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Zika Virus Response Updates from FDA

Zika Virus Response Updates from FDA

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Aedes aegypti mosquito while she was in the process of acquiring a blood meal from her human host (Credit: CDC/James Gathany)

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.

Zika sidebar image
 

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 (PDF, 199 KB) regarding the first confirmed Zika virus infection in Brazil. Currently, outbreaks are occurring in many countries.

Imported Zika virus disease cases have been reported in returning travelers. These imported cases could potentially result in local spread of the virus in some areas of the continental United States.

On July 29, 2016, CDC announced that likely local mosquito-borne Zika virus transmission has been reported in the continental United States. Locally transmitted Zika virus has also been reported in the Commonwealth of Puerto Rico, the U.S. Virgin Islands, and 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 and Guillain-Barré Syndrome, from CDC

Pregnancy

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 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, and CDC updates guidance for infants born to mothers with possible Zika virus infection during pregnancy (October 19, 2017)

Preventing pregnancy: If you decide that now is not the right time to have a baby, talk to your healthcare provider. View an easy-to-read chart with information on the safety and effectiveness of FDA-approved medicines and devices for birth control: Birth Control Guide (PDF, 2.6 MB) – en Español Guía de Métodos Anticonceptivos (PDF, 433 KB)

Medical Products

There are no FDA-approved vaccines for Zika virus. Several investigational vaccines are under development, including early human clinical trials.

There are no FDA-approved treatments for Zika virus, nor is the FDA aware of treatments in advanced development for Zika at this time. Also see Zika Virus Treatment Research, from NIAID, and BARDA’s Medical Countermeasure Response to Zika

Diagnostics: FDA-authorized diagnostic tests for detecting Zika virus antibodies:

  • ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S. FDA reviewed the data for the test through the De Novo premarket review pathway. Previously, tests for detecting Zika virus immunoglobulin (IgM) antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s Emergency Use Authorization (EUA) authority. For more information, see Serological assays below
  • ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies.  Previously, the test had been authorized only for emergency use under FDA’s EUA authority.

FDA encourages commercial diagnostic developers and researchers developing laboratory developed tests for Zika virus to submit an EUA request or consider pursuing a premarket submission. 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, including nucleic acid-based tests to diagnose active Zika infection.

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.

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

For updates by date before 2019, please visit our archive.

  • On February 28, 2019, FDA published a web page: Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World - CDC has changed information on its Blood and Tissue Safety webpage used to communicate epidemiological information about ZIKV to the blood and tissue collection community. The webpage includes a world map of areas with risk of Zika for other countries and territories outside of U.S. states. A new process has been developed to indicate risk for these areas that assigns one of four categories. FDA considers countries and territories outside the U.S. states categorized as “Red” (current outbreak) or “Purple” (any prior or current reports of mosquito-borne Zika transmission) as areas with increased risk of ZIKV transmission.
  • Revised guidance - On July 6, 2018, FDA announced the availability of a revised final guidance: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components (PDF, 222 KB). This revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing for Zika virus of individual units of blood donated in the U.S. states and territories. The revised guidance explains that, in order to comply with applicable testing regulations, blood establishments must continue to test all donated Whole Blood and blood components for Zika virus using a nucleic acid test. The revised guidance explains the basis for the FDA’s determination that pooled testing of donations using a screening test licensed for such use by the FDA is a sufficient method for complying with these regulations and effectively reducing the risk of Zika Virus transmission, unless there is an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area that would trigger individual donation testing in that location. Alternatively, blood establishments may use an FDA-approved pathogen-reduction device for plasma and certain platelet products. (Federal Register notice) Also see: FDA announces revised guidance on the testing of donated blood and blood components for Zika virus

  • Revised guidance - On May 2, 2018, FDA issued revised guidance for establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps): Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry (PDF, 86 KB). This guidance updates information in the March 2016 guidance by: This update supports the continuation of recommendations to screen living donors of HCT/Ps for risks of infection with ZIKV based on geographic areas with risk.

    This update supports the continuation of recommendations to screen living donors of HCT/Ps for risks of infection with ZIKV based on geographic areas with risk.

    Previously, on March 1, 2016, as an additional safety measure against the emerging Zika virus outbreak, FDA issued this guidance as a part of ongoing efforts to protect HCT/Ps and blood products from Zika virus transmission. Read the news release 

    1. providing findings from more recent epidemiological studies including impact on public health;

    2. reporting new data that informs the potential for transmission of ZIKV;

    3. discussing the current status of availability of ZIKV tests;   

    4. updating sexual contact risk factors;

    5. updating when an area is considered to have an increased risk for ZIKV transmission; and,

    6. providing additional scientific references.

  • On July 5, 2018, FDA approved the Procleix Zika Virus Assay, manufactured by Grifols Diagnostics Solutions, Inc. The Procleix Zika Virus Assay is a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components for transfusion. It is also intended for use in testing plasma or serum specimens to screen other living donors of organs and human cells, tissues, and cellular and tissue-based products (HCT/Ps), and in testing blood specimens to screen cadaveric donors. The assay is intended for use in testing individual donor samples. It is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 16 individual specimens from volunteer donors of whole blood components.  It is not intended for use as an aid in the diagnosis of Zika virus infection. For more information see the approval letter (PDF, 41.2 KB) and Safety of the Blood Supply below

  • On October 5, 2017, FDA approved the first test for screening Zika virus in blood donations. FDA approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. It is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.

    Before October 5, 2017, several blood collection establishments used the cobas Zika test under IND in order to follow the recommendations in the FDA’s 2016 guidance document. The data collected from this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to screen blood donors for Zika virus infection. The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in clinical specificity of more than 99 percent.

    The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems, Inc.

    Previously, 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.

  • FDA continues to work with public health authorities in territories with confirmed Zika virus to take rapid and appropriate steps to help ensure safe blood is available. Prior to the revised guidance issued on August 26, 2016, FDA took steps to protect the blood supply in areas with confirmed Zika virus transmission.

  • On March 5, 2016, the first batch of blood products arrived in Puerto Rico in response to HHS efforts to arrange and fund shipment of blood from the continental United States to Puerto Rico to ensure an adequate supply of safe blood for island residents. The Commonwealth of Puerto Rico was the first U.S. territory to experience active mosquito-borne Zika transmission.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.

  • On March 13, 2017, the CDC announced that based on a retrospective analysis of Zika virus (ZIKV) infections they identified a potential increased risk to blood and tissue safety, including semen, in Florida’s Miami-Dade, Palm Beach, and Broward counties dating back to June 15, 2016. While Miami-Dade County is the only part of Florida currently (July 29, 2016 to present) designated by CDC as an area of active ZIKV transmission for the purposes of blood and tissue safety intervention, people in this part of Florida regularly travel within and between these three counties and may not recognize that they have been in an area of active ZIKV transmission. This information has been added to CDC’s webpage used to communicate epidemiological information about ZIKV to the blood and tissue collection community.

    The potential increased risk to blood and tissue safety, and particularly to semen, in this area due to CDC’s announcement is considered to be very low. However, as a precaution, the Food and Drug Administration is informing establishments that collect tissues (i.e., human cell, tissues, and cellular and tissue-based products – HCT/Ps) and blood components of the potential increased risk, so they may consider whether and how this new information impacts their practices. 

    Also see the FDA’s communication to tissue establishments: Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Zika Virus and the FDA’s communication to blood establishments: Important Information for Blood Establishments Regarding Zika Virus 

  • 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
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.

Note about the LightMix Zika rRT-PCR Test (Roche Molecular Systems Inc.): In response to Roche Molecular Systems Inc.’s request dated March 10, 2017 to withdraw the LightMix Zika rRT-PCR Test due to technical performance and business considerations, on March 13, 2017 FDA revoked the EUA for emergency use of the LightMix Zika rRT-PCR Test.  As of March 13, 2017, the LightMix Zika rRT-PCR Test that was authorized by FDA for use by clinical laboratories for the qualitative detection of RNA from Zika virus is no longer authorized by FDA. (Federal Register notice

Zika diagnostic tests currently authorized under EUA

Performance characteristics of Zika virus diagnostic tests

FDA has posted new tables detailing performance characteristics of Zika virus diagnostic tests (assays) currently available for use under EUA. The tables include information about analytical sensitivity, along with other performance characteristics determined during EUA evaluation. (May 3, 2018) 

Tests currently authorized under EUA are listed below. For additional information about current Zika diagnostic EUAs, including fact sheets and instructions for use, please see the CDRH page Emergency Use Authorizations.

Nucleic acid testing-based assays (molecular tests) - detect genetic material in samples of bodily fluids, such as serum and urine, to diagnose active Zika infection

  • Aptima Zika Virus assay (Hologic, Inc.)
  • CII-ArboViroPlex rRT-PCR (Columbia University)
  • Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.)
  • RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)
  • RealTime ZIKA (Abbott Molecular, Inc.)
  • Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)
  • TaqPath Zika Virus Kit (Thermo Fisher Scientific)
  • Trioplex rRT-PCR (CDC)
  • VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.)
  • Zika Virus Detection by RT-PCR (ARUP Laboratories)
  • Zika Virus Real-time RT-PCR Test (Viracor Eurofins)
  • Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.)
  • Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)

Serological assays - detect antibodies against Zika virus in the blood, to assess whether individuals who may have recently been exposed to Zika have actually been infected

FDA-authorized diagnostic tests for detecting Zika virus antibodies

  • ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing (PDF, 175 KB) of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S. Previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s EUA authority.

    FDA can only issue an EUA when specific criteria are met, including that there are no adequate, approved and available alternatives. With the marketing authorization granted for the ZIKV Detect 2.0 IgM Capture ELISA, FDA has also revoked the EUA for this device, which was initially authorized for emergency use in 2016. In addition, FDA is considering whether the ZIKV Detect 2.0 IgM Capture ELISA test is an adequate, approved and available alternative to other currently available Zika virus antibody diagnostic tests available under EUA. Currently, there are numerous other active EUAs for tests to diagnose Zika virus infection, several of which (listed below) detect Zika virus antibodies like the ZIKV Detect 2.0 IgM Capture ELISA. FDA is communicating with the four EUA holders to gather information to evaluate whether FDA should revoke the EUAs for these specific tests on the ground that the statutory criteria for the authorization are no longer met. The ZIKV Detect 2.0 IgM Capture ELISA marketing authorization does not impact the availability of the other Zika diagnostics (nucleic acid testing-based assays listed above) available under EUA.

  • ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies.  Previously, the test had been authorized only for emergency use under FDA’s EUA authority.

Serological assays currently authorized for emergency use under EUA:

  • DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.)
  • LIAISON XL Zika Capture IgM Assay (DiaSorin Incorporated)
  • Zika MAC-ELISA (CDC)

Also see the August 17, 2017 press release: FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection - As an additional measure in the fight against Zika virus, FDA made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests, to help ensure that tests to detect recent Zika infection are accurate and reliable, and to help test manufacturers know if their tests differentiate between infections with Zika virus or other flaviviruses such as Dengue, and West Nile viruses, which all have similar antibodies. More: Zika Virus Reference Materials

FDA Safety Communication: FDA warns health care providers against relying solely on Zika virus serological IgM assay results [ARCHIVED]; reminds them to wait for confirmatory test results before making patient management decisions.

Investigational Products

Genetically Engineered Mosquitoes | Medical Products

Genetically Engineered Mosquitoes

Final guidance - October 4, 2017: FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products - The final Guidance for Industry #236 – Clarification of FDA and EPA Jurisdiction over Mosquito-Related Products (PDF, 85 KB) – clarifies that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes, and that are not intended to cure, mitigate, treat, or prevent a disease are not “drugs” under the Federal Food, Drug, & Cosmetic Act, and will be regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act. The FDA will continue to have jurisdiction over mosquito-related products that are intended to prevent, treat, mitigate, or cure a disease (including by an intent to reduce the level, replication, or transmissibility of a pathogen in mosquitoes). (Federal Register notice)

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. 

 

Medical Products (Vaccines, Therapeutics, Diagnostics)

  • Vaccines and therapeutics: There are no FDA-approved vaccines or treatments for Zika at this time. Several investigational vaccines are under development, including early human clinical trials. FDA is prepared to evaluate the safety and efficacy of any investigational vaccines and therapeutics that might be developed to help mitigate this outbreak.

  • FDA-authorized diagnostic tests for detecting Zika virus antibodies:

    • ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S. Previously, tests for detecting Zika virus immunoglobulin (IgM) antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s EUA authority. For more information, see Serological assays above

      The ZIKV Detect 2.0 IgM Capture ELISA marketing authorization does not impact the availability of the nucleic acid testing-based assays (listed above) available under EUA to diagnose active Zika infection. Developers should consider whether the ZIKV Detect 2.0 IgM Capture ELISA is an adequate, approved, and available alternative to any product currently under development for Zika diagnosis based on detection of Zika virus antibodies or antigens. If you believe ZIKV Detect 2.0 IgM Capture ELISA is an adequate, approved, and available alternative to your product under development, then FDA encourages you to consider pursuing a premarket submission instead of an EUA and recommends that you submit a Q-submission to the Agency.

    • ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.

  • FDA encourages commercial diagnostic developers and researchers developing laboratory developed tests for Zika virus to submit an EUA request or consider pursuing a premarket submission. 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. In July 2017, FDA also made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. Developers planning a future premarket submission will have priority to receive the panel of human plasma samples, considering the grant of a De Novo classification request for the ZIKV Detect 2.0 IgM Capture ELISA on May 23, 2019. 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.
  • Don't use insect repellent on babies. Repellent used on older children should contain no more than 10 percent DEET. Oil of eucalyptus products should not be used in children under 3 years.

Events

For events prior to 2019, please visit our archive.

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

Translations

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Note: Spanish and Portuguese translations of this page are archived, and were last updated on the date listed at the bottom of the archived page.

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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