Novel coronavirus (2019-nCoV)

FDA is working with U.S. Government partners, including CDC, and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

What's new

February 4, 2020: FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic - FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country. Additional technical information and fact sheets
February 4, 2020: Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak - The potential for transmission of 2019-nCoV by blood and blood components is unknown at this time. However, respiratory viruses, in general, are not known to be transmitted by blood transfusion, and there have been no reported cases of transfusion-transmitted coronavirus. Routine blood donor screening measures that are already in place should prevent individuals with clinical respiratory infections from donating blood. As a precaution, blood establishments may wish to consider whether to provide donor education, encourage self-deferral, and manage post-donation information about 2019-nCoV. Read more
January 27, 2020: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures - “We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”
January 27, 2020: FDA requests that diagnostic test sponsors interested in potential Emergency Use Authorization (EUA) for tests to detect 2019-nCoV contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates. Also see: How to Submit a Pre-EUA for In vitro Diagnostics to FDA

Please Be Advised

In light of the public health emergency declared for the Novel Coronavirus, visitors to FDA campuses and buildings may be asked questions related to recent international travel.

Additional resources:

Fast facts

FDA is working with U.S. Government partners, including the U.S. Centers for Disease Control and Prevention (CDC), and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

While the U.S. Government considers this a serious public health concern, based on current information, the immediate health risk from 2019-nCoV to the general American public is considered low at this time.

2019-nCoV resources from CDC include:

For more information, visit www.cdc.gov/novelcoronavirus.

About coronaviruses

Coronaviruses are a large family of viruses. Some cause illness in people; numerous other coronaviruses circulate among animals, including camels, cats, and bats.
Rarely, animal coronaviruses can evolve and infect people and then spread between people such as has been seen with Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV).
A novel coronavirus means that this strain has not previously been identified in humans.
More about coronaviruses, from CDC:

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FDA's role

FDA plays a critical role in protecting the United States from threats including emerging infectious diseases. In collaboration with interagency partners, product developers, international partners and global regulators, FDA’s roles in preparedness and response include:

Facilitating the development and availability of medical countermeasures (MCMs) that can be used to diagnose, prevent, or treat emerging diseases. Also see: What are medical countermeasures?
Providing regulatory advice, guidance, and technical assistance to sponsors developing investigational MCMs for emerging threat indications.
Working with medical product sponsors to clarify regulatory and data requirements necessary to rapidly advance development of products essential to supporting response efforts.
Providing review and feedback on development proposals including design and set-up of clinical trials for establishing the safety and efficacy of investigational products and data assessment.
Protecting the safety of the nation’s blood supply and human cells, tissues, and cellular/tissue-based products for transplantation. Also see: Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
Enabling access to investigational MCMs—when necessary—through an appropriate mechanism such as under an Emergency Use Authorization (EUA) or under expanded access mechanisms when the clinical circumstances warrant.
Protecting consumers against fraudulent products - Unfortunately, during emergency situations or outbreaks, fraudulent products claiming to prevent, treat or cure conditions associated with the emergency or outbreak almost always appear for sale. The FDA monitors for fraudulent products and false product claims related to 2019-nCoV and other conditions and takes appropriate action to protect consumers.

Medical countermeasures

There are currently no FDA-approved medical countermeasures for 2019-nCoV. 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.

Diagnostics

There are no FDA-approved diagnostics for 2019-nCoV.
Diagnostic Emergency Use Authorizations (EUAs):
- FDA requests that diagnostic test sponsors interested in potential EUA for tests to detect 2019-nCoV contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates. Also see: How to Submit a Pre-EUA for In vitro Diagnostics to FDA
- On February 4, 2020, FDA authorized emergency use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. For additional technical information and fact sheets, see: Emergency Use Authorizations (Devices).

Vaccines

There are no FDA-approved vaccines to prevent 2019-nCoV or other coronaviruses.
Biological product sponsors, including vaccine developers, can email industry.biologics@fda.hhs.gov or call 1-800-835-4709 for further information.

Therapeutics

There are no FDA-approved therapeutics (drugs) to treat 2019-nCoV or other coronaviruses.
Sponsors wishing to develop therapeutics are encouraged to submit information and questions via the Pre-IND Consultation program (see the web page or call 301-796-1500 for additional information on this program). Information regarding any clinical trials that may be initiated may be searched for at www.ClinicalTrials.gov.

For product developers

The Biomedical Advanced Research and Development Authority (BARDA), a component of the HHS Assistant Secretary of Preparedness and Response (ASPR), is supporting U.S. government market research to identify medical countermeasures with the potential to help address the 2019-nCoV outbreak. If your company is developing diagnostics, therapeutics, vaccines, or other products, submit your ideas to BARDA's online portal.

Also see above for FDA information for product developers regarding specific types of MCMs.

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Press and statements

For more updates, follow @SteveFDA , @US_FDA , @FDA_Global , and @FDA_MCMi on Twitter.

February 4, 2020: FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic - FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.
January 27, 2020: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures - “We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”