Examining the U.S. Public Health Response to the Zika Virus

March 2, 2016

Witness: Thomas Frieden, MD, MPH

Testimony: House Energy and Commerce Committee, Subcommittee on Oversight and Investigations

Introduction

Good morning Chairman Murphy, Ranking Member DeGette, and members of the Subcommittee. Thank you for the opportunity to testify before you today on Centers for Disease Control and Prevention’s (CDC’s) efforts to prepare for and respond to the Zika virus outbreak, which threatens the United States and the rest of the Americas. The Administration has requested approximately $1.9 billion in emergency funding to respond to the Zika virus outbreak, including $828 million for CDC, in support of both the domestic and international response, with particular attention to emergency assistance to the Commonwealth of Puerto Rico and other U.S. Territories and States with local transmission of Zika virus.

CDC is the nation’s health protection agency, working 24-7 to save lives and protect people against unpredictable threats such as the Zika virus. Nature is a formidable adversary, and Zika is our newest threat, particularly to pregnant women. CDC has some of the world’s leading experts both in diseases spread by mosquitos and in birth defects. We must act swiftly to stop the spread of the Zika virus, both domestically and globally. While we are learning more about the Zika virus every day, there are many things we do not know yet about Zika. These include our understanding of the spectrum of effects of Zika infection during pregnancy, the risk the virus may play in microcephaly, Guillain-Barré syndrome and other possible complications, the duration of Zika infectivity in semen, and determining what other factors may play a part in the consequences associated with the virus. In addition to answering these questions, we are also working to accelerate optimal mosquito control strategies, improve testing and assure preparedness for rapid detection, control, and prevention within the United States and U.S. territories.

We are making advancements in these areas and will need the additional requested funding to do so. We are figuring out more about Zika literally every day, and will share information – and adjust our guidelines and recommendations – as we learn more. That is the nature of a scientific response to an emerging health threat. The doctors, scientists, entomologists, and others at CDC are working nonstop to protect Americans from this and other health threats. We have already made significant progress identifying the Zika virus in brain tissue of affected deceased infants, developing new diagnostic tests, issuing guidance, conducting epidemiological investigations along with affected countries, and improving monitoring and surveillance in the United States including in the Commonwealth of Puerto Rico and the other U.S. territories. Much of what we know about Zika and similar viruses today is based on the work that’s been done by CDC scientists. But there are still many things we do not yet know. We will continue to use the best of modern science to protect the American people. I understand that Zika virus and the emergence of serious birth defects cause concern. We are committed to providing the American people with the most accurate and timely information about Zika virus and the current outbreak.

CDC is working in collaboration with other components of the Department of Health and Human Services (HHS), including the Office of the Assistant Secretary for Preparedness and Response (ASPR) and its Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health, and the Food and Drug Administration (FDA). We are also working with partners across the U.S. Government to communicate with travelers and health care providers, update travel alerts and clinical guidance, and develop improved mosquito-control methods.

Zika and its history

Zika is a flavivirus, which is closely related to dengue, yellow fever and West Nile viruses. Zika virus is primarily spread to people through the bite of infected Aedes species mosquitos, particularly Aedes aegypti. The Aedes aegypti mosquitos, which also transmit dengue and chikungunya viruses, are extremely difficult to control. They bite during the day, indoors and outdoors, and they preferentially feed on humans. And they need only the smallest bit of water to breed – just a bottle cap is enough. The mosquitos become infected when they bite a person with Zika virus. These infected mosquitos can then spread the virus to other people through bites. Case reports of other modes of transmission include spread through sexual transmission and blood transfusion. Of great concern, Zika virus infection in a pregnant woman has been linked to issues in fetal development, and the virus has been detected in association with fatal brain malformation in newborns as well as in miscarriages.

While its adverse effects were unforeseen, Zika is not a new virus. It was first recognized in 1947 and has caused occasional illness in Africa and Asia, but the first outbreak we know of occurred in 2007 in the small Pacific island of Yap. Last May, the first local transmission of Zika in the Americas was reported in Brazil, and by the end of 2015, Brazilian authorities estimated that the outbreak there involved perhaps a million suspected cases of Zika virus. In recent months, the virus has spread rapidly throughout Latin America and the Caribbean, as well as to parts of the Pacific. As of February 18, 2016, 32 countries and territories, including the Commonwealth of Puerto Rico, a United States Territory, the U.S. Virgin Islands, and American Samoa have reported local transmission of the Zika virus.

Symptoms and Adverse Outcomes

Many people exposed to Zika virus will have only mild symptoms - such as fever, rash, joint pain, and red eyes or conjunctivitis - that will last no more than a week. In past outbreaks, about four out of five people infected with Zika appear not to have had symptoms at all, although we do not know if that is the pattern in this outbreak.

Increasing evidence suggests that Zika virus infection may be associated with more serious health outcomes. In October 2015, Brazilian authorities recognized a concerning increase in microcephaly, which has occurred in close sequence to Brazil’s outbreak of Zika virus. Microcephaly is a usually rare, serious condition where a baby’s head is smaller than expected based on age and sex. Microcephaly is not a diagnosis in and of itself, but a sign that the brain did not develop as it should in the womb. Babies with microcephaly can have a range of problems, including seizures, developmental delay, feeding problems and hearing loss. In some cases these problems can be fatal.

Laboratory tests at CDC strongly suggest a link between Zika virus infection during pregnancy and microcephaly. We do not fully understand the nature of this relationship, or if there are important cofactors. We also do not know what, if any, other outcomes might be associated with Zika infection during pregnancy among infants who do not have microcephaly. Microcephaly in infants can be devastating to the affected families, and this ongoing outbreak is concerning to everyone, especially for pregnant women, and their families who may travel to or live in the infected areas. The association between Zika virus and microcephaly is unexpected. A new infectious cause of fetal malformations has not been identified in decades. Zika virus spread in the Americas and its effect on pregnancy are developments that we are working with partners to better understand.

Our key priority at this point is to reduce the risk to pregnant women of Zika virus infection. Given the potential risks associated with maternal Zika infection, prevention is key for this response, with a parallel approach of acting based on what we know now and, at the same time, discovering more so that we can better prevent adverse health outcomes in the future. That’s why, during the same week we identified Zika in brain tissue specimens from affected infants, we issued a warning to advise pregnant women not to travel to affected areas. That’s why we are working intensively with the Commonwealth of Puerto Rico and other areas to get support to women who are or who may become pregnant and do what we can to reduce the threat of Zika there. And that’s why we are engaging in studies with international partners so that we can more fully understand the magnitude of risk and the range of outcomes associated with Zika virus infection during pregnancy.

Health authorities in Brazil and elsewhere have also reported an increase in suspected cases of Guillain-Barré syndrome, a rare neurologic disorder in which a person's own immune system damages nerve cells, leading to nerve damage or paralysis that lasts for several weeks or several months. Most people fully recover, but it can take a few months or even years to do so. Some people with Guillain-Barré syndrome have permanent damage and, in rare cases, people have died. It is difficult to determine if any particular pathogen “caused” or “triggered” Guillain-Barré syndrome. Currently, we do not know if Zika virus infection causes Guillain-Barré syndrome. However, the development of Guillain-Barré syndrome is a recognized after-effect of a variety of different infections. CDC is currently collaborating with public health officials in Brazil to investigate whether there is any causal link between Zika infection and Guillain-Barré syndrome.

Domestic Activities

While we are working to better understand these health outcomes, transmission, diagnostics, and mosquito control, CDC is moving quickly to respond. We have moved our Emergency Operations Center to the highest alert level for Zika virus to further enhance our response activities in areas with current local transmission and to accelerate preparedness efforts in anticipation of local transmission in the continental United States.

For the Commonwealth of Puerto Rico as well as the U.S. Virgin Islands and American Samoa, a surge in resources is urgently needed. The population of Aedes aegypti mosquitos is widespread on these islands, protective environmental factors such as window screens are not as prominent, and the density of people puts people there at high risk for transmission. All three areas have already reported local Zika transmission, with Puerto Rico alone reporting at least 30 cases. Furthermore, recent outbreaks of dengue and chikungunya suggest that Zika virus may spread extensively and rapidly in these areas. CDC has deployed staff to the U.S. Virgin Islands, American Samoa, and Puerto Rico to support response activities and provide technical assistance to health departments there. CDC and the CDC Foundation are also partnering to create Zika prevention kits. Containing educational materials, and initial supplies of prevention tools such as insect repellant, the purpose of these kits is to help pregnant women in areas with local Zika transmission protect themselves and their pregnancies. Five thousand of these kits have been dispatched to the Commonwealth of Puerto Rico, the U.S. Virgin Islands, and American Samoa; and CDC plans to distribute more than 45,000 kits to these areas in the future.

While we have not yet seen transmission of the Zika virus by mosquitos within the continental United States, we expect many returning travelers will have Zika infection. As a potential benchmark, we received reports of 3,270 travelers from 49 states with laboratory confirmed cases of chikungunya infection in 2014 and 2015. There are about 40 million people travelling between the continental U.S. and Zika-affected areas each year. Therefore, all U.S. jurisdictions must be prepared to evaluate, test, and manage patients with potential Zika virus infection, particularly pregnant women. Furthermore, Aedes aegypti is found in many areas of the United States, raising the risk of local transmission. The most recent data available suggest that Aedes aegypti are found in 13 states and Aedes albopictus are found in 31 states and the District of Columbia. Recent chikungunya and dengue clusters in the United States suggest that Zika outbreaks in the U.S. mainland may be relatively small and localized due to protective factors like window screens and less dense living conditions; however, any local outbreaks will be of deep concern to the people living there, and we must be prepared for different scenarios including more extensive transmission risk.

CDC is working with health departments across the country to ensure coordination and to expand capacity for detecting and responding to Zika virus. Surveillance is essential to monitor and quickly identify areas with local transmission. We conduct multi-faceted surveillance for arboviruses, including Zika, through ArboNET, an integrated network which funds, through our Epidemiology and Laboratory Capacity cooperative agreements, staff in 49 states, the Commonwealth of Puerto Rico, and six large municipalities to conduct human case investigations, collect and test mosquitos, and perform laboratory analysis on arboviruses including Zika. Zika virus is now a nationally notifiable disease, meaning states report the virus to CDC, which will aid Zika surveillance efforts. CDC is also working with several states and the Commonwealth of Puerto Rico to determine a baseline prevalence of microcephaly so that any increase, should it occur, can be quickly and accurately identified.

With support from the President’s emergency request, CDC will build on its current efforts to provide financial and technical resources to states and territories through its cooperative agreements to strengthen their capacity to prepare for and respond to emerging insect-borne threats such as Zika virus. These resources may be used to help health departments expand their capability to manage cases of local Zika virus transmission in their areas and to implement community education and prevention programs to reduce human-mosquito contact and subsequently, the risk of Zika transmission. Resources will also be used to implement mosquito control strategies, including mosquito surveillance. Current mosquito surveillance capacity is uneven across the country, which makes our knowledge about the locations of the two mosquito vectors that transmit Zika virus potentially incomplete. To effectively track the spread of the outbreak, it is critical that states and territories receive specimens and test for Zika virus to diagnose and report travel-related and locally acquired cases of Zika. Under the emergency request CDC will expand its efforts to assist public-health labs nationwide to test for Zika and to provide the guidance on how to interpret test results. In addition, CDC is available to provide testing of any Zika samples upon request. We are working to expand the number of health departments that have the ability to perform testing, but will need to increase the existing capacity to meet the projected demand for Zika testing. Given that, last year, it is estimated that approximately 500,000 travelers to areas of current Zika transmission were pregnant women and 36,000 pregnant women are currently living in the Commonwealth of Puerto Rico, the expansion of testing capacity in public health labs nationwide, included in the request, is urgently needed in order to ensure that every pregnant woman needing testing for Zika virus has access.

Recognizing the potential for Zika virus transmission through blood transfusions, CDC is collaborating with FDA to ensure the safety of the blood supply from Zika virus, particularly in regions experiencing local outbreaks. CDC has sent experts to the Commonwealth of Puerto Rico to assess the steps needed to assure both that Puerto Rico’s blood supply needs are met and that transfusion-transmitted Zika is prevented.

CDC experts are working intensively to learn more about the outbreak and provide people with the information they need to protect themselves. We will continue to issue travel alerts for the affected areas as confirmation of the virus is reported, and we'll keep the American people informed as the situation changes. We recognize people are eager for information, and our website has exceeded half a million views in recent days.

CDC has also provided guidance for doctors and other clinicians on evaluation, treatment and follow-up care of pregnant women and infants with possible exposure to Zika virus, partnering with organizations from around the health care community to help distribute this information as widely as possible. Our guidance will continue to be updated as our knowledge increases. We have recently updated our guidance to provide recommendations for the clinical care and management of pregnant women living in areas where Zika transmission is widespread, with special consideration to the ongoing risk of maternal Zika virus infection throughout pregnancy. These guidance documents were prepared in consultation with the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the America Academy of Pediatrics.

CDC also wants to ensure that the general public knows what it can do to protect itself. Pregnant women should postpone travel to regions with ongoing Zika virus transmission. If they must travel, or if they live in affected areas, CDC recommends pregnant women talk to their doctors or other healthcare providers first and strictly follow steps to prevent mosquito bites. Reducing exposure to mosquitos is important for anyone traveling to or residing in areas where the virus is circulating. Wearing long sleeves, long pants, using EPA-registered repellents such as DEET and permethrin-treated clothing (both of which are safe to use in pregnancy), and using other protections such as air-conditioning will reduce exposure to mosquito bites. Given the potential for Zika virus to be spread through sex, pregnant women and their male partners living in or who have been to Zika-affected areas should abstain from sex or use condoms for the duration of pregnancy. This is a rapidly changing situation and our understanding of the risks concerning Zika virus infection is incomplete and evolving. As we get new information, we will update our advice.

Global Activities

On February 1, the World Health Organization (WHO) declared the recent cluster of microcephaly cases and other neurological disorders (such as Guillain-Barré syndrome) and their possible association with Zika virus, a public health emergency of international concern, a reflection of the seriousness of this unfolding health threat. CDC is coordinating its response with the U.S. Agency for International Development, as well as the Pan American Health Organization (PAHO), the regional arm of the World Health Organization (WHO), and other parts of WHO, and is collaborating with many international partners to learn more about this outbreak. We are working with the Brazilian Ministry of Health on investigation and research partnerships. Specifically, one partnership involves studying the link between Zika virus infection and microcephaly, while another is examining the relationship between Zika virus and Guillain-Barré syndrome. Research teams from CDC are also in other countries, including Colombia, to explore collaborations that will shed light on the risk of microcephaly in relation to Zika virus infection during pregnancy.

In addition, CDC is offering support to all countries so that they can test samples from microcephaly cases for serologic evidence of Zika virus infection, and CDC is helping countries throughout the Americas establish in-country diagnostic capacity. To that end, we are currently, and in conjunction with PAHO, providing training to laboratorians in South and Central America on diagnostic tests, including two recent workshops in Brazil and Nicaragua.

CDC’s Central American office has also facilitated the verification of Zika cases in several countries throughout Latin America, including Colombia, Venezuela, and Nicaragua. At the request of the Department of State’s Bureau of Medical Services, staff from CDC’s Global Disease Detection Center in Guatemala has been involved in communication efforts to ensure that new information regarding Zika virus and its possible link to birth defects is communicated to U.S. Mission Health Unit staff throughout the Americas.

The Global Health Security Agenda, with critical support from Congress, is collaborating with countries around the world so that we can find, stop, and prevent health threats when and where they first emerge. Zika has been present in Africa for decades, and it’s possible that it could become linked to microcephaly there as well. The sooner we detect a problem, wherever it occurs, the more rapidly we can respond to it and prevent it from spreading. It is in all of our best interests to work with others to improve public health capacity around the world.

Improving the tools and information for responding to Zika

We need a better understanding of the epidemiology of Zika and potential Zika-associated birth defects and other adverse health outcomes. We need better diagnostic methods that can quickly and clearly differentiate between similar viruses to detect evidence of past Zika infection. Testing for current Zika infection is only reliable in the first week of illness. A Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test can provide a definitive diagnosis of Zika, but only if it is performed within about seven days of symptom onset. The tests we have available for Zika in persons who are no longer ill may have cross-reactivity with similar flaviviruses, particularly dengue, which can lead to false-positive or inconclusive results and confirmatory testing is required. Diagnosis is particularly challenging with Zika virus since most people will not experience symptoms. We also need to determine how long a man who has been infected with Zika may continue to be able to sexually transmit the virus to a partner, and we need better tools to screen the blood supply.

We also need to advance our ability to control the mosquito population. Existing methods for mosquito control all have shortcomings, especially in areas where the population of Aedes mosquitos is rampant. Furthermore, in some areas like the Commonwealth of Puerto Rico, mosquitos may have developed resistance to certain insecticides, which could reduce the range of substances that can be used to effectively decrease mosquito populations. We need to implement the best tools we have today, improve current vector control strategies, and identify better options. We also need better mosquito surveillance to determine the location of mosquitos and areas with mosquito resistance to insecticides, which would inform the implementation of new mosquito control techniques.

Finally, a vaccine is needed to protect people at risk of Zika virus infections, particularly preventing infection among women of childbearing age. At CDC, our scientists developed both a West Nile virus vaccine, which is currently in use for animal protection in the United States, and a dengue vaccine, which is currently in clinical trials. The President’s request will increase Zika research, improve diagnostics and support advancements in vector control methods. Although availability of a licensed Zika vaccine is several years away, we do not know how long Zika will be a problem in the Americas nor whether the mosquito control efforts that must be implemented will yield durable results.

Conclusion

Microbes continue to be formidable adversaries. To protect Americans, the Zika emergency request invests in the laboratories, disease detectives, disease tracking systems, mosquito control, and investigations needed to continue to improve these essential tools.

The emergence and reemergence of health threats, including those spread by mosquitos and other vectors is not a unique event but something we expect to continue to see in the future. These outbreaks cannot be expected to occur in isolation of one another. The Commonwealth of Puerto Rico and Hawaii were already responding to outbreaks of dengue when Zika virus arose as an urgent health threat. We need to address the threat of mosquito-borne diseases systematically, rather than episodically. Thank you again for the opportunity to appear before you today. I appreciate your attention to this concerning outbreak and I look forward to answering your questions.