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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.

 

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. For information on current outbreaks, see from CDC:

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) 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.
  • LIAISON XL Zika Capture IgM Assay II – On October 28, 2019, FDA cleared the LIAISON XL Zika Capture IgM Assay II 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.

Safety of the 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.

Emergency Use Authorization

FDA stands ready to use our authorities to the fullest extent to help facilitate the development and availability of products for Zika virus. 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.

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)

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.

  • Diagnostics: For a list of FDA-authorized diagnostic tests for detecting Zika virus antibodies, see Diagnostics above.

    • 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

Español Português 

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

Related Links

Resources for Healthcare Providers

 

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