Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., July 13, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

    --  FDA scientists have identified specific areas of the so-called spike
        proteins on the surface of the COVID-19-causing virus that appear to be
        key to triggering strong protective antibody responses in rabbits
        exposed to the virus. The virus uses one part of the spike protein to
        attach to a cell and another to fuse with the cell membrane, enabling
        the virus to infect the cell. The scientists studied antibody response
        to SARS-CoV-2 spike proteins, which could help inform vaccine design by
        increasing our understanding of the various triggered antibody
        responses.As of mid-June, the COVID-19 pandemic has caused more than
        eight million cases of infection and approximately 450,000 deaths
        globally, making the development of safe and effective vaccines to
        prevent this disease a priority. The spike glycoprotein is the key
        target for protective antibodies against both SARS-CoV-2 (the COVID-19
        virus) and the related SARS-CoV-1 virus. Therefore, many vaccine
        candidates that trigger antibodies -- against specific areas on the
        SARS-CoV-2 spike protein -- are being investigated. To help build
        sufficient scientific knowledge about the quality of antibody responses,
        the FDA scientists exposed rabbits to the virus and evaluated antibody
        responses triggered by various SARS-CoV-2 spike antigens that are
        similar to those being used to develop vaccines to prevent COVID-19.
    --  Today, FDA released a blueprint for implementing the New Era of Smarter
        Food Safety, an FDA initiative that represents a new approach to food
        safety, leveraging technology and other tools to create a more digital,
        more traceable, and safer food system. The blueprint outlines how FDA
        plans to usher in this new era. Together with the Food Safety
        Modernization Act, the blueprint moves the nation's food production
        closer to achieving an Integrated Food Safety System. Among other
        factors included in the blueprint implementation are: (1) Tech-enabled
        traceability to facilitate tracking events and sharing key data across
        regulatory agencies, industry and other public health partners to avoid
        duplication of effort and complexity; (2) Smarter tools and methods to
        prevent and respond to food-borne illness outbreaks through
        evidence-based improvements in and/or implementation of root-cause
        analyses, artificial intelligence and machine learning applications for
        screening imported foods, mutual reliance with FDA's state inspections
        partners, enhanced outbreak responsiveness, and modernization of product
        recalls; (3) New business models and retail modernization involving
        FDA's strategic partners in adapting the regulatory framework to new and
        innovative business models. FDA will also promote facility and equipment
        design that support preventive controls for retail food safety
        management (e.g., the development and use of commercial Smart Kitchen
        Equipment).
    --  The FDA has issued emergency use authorizations (EUA) to:
        --  electroCore, Inc., for its GammaCore Sapphire Non-invasive Vagus
            Nerve Stimulator. This stimulator is intended for use at home or in
            health care settings to treat adult patients with known or suspected
            COVID-19 who are experiencing worsened asthma-related shortness of
            breath and reduced airflow, and for whom approved drug therapies are
            not tolerated or provide insufficient symptom relief as assessed by
            the patient's healthcare provider. The device improves airflow and
            provides relief from exacerbated asthma-related shortness of breath
            in such patients. The device is placed on either side of the
            patient's neck for two consecutive two-minute stimulations at the
            onset of respiratory distress or shortness of breath for up to 24
            stimulations every 24 hours.
        --  Circadiance, under the umbrella EUA for ventilators, for its
            SleepWeaver Prevent CPAP Mask. The product is a CPAP mask that was
            modified by combining it with an N95.
    --  Testing updates:
        --  To date, the FDA has currently authorized 175 tests under EUAs;
            these include 145 molecular tests, 28 antibody tests, and 2 antigen
            tests.

Additional Resources:

    --  FAQs on Testing for SARS-CoV-2
    --  Policy for Coronavirus Disease-2019 Tests During the Public Health
        Emergency (Revised)
    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Lee.Herring@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

View original content to download multimedia:http://www.prnewswire.com/news-releases/coronavirus-covid-19-update-daily-roundup-301092599.html

SOURCE U.S. Food and Drug Administration