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FDA Covid-19 EUAs the Week of November 16, 2020

The US Food & Drug Administration (FDA) had a busy week granting several emergency use authorizations (EUAs) and forming an advisory committee to discuss the first Covid-19 vaccine candidate.

• Tue, Nov 17: the first completely at-home rapid self-test kit for molecular detection of Covid-19
  • “A test that can be fully administered entirely outside of a lab or health care setting has always been a major priority for the FDA to address the pandemic.”
  • Lucira Health’s says: “We hope to have our product available in the next few months…our test is presently only authorized for prescription use for individuals suspected of COVID-19 by a healthcare provider, not for individual sale.”
  • Anyone age 14+ with a prescription from their health care provider will be able to use this home kit to self-collect via a nasal swab, swirl it in a vial, then place in a test unit which can provide results within 30 minutes.�� Anyone being tested should report their results to their health care provider who is supposed to then report those results to public health officials.
  • Anyone with a positive result should self-isolate and follow their health care provider’s medical advice.
  • Anyone with a negative result that exhibits symptoms should seek a second test conducted by their health care provider.
• Thu, Nov 19: a drug combination to treat Covid-19
  • Remdesivir was the for Covid-19 back on October 22 (and had an EUA back on May 1). It is an intravenous antiviral drug used on certain hospitalized patients with Covid-19.
  • Now the prescription oral tablet medication baricitinib, which is primarily approved for rheumatoid arthritis, has been granted an EUA in combination with remdesivir for treatment of certain hospitalized patients with Covid-19.�� It is not authorized on its own to treat Covid-19, as it is focused on anti-inflammation while remdesivir is the antiviral component of this combination treatment.
• Fri, Nov 20: advisory committee to discuss first Covid-19 vaccine candidate
  • The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Thu, Dec 10, to discuss the EUA request from Pfizer (in partnership with BioNTech) on its vaccine which has shown high rates of success (above 94%) in preventing Covid-19.�� The FDA intends to issue a Federal Register notice the week of Nov 23 with details of the upcoming meeting and a request for public comment.
• Sat, Nov 21: monoclonal antibodies for treatment of mild to moderate Covid-19
  • “Casirivimab and imdevimab must be administered together by intravenous (IV) invusion” and “are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.”�� The FDA goes on to say monoclonal antibodies “may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.”
  • “Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens 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.”
  • This comes on the heels of the November 9 “for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19.”

Earlier on November 6, the FDA had granted the first for a serology test to detect neutralizing antibodies from recent or prior COVID-19 infections.�� The 50+ previous EUAs for numerous antibody (serology) tests could only detect the presence of binding antibodies that “bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells.”�� The detection of neutralizing antibodies is of great interest to learn more about this virus and our immune response.

As a reminder, authorized or approved Covid-19 diagnostic tests, including serology tests and the Lucira test discussed above, are part of what health plans must cover without cost sharing or other medical management restrictions when they are ordered by a health care provider.

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IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.