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  1. MCM Issues

Novel coronavirus (COVID-19)

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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.
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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.

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

What's new

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 COVID-19 to the general American public is considered low at this time.

COVID-19 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 (HCT/Ps) for transplantation. Also see: Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak and Important Information for HCT/P Establishments Regarding the 2019 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.

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Medical countermeasures

There are currently no FDA-approved medical countermeasures for COVID-19. 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

Vaccines

  • There are no FDA-approved vaccines to prevent COVID-19 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 COVID-19 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 COVID-19 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

  • February 14, 2020: FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad - FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.
  • February 5, 2020: CDC Media Telebriefing: Update on 2019 Novel Coronavirus (COVID-19), including updates from FDA Chief Scientist RADM Denise Hinton
  • 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 30, 2020: The HHS Assistant Secretary for Preparedness and Response (ASPR) hosted a stakeholder listening session (transcript PDF) to discuss medical countermeasure challenges associated with 2019-nCoV outbreak. FDA Acting Assistant Commissioner for Counterterrorism Policy Michael Mair provided FDA remarks.
  • 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.”

Additional resources

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Contact FDA

Consumers and general information: contact FDA
You may also call 1-888-INFO-FDA / (1-888-463-6332)

Report a fraudulent COVID-19 product
Includes options for phone and online reporting

Press: contact the Office of Media Affairs
Email fdaoma@fda.hhs.gov or call 301-796-4540

Therapeutics sponsors interested in submitting drug development proposals for review
See the Pre-IND Consultation Program link above or call 301-796-1500 for more information on this program.

Diagnostic test sponsors interested in EUA
Email CDRH-EUA-Templates@fda.hhs.gov for further information.

Biological product sponsors, including vaccine developers
Email industry.biologics@fda.hhs.gov or call 1-800-835-4709 for further information.

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