1^st and we expect widespread participation from states.  We think that will result in more rapid plans for what and how to make progress in both the tracking of the mosquitoes as well as control.  this includes things like making sure that all of the cases are visited or at least contacted and are provided with the means to reduce their risk of mosquito bites as well as their risk of transmitting to others through sexual contact.

DAN CHILDS: Thank you.

OPERATOR our next question comes from Lena Sun with the “Washington post.”  Your line is open.

LENA SUN: so i had a follow-up question to those which is so both at CDC and NIH what are the things that you are not doing because you are moving funds from those areas to deal with Zika?

TONY FAUCI: well, let me take a shot in the vaccine area and then hand it over to tom.  So, Lena, the people right now who are working on the Zika approach are on a team that i believe you visited at the vaccine research center.  So we have a limited amount of resources and as we showed you when you were there, we are doing universal influenza vaccine, we’re working on an HIV vaccine and we’re working on an important respiratory syncytial virus vaccine.  when we get to the point where we’re going to have to utilize money, we’ll have to slow down at least one and maybe all three of those until we get the money to be able to go back and start spending the money that was originally allocated for that for what we wanted to spend it for.  So there’s a give and take, there’s a net sum there and you just can’t make it more than it is if you don’t have new resources.  So something has to either slow down or stop.  We tried very hard not to stop things because then it really is tough to recharge them and get them going again but you actually slow it down.

TOM FRIEDEN: And i guess similar to that if you look at — we have dengue branch in Puerto Rico.  There is basically no dengue work going on now and that’s dengue risk not just in Puerto Rico but in all of the U.S. and globally.  If you look at Fort Collins, that’s our vector-born program and that’s basically fully dedicated to the Zika response which means some of the new tickborne viruses that we’ve identified in the continental U.S. the work on those has stopped.  if you look at the work we’re doing to produce large numbers of test materials, PCR and IGM, we are converting not just our labs in Fort Collins and elsewhere but our core facility in Atlanta. So much of the work we do on drug resistance and other areas is having to take a backseat to Zika.  So that’s the impact on the rest of CDC.  That is in addition to the fact that it’s very difficult to scale up the large scale type of programs that we need on mosquito control to protect pregnant women.

LENA SUN: Thank you. And one quick other question.  Dr. Frieden, i thought you mentioned early on in the call that you were about to prove the link to Guillain-Barre.  Can you elaborate?

TOM FRIEDEN:  I would say the study that came out in the “Lancet” a week ago was highly suggestive of a link.  We’re not surprised to see the link.  We’ve seen this with a variety of infections.  The studies from the “lancet” was from French Polynesia.  The time frame clustering of cases of Guillain-Barre following Zika infection is highly suggestive.  the only issue was given that the study was a couple years ago in French Polynesia, some of the laboratory testing was a little non-standard necessarily given the challenges of this kind of responding and where we are with laboratory testing so i just think that before we say it’s definitive, we probably need to see that study replicated in another study — either ours or somebody else’s that uses standard laboratory techniques.  We hope to have our results of our study by the end of the month.  That’s the study we did in collaboration with the Brazilian public health authorities.

KATHY HARBEN Next question, please.

OPERATOR the next question coming from Robert King with “Washington examiner.”  Your line is open.

ROBERT KING: thanks for taking my question.  going back to the kind of the whole funding situation, can you give me an idea of how many more cases of Zika in the U.S. and in Puerto Rico could occur if you don’t get additional funding?

TOM FRIEDEN: well, i don’t have a crystal ball so i can’t tell you what the numbers will be with and without rapid supplemental funding.  What i can tell you that it is definitely interfering with our ability to mount a robust response and it’s interfering with our ability to continue to protect Americans from other health threats because we have to redeploy existing staff to this effort and we’re not able to back fill their roles.  I can only say that time is of the essence in order to protect pregnant women.  the sooner we’re able to get a robust program up and running the more we can reduce the risk to pregnant women, understanding that nothing we do is going to eliminate that risk but the quicker we can take action to reduce that risk the more women we can protect.

ROBERT KING:  A quick follow-up.  Time is of the essence, you said.  When do you need congress to approve this funding?  I’m sure you would like it now but what kind of time frame do you really need it by?

TOM FRIEDEN:  i can just say the sooner the better because realistically once funding gets approved there are still administrative requirements to get it out, whether it’s hiring or selection of contractors or entering into contracts with jurisdictions, providing money to states so that they can begin hiring staff and establishing contracts more mosquito control so the sooner the better.

TONY FAUCI: I can just add something that tom said that i mentioned that one of the several hearings I’ve been at.  One of the issues that’s kind of a subtle negative impact on what we do if funding is delayed, we have been gratified by the interest that we’ve had on the part of pharmaceutical companies that want to partner with us to develop several of the countermeasures that we’re talking about.  When it looks like the funding on our part is somewhat tenuous that we may or may not get it or we don’t know where we’re going to get it, we’re looked upon a bit as kind of a non-reliable partner which is what you do not want to establish that kind of relationship.  you want to seek to have a collaboration but you want to know you’re a reliable partner and uncertainty about funding and how much we’re going to put in and how much we’ll be able to do really brands us a little bit, if not a lot, like an unreliable partner.  That’s one of the concerns i have that.

ROBERT KING:  has that started now?  Have you seen — have you heard concerns from pharmaceutical companies?

TONY FAUCI no, but i have experience over many years in which we’ve developed relationships and we thought we would get funding and we didn’t and then companies would lose interest.  I have not seen that in this case with Zika but historically i have seen that.

KATHY HARBEN Thank you.  Next question, please.

OPERATOR Next question comes from Kelsey Nowakowski with the Virgin Islands source.  Your line is open.

KELSEY NOWAKOWSKI thank you for taking my call.  So I’ve been speaking with some of the CDC epidemiologists that have been stationed on St. Croix in the U.S. Virgin islands and I’m just trying to get a sense of how some of these estimates that Zika could affect one in five in Puerto Rico play out in the U.S. Virgin Islands.  and then a second question about how travel is still being encouraged here but I’m curious to know if that could actually lead to the spread of the virus if someone is coming here from places where the mosquito that spreads the disease is present, say in Texas or Florida.

TOM FRIEDEN: So first off from what we understand from U.S. virgin islands — and there may be people in the room from the CDC response who can speak to this further — the population density is somewhat less than Puerto Rico so while we may see a similar ultimate level of infection, the pace of infection may be a little more gradual there given the lower human population density.  In terms of travel, really our focus is pregnant women and information to men who travel whose partners are or may be pregnant to reduce the risk in that situation.  the fact is, there are 40 million people who travel from the U.S.to Zika-affected areas each year.  Travelers for many reasons ranging from business to family reunion to vacation and we give our advice on travel and the reason for that travel.  Thank you.

KELSEY NOWAKOWSKI Thank you.

KATHY HARBEN: Next question, please.

OPERATOR our next question comes from Sandee LaMontte with CNN.  Your line is open.

SANDEE LAMONTTEWITH– hi there.  Thank you for taking my questions.  I’d like to explore the “new England journal of medicine” paper and comments and this is for both dr. Fauci and dr.  Frieden.  We’re talking about this moving way beyond the realm of microcephaly at this time.  Can you speak more to the source of abnormalities that you see or hear about what might be showing up in babies that are — may not be detected by ultrasound and other sorts of things along that line?  I also have a follow-up question on Guillain-Barre.

TONY FAUCI: Okay, let me take a quick shot at it and then lateral it to tom.  One of the problems that you run into is that it is — we know this violence is neurotropic.  One of the manifestations that could be a tip of the iceberg type thing is when you see an absolutely gross abnormality like microcephaly. But when you think of the terms of the effect of the virus on a developing fetus, you may not see the gross abnormality but then at various times following birth you may see things that you didn’t notice in a stillborn more to a miscarried fetus and that could be involvement of the eye, and we know that there are ocular involvements that we’ve seen in some of these cases.  You may have visual impairment if not blindness, you may have hearing abnormalities.  There could be developmental retardation that could be profound without necessarily having a baby that’s micr cephalic.  and that was the concern i get because if you have 29 percent clearly identifiable by ultrasound you can be almost certain that there’s going to be a definitely additive percentage, exactly how much i do not know, and that’s the reason why we’re going to be doing the kinds of follow-up studies of cohorts and case controls of looking at babies one, two, three, four, five years following birth which is very important study that’s going to be done.  So we do not yet know at this point what the ultimate attack rate of some sort of abnormality would be on the fetus.  That was the reason i expressed that concern when i mentioned the “New England journal of Medicine” paper.

TOM FRIEDEN:  I totally agree with everything Dr. Fauci said.  The other thing that i found very striking about the web annex of that paper is that in all three trimesters of pregnancy there were definite fetal effects.  So i think what we’re saying basically is the more we learn about Zika in pregnancy the more concerned we are.

SANDEE LAMONTTEWITH: can i follow up on that before I move on to the other?  Which is that there are many babies that are being listed as non-affected when they’re born down in Brazil and other areas.  Are we now saying that that may not be the case?

TOM FRIEDEN: I think the term we have used is “no apparent abnormalities.”  But we know from rubella, for example, that even 20 years later possible neurological and psychiatric implications were being studied.  So it’s going to be very difficult to know for certain what the impacts are and in what proportion of infants.  We remain most concerned about the first trimester of pregnancy given the analogy to rubella, but the “New England Journal” article was striking in outlining a not insignificant portion of pregnancies in the third trimester and second trimester that had some sort of problem that appears that it may well have been Zika-associated.  Dr. Fauci?

TONY FAUCI: I agree completely.  And, in fact, there are situations now that we’re getting individual reports that you have a person who gets infected at, you know, 29 weeks or so, gets an ultrasound that looks normal at 30 and then suddenly at 35 weeks you have intrauterine growth retardation, which is strong evidence that something bad happened during and following that infection. So the idea of not just the first trimester is really quite concerning, (garbled)

SANDEE LAMONTTEWITH thank you very much.

KATHY HARBEN: next question, please.

OPERATOR: Yes, our next question comes from Rebecca Spalding with Bloomberg news.  Your line is open.

REBECCA SPALDING: hi, Dr. Frieden, thank you so much for taking my call.  Just to go back to the question about widespread resistance to insecticide.  Is the CDC looking at any of the more experimental solutions that the WHO has mentioned they are looking into?  I’m thinking of oxytest, genetically modified mosquitos what the international atomic energy association, their solution.  Is that something you’re looking into?

TOM FRIEDEN We’re certainly open to any possibilities.  The genetically modified mosquitos are one.  another promising technology is infecting mosquitos with Wolbachia a bacteria that infects many mosquito species but not Aedes — however i think realistically in the next few months it would be difficult to see a large scale impact of those new technologies in Puerto Rico, although we’re very supportive of efforts to look into them and to explore that with communities rand the government there.  I think one of the challenges with those new technologies is just how short the life span is of the mosquito. Most Aedes only travel about 200 yards in their lifetime so if you’re going to try to replace a mosquito population, these are studies that have been done in relatively small areas and have been very intensive and in the case of the genetically modified mosquitos have involved the release of tens of millions of mosquitos in the case of Wolbachia. That is  reason is done only in quite small areas.  So though they’re promising technologies that we need to pursue, i think we also have to be realistic about what the impact in this mosquito season is likely to be.

KATHTY HARBEN: Thank you. We have time for one more question.

OPERATOR Last question comes from Leigh Ann Winick with CBS News.  Your line is open.

LEIGN ANN WINICK thanks very much.  Can you give more details on the diagnostic challenges and what that means with doctors advising people when to get tested if they’re worried about exposure and the need to repeat tests?

TOM FRIEDEN: sure, i do want to say that we’ve really had terrific work from the CDC laboratory experts, the doctors, laboratory scientists, we’ve been able to produce more than a half a million Zika tests.  We’ve rolled those out to two dozen labs around the U.S.as well as to labs around the world.  For diagnosis of acute infection, someone who’s sick or someone who has the infection in their blood, that’s quite accurate and we’re able to identify that in the overwhelming number of cases.  That’s the PCR test.  It’s a real-time PCR test and we’re now in the final stages of a new PCR test that will be particularly helpful in Puerto Rico as well as internationally in areas where there’s Dengue and Chikungunya.  It’s a trioplex that includes both, well, all three of dengue, chikungunya and Zika.  It’s a pan-Dengue assay, all four of the Dengue serotypes.  So the lab has done really fantastic work, working seven days a week to make those tests available.  The IGM tests are approved by FDA under emergency use authorization.  We had a good set of interactions with FDA to get that approved and we’re rolling that out to labs around the U.S. it’s not a simple test.  It does involve a couple of days of testing and it’s not necessarily definitive because if people have had prior infections with dengue or chikungunya there can be cross-reactivities.  And as of now there are not commercially available tests for these in the U.S. and where we’ve looked at the commercially available tests outside of the U.S., we have been very disappointed with their performance. So we want to continue to roll out what we’ve got and continue to optimize the tests that are available.  But at the present we don’t have anything for a man who’s concerned he might have been infected to get tested and determine whether he has an infection.

LEIGN ANN WINICK: Could you elaborate on that?  What do you mean you don’t have to wait for a man concerned who might have been affected? That some time has lapsed?

TOM FRIEDEN: Anyone who’s sick and visited a Zika infected area should and can get tested.  Any pregnant woman who has symptoms should get tested and pregnant women should be tested as per CDC guidelines if they are living in an area where Zika is spreading. In terms of men who have returned from a Zika-affected area, that’s more complex and first off we don’t know yet how long the IGM remains in the body so if he returned four months earlier and has a negative.  We’re not sure that means he may be infectious by sexual route.  So there’s still a lot we don’t know and that’s why our recommendations have been consistent from the first week we identified sexual transmission, that men who have traveled to or lived in an area with Zika transmission use a condom every time if they have sexual relations with a pregnant woman.  Let me just — I’d just like to say a couple of last words, maybe before doing that, Dr.  Fauci do you want to say any last words and then i will.

TONY FAUCI: No, just one brief thing, tom to reemphasize how important it is that we get the support to do these things because this is — i am not and — tom and i, neither of us are alarmists but this is a serious situation that we need to step to the plate and we need to step to the plate very, very intensively.  We’re already doing that but we can’t sustain it if we don’t have the support that we need.

TOM FRIEDEN: Thank you, Tony.  I agree 100 percent.  Time is of the essence.  We anticipate in the coming weeks and month we will see large increases of cases in Puerto Rico.  We will continue to see travelers coming to the U.S. from Zika-affected areas with Zika.  We may see more Zika affected infants in the U.S. We already have one infant with severe Zika associated microcephaly and we have the risk of clusters of cases in parts of the U.S. where the Zika-carrying mosquitos are present. So there’s much more to be done and the sooner we get ample resources for a response the more effectively we can protect pregnant women.  Thank you all very much for your attention.

KATHY HARBEN Thanks, Dr. Frieden and Dr. Fauci.  Thank you, reporters.  For follow-up questions call the press office at 404-639-3286 or e-mail us at media@CDC.gov.  This concludes our call.  Thank you.

OPERATOR thank you for your participation. You may disconnect at this time.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES