Zika response updates from FDA, including an Emergency Use Authorization issued today

FDA Medical Countermeasures  Initiative Update

New Emergency Use Authorization Zika Virus

On February 26, 2016, FDA issued an Emergency Use Authorization (EUA) to authorize  the use of the CDC’s Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked  Immunosorbent Assay (MAC-ELISA) test for the detection of Zika virus antibodies in  individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological  criteria (e.g., recent history of travel to geographic regions during a period of active Zika virus transmissions at the time of travel or other epidemiologic criteria for which Zika virus  testing may be indicated as part of a public health response).  The CDC and FDA have been working closely together as CDC obtained necessary  performance data that was then reviewed by FDA in order to authorize the emergency  use of this in vitrodiagnostic test for the detection of antibodies to Zika virus.  More about this EUA  Related information New! Zika Virus Response Updates from FDA More about Zika MAC-ELISA, including fact sheets and instructions for use About Emergency Use Authorization Summary of the process for EUA issuance (graphic) 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. (Credit: CDC/Division of Vector-borne Diseases)

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Zika Virus in the Americas: An HHS Expert Consultation to Accelerate the Development of Countermeasures

March 28-29, 2016

 Rockville, MD

The workshop will review current information about the virus’ epidemiology (including potential link to microcephaly), and clinical manifestations and pathogenesis of Zika virus. There will also be discussion of strategies to accelerate the development of vaccines, diagnostics, therapeutics and novel vector control methods and ensure blood supply safety.

This consultation is supported by NIAID, NICHD, ASPR/BARDA, CDC and FDA within the U.S. Department of Health and Human Services.

View the draft agenda

Register

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FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States

As a safety measure against the emerging Zika virus outbreak, FDA issued a new guidance (PDF, 111 KB) recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.

Read the news release

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News updates

More events:

• March 3, 2016: Advancing the Development of Biomarkers in Traumatic Brain Injury (Silver Spring, MD and webcast) -On-site registration may be available, if space permits.

• March 4, 2016: Vaccines and Related Biological Products Advisory Committee (Silver Spring, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season

• New series! March 10, 2016: FDA Grand Rounds - The Host Response to Pertussis Infection and Vaccination (webcast), presented by Tod Merkel, PhD, Principal Investigator in FDA's Center for Biologics Evaluation and Research (CBER). The 45-minute presentation is followed by questions from the audience.

• April 5-6, 2016: Public Workshop: Proposed Pilot Project(s) under the Drug Supply Chain Security Act (Silver Spring, MD and webcast) - limited seating - submit registration requests by March 11, 2016

View more events on the frequently updated MCMi News and Events page

Guidance and information for industry:

• FDA is announcing the availability of a draft guidance for industry Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax (PDF, 565 KB). The purpose of this draft guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled “Inhalational Anthrax (Post-Exposure)—Developing Antimicrobial Drugs” issued in March 2002. Comment by April 18, 2016. (Federal Register notice) (February 16, 2016)

• FDA announced that influenza virus neuramindase (NA) is available for licensing. This technology may offer an alternative to currently available therapeutic NA inhibitors. Potential commercial applications include: prophylactic and therapeutic against influenza virus infections; diagnostic tests for influenza virus infections; and reagent to measure the potency of H1N1 NA in influenza virus vaccines. (February 12, 2016)

• How to submit comments

Funding opportunities and other deadline reminders:

• FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 22, 2017. Learn more and view current projects

• FDA calls on the genomics community to further assess, compare, and improve techniques used in DNA testing by launching the first PrecisionFDA challenge. The challenge is open through April 25, 2016.

• New resource! View more funding opportunities and challenge information (scroll to bottom of page).

In case you missed it:

• Meeting videos are available for the February 16, 2016 Institute of Medicine workshop Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus. Presentations are also available, under Other Meeting Resources, on the right side of the videos page.

• In response to the manufacturer's request, on February 12, 2016 FDA reissued the July 17, 2015 Emergency Use Authorization (EUA) for the RealStar® MERS-CoV RT-PCR Kit. The amendments include a new Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases (PDF, 285 KB).

• FDA Statement on Senate Confirmation of Dr. Robert M. Califf (February 24, 2016)

• NIAID and West Africa partners announce initial results from Ebola clinical trials:Experimental Ebola Vaccines Well Tolerated, Immunogenic in Phase 2 Study (PREVAIL 1),Experimental Ebola Drug ZMapp May Benefit Patients, but Insufficient Data to be Certain, Study Finds (PREVAIL 2), Ebola Survivor Study Yields Insights on Complications of Disease (PREVAIL 3) (February 23, 2016)

• FDA is offering a free continuing education online course  to help health care providers understand biosimilars - learn more at FDA Voice (February 18, 2016)

• Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance  (full article PDF, 413 KB) - journal article in Public Health Reports - Medical countermeasures (MCMs) are medical products used during public health emergencies. This study, conducted within the Mini-Sentinel Initiative, sought to develop the patient identification and matching processes necessary to assess safety outcomes for MCMs.Abstract only - more about Mini-Sentinel (February 2016)