Conferencia de prensa del HHS sobre la gripe H1N1, 4-29-09

29 de abril de 2009
11:00 a.m., hora estándar del este

Secretaria del HHS, Kathleen Sebelius

Dr. Joshua Sharfstein, Comisionado interino de la FDA

Dr. Anthony Fauci, Director del NIAID/NIH

Dr. Jesse Goodman, Director del Centro de Evaluación Biológica e Investigación (CBER, por sus siglas en inglés) de la FDA

Dr. Bruce Gellin, Director de la Oficina del Programa de Vacunación Nacional, HHS
Dr. Richard Besser, Director interino de los CDC, vía satélite
RADM William Craig Vanderwagen, Subsecretario de Preparación y Respuesta,
Departamento de Salud y Servicios Humanos (HHS) de EE. UU.,
Robin Robinson, Ph.D., director de La Autoridad de Investigación Biomédica Avanzada y de Desarrollo (BARDA), Oficina del Subsecretario de Preparación y Respuesta (ASPR) del HHS.

KATHLEEN SEBELIUS, SECRETARIA DE SALUD Y SERVICIOS HUMANOS: y más casos se identifican a diario. Decidimos combatir este brote y hacer todo lo que podamos para proteger la salud de todos los estadounidenses.

Es un honor para mí asumir la posición de conducción de este importante departamento, y quiero asegurarles a todos que se están realizando esfuerzos sobre este brote de influenza, no solamente dentro de la agencia sino en todo el gobierno desde hace un tiempo.

Anoche, llegué de un viaje procedente de Washington e inmediatamente después de mi juramento, me reuní con los funcionarios de La Casa Blanca para debatir sobre la respuesta nacional ante el brote de la gripe. Los CDC y todo el departamento han estado haciendo un excelente trabajo para reaccionar ante este brote y quiero agradecer a aquellas personas de mi equipo y al Dr. Rich Besser, quién nos acompaña a través de una videoconferencia, por el sensacional trabajo que logró en Atlanta gracias a su esfuerzo.

Le solicité al equipo de conducción que estuviera presente hoy para debatir lo que se está haciendo para hacerle frente a este brote. Me acompañan Josh Sharfstein, comisionado interino de la FDA; Dr. Jesse Goodman, científico interino principal de la FDA; Dr. Bruce Gellin, director del Programa de Vacunación Nacional del HHS; Dr. Craig Vanderwagen, subsecretario interino de Preparación y Respuesta; Dr. Robin Robinson, director de La Autoridad de Investigación Biomédica Avanzada y de Desarrollo; Dr. Tony Fauci, director del Instituto Nacional de Alergia y Enfermedades Infecciosas, NIH y Rich Besser, director interino de los Centros para el Control y la Prevención, quien nos acompaña a través de una videoconferencia desde Atlanta.

Actualmente todas estas personas y sus respectivas agencias han trabajado con nuestros colegas en todos los niveles gubernamentales para implementar las medidas necesarias para reducir la enfermedad, minimizar el desajuste en nuestras comunidades, escuelas y lugares de trabajo. Ellos tienen los recursos y las herramientas indispensables para hacerle frente al brote.

Además, todas las agencias del Departamento de Salud y Servicios Humanos han estado trabajando intensamente para informar al público sobre las medidas que pueden tomar para protegerse y reducir la diseminación del virus.

La información está disponible en www.cdc.gov, y las oficinas del HHS distribuyeron herramientas basadas en Internet que ofrecen enlaces a recursos y datos sobre el virus H1N1 2009 en estados y comunidades y a nuestros socios.

Hoy más tarde, publicaremos en el sitio web información y pautas adicionales para padres y familias.

El HHS está trabajando en estrecha colaboración con departamentos de salud locales y estatales y otros más para asegurarse que todos los estadounidenses que estén infectados por el virus de la gripe, reciban el tratamiento que necesitan. El asesoramiento sobre el tratamiento antiviral que médicos y profesionales clínicos pueden utilizar, ha sido desarrollado y publicado en sitio web de los CDC.

El Gobierno Federal posee alrededor de 50 millones de tratamientos con los medicamentos antivirales Tamiflu y Relenza en la reserva nacional estratégica. El gobierno ya comenzó a enviar medicamentos y demás suministros personales desde la reserva hacia los estados. A medida que se distribuyen los recursos, los estados con casos confirmados son prioritarios.

Quiero aclarar que estos medicamentos son eficaces para tratar a pacientes que contrajeron el virus de la gripe H1N1 2009. Sin embargo, la gripe siempre es grave. Sabemos que millones de estadounidenses está afectados con influenza cada año. Un promedio de 200,000

estadounidenses son hospitalizados cada año y miles mueren a causa de la influenza y sus complicaciones.

Pero aún desconocemos lo que este virus traerá aparejado. Esperamos tener más casos, más hospitalizaciones y lamentablemente más muertes debido al brote.

En la actualidad, la FDA y los Centros para el Control y la Prevención de Enfermedades están desarrollando cepas de referencia del virus, que es la información de un virus que se necesita para crear una vacuna. Hoy, el HHS está tomando una serie de medidas en el desarrollo de esa vacuna. Iniciamos el proceso y estamos a toda marcha, por lo que éste avanza más rápido que nunca.

Asumimos el compromiso de asegurar que estas vacunas son seguras. El HHS y la Administración de Alimentos y Medicamentos controlarán la fabricación de una potencial vacuna y llevarán a cabo una estricta supervisión para garantizar que la misma sea segura y efectiva para su uso.

Mientras que se da inicio a la fabricación de la vacuna, los NIH realizarán pruebas clínicas para garantizar que estén disponibles apropiadas fórmulas y dosis de la vacuna. El trabajo efectuado por los NIH y la FDA será de vital importancia y ayudará a que este proceso se lleve a cabo de la manera más eficaz posible.

Trabajaremos rápidamente pero la seguridad es y seguirá siendo nuestra principal prioridad. Habrá supervisiones rigurosas mientras trabajamos para fabricar esta importante vacuna.

En el ínterin, hay cosas que todo estadounidense puede hacer y a pesar de que parecen relativamente sencillas, son altamente efectivas. Lávese las manos con frecuencia.

Cúbrase la boca y la nariz al toser o estornudar y no asista al trabajo o a la escuela si se siente enfermo. No lleve a su hijo a la guardería o a la escuela si usted presenta síntomas similares a los de la gripe. Estas acciones contendrá la propagación de esta enfermedad.

Me gustaría llamar ahora al Dr. Rich Besser, director interino de los CDC, para que brinde actualizaciones adicionales sobre el brote.

DR. RICH BESSER, DIRECTOR INTERINO, CDC: Muchas gracias, Señora Secretaria. Espero que me puede escuchar allá en Washington.

SEBELIUS: Lo escuchamos.

BESSER: La situación sigue siendo de mucha incertidumbre, cambia muy rápidamente. Nuestro enfoque es continuar con las medidas dinámicas y reducir el impacto sobre la salud de las personas.

Me gustaría ofrecer una actualización de la situación. Esta mañana confirmamos la primera muerte de un niño a causa de la gripe H1N1 en Estados Unidos, un pequeño de 23 meses de edad de Texas.

Es una noticia muy triste. Como padre y pedíatra me siento conmovido ante este hecho y acompaño en el sentimiento a toda la familia de Texas que está atravesando esta situación.

Tal como debatíamos la semana pasado, la influenza es una enfermedad muy grave y de las cuales debemos prever una variedad de infecciones.

Tuvimos situaciones en México y Estados Unidos que, de alguna manera, parecen diferentes. Hemos escuchado informes de complicaciones graves que provienen de México y desde el comienzo tuvimos enfermedades mucho menos graves en este país.

Mientras continuamos en la búsqueda de casos, esperamos ver más casos en un espectro más amplio y eso es lo que estamos presenciando.

Sabemos que debido a la gripe anual y la gripe de temporada 36,000 personas mueren en los Estados Unidos, por lo tanto si lo describimos objetivamente, éste es un virus grave. Nos enfrentamos a un brote grave y estamos tomando medidas enérgicas.

Permítanme que les cuente dónde nos encontramos en cuanto a nuestro número de casos y nuestras actualizaciones. Les recordamos que estas cifras varían rápidamente. Actualizamos el sitio web de los CDC diariamente con números de casos a las 11:00 a.m. y usamos dichas cifras para informar durante el próximo ciclo de 24 horas.

Estamos informando 91 casos confirmamos en 10 estados de los Estados Unidos. Este en un porcentaje mayor en comparación con el informe de ayer de cinco estados.

Tenemos los siguientes casos registrados: Nueva York con 51, Texas con 16, California con 14, Massachusetts con dos, Michigan con dos, Arizona con uno, Nevada con uno, Indiana con uno, Kansas con dos y Ohio con uno. Sin embargo, estas cifras están prácticamente desactualizadas al momento en que las anuncio, dada las actividades que se llevan a cabo en todo el país para buscar más casos e investigarlos.

Estamos observando un rango de edades más amplio entre los casos. La edad mediana es 22 años con un rango de 81 años. Observamos que el 64 por ciento son menores de 18 años. Hasta ahora Hubo cinco hospitalizaciones, incluido un niño que murió, pero contamos con una cantidad de casos posibles de personas que han sido hospitalizadas y estimamos que el número seguirá en aumento.

El síntoma más reciente de un caso fue el 24 de abril. En este momento, no sabemos lo suficiente para comentar sobre el contagio, pero estamos buscando intensamente el contagio en el país como en el exterior. Seguimos participando en equipos de varios estados, como parte del esfuerzo trinacional en México, para investigar y comprender su situación actual.

Estamos trabajando sobre estas investigaciones junto a la Organización Mundial de la Salud y la Organización Panamericana de la Salud.

Estamos trabajando día y noche en la utilización de materiales para apoyar los esfuerzos locales y estatales. En esta etapa, no existe ningún estado que se encuentre en problemas en términos de suministros de antivirales o su capacidad de cuidar a los pacientes, pero con nuestro enfoque de avance y que intenta ser dinámico, actualmente estamos distribuyendo el 25 por ciento de los suministros de la reserva que son repartidos para cada estado a aquellos estados, y algunos de los estados los recibieron y el resto lo recibirán el 3 de mayo.

Seguimos emitiendo una guía que la desarrollados junto con nuestros socios. La guía para mujeres embarazadas y la gripe H1N1 está en camino. También publicamos guías para los médicos clínicos que cuidan de niños. Tenemos recomendaciones antivirales para pacientes en contacto cercano y publicamos una guía para ayudar a que las tripulaciones de las aerolíneas identifiquen pasajeros potencialmente enfermos.

Cuando termine mis comentarios, escucharemos una actualización de algunos de los trabajos que está realizando la Administración de Alimentos y Medicamentos para apoyar la investigación y el control de este brote y luego escucharemos una actualización sobre los trabajos de la vacuna que se realizan en el departamento.

Quisiera comentarles sobre ciertos problemas en torno a los viajes. Existe una alerta sobre viajes para México y lo que recomendamos es que se posterguen los viajes secundarios a ese país. Las fronteras permanecen abiertas y hemos aumentado nuestra vigilancia, por lo tanto los oficiales de la aduana y la patrulla de fronteras están buscando de manera a personas que pudieran estar enfermas. Además, entregan advertencias de los CDC sobre viajes y salud para que las personas conozcan cuales son los síntomas de la gripe H1N1 y cuando deben consultar a su médico.

Las personas que están identificadas como enfermas son derivadas a profesionales de la salud pública para más evaluaciones.

Los problemas surgen sobre porqué no cerramos la frontera y hemos aprendido mucho de brotes anteriores, especialmente sobre cómo aprovechar de mejor manera nuestros recursos para controlar los brotes, ubicando esos recursos en áreas que sabemos serán efectivas.

Recientemente, lo que aprendimos del brote SARS, y en especial de la experiencia del director general de la OMS en Hong Kong es que los esfuerzos intensos para poner en práctica los exámenes de detección en la frontera en las entradas y salidas no fueron una manera efectiva de identificar casos o evitar contagios, por lo tanto continuaremos con los esfuerzos en aquellas cosas que consideramos producirán el mayor impacto en reducir el efecto de este brote en nuestra población y las poblaciones del mundo.

Recomendamos múltiples acciones, tal como la Secretaria comentó. Las personas pueden hacer mucho en cuanto a la planificación en caso de que las escuelas estén cerradas en sus comunidades y la prevención del contagio de infecciones de persona a persona. Si se esfuerzan hacia ese objetivo y asumen esa responsabilidad, continuaremos con nuestro trabajo de ayudar a las comunidades en la preparación y la mitigación, para reducir el impacto en sus comunidades.

What are we in? We call this a pre-pandemic period. We are investigating an outbreak of a new strain of influenza. What do you call this matters much less than what we do about it, and we are being aggressive in our efforts. No single action will control this, but the combination of actions that are being taken across the country at the state, Federal and local level, will be effective at decreasing the impact of this event. But as we continue to look for cases, we expect to see more severity, and unfortunately I would anticipate that we will see additional deaths.

Deseo reiterar que toda nuestra guía que proporcionamos es parcial. A medida que tenemos más información, la cambiaremos. A medida que la situación cambie, la adaptaremos y responderemos en concordancia.

At this point, I’d like to turn the podium over to Dr. Josh Sharfstein at the FDA so he can talk about the tremendous efforts going on there to respond to this outbreak.

JOSH SHARFSTEIN, ACTING FDA COMMISSIONER: Thank you very much, Dr. Besser, and on behalf of everyone at the FDA, I want to thank you and the CDC for the tremendous work you’re doing, and the collaboration that we’ve had, and I also want to take a special moment to welcome Secretary Sebelius and just say how happy we are that you’re here.

FDA is working as part of the team led by HHS in close coordination with other public health agencies. I’ve asked Dr. Jesse Goodman, who is the FDA’s Acting Chief Scientist, international expert in infectious disease and in flu vaccine manufacturing and licensing, to coordinate and lead FDA’s efforts on the H1N1 flu virus.

We have shifted from our ordinary approach within FDA to an incident management structure that includes seven specific teams. All of the FDA’s centers are engaged in this effort, and what I’m going to do is just briefly mention what these seven teams are now working on the virus.

The first, and these are in no particular order, we have a vaccine team, and the goal of the vaccine team is to facilitate the availability of a patient effective vaccine for this disease. There is a tremendous amount of work all the way from the lab to anticipating to licensure, going on in FDA working in collaboration with CDC and NIH in developing the actual reference strain of the virus that will be used for a vaccine, as well as thinking through how the potency of the vaccine will be tested, what the clinical trials will look like, and ultimately what the application for approval will look like.

We have an antiviral team. This is the team that approves two emergency use authorizations or prepared for my approval, two authorizations for antiviral medications which were assigned early Monday morning to make antiviral drugs available and permit the strategic stockpile to go for Tamiflu. This included authorization for use under age one.

There is an – and I should say that team is also actively engaged in all of the manufacturers of products that could be effective against this virus so that we could be ready and clinicians could have access to treatments that we believe are promising.

There is an in vitro diagnostics team, which is responsible for the lab tests to identify the flu, and we work very closely with CDC, but – in approving another emergency use authorization to permit the distribution. There are tests for this virus around the country, and that also happened early Monday morning.

We have a personal protective equipment team that approved – that handled the emergency use authorization on N95 masks, which have use in accordance with the CDC guidance, and they are also working with manufacturers of other personal protective equipment on their supply to make sure that it’s available when we need it.

There’s a blood team that is thinking in advance of any implications for the blood supply.

We have a shortage team that is working to facilitate the availability of antiviral drugs in coordination with the department in talking to manufacturers about their production capacity and what they will be able to do.

And finally we have assembled (ph) a consumer protection team to start thinking about the fact that there may be treatments that may be marketed to people that potentially are dangerous and fraudulent, and we want to keep that activity to a minimum.

So across all these areas, FDA has been literally working around the clock in coordination with other agencies, and we believe that the structure that we’ve set up is going to be flexible enough to see these current efforts through, as well as engage in all the other activities that will be important.

Gracias.

BESSER: I’d like to ask Dr. Fauci from the National Institute of Health to talk a bit more about some of the vaccine development efforts underway.

DR. TONY FAUCI, NATIONAL INSTITUTE OF HEALTH: Thank you, Dr. Besser. I’ll be quite brief.

I just want to summarize that the NIH, as traditionally been the case, is the research, both basic and clinical limb, of the HHS team that you’ve heard from and will continue to hear from in this approach towards this new virus.

What is going on now is a question often asked regarding vaccines and what are we doing. As you know and have heard through the media that the strain of the vaccine has been isolated by the CDC. That will be made into what we call a reference strain for the purpose of developing vaccines.

A reference strain is then put into what we call a seed virus for growth to determine the best conditions to grow it in order to make enough for a vaccine.

Right now that process has already started. The virus reference strains have been distributed to the appropriate people and will continue to be distributed to those who would utilize it.

At the NIH, our purpose and our function, which we’ve already geared up for, is to do the clinical trials on the pilot lots that will emerge from the production through our pharmaceutical company partners. Those trials will take a period of months. They will probably begin within a couple of months, and the purpose of those trials is to determine the safety, the immunogenicity, which means does it induce a response that you would predict would be protective, and importantly, what is the proper dose.

So again, we’re part of the team that is in the process, that has already been launched, a pre-planned process of developing a vaccine for this problem that we have right now, and this again is going to be a stepwise process that we will continually update you with.

Thank you very much.

UNIDENTIFIED PARTICIPANT: Thanks, Dr. Fauci.

The Secretary has to run up to the Hill for a meeting, but has time for a few questions.

SEBELIUS: And if they’re tough, I’m going to defer to Dr. Besser.

Sí.

UNIDENTIFIED PARTICIPANT: Hi, Madam Secretary. (INAUDIBLE) indicated concerns about community transmission in regards to the cases in New York City, and so I’m wondering with that concern, aside from school closures, are there steps that are under consideration?

SEBELIUS: Well, currently I think, as Dr. Besser said, the situation is being evaluated on an ongoing basis. As you know the way response works, it starts at the local level, and in the discussions with local partners, I think, the CDC has recommended first of all that schools close when an infected student has been identified.

More aggressive steps have been considered by some school districts, and I think that is currently under discussion, but as you know there then is a large ripple effect. What happens to the parents, where do those children go, do you close the daycare center if a younger sibling is there, so I think closing a broader affected area is always being actively monitored and under discussion, and right now there are some affected districts that have taken broader steps, closing a series of schools, but the CDC recommendation currently is if an infected student is identified, close that school, and contain the illness at that level.

I talked to Dr. Chan this morning, the Director of the World Health Organization. There is again daily conversation about this, not only across the U.S. government agencies but I would suggest around the world, and those collaborations will continue, and this is a situation that is evolving and updated on a regular basis.

Yes, sir.

UNIDENTIFIED PARTICIPANT: Was the – can I ask you a couple of questions about the toddler this morning? Do you know whether or not the baby or the toddler was being treated with antivirals, and if so, is that cause for any concern that they may not be as effective as people think?

SEBELIUS: I’m going to ask Dr. Besser to answer that question.

BESSER: (INAUDIBLE) Whenever we have a case of confirmed H1N1 disease, we’re going to look at the specifics on when did the illness start, what type of treatment was received, how long did it take between illness onset and treatment, and the Texas State Department of Health is actively investigating this case, and I would refer you to them for those details.

But I do want to caution you that there’s very little you will glean from one case. It’s looking at these cases together where patterns start to emerge that will help us improve and refine treatment guidelines and continue to evaluate our control strategies.

SEBELIUS: One more question (INAUDIBLE) and then Dr. Besser (INAUDIBLE)

UNIDENTIFIED PARTICIPANT: (INAUDIBLE)

UNIDENTIFIED PARTICIPANT: (INAUDIBLE) with “Congressional Quarterly.” I just wondered in light of what is going to be I am sure growing public interest in Tamiflu, could you clarify what that drug can and can’t do and under what circumstances people you know would seek to use it?

SEBELIUS: Well, again, I would like to refer to the scientists and to – and the doctors to answer this question, so Dr. Besser, maybe you could answer the question about how effective the antiviral is and what people can expect, and thank you all very much. I’m going to turn over to Dr. Besser.

BESSER: Thank you very much, Madam Secretary.

We know that this virus that’s circulating is susceptible, can be treated by Oseltamivir, which is Tamiflu, and Zanamivir, which is Relenza, and that’s good news, and we have treatment guidance up on our Web site, and we’ve distributed to the clinical community so that they know how to use those drugs across patient populations.

There are other circumstances in which we’re recommending that antiviral treatment be used. Close contacts in the family who have underlying medical conditions that would put them at a greater risk of severe influenza, that’s a group that – for whom drugs are recommended.

And so as we learn more, as we learn more about severity and transmission, we’ll continue to update our treatment guidelines, and again, one of the reasons we have pushed forward with distributing the first 25 percent of the antiviral to the states is so that they have those drugs on hand should additional treatment be required.

Next question?

UNIDENTIFIED PARTICIPANT: Yes.

JARED (ph) (INAUDIBLE), DOW JONES: Hi, Jared (ph) (INAUDIBLE) from Dow Jones. What does the federal government do in the case, where, somebody comes over on a plane from Mexico …

UNIDENTIFIED PARTICIPANT: Right.

JARED (ph): … and they come here and they – turns out they do have the swine – they do have swine flu, what do you do for the rest of the other passengers who, maybe, aren’t ill on the plane?

TONY (ph): Well, we’re calling it the 2009 H1N1 flu, now. That’s the name for it. But having said that Rich (ph), why don’t you …

RICH (ph): Yes, thanks Tony (ph). We know from previous experience the importance of, yes, investigating and controlling outbreaks that could occur on airliners. This is something that happens all the time.

We have a quarantine system in this country. And one of the big functions of that is so that when there’s an identified illness, on a plane, either an illness that’s identified in flight or one that’s identified after a plane has landed, we use this system to identify who was on the plane and to take appropriate measures.

In the setting where we have a confirmed case of someone who was symptomatic on an airliner, we would work to notify those individuals, so that they would understand that there had been exposure and appropriate measures could be taken. Those measures would depend on the individual and their underlying medical condition. And whether we thought there had been an exposure that put them at risk.

TONY (ph): Thank you, Rich (ph).

UNIDENTIFIED PARTICIPANT: Next question.

TONY (ph): Next question, yes, right back there.

ANDREA BRUCE (ph), PBS NEWS: Good morning, Andrea Bruce (ph), PBS News. Two questions; one, of the – maybe this is for Dr. (Shar’s) team first and then for you, second.

TONY (ph): Yes, sure.

BRUCE (ph): Of the 50 million or so doses of antiviral, which were on the stockpile, which were released with the order on Monday, can you update on us how many have actually been shipped and to which states?

And secondarily, I know that it’s hard to give an exact timeline …

TONY (ph): Sure.

BRUCE (ph): … for vaccine production but we’ve heard and been speaking broadly, a couple of months, could you give us a better sense of where you are on, on the timeline and give me …

TONY (ph): Sure, Dr. Bresser (ph) will be because CDC’s responsibility for the strategic national stockpile; Rich (ph).

RICH (ph): Yes, thanks Tony (ph). Well, the stockpile is moving. As of this morning, New York City and New York State and Indiana had received their full allotment. There’s a number of states that have received partial allotments and by May 3rd, they all will have received their allotments.

You know this is a very forward-leaning move and so, there are no states that are having any shortages of these drugs, within the medical community.

TONY (ph): OK, next question; yes.

UNIDENTIFIED PARTICIPANT: Could you just remind us why we’re concerned about this; 36,000 deaths a year from flu. You’ve only got 150 or so, in Mexico, at this point. No deaths in the United States. Isn’t it possible that you’re simply looking where you have not looked before and that this goes on …

TONY (ph): Sure.

UNIDENTIFIED PARTICIPANT: … sort of all the time.

TONY (ph): Right.

UNIDENTIFIED PARTICIPANT: Why the concern?

TONY (ph): Yes.

UNIDENTIFIED PARTICIPANT: And then a final question about the distribution of the Tamiflu stockpile. Some states had not bought their allotments before …

TONY (ph): Right.

UNIDENTIFIED PARTICIPANT: … Florida; Texas.

TONY (ph): Right.

UNIDENTIFIED PARTICIPANT: Is that causing any problems, the fact that some states had not stepped up …

TONY (ph): Sure. I’ll answer quickly and then, I’ll hand it over to, Rich (ph). This is a virus that is, what we call a pre-pandemic. And it has pandemic potential, which means it’s a virus that we’ve never seen before.

There’s no background immunity, in the population. And it is spreading from human-to-human, which – all of which has the potential for a pandemic. So, the question you asked is a reasonable question, why is this not something that we’ve seen before?

The fact is, we have not seen this before, with this particular virus. So, it really is something different. Rich (ph), you want to pick up on that?

RICH (ph): Yes, thanks very much. You know at the start of an outbreak, you don’t know what the course is going to look like. You don’t know if this is a virus that’s going to fizzle out, in a couple weeks or one that is going to become more-or-less a virulent in the diseases it causes.

Because of that we’ve been undertaking, as a global community and as a national community, intensive planning in the event that we do enter a pandemic. And we’re using those plans and we’re asking people at the state and local level, whether they be governmental or business or community or faith-based, to look at the planning that they’ve undertaken and move forward. So that if this were to develop into something more severe, they would know what they would need to do.

If we could see into the future, it would be absolutely wonderful because then we could tailor all of our responses, specifically, to what would be occurring. But that’s not the case and that’s why we’re being aggressive and forward-leaning. And we’re going to continue to adapt our strategy and approach based on what we’ve learned.

Now, regarding the stockpile question; yes, different states have decided – had decided to purchase variable amounts of anti-virus, for many different reasons. Some, their budgets just would not allow for additional purchases. Others, took a different strategy in terms of thinking about how they would want to control a future pandemic.

But every state has a proportional share of the strategic national stockpile and that contains approximately 50 million treatment courses. So, we have a large supply of antivirals to distribute in the country, to help support the treatment of patients who may be sick.

TONY (ph): Just to underscore, again, part of your question, this is, as we know, influenzas traditionally and historically are unpredictable. And as Rich (ph) said, we don’t know – this is a dynamic situation where its going, so when you have an unpredictable virus that is a virus that we’ve not seen before that underscores the kinds of caution and preparatory issues that we’re dealing with; next question.

JENNIFER LUBELT (ph), MODERN HEALTHCARE MAGAZINE: Jennifer Lubelt (ph), Modern Healthcare Magazine; if this is such a concern, why aren’t you doing more to close the borders to Mexico; restricting air travel, if Mexico is such a hot bed? And another question I had is, there was a scare in the 1970’s regarding this virus, why hasn’t a vaccine ever been developed on it?

TONY (ph): OK, I’ll hand over to, Rich (ph), the issue with the borders but with regard to the 1970’s, you’re referring to the 1976 so-called swine flu. That was a completely different virus than the virus we’re dealing with right now. Completely different in the sense that the genes are different and it doesn’t have any relationship.

The designation of H1N1 is the same. It was called the swine flu but from a viral standpoint in spreading, it’s quite, quite different. Rich (ph), do you want to do the travel?

RICH (ph): Thanks. We are undertaking a number of efforts, at the border. As I mentioned earlier, the Customs and Border Patrol are looking for individuals who appear sick and are referring them to public health professionals for evaluation.

We’re handing out information sheets to individuals, as they cross the border, so that they know what the signs and symptoms of H1N1 disease are. And they know what they should do if they become ill.

We also know from many, many years of experience, in terms of controlling infectious diseases, especially, infections such as influenza, which are quite contagious that intensive efforts at border entry and exit screening, are not an effective mechanism for preventing introduction of an infectious disease. Our overarching global strategy and one that we would’ve implemented had bird flu, for instance, started in a faraway place, would be to try and send a team to control that or quench it or knock it out where it was first starting.

And at the same time, implement some border control to delay, maybe, by a matter of a couple weeks, the introduction into our own borders. We never had any sense that we would be able to prevent, fully, a new infectious agent from entering once it left its closely contained area. But the idea was, maybe, we could delay its entry, within the border.

We’re faced with a situation here, in which, at the time of detection – this was not detected in a faraway place. This virus was detected in San Diego. And the ability to identify it in Mexico was based on a lot of the preparedness work that was going on here, as part of our pandemic preparedness efforts, to develop new points of care testing.

And they identified, in San Diego, a new novel virus that was sent to CDC. And that was identified as the – a new H1N1 virus. We shared that as we always do with the international community. And the Canadians identified that as the strain that was causing an outbreak in Mexico.

And so, increasing efforts at the border; putting major efforts in terms of entry and exit screening or trying to close the border, would use up major resources that could be applied at things we know work. And that is one of our overarching principles. We – there are thousands of things you could do.

We want to do the things that we think are going to have the greatest impact on controlling and slowing this and decreasing the impact on people’s health.

TONY (ph): Thank you, Rich (ph). You had your hand up young lady, yes.

UNIDENTIFIED PARTICIPANT: Hi, thank you. I just wanted to follow-up on an earlier question. I was not clear as to whether it’s known; whether the child that died was taking antiviral treatments.

TONY (ph): Is that known?

RICH (ph): I need to refer you to the Texas State Department of Health. We don’t like to comment on individual patients and their courses and their history. And so, I would refer you to them.

They are doing the investigation in terms of when this child became sick; when this child received treatment and the course there. And so, I think they are discussing this in a press conference or in other manners.

TONY (ph): Yes, also, to underscore the point that was made earlier, you’ve got be careful and I urge the press, to take a single patient and whether or they not got a drug and whether or not they did well or not, its such a complicated situation you would not want to make any conclusions about the efficacy of a drug, in order – just basis of one patient.

UNIDENTIFIED PARTICIPANT: And then, could I just clarify, quickly, on the distribution of the stockpile, when we say that New York City and New York State have received their entire allocation, we’re talking about the 25 percent of their – is that correct?

RICH (ph): That’s correct.

TONY (ph): Jessie (ph); go.

JESSIE (ph): Yes, I just want to comment that the anti-influenza drugs, they are effective. They can reduce the severity of illness and its complications but that’s very proportionate to their early use. Some people can become too sick for them to be really effective and they’re not absolutely. So that’s a very, very important message.

TONY (ph): Right; yes.

UNIDENTIFIED PARTICIPANT: A follow-up on another question, I’m not sure you answered it. When can we see a vaccine ready? I mean what sort of timeline?

You talked about various timelines but when – what’s the end date for …

TONY (ph): You know this is a process of decision making that will go on about the types of tracks that we’re going to do. So, when you talk about when will there be vaccine, there will be vaccine in pilot lots within a period of a few months.

That will be determined whether or not we have the right dose or whether or not it induces the immune response that we feel is appropriate; whether or its not safe. A lot of things happen on the way to that that will dictate whether it grows well; whether we’re going to have X-amount versus 10X amounts. So, those are the kinds of things that really are an iterative ongoing process.

But actual vaccine to be able to test in people, not distributed and again, I want to underscore the importance of people understanding the difference of making a vaccine that we have available for a decision point, of what we will do with it versus, I think, the underlying point that you’re making, when is it going to be for people? There’s a big difference between having it ready and distributing it. We’re just talking about the process, now, of gearing up to get the doses ready.

RICH (ph): Dr. Pattea (ph), I’d like to see if Dr. Gellin, would like to add anything about that process and timeline.

GELLON (ph): Thank you, Rich (ph). I think that Tony (ph) said it well. I mean we’re – its going now as fast as it can go and (INAUDIBLE) work its way through from the laboratory into the manufacturers. And then the clinical testing will go long before then.

We’re hopeful that by early fall we could, potentially, have something available but as Tony (ph) said that decision about what to do with it, is separate from having it. So, I think, the bottom line here, is that you – in the same way that Rich (ph) has mentioned the importance of being forward-leaning; to be prepared; its really the same thing with the vaccine preparation because if you wanted to use a vaccine, you have to have it. Thanks, Rich (ph).

UNIDENTIFIED PARTICIPANT: By early fall, you’re hopeful that you’ll have a vaccine ready but not one that necessarily can be used.

TONY (ph): There will certainly – well, what we’re talking about when you hear people talk about early fall, there will be doses likely then. How many and what we’ll do with them are an issue, the decision making with it (ph), how it relates, for example, to the seasonal flu vaccine distribution and manufacturing, is an important issue. All of these decisions will be made on the basis of the dynamic situation, as it evolves right now.

RICH (ph): Dr. Gellon (ph), would you like to add anything about that?

GELLON (ph): No. No, I don’t think so, thanks.

TONY (ph): Yes.

UNIDENTIFIED PARTICIPANT: Thanks. I wondered if I could follow-up on the effectiveness of the antivirals. Given the – given how new this virus apparently is, how do you know that in fact, these antivirals are effective in …

PATTEA (ph): Its an excellent question and you want to distinguish between effective in someone who is sick and you give it to them because that varies on when you get it to them. I mean if someone comes in, in the early phase traditionally and we’re not even talking about this particular virus, with something like Tamiflu or Relenza, the earlier you get the treatment, the better.

When you talk about how we are saying that something is sensitive to a particular drug, its based on an in vitro-type of testing, the, in the test tube determination of whether or not this particular virus would respond, in the sense, of being suppressed by the drug. So, when we say that something is sensitive to Tamiflu or sensitive to Relenza, we’re talking about the in vitro determination.

You can have a drug that is sensitive – a virus that’s sensitive to a drug and it really has a number of other complicating factors about when you get to the patient. How ill is the patient? Is it used as prophylaxis or is it used as therapy? And is it used as early a therapy or not?

So, all we can say right now is that on the basis of those in vitro determinations, it’s sensitive.

RICH (ph): Dr. Pattea (ph), let me add on there. One of the areas that’s being looked at, in Mexico and that is a critically important question, is the effectiveness of treatment and the effectiveness of when treatment was introduced.

And so that really pushes on the importance of the studies that are going on in Mexico. That’s where they’ve seen the most cases. That’s where they’ve had the most experience with treatment. And so, looking to see what can we learn from that about this virus and the impact of treatment will be essential to modifying and refining our guidance here.

TONY (ph): Yes; go.

UNIDENTIFIED PARTICIPANT: (INAUDIBLE).

TONY (ph): So, one more and then we’ll take the gentleman behind you.

UNIDENTIFIED PARTICIPANT: Just a quick follow-up.

TONY (ph): Yes.

UNIDENTIFIED PARTICIPANT: Do you, at this point then, have any estimates of the number of patients, either in Mexico; in this country or elsewhere, in the world, where patients have actually been treated with either of the antivirals?

TONY (ph): I’ll refer that to Dr. Bresser (ph); Rich (ph).

RICH (ph): Yes, thanks Tony . No, we don’t have information to share on that. We have teams in Mexico who are reviewing charts; who are doing interviews, to try and glean as much information from that as they can.

We’re also collecting clinical information here, in the United States. You know this is a dynamic situation that’s rapidly changing. When we talked yesterday, we were talking about 60 some odd cases. Two days before that we were at 20.

And with each of these cases, we’re trying to learn as much as we can. The initial cases in this country, the vast majority had not received treatment because they had illness that was not very severe. And they were identified as parts of groups or clusters or part of the surveillance process itself.

So, we will continue to look at that and try and determine what is the treatment effectiveness of this drug, with this virus.

TONY (ph): OK. Thanks, Rich (ph). We have one last question – one last and then, one up there; yes, please. You got it.

UNIDENTIFIED PARTICIPANT: Thank you. This question is for Dr. Bresser (ph). I know you had spoke to this before but has the government, at all yet, had to use its quarantine powers and if so, where?

RICH (ph): You know the – when we talk about quarantine, we talk about isolating or putting aside individuals who may have been exposed to a disease. What we are recommending here, in this situation, is what we would call, voluntary isolation.

So, you have an individual who’s sick with the flu. We tell them to go home. Stay home for, at least, seven days or one day passed the end of your symptoms.

We are also suggesting that people consider, what we call, voluntary quarantine. In that situation, family members who’ve been exposed, we want them to decrease the amount of contact they have with others in the community not because they’re definitely sick but in an abundance of caution, to try and reduce the likelihood that they would spread infection, if they were sick.

We have not implemented any more aggressive quarantine powers and we wouldn’t envision doing so. It has very little role in the control of an infectious disease like influenza.

TONY (ph): Thank you, Rich (ph); the last question, young lady; yes.

UNIDENTIFIED PARTICIPANT: I think that the normal American when they get flu-like symptoms, they kind of go home but they don’t necessarily go to the doctor. At what point should Americans feel like they need to actually go to the doctor and be identified as someone who may have swine flu or H1N1 and what should they do?

TONY (ph): Yes, right. So, there are guidelines on the CDC Web site for that so, Rich (ph), you want to summarize that?

RICH (ph): Yes, thanks, Tony (ph). I would refer people to the Web site. If you are an individual who has flu-like symptoms, so fever, aches, respiratory symptoms; maybe, some nausea or diarrhea and you have an underlying medical condition, you should, definitely, contact your doctor. And see whether you should be evaluated and treated.

If you have milder symptoms, I would say, before going into your doctor’s office or going to an emergency room, give a call and see. If you’ve had contact with someone who has been diagnosed with this H1N1 virus or if you’ve traveled to Mexico, you should definitely give your doctor a call, let them know and let them know how best they want to manage you and your illness.

This is a relationship between the healthcare provider and the patient. And we’re providing some guidance here but it needs to be individualized based on the age of the patient; the severity of the symptoms and any other underlying health conditions that may be in place.

TONY (ph): Thank you very much, Rich (ph) and on behalf of the team, I want to thank you all for your attention and your thoughtful questions. Thank you very much.

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