Emergency Preparedness and Response

Zika Virus Response Updates from FDA

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Fast Facts

About Zika

Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. Most people never know that they have been infected with the virus. It is estimated that four out of five people with Zika virus infections have no symptoms at all. When symptoms do occur, the most common symptoms are fever, rash, joint pain, and conjunctivitis (red eyes). Even in those who develop symptoms, the illness is usually mild, with symptoms lasting from several days to a week.

A pregnant woman applies mosquito repellant.

A pregnant woman applies mosquito repellant. Using insect repellants will help to protect her from being bitten by a mosquito that may be carrying a virus such as Zika; this will also protect her unborn baby from the virus. (Image: CDC/Division of Vector-borne Diseases)

Locations Affected

Prior to 2015, Zika virus outbreaks had occurred in areas of Africa, Southeast Asia, and the Pacific Islands. However, in May 2015, the Pan American Health Organization (PAHO) issued an alert disclaimer icon (PDF, 199 KB) regarding the first confirmed Zika virus infection in Brazil. Currently, outbreaks are occurring in many countries.

As of June 14, 2016, no locally transmitted Zika virus disease cases have been reported in the continental United States, but imported cases have been reported in returning travelers. These imported cases could potentially result in local spread of the virus in some areas of the United States. Locally transmitted Zika virus has been reported in the Commonwealth of Puerto Rico, the U.S. Virgin Islands and, most recently, American Samoa.

Guillain-Barré Syndrome

Since the outbreak in Brazil began, we have seen reports of Guillain-Barré syndrome (a disorder in which the immune system attacks the nervous system) and birth defects.  More: Zika Virus Disease Q&A, from CDC

Pregnant Women and Birth Defects

Zika virus can be transmitted from a pregnant mother to her fetus. Scientists at the Centers for Disease Control and Prevention (CDC) have concluded, after careful review of existing evidence, that Zika virus is a cause of microcephaly, a condition in which a baby’s brain and head is smaller than expected, and other severe fetal brain defects. In the April 13, 2016 report disclaimer icon published in the New England Journal of Medicine, the CDC authors describe a rigorous weighing of evidence using established scientific criteria.

The finding that Zika virus infection can cause microcephaly and other severe fetal brain defects means that a woman who is infected with Zika during pregnancy has an increased risk of having a baby with these health problems. It does not mean, however, that all women who have Zika virus infection during pregnancy will have babies with problems. As has been seen during the current Zika outbreak, some infected women have delivered babies that appear to be healthy. More: Zika and pregnancy, from CDC

Medical Products

There are no FDA-approved vaccines for Zika virus, nor is the FDA aware of vaccines or treatments in advanced development for Zika at this time. FDA stands ready to work with medical product developers to clarify regulatory and data requirements necessary to move products forward in development as quickly as possible.

There are no commercially available diagnostic tests cleared by FDA for the detection of Zika virus. FDA encourages commercial diagnostic developers and researchers developing laboratory developed tests for Zika virus to submit an EUA request. FDA will work interactively with developers to support such requests. See Zika Virus Diagnostic Development for information on FDA support for Zika virus diagnostic development and Emergency Use Authorization for information about Zika virus diagnostics available under EUA.

See also: Zika Symptoms, Diagnosis, & Treatment, from CDC

Prevention

The best way to prevent Zika and other diseases spread by mosquitoes is to avoid being bitten. More: Prevention, from CDC


Zika Information from FDA

Updates by Date
Safety of the Blood Supply
  • FDA is working with public health authorities in territories with confirmed Zika virus to take rapid and appropriate steps to help ensure safe blood is available. On February 16, 2016, FDA issued new guidance (PDF, 111 KB) for immediate implementation recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus, potentially have been exposed to the virus, or those with a confirmed infection. FDA is also working to assist blood collection establishments in implementing appropriate donor deferral measures for travelers who have visited affected regions in order to protect the blood supply in the United States.  More: About Regulation of the Blood Supply  

    See also:  Questions and Answers Regarding - Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry (PDF, 310 KB), posted March 11, 2016 
  • As an additional safety measure against the emerging Zika virus outbreak, on March 1, 2016, FDA issued new guidance (PDF, 78 KB) for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues. The new guidance is a part of the FDA’s ongoing efforts to protect HCT/Ps and blood products from Zika virus transmission. Read the news release 
  • HHS is arranging and funding shipments of blood products from the continental United States to Puerto Rico to ensure an adequate supply of safe blood for island residents as the Commonwealth of Puerto Rico experiences active mosquito-borne Zika transmission.  The first batch of blood products arrived in Puerto Rico on March 5, 2016.
  • On March 30, 2016, FDA announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. Once screening of blood donations for Zika virus using the investigational test begins, blood establishments in Puerto Rico may resume collecting donations of Whole Blood and blood components. Read the news release
  • There is a potential risk that the Zika virus can be transmitted by HCT/Ps used as part of a medical, surgical, or reproductive procedure. HCT/Ps include products such as corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells (HPCs), gestational tissues such as amniotic membrane, and reproductive tissues such as semen and oocytes. According to the Centers for Disease Control and Prevention, Zika virus can be spread by a man to his sexual partners. And to date, there have been several cases of sexual transmission in the U.S. Current information about Zika virus detection in semen suggests that a period of ineligibility longer than the waiting period that has been recommended for donors of Whole Blood and blood components is necessary for HCT/P donors.
  • Recommendations for living donors of HCT/Ps: Donors should be considered ineligible if they were diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of those risk factors, within the past six months. Donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if they have had any of the above risk factors at any point during their pregnancy.
  • Recommendations for deceased (non-heart-beating) donors: Donors should be considered ineligible if they were diagnosed with Zika virus infection in the past six months.
  • In addition to the guidance documents addressing the nation’s blood supply and HCT/Ps, FDA continues to prioritize the development of blood donor screening and diagnostic tests that may be useful for identifying the presence of or recent infection with the virus, prepare to evaluate the safety and efficacy of investigational vaccines and therapeutics that might be developed, and review technology that may help suppress populations of the mosquitoes that can spread the virus.
  • Advice to blood collection establishments on non-travel related cases of Zika virus in Florida (July 27, 2016): The Office of the ‎Florida Department of Health State Surgeon General has announced that it is conducting an epidemiological investigation into a number of non-travel related cases of Zika virus in Miami-Dade and Broward Counties. These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States. Miami-Dade County and Broward County are adjacent counties in South Florida.

    In consideration of the possibility of an emerging local outbreak of Zika virus, and as a prudent measure to help assure the safety of blood and blood products, FDA is requesting that all blood establishments in Miami-Dade County and Broward County cease collecting blood immediately until the blood establishments implement testing of each individual unit of blood collected in the two counties with an available investigational donor screening test for Zika virus RNA or until the blood establishments implement the use of an approved or investigational pathogen inactivation technology. Additionally, FDA recommends that adjacent and nearby counties implement the precautions above to help maintain the safety of the blood supply as soon as possible.

    For blood collection establishments outside of this region, FDA suggests that donors who have traveled to Miami-Dade and Broward Counties during the previous 4 weeks be deferred. 

    FDA will continue to monitor this potential outbreak in cooperation with the Centers for Disease Control and Prevention (CDC) and Florida State public health authorities and provide updates as additional information becomes available. 
Emergency Use Authorization (EUA)
  • While many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to the public health. Access to a diagnostic test that can identify patients with Zika virus infections is critical to supporting response efforts and expanding domestic readiness. Potential links between Zika virus infection and neurological complications (i.e., Guillain-Barré Syndrome), as well as microcephaly and other poor pregnancy outcomes associated with Zika virus infection during pregnancy,  have also increased the importance of having a diagnostic test available for Zika virus. As there are no commercially available diagnostic tests cleared or approved by the FDA for the detection of Zika virus infection, it was determined that an EUA is crucial to ensure timely access to a diagnostic tool.
  • An EUA is a tool that FDA can use to allow the use of certain medical products for emergencies based on scientific data.  The U.S. Secretary of Health and Human Services (HHS) has declared that circumstances exist to allow the emergency use of authorized diagnostic tests for Zika virus infection, such as the Zika MAC-ELISA.
  • Draft EUA review templates for Zika are available to product sponsors/manufacturers by email request to: CDRH-ZIKA-Templates@fda.hhs.gov

Zika MAC-ELISA (CDC)

  • The Zika MAC-ELISA is a laboratory test to detect proteins the human body makes to fight a Zika virus infection.  These proteins, called antibodies, appear in the blood starting 4-5 days after the start of illness and last for up to 12 weeks.  In some people, they are present for longer than 12 weeks. 
  • The CDC Zika MAC-ELISA test has been authorized under the EUA for use by qualified laboratories in the U.S. designated by the CDC that are certified to perform high-complexity tests. More about the Zika MAC-ELISA, including fact sheets and instructions for use
  • Because of the possibility of false positive results in patients who were previously infected with viruses similar to the Zika virus (i.e., flaviviruses, such as dengue), under the terms of the EUA, positive and inconclusive results must be further tested by the CDC or by authorized laboratories in consultation with the CDC to confirm the presence of antibodies to Zika virus. Statement from CDC on the Zika MAC-ELISA
  • In response to CDC's request to amend the CDC Zika MAC-ELISA EUA, on June 29, 2016, FDA reissued the February 26, 2016, EUA in its entirety with the CDC-requested amendments incorporated.

Trioplex rRT-PCR (CDC)

  • The CDC Trioplex rRT-PCR test has been authorized under the EUA for use by qualified laboratories in the U.S. designated by the CDC that are certified to perform high-complexity tests. More about the Trioplex rRT-PCR, including fact sheets and instructions for use
  • The assay (test)  is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health investigation). Statement from CDC on the Trioplex rRT-PCR

Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics, Inc.)

  • The Zika Virus RNA Qualitative Real-Time RT-PCR test was authorized under EUA on April 28, 2016 for the qualitative detection of RNA from Zika virus in human serum specimens. This is the first commercial test to detect Zika virus that has been authorized by FDA for emergency use. More about the Zika Virus RNA Qualitative Real-Time RT-PCR, including fact sheets and instructions for use
  • This test is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated).
  • This test is for use by qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high-complexity tests.

RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)

  • On May 13, 2016 FDA issued an EUA to authorize the emergency use of the altona Diagnostics RealStar Zika Virus RT-PCR Kit U.S. for the qualitative detection of RNA from Zika virus in serum or urine (collected alongside a patient-matched serum specimen). More about the RealStar Zika Virus RT-PCR Kit U.S., including fact sheets and instructions for use 
  • This test is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated).
  • This test is intended for use by laboratories certified under CLIA to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

Aptima Zika Virus assay (Hologic, Inc.)

  • On June 17, 2016, FDA issued an EUA to authorize emergency use of the Aptima Zika Virus assay for the qualitative detection of RNA from Zika virus in human serum and plasma specimens. More about the Aptima Zika Virus assay, including fact sheets and instructions for use
  • This test is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated).
  • This test is intended for use by laboratories certified under CLIA to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR Test (Viracor-IBT)

  • On July 19, 2016 FDA issued an EUA to authorize the emergency use of the Viracor-IBT test for the qualitative detection of RNA from Zika virus in human serum, plasma or urine. More about the Viracor-IBT test, including fact sheets and instructions for use
  • This test is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated).
  • Testing is limited to Viracor-IBT's laboratory in Lee's Summit, MO, or other laboratories designated by Viracor-IBT that are also certified under CLIA to perform high complexity tests.
Investigational Products

Genetically Engineered Mosquitoes | Medical Products

Genetically Engineered Mosquitoes

The Zika virus outbreak highlights the importance that novel vector control measures may play in protecting the public health. Reviewing the use of innovative strategies to help suppress the population of virus-carrying mosquitoes is one of many activities in which FDA is engaged to help mitigate the threat of vector-borne epidemics, such as Zika. 

  • FDA’s Center for Veterinary Medicine is currently reviewing information in an Investigational New Animal Drug (INAD) file from Oxitec, Ltd., regarding the company’s genetically engineered line of the mosquito Aedes aegypti (OX513A), with the intent of suppressing the population of that mosquito at the release site(s). Ae. aegypti is known to transmit the debilitating human virus-caused diseases Zika, dengue, yellow fever, and chikungunya.  More: Oxitec Mosquito
  • On March 11, 2016, in compliance with FDA regulations, FDA released for public comment a draft environmental assessment (EA) (PDF, 33 MB) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya. The FDA also released a preliminary finding of no significant impact (FONSI) (PDF, 148 KB) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment.
  • The goal of the proposed field trial is to determine whether released Oxitec GE mosquitoes will mate with local wild-type Aedes aegypti and suppress their population at the release site. The proposed study is not seeking to evaluate whether release of Oxitec’s GE mosquitoes will reduce Zika virus transmission. Oxitec’s mosquitoes are one possible approach that could be incorporated into an integrated program to help mitigate the threat of vector-borne epidemics; however, it is too early to say with any certainty whether such an approach would be successful.  
  • The public comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes closed on May 13, 2016. Because this is a first of its kind application, FDA understands how important the public comment period process is. FDA is reviewing the thousands of comments received and intends to issue a final EA and FONSI, or prepare an environmental impact statement (EIS) as expeditiously as possible. While we cannot speculate on a timeframe for completing the environmental review for the proposed field trial, this is a top priority for FDA. Statement.
Medical Products (Vaccines, Therapeutics, Diagnostics)
  • There are no vaccines or treatments in advanced development for Zika at this time.
  • Vaccines and therapeutics: FDA is prepared to evaluate the safety and efficacy of any investigational vaccines and therapeutics that might be developed to help mitigate this outbreak.
  • Diagnostics: There are no commercially available diagnostic tests cleared by FDA for the detection of Zika virus. FDA encourages commercial diagnostic developers and researchers developing laboratory developed tests for Zika virus to submit an EUA request. FDA will work interactively with developers to support such requests. See Zika Virus Diagnostic Development for information on FDA support for Zika virus diagnostic development and Emergency Use Authorization for information about Zika virus diagnostics available under EUA.

    To help Zika diagnostic manufacturers assess traceability of their tests (a requirement for Emergency Use Authorization), FDA has created the FDA Zika Virus Reference Materials for NAT-based IVD devices, available upon request to Zika device developers who have a pre-EUA submission with the agency and have established the analytical and clinical performance of their assay. View an infographic about the FDA Zika Virus Reference Materials (PDF, 120 KB)
Fraudulent Products
  • Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear. FDA monitors for fraudulent products and false product claims related to the Zika virus and takes appropriate action to protect consumers. Consumers who have seen these fraudulent products or false claims are encouraged to report them to the FDA.
Using Insect Repellents Safely
  • All insect repellents, including products combined with sunscreen, should be used according to instructions on the label.
  • Use insect repellents that contain active ingredients registered by the Environmental Protection Agency (EPA) for use on skin and clothing. EPA registration of insect repellent active ingredients indicates the materials have been reviewed and approved for human safety and effectiveness when applied according to instructions on the label.
  • Insect repellents containing DEET should not be used on children under 2 months of age. Oil of lemon eucalyptus products should not be used on children under 3 years of age. More: Insect repellent use and safety in children
Events
More About FDA's Role
  • FDA is committed to working with the global community as it responds to the Zika virus outbreak. The FDA has a critical role in facilitating the development, and availability of investigational products for use against emerging infectious diseases, such as the Zika virus.
  • FDA is actively working with our Federal colleagues at the CDC, National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and is prepared to evaluate the safety and efficacy of any investigational vaccines and therapeutics that might be developed to help mitigate this outbreak. The agency is also encouraging development of diagnostic tests that may be useful for identifying the presence of the virus, and is taking steps to help ensure the safety of our nation’s blood supply.
  • While FDA cannot comment on the development of specific medical products, it’s important to note that every FDA regulatory decision is based on a risk-benefit assessment of scientific data that includes the context of use for the product and the patient population being studied. Approaches that will be able to show whether a product has a favorable risk-benefit profile for its proposed use may require careful planning. This may prove challenging for Zika virus since its symptoms are often mild or nonspecific.
  • Emergency use: FDA stands ready to use our authorities to the fullest extent to help facilitate the development and availability of products for Zika virus, as we did during the 2014 Ebola epidemic. Under the FDA’s Emergency Use Authorization (EUA) mechanism, the agency can enable the use of an unapproved medical product, or the unapproved use of an approved medical product, during emergencies, when, among other circumstances, there are no adequate approved, and available alternatives. An EUA is an important mechanism that allows broader access to available medical products under specific circumstances.
  • Blood supply: FDA is responsible for regulatory oversight of the U.S. blood supply. FDA works closely with other parts of the Public Health Service (PHS) to establish blood standards, and to identify and respond to potential threats to blood safety or supply. More: Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood

Contact FDA

General Info/Consumers
1-888-INFO-FDA / (1-888-463-6332)

Report a Fraudulent Zika Product
Report form and instructions

Press
Office of Media Affairs
fdaoma@fda.hhs.gov
301-796-4540

Clinicians
Emergency Investigational New Drug (EIND) Applications for Antiviral Products
301-796-1500

Diagnostic Product Sponsors/Manufacturers - EUA Templates
Draft EUA review templates for Zika are available by email request to:
CDRH-ZIKA-Templates@fda.hhs.gov

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Page Last Updated: 07/28/2016
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