December 9, 2020

FDA Authorizes Two COVID-19 Vaccines, At-Home Test, More Treatments

As the COVID-19 pandemic continues to claim lives and attack the health of tens of thousands daily, the FDA continues efforts to bring treatments and tests to the public. In December, this included emergency use authorizations (EUA) for the first-ever vaccines for the virus, two new treatments, and one new test.

It must be noted that an EUA is not an FDA approval; an EUA is a declaration that circumstances exist to justify the emergency use of drugs and biological products that have not been FDA-approved, particularly when no other effective alternatives are available, assuming the benefits appear to outweigh the risks.

FDA Issues EUA for First COVID-19 Vaccine

On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

Read the full FDA announcement here.

FDA Issues EUA for Second COVID-19 Vaccine

On December 18th, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

The vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

Moderna COVID-19 Vaccine is administered as a series of two doses, one month apart. The available safety data to support the EUA include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S. Read the full FDA announcement here.

FDA Issues EUA to Baricitinib and Remdesivir for Hospitalized COVID-19 Patients

The FDA issued an emergency use authorization (EUA) for the drug combination of baricitinib and remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Baricitinib is FDA-approved for the treatment of moderately to severely active rheumatoid arthritis, while remdesivir is FDA-approved for the treatment of COVID-19 in hospitalized COVID-19 patients weighing 40 kilogram (88 pounds) or more.

Drug information, contraindications, adverse effects, and other considerations are available for both individual drugs in their respective drug labels. Click here for more information on remdesivirClick here for more information on baricitinib.

FDA Issues EUA for Casirivimab and Imdevimab for Mild-to-Moderate COVID-19

The FDA issued an EUA for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19.

These drugs are investigational monoclonal antibodies; monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

Casirivimab and imdevimab must be administered together by intravenous (IV) infusion. Casirivimab and imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

FDA Issues EUA to First At-Home Test with At-Home Results

The FDA issued an EUA to the Lucira COVID-19 All-In-One Test Kit, a single-use COVID-19 test that individuals can use at home, on their own, which delivers results in 30 minutes or less.

The test kit has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages, but samples must be collected by a healthcare provider when the test is used at the POC for individuals younger than 14 years old.

The test is currently authorized for prescription use only.

The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.

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